THE HEALTH AND SOCIAL SERVICES COMMITTEE in pursuance of Articles 57 and 110 of the Medicines (Jersey) Law 1995, after consultation with the Medicines Advisory Council and having otherwise complied with Article 110 of the Law, orders as follows –

Commencement [see endnotes]

1 Interpretation

(1) In this Order, unless the context otherwise requires –

“aerosol” means a product that is dispersed from its container by a propellent gas or liquid;

“controlled drug” has the same meaning as it has in Article 3 of the Misuse of Drugs (Jersey) Law 1978;

“cyanogenetic substances” means preparations –

(a) that are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17; or

(b) that contain more than 0.1% by weight of any substance having the formula α-cyanobenzyl-6-O-ß-d-glucopyranosyl-ß-d-glucopyranoside or α-cyanobenzyl-ß-d-glucopyranosiduronic acid;

“dosage unit” means –

(a) where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article; and

(b) where a medicinal product is not in any such form, the quantity of the product that is used as the unit by reference to which the dose is measured;

“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal, when a local action only is intended and extensive systemic absorption is unlikely to occur; but does not mean application by means of a throat spray, throat pastille, throat lozenge, throat tablet, nasal drop, nasal spray, nasal inhalation or teething preparation;

“health prescription” means a prescription described in Article 15(2) of the Health Insurance (Jersey) Law 1967;

“health record” has the same meaning as in the Data Protection (Jersey) Law 2018;

“inhaler” does not include an aerosol;

“Law” means the Medicines (Jersey) Law 1995;

“master” has the same meaning as it has in the Merchant Shipping Act 1894 of the United Kingdom;

“maximum daily dose” or “MDD” means, in relation to a substance contained in the amount of a medicinal product for internal use, the recommended maximum quantity to be taken or administered in a period of 24 hours;

“maximum dose” or “MD” means, in relation to a substance contained in the amount of a medicinal product for internal use, the recommended maximum quantity to be taken or administered at any one time;

“maximum strength” means such of the following as may be specified –

(a) the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;

(b) the maximum number of units of activity contained in a dosage unit or a weight of a medicinal product; and

(c) the maximum percentage of a substance contained in a medicinal product calculated in terms of weight in weight, weight in volume, volume in weight or volume in volume, as appropriate;

“medicinal product” does not include a veterinary drug;

“occupational health scheme” means a scheme in which a person in the course of a business carried on by him or her provides facilities for his or her employees, for the treatment or prevention of disease;

“operator”, in relation to an aircraft, means the person for the time being having the management of the aircraft;

“parenteral administration” means administration by breach of the skin or mucous membrane;

“prescription only medicine” means a medicinal product that is specified by this Order as a prescription only medicine;

“registered optometrist” has the same meaning as it has in Article 1(1) of the Opticians (Registration) (Jersey) Law 1962;

“repeatable prescription” means a prescription containing a direction that it shall or may be dispensed more than once;

“soaps” means any compounds of a fatty acid with an alkali or amine;

“state registered paramedic” means a person who is registered in the register established and maintained under section 60 and paragraph 1(a) of Schedule 3 to the Health Act 1999 of the United Kingdom;

“supplementary prescriber” means an appropriate practitioner referred to in Article 5(d), (e) or (f) whose entry on the register established and maintained under article 5 of the Nursing and Midwifery Order 2001 of the United Kingdom, as referred to in the Health Care (Registration) (Prescribed Qualifications) (Jersey) Order 2003, indicates that he or she is, or may act as, only a supplementary prescriber;

“unit preparation” means a preparation (including a mother tincture) that is prepared by a process of solution, extraction or trituration, with a view to being diluted tenfold or one hundredfold (either once or repeatedly) in an inert diluent and then used either in that diluted form or (where applicable) by impregnating tablets, granules, powders or other inert substances.[2]

(2) In this Order –

(a) in Schedules 1 and 2, the following abbreviations are used –

“g” for gram;

“iu” for international unit of activity;

“mcg” for microgram;

“mg” for milligram; and

“ml” for millilitre; and

(b) in Schedule 1 –

(i) entries in any of columns 2, 3 and 4 of Parts 1 and 2 relate only to the substances specified in column 1 against which they appear,

(ii) where, in relation to a particular substance specified in column 1, an entry in any of columns 2, 3 and 4 bears a number or letter, that entry relates only to entries in the other of columns 2, 3 and 4 that bear the same number or letter, and

(iii) the entries in column 4 of Part 1 shall be read subject to the note at the end of that Part.

(3) Without prejudice to Article 10 of the Interpretation (Jersey) Law 1954, every provision in the Medicines (Jersey) Law 1995 that relates in any other way to its interpretation shall also apply in the same way to this Order, unless the context otherwise requires.

2 Prescription only medicines

The following descriptions and classes of medicinal products are specified for the purposes of Article 57(1)(a) of the Law, and are accordingly prescription only medicines, namely –

(a) medicinal products that consist of or contain a substance specified in column 1 of Part 1 of Schedule 1 to this Order;

(b) medicinal products that are controlled drugs;

(c) medicinal products that are for parenteral administration, whether or not they fall within sub-paragraph (a) or (b) of this paragraph;

(d) medicinal products that –

(i) are not of a description and do not fall within a class specified in any of sub-paragraphs (a), (b) and (c) of this paragraph,

(ii) are of a description in respect of which the conditions in Article 58(1) of the Law are fulfilled, and

(iii) are products in respect of which a product licence is granted, after the commencement of this Order, containing a provision to the effect that the method of sale or supply of the medicinal product is to be only in accordance with a prescription given by a person who is an appropriate practitioner; and

(e) cyanogenetic substances, other than preparations for external use.[3]

3 Medicinal products that are not prescription only medicines

(1) Notwithstanding Article 2, a medicinal product shall not be a prescription only medicine by reason that it consists of or contains a substance specified in column 1 of Part 1 of Schedule 1, where –

(a) in relation to that substance there is an entry in any of columns 2, 3 and 4;

(b) the maximum strength in the product of that substance does not exceed the maximum strength (if any) specified in column 2; and

(i) if a pharmaceutical form or a route of administration is specified in column 3, in such pharmaceutical form, and for administration only by such route, as may be so specified,

(ii) if a use is specified in column 3, in a container or package labelled (in either case) to show a use so specified to which the medicinal product is to be put but no use not so specified,

(iii) if a maximum dose is specified in column 4, in a container or package labelled (in either case) to show a maximum dose not exceeding that specified, and

(iv) if a maximum daily dose is specified in column 4, in a container or package labelled (in either case) to show a maximum daily dose not exceeding that specified.

(2) Notwithstanding Article 2 of this Order, a medicinal product shall not be a prescription only medicine by reason that it is a controlled drug, where –

(a) it contains not more than one of the substances specified in column 1 of Part 2 of Schedule 1 to this Order and no other controlled drug;

(b) it contains that substance at a strength that does not exceed the maximum strength specified in column 2; and

(i) in such pharmaceutical form as may be specified in column 3, and

(ii) in or from a container or package labelled (in either case) to show a maximum dose not exceeding that specified in column 4.

(4) Notwithstanding Article 2, a medicinal product specified in Part 3 or 4 of Schedule 1 shall not be a prescription only medicine.

4 New medicinal products

For the purposes of Article 58(2)(a) of the Law their duration shall be a period of 5 years.

5 Appropriate practitioner[4]

For the purposes of the Law, the following shall be appropriate practitioners –

(a) a doctor;

(b) a dentist;

(d) a midwife prescribing practitioner registered under the Health Care (Registration) (Jersey) Law 1995;

(e) a nurse prescribing practitioner registered under the Health Care (Registration) (Jersey) Law 1995;

(f) a specialist community public health nurse prescribing practitioner registered under the Health Care (Registration) (Jersey) Law 1995.

6 Conditions for prescriptions relating to sale and supply[5]

(1) For the purposes of Article 57(2)(a) of the Law (read with paragraph (4) of that Article), a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions in paragraph (2) of this Article are fulfilled.

(2) The conditions to which paragraph (1) refers are –

(a) the prescription shall be written in ink or otherwise so as to be indelible, unless it is a health prescription that is not for a controlled drug specified in any of Schedules 1, 2 and 3 to the Misuse of Drugs (General Provisions) (Jersey) Order 1989, in which case it may be written using carbon paper or similar material;

(b) the prescription shall be signed in ink, with his or her own name, by the practitioner giving it;

(i) the address of the practitioner giving it,

(ii) the appropriate date,

(iii) by virtue of which of the paragraphs of Article 5 the practitioner giving it is an appropriate practitioner,

(iv) where the practitioner giving it is an appropriate practitioner other than a veterinary surgeon, the name and address of the person for whose treatment it is given and (if that person is under 12) his or her age, and

(v) where the practitioner giving it is a veterinary surgeon, the name and address of the person to whom the prescription only medicine is to be delivered, and a declaration by that veterinary surgeon that the prescription only medicine is prescribed for an animal or herd under his or her care;

(ca) in the case of a prescription given by a supplementary prescriber, the supplementary prescriber –

(i) has given the prescription in accordance with the terms of a clinical management plan containing the information specified in Schedule 4, such plan relating to an individual patient and to which the following are parties –

(A) the patient,

(B) the patient’s doctor or dentist, and

(ii) has access to the health records of the patient to whom the clinical management plan relates to the extent that such records are used by the doctor or dentist who is a party to the plan;

(d) the prescription shall not be dispensed after the end of the period of 6 months from the appropriate date unless it is a repeatable prescription, in which case it shall not be dispensed for the first time after the end of that period or otherwise than in accordance with the direction contained in the repeatable prescription; and

(e) in the case of a repeatable prescription that does not specify the number of times that it may be dispensed, the prescription shall not be dispensed on more than 2 occasions unless it is a prescription for oral contraceptives, in which case it may be dispensed 6 times before the end of the period of 6 months from the appropriate date.[6]

(3) The restrictions in Article 57(2)(a) of the Law shall not apply to a sale or supply of a prescription only medicine that, by reason only that a condition in paragraph (2) of this Article is not fulfilled, is not in accordance with a prescription given by an appropriate practitioner, where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is fulfilled in relation to that sale or supply.

(4) In paragraph (2), the “appropriate date” means –

(a) in the case of a health prescription –

(i) the date on which it was signed by the practitioner by whom it was given, or

(ii) if it also contains a date indicated by him or her as being the date before which it shall not be dispensed, the later of the 2 dates; and

(b) in every other case, the date on which the prescription was signed by the practitioner by whom it was given.

6A Conditions for prescriptions – administration[7]

(1) For the purposes of Article 57(2)(b) of the Law (read with paragraph (4) of that Article), a prescription only medicine shall not be taken to be administered by a supplementary prescriber or by a person acting in accordance with the directions of a supplementary prescriber unless the conditions in paragraph (2) are met.

(2) Those conditions are that –

(a) the supplementary prescriber is acting in accordance with the terms of a clinical management plan containing the information specified in Schedule 4, such plan relating to an individual patient to which the following are parties –

(i) the patient,

(ii) the patient’s doctor or dentist, and

(iii) the supplementary prescriber; and

(b) the supplementary prescriber has access to the health records of the patient to whom the clinical management plan relates to the extent that such records are used by the doctor or dentist who is a party to the plan.

7 Exemption for highly diluted medicinal products

The restrictions in Article 57(2) of the Law shall not apply to the sale, supply or administration of a medicinal product that is not for parenteral administration and only consists of or only contains one or more of the substances specified in column 1 of Part 1 or 2 of Schedule 1 to this Order, where –

(a) each unit preparation has been diluted to at least one part in a million (6x), and the person selling, supplying or administering the medicinal product has been requested by or on behalf of a particular person and in that person’s presence to use his or her own judgment as to the treatment required; or

(b) each such unit preparation has been diluted to at least one part in a million million (6c).

8 Exemptions for specified categories of persons

(1) The restrictions in Article 57(2)(a) of the Law shall not apply –

(a) to the sale or supply by a person specified in column 1 of Part 1 of Schedule 2 to this Order; or

(b) to the supply by a person specified in column 1 of Part 2 of Schedule 2 to this Order,

of a prescription only medicine specified in column 2 of Part 1 or 2 of that Schedule in relation to that person, where the conditions in the corresponding paragraph in column 3 of that Part are fulfilled.

(2) The restriction in Article 57(2)(b) of the Law shall not apply to the administration by a person specified in column 1 of Part 3 of Schedule 2 to this Order of a prescription only medicine for parenteral administration specified in column 2 of that Part in relation to that person, where the conditions in the corresponding paragraph in column 3 of that Part are fulfilled.

9 Exemption for emergency sale or supply

(1) The restrictions in Article 57(2)(a) of the Law shall not apply to the sale or supply of a prescription only medicine by a person who is lawfully conducting a retail pharmacy business, where the conditions in paragraph (2) of this Article or the alternative conditions in paragraph (3) of this Article are fulfilled.

(2) The conditions to which paragraph (1) of this Article refers are –

(a) the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied that the sale or supply has been requested by a doctor who, by reason of any emergency, is unable to furnish a prescription immediately;

(b) the doctor has undertaken to furnish the person lawfully conducting the retail pharmacy business with a prescription within 72 hours;

(d) the prescription only medicine is not a controlled drug specified in any of Schedules 1, 2 and 3 to the Misuse of Drugs (General Provisions) (Jersey) Order 1989; and

(e) an entry is made in the register to be kept under Article 3(1) of the Medicines (Sale and Supply) (Miscellaneous Provisions) (Jersey) Order 1997, within the appropriate time specified in that Article, of the information in paragraph 1 of Schedule 2 to that Order.

(3) The alternative conditions to which paragraph (1) of this Article refers are –

(a) the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting a prescription only medicine and is satisfied –

(i) that there is an immediate need for that prescription only medicine to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,

(ii) that treatment with that prescription only medicine has been prescribed on a previous occasion by a doctor for the person requesting it from the pharmacist, or (as far as the pharmacist is reasonably able to ascertain) has been lawfully prescribed on a previous occasion by a medical practitioner outside Jersey for the person requesting it from the pharmacist, and

(iii) as to the dose which, in the circumstances, it would be appropriate for that person to take;

(b) the prescription only medicine –

(i) will be sold or supplied in no greater quantity than will provide 5 days’ treatment,

(ii) is a preparation of insulin, an aerosol for the relief of asthma, an ointment or a cream, and has been made up for sale in a container elsewhere than at the place of sale or supply, and is the smallest pack that the pharmacist has available for sale or supply,

(iii) is an oral contraceptive and is sufficient, but no more than sufficient, for a full cycle, or

(iv) is an antibiotic for oral administration in liquid form, and is the smallest quantity that will provide a full course of treatment;

(c) the prescription only medicine does not consist of or contain a substance specified in Schedule 3 to this Order and is not a controlled drug specified in any of the Schedules to the Misuse of Drugs (General Provisions) (Jersey) Order 1989;

(d) an entry is made in the register to be kept under Article 3(1) of the Medicines (Sale and Supply) (Miscellaneous Provisions) (Jersey) Order 1997 within the appropriate time specified in that Article, of the information in paragraph 3 of Schedule 2 to that Order; and

(e) the container or package of the prescription only medicine is labelled so as to show –

(i) the date on which the prescription only medicine is sold or supplied,

(ii) the name, quantity and (unless it is apparent from the name) the pharmaceutical form and strength of the prescription only medicine,

(iii) the name of the person requesting the prescription only medicine,

(iv) the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied, and

(v) the words “Emergency Supply”.[8]

(4) The conditions in paragraph (2)(d) of this Article and in paragraph (3)(c) of this Article shall not apply where the prescription only medicine –

(a) consists of or contains phenobarbitone or phenobarbitone sodium (but no other substance specified in Schedule 3 to this Order or in any of the Schedules to the Misuse of Drugs (General Provisions) (Jersey) Order 1989); and

(b) is sold or supplied for use in the treatment of epilepsy.

10 Exemption for sale or supply in hospitals or the prison[9]

(1) The restrictions in Article 57(2)(a) of the Law shall not apply to the sale or supply of any prescription only medicine –

(a) in the course of the business of a hospital; or

(b) by a pharmacy to the prison under the terms of a contract to supply medicinal products for the benefit of prisoners,

in accordance with the written directions of an appropriate practitioner, other than a supplementary prescriber, even though those directions do not fulfil the conditions in Article 6(2) of this Order.

(2) In the case of directions given by a supplementary prescriber, paragraph (1) applies except that the condition in Article 6(2)(ca) must be fulfilled as if the references to a prescription in that sub-paragraph were references to the directions given by the supplementary prescriber.

11 Exemption for authorised needle supply services[10]

The restrictions of Article 57(2)(a) of the Law shall not apply to the supply by a person, for parenteral administration, of ampoules of sterile water, if the supply is made by the person in the course of acting on behalf of a service provided by or on behalf of the States for the purpose of enabling the supply of syringes, and associated articles, so as to reduce the spread of disease.

12 Exemption for sale or supply in cases involving another’s default

The restrictions in Article 57(2)(a) of the Law shall not apply to the sale or supply of a prescription only medicine by a person who, having exercised all due diligence, believes on reasonable grounds that the product sold or supplied is not a prescription only medicine, and it is because of an act or default of another person that the product is a product to which that sub-paragraph applies.

13 Exemption in the case of forged prescription

The restrictions in Article 57(2)(a) of the Law shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

14 Exemption for parenteral administration to human beings

The restriction in Article 57(2)(b) of the Law shall not apply to the administration to human beings of any of the following medicinal products for parenteral administration, namely –

adrenaline injection BP;

atropine sulphate injection;

chlorpheniramine injection;

cobalt edetate injection;

dextrose injection strong B.P.C.;

diphenhydramine injection;

glucagon injection;

hydrocortisone injection;

mepyramine injection;

naloxone injection;

promethazine hydrochloride injection;

snake venom antiserum;

sodium nitrite injection;

sodium thiosulphate injection; and

sterile pralidoxime injection,

where it is administered for the purpose of saving life in an emergency.

15 Exemption for non-parenteral administration to human beings

The restriction in Article 57(2)(b) of the Law shall not apply to the administration to human beings of a prescription only medicine that is not for parenteral administration.

16 Citation

This Order may be cited as the Medicines (Prescription Only) (Jersey) Order 1997.

SCHEDULE 1

(Articles 1(2), 2(a), 3(1) and 7)

PART 1[11]

PRESCRIPTION ONLY MEDICINES

[Note –

(x) indicates that the entry is to be read subject to paragraph 1 of the note at the end of Part 1 of Schedule 1

(y) indicates that the entry is to be read subject to paragraph 2 of the note at the end of Part 1 of Schedule 1]

Prescription Only Medicine	Circumstances In Which Substances Are Not Prescription Only Medicines
Column 1	Column 2	Column 3	Column 4
Substance	Maximum strength	Use, pharmaceutical form or route of administration	Maximum dose and maximum daily dose
Acamprosate
Acarbose
Acebutolol Hydrochloride
Aceclofenac
Acemetacin
Acetarsol
Acetazolamide
Acetazolamide Sodium
Acetohexamide
Acetylcholine Chloride	0.2%	External
Acetylcysteine
Aciclovir
Acipimox
Acitretin
Aclarubicin Hydrochloride
Aconite	1.3%	External
Acrivastine
Acrosoxacin
Actinomycin C
Actinomycin D
Adapalene
Adenosine
Adrenaline		(1) By inhaler (2) External
Adrenaline Acid Tartrate		(1) By inhaler (2) External
Adrenaline Hydrochloride		(1) By inhaler (2) External
Adrenocortical Extract
Aclofenac
Albendazole
Alclometasone Dipropionate
Alcuronium Chloride
Aldesleukin
Aldosterone
Alendronate Sodium
Alfacalcidol
Alfuzosin Hydrochloride
Allergen Extracts
Allopurinol
Allyloestrenol
Aloxiprin
Alphadolone Acetate
Alphaxalone
Alprenolol
Alprenolol Hydrochloride
Alprostadil
Alseroxylon
Altretamine
Amantadine Hydrochloride
Ambenonium Chloride
Ambutonium Bromide
Amcinonide
Ametazole Hydrochloride
Amethocaine		Any use (except local ophthalmic use)
Amethocaine Gentisate		Any use (except local ophthalmic use)
Amethocaine Hydrochloride		Any use (except local ophthalmic use)
Amikacin Sulphate
Amiloride Hydrochloride
Aminocaproic Acid
Aminoglutethimide
Aminopterin Sodium
Amiodarone Hydrochloride
Amiphenazole Hydrochloride
Amisulpride
Amitriptyline
Amitriptyline Embonate
Amitriptyline Hydrochloride
Amlodipine Besylate
Ammonium Bromide
Amodiaquine Hydrochloride
Amorolfine Hydrochloride
Amoxapine
Amoxycillin
Amoxycillin Sodium
Amoxycillin Trihydrate
Amphomycin Calcium
Amphotericin
Ampicillin
Ampicillin Sodium
Ampicillin Trihydrate
Amsacrine
Amygdalin
Amyl Nitrite
Amylocaine Hydrochloride		Any use (except local ophthalmic use)
Anastrazole
Ancrod
Androsterone
Angiotensin Amide
Anistreplase
Anterior Pituitary Extract
Antimony Barium Tartrate
Antimony Dimercaptosuccinate
Antimony Lithium Thiomalate
Antimony Pentasulphide
Antimony Potassium Tartrate
Antimony Sodium Tartrate
Antimony Sodium Thiogycollate
Antimony Sulphate
Antimony Trichloride
Antimony Trioxide
Antimony Trisulphide
Apiol
Apomorphine
Apomorphine Hydrochloride
Apraclonidine Hydrochloride
Aprotinin
Arecoline Hydrobromide
Argipressin
Aristolochia
Aristolochia Clematitis
Aristolochia Contorta
Aristolochia Debelis
Aristolochia Fang-chi
Aristolochia Manshuriensis
Aristolochia Serpentaria
Arsenic
Arsenic Triiodide
Arsenic Trioxide
Arsphenamine
Aspirin		Any form (except non-effervescent tablets or capsules)
Astemizole
Atenolol
Atorvastatin
Atorvastatin Calcium
Atovaquone
Atracurium Besylate
Atropine		(1) Internal: (a) by inhaler (b) otherwise than by inhaler	(b) 300 mcg (MD) 1 mg (MDD)(x)
		(2) External (except local ophthalmic use)
Atropine Methobromide		(1) Internal: (a) by inhaler (b) otherwise than by inhaler	(b) 400 mcg (MD) 1.3mg (MDD)(x)
		(2) External (except local ophthalmic use)
Atropine Methonitrate		Internal: (a) by inhaler (b) otherwise than by inhaler	(b) 400 mcg (MD) 1.3 mg (MDD)(x)
Atropine Oxide Hydrochloride		(1) Internal: (a) by inhaler (b) otherwise than by inhaler	(b) 360mcg (MD) 1.2mg (MDD)(x)
		(2) External (except local opthalmic use)
Atropine Sulphate		(1) Internal: (a) by inhaler (b) otherwise than by inhaler	(b) 360 mcg (MD) 1.2 mg (MD)(x)
		(2) External (except local ophthalmic use)
Auranofin
Azapropazone
Azathioprine
Azathioprine Sodium
Azelaic Acid
Azelastine Hydrochloride
Azidocillin Potassium
Azithromycin
Azlocillin Sodium
Aztreonam
Bacampicillin Hydrochloride
Bacitracin
Bacitracin Methylene Disalicylate
Bacitracin Zinc
Baclofen
Balsalazide Sodium
Bambuterol Hydrochloride
Barium Carbonate
Barium Chloride
Barium Sulphide
Beclamide
Beclomethasone
Beclomethasone Diproprionate
Belladonna Herb		(1) Internal (2) External	(1) 1 mg of the alkaloids (MDD)
Belladonna Root		(1) Internal (2) External	(1) 1 mg of the alkaloids (MDD)
Bemegride
Bemegride Sodium
Benapryzine Hydrochloride
Bendrofluazide
Benethamine Penicillin
Benoxaprofen
Benperidol
Benserazide
Benserazide Hydrochloride
Bentiromide
Benzathine Penicillin
Benzbromarone
Benzhexol Hydrochloride
Benzilonium Bromide
Benzocaine		Any use (except local ophthalmic use)
Benzoctamine Hydrochloride
Benzoyl Peroxide	10.0%	External
N-Benzoyl Sulphanilamide
Benzquinamide
Benzquinamide Hydrochloride
Benzthiazide
Benztropine Mesylate
Benzylpenicillin Calcium
Benzylpenicillin Potassium
Benzylpenicillin Sodium
Beractant
Betahistine Hydrochloride
Betamethasone
Betamethasone Adamantoate
Betamethasone Benzoate
Betamethasone Dipropionate
Betamethasone Sodium Phosphate
Betamethasone Valerate
Betaxolol Hydrochloride
Bethanechol Chloride
Bethanidine Sulphate
Bezafibrate
Bicalutamide
Biperiden Hydrochloride
Biperiden Lactate
Bismuth Glycollylarsanilate
Bisoprolol Fumarate
Bleomycin
Bleomycin Sulphate
Bretylium Tosylate
Brimonidine Tartrate
Bromhexine Hydrochloride
Bromocriptine Mesylate
Bromperidol
Bromvaletone
Brotizolam
Budesonide
Bufexamac
Bumetanide
Buphenine Hydrochloride			6 mg (MD) 18 mg (MDD)
Bupivacaine		Any use (except local ophthalmic use)
Bupivacaine Hydrochloride		Any use (except local ophthalmic use)
Buserelin Acetate
Buspirone Hydrochloride
Busulphan
Butacaine Sulphate		Any use (except local ophthalmic use)
Butorphenol Tartrate
Butriptyline Hydrochloride
Cabergoline
Calcipotriol
Calcipotriol Hydrate
Calcitonin
Calcitriol
Calcium Amphomycin
Calcium Benzamidosalicylate
Calcium Bromide
Calcium Bromidolactobionate
Calcium Carbimide
Calcium Folinate
Calcium Metrizoate
Calcium Sulphaloxate
Candesartan Cilexetil
Candicidin
Canrenoic Acid
Cantharidin	0.01%	External
Capreomycin Sulphate
Captopril
Carbachol
Carbamazepine
Carbaryl
Carbasalate Calcium
Carbenicillin Sodium
Carbenoxolone Sodium		(1) Pellet	(1) 5 mg (MD) 25 mg (MDD)
	(2) 2.0%	(2) Gel
Carbidopa
Carbimazole
Carbocisteine
Carbon Tetrachloride
Carboplatin
Carboprost Trometamol
Carbuterol Hydrochloride
Carfecillin Sodium
Carindacillin Sodium
Carisoprodol
Carmustine
Carperidine
Carteolol Hydrochloride
Cefaclor
Cefadroxil
Cefazedone Sodium
Cefdinir
Cefixime
Cefodizime Sodium
Cefotaxime Sodium
Cefoxitin Sodium
Cefpodoxime Proxetil
Cefprozil
Cefsulodin Sodium
Ceftazidime
Ceftizoxime Sodium
Ceftriaxone Sodium
Cefuroxime Axetil
Cefuroxime Sodium
Celiprolol Hydrochloride
Cephalexin
Cephalexin Sodium
Cephaloridine
Cephalothin Sodium
Cephamandole Nafate
Cephazolin Sodium
Cephradine
Cerium Oxalate
Cerivastatin
Cerivastatin Sodium
Ceruletide Diethylamine
Cetirizine
Chenodeoxycholic Acid
Chloral Hydrate		External
Chlorambucil
Chloramphenicol
Chloramphenicol Cinnamate
Chloramphenicol Palmitate
Chloramphenicol Sodium Succinate
Chlorhexadol
Chlormadinone Acetate
Chlormerodrin
Chlormethiazole
Chlormethiazole Edisylate
Chlormezanone
Chloroform	(1) 5.0%	(1) Internal (2) External
Chloroquine Phosphate		Prophylaxis of malaria
Chloroquine Sulphate		Prophylaxis of malaria
Chlorothiazide
Chlorotrianisene
Chlorphenoxamine Hydrochloride
Chlorpromazine
Chlorpromazine Embonate
Chlorpromazine Hydrochloride
Chlorpropamide
Chlorprothixene
Chlorprothixene Hydrochloride
Chlortetracycline
Chlortetracycline Calcium
Chlortetracycline Hydrochloride
Chlorthalidone
Chlorzoxazone
Cholestyramine
Chorionic Gonadotrophin
Ciclacillin
Ciclobendazole
Cidofovir
Cilastatin Sodium
Cilazapril
Cimetidine
Cimetidine Hydrochloride
Cinchocaine	3.0%	Any use (except local ophthalmic use)
Cinchocaine Hydrochloride	Equivalent of 3.0% of Cinchocaine	Any use (except local ophthalmic use)
Cinchophen
Cinoxacin
Ciprofibrate
Ciprofloxacin
Ciprofloxacin Hydrochloride
Cisapride
Cisplatin
Citalopram Hydrobromide
Clarithromycin
Clavulanic Acid
Clenbuterol Hydrochloride
Clidinium Bromide
Clindamycin
Clindamycin Hydrochloride
Clindamycin Palmitate Hydrochloride
Clindamycin Phosphate
Clioquinol	(1) 35 mg	(1) Treatment of mouth ulcers (2) External (except treatment of mouth ulcers)	(1) 350 mg (MDD)
Clobetasol Propionate
Clobetasone Butyrate
Clofazimine
Clofibrate
Clomiphene Citrate
Clomipramine
Clomipramine Hydrochloride
Clomocycline
Clomocycline Sodium
Clonidine
Clonidine Hydrochloride
Clopamide
Clopenthixol Decanoate
Clopenthixol Hydrochloride
Clorexolone
Clostebol Acetate
Clotrimazole		External but, in the case of vaginal use, only for the treatment of vaginal candidiasis
Cloxacillin Benzathine
Cloxacillin Sodium
Clozapine
Cocculus Indicus
Co-dergocrine Mesylate
Colaspase
Colchicine
Colestipol Hydrochloride
Colfosceril Palmitate
Colistin Sulphate
Colistin Sulphomethate
Colistin Sulphomethate Sodium
Coniine
Conium Leaf	7.0%	External
Corticotrophin
Cortisone
Cortisone Acetate
Co-tetroxazine
Co-Trimoxazole
Copropamide
Crotethamide
Croton Oil
Croton Seed
Curare
Cyclofenil
Cyclopenthiazide
Cyclopentolate Hydrochloride
Cyclophosphamide
Cycloserine
Cyclosporin
Cyclothiazide
Cyproterone Acetate
Cytarabine
Cytarabine Hydrochloride
Dacarbazine
Dalteparin Sodium
Danazol
Danthron
Dantrolene Sodium
Dapsone
Dapsone Ethane Ortho Sulphonate
Daunorubicin Hydrochloride
Deanol Bitartrate			26 mg (MDD)
Debrisoquine Sulphate
Demecarium Bromide
Demeclocycline
Demeclocycline Calcium
Demeclocycline Hydrochloride
Deoxycortone Acetate
Deoxycortone Pivalate
Deptotropine Citrate
Dequalinium Chloride	(1) 0.25 mg	(1) Internal: throat lozenges or throat pastilles
	(2) 1.0%	(2) External: paint
Deserpidine
Desferrioxamine Mesylate
Desflurane
Desfluorotriamcinolone
Desipramine Hydrochloride
Deslanoside
Desmopressin
Desogestrel
Desonide
Desoxymethasone
Dexamethasone
Dexamethasone Acetate
Dexamethasone Isonicotinate
Dexamethasone Phenylpropionate
Dexamethaone Pivalate
Dexamethasone Sodium m-Sulphobenzoate
Dexamethasone Sodium Phosphate
Dexamethasone Troxundate
Dexfenfluramine Hydrochloride
Dextromethorphan Hydrobromide		Internal	In the case of a controlled release preparation: equivalent of 30 mg of Dextromethor-phan (MD) equivalent of 75 mg of Dextromethor-phan (MDD)
			In any other case: equivalent of 15 mg of Dextromethor-phan (MD) equivalent of 75 mg of Dextromethor-phan (MDD)
Dextrothyroxine Sodium
Diazoxide
Dibenzepin Hydrochloride
Dichloralphenazone
Dichlorphenamide
Diclofenac Diethylammonium
Diclofenac Potassium
Diclofenac Sodium
Dicyclomine Hydrochloride			10 mg (MD) 60 mg (MDD)
Didanosine
Dienoestrol
Diethanolamine Fusidate
Diflucortolone Valerate
Diflunisal
Digitalin
Digitalis Leaf
Digitalis, Prepared
Digitoxin
Digoxin
Dihydralazine Sulphate
Dihydroergotamine Mesylate
Dihydrostreptomycin
Dihydrostreptomycin Sulphate
Diloxanide Furoate
Diltiazem Hydrochloride
Dimercaprol
Dimethisoquin Hydrochloride		Any use (except local ophthalmic use)
Dimethisterone
Dimethothiazine Mesylate
Dimethyl Sulphoxide
Dimethyltubocurarine Bromide
Dimethyltubocurarine Chloride
Dimethyltubocurarine lodide
Dinoprost
Dinoprost Trometamol
Dinoprostone
Diphenhydramine Hydrochloride		All preparations except liquid-filled capsules
Dipivefrin Hydrochloride
Dipyridamole
Disodium Etidronate
Disopyramide
Disopyramide Phosphate
Distigmine Bromide
Disulfiram
Dithranol	1.00%
Dobutamine Hydrochloride
Dolasetron Mesilate
Domperidone
Domperidone Maleate
Donepezil
Donepezil Hydrochloride
Dopamine Hydrochloride
Dopexamine Hydrochloride
Dorzolamide Hydrochloride
Dothiepin
Dothiepin Hydrochloride
Doxapram Hydrochloride
Doxazosin Mesylate
Doxepin Hydrochloride
Doxorubicin
Doxorubicin Hydrochloride
Doxycycline
Doxycycline Calcium Chelate
Doxycycline Hydrochloride
Droperidol
Drostanolone
Drostanolone Propionate
Dydrogesterone
Dyflos
Econazole		External, but in the case of vaginal use, only for the treatment of vaginal candidiasis
Econazole Nitrate		External, but in the case of vaginal use, only for the treatment of vaginal candidiasis
Ecothiopate Iodide
Edrophonium Chloride
Eflornithine Hydrochloride
Eformoterol Fumarate
Embutramide
Emepronium Bromide
Emetine	1.0%
Emetine Bismuth
Iodide
Emetine Hydrochloride	Equivalent of 1.0% of Emetine
Enalapril Maleate
Encephalitis Virus, Tick-borne, Central European
Enoxacin
Enoxaparin Sodium
Enoximone
Ephedrine		(1) Internal (other than nasal sprays or nasal drops)	(1) 30 mg (MD) 60 mg (MDD)
	(2) 2.0%	(2) Nasal sprays or nasal drops
		(3) External
Ephedrine Hydrochloride		(1) Internal (other than nasal sprays or nasal drops)	(1) Equivalent of 30 mg of Ephedrine (MD) Equivalent of 60 mg of Ephedrine (MDD)
	(2) Equivalent of 2.0% of Ephedrine	(2) Nasal sprays or nasal drops
		(3) External
Ephedrine Sulphate		(1) Internal (other than nasal sprays or nasal drops)	(1) Equivalent of 30 mg of Ephedrine (MD) Equivalent of 60 mg of Ephedrine (MDD)
	(2) Equivalent of 2.0% of Ephedrine	(2) Nasal sprays or nasal drops
		(3) External
Epicillin
Epirubicin
Epirubicin Hydrochloride
Epithiazide
Epoetin Alfa
Epoetin Beta
Epoprostenol Sodium
Ergometrine Maleate
Ergometrine Tartrate
Ergot, Prepared
Ergotamine Tartrate
Erythromycin
Erythromycin Estolate
Erythromycin Ethyl Carbonate
Erythromycin Ethyl Succinate
Erythromycin Lactobionate
Erythromycin Phosphate
Erythromycin Stearate
Erythromycin Thiocyanate
Esmolol Hydrochloride
Estramustine Phosphate
Estramustine Sodium Phosphate
Etafedrine Hydrochloride
Ethacrynic Acid
Ethambutol Hydrochloride
Ethamivan
Ethamsylate
Ethiazide
Ethinyl Androstenediol
Ethinyloestradiol
Ethionamide
Ethisterone
Ethoglucid
Ethoheptazine Citrate
Ethopropazine Hydrochloride
Ethosuximide
Ethotoin
Ethyl Biscoumacetate
Ethyloestrenol
Ethynodiol Diacetate
Etodolac
Etomidate
Etomidate Hydrochloride
Etoposide
Etretinate
Exemestane
Famotidine
Fazadinium Bromide
Felbinac
Felodipine
Felypressin
Fenbufen
Fencamfamin Hydrochloride
Fenclofenac
Fenfluramine Hydrochloride
Fenofibrate
Fenoprofen
Fenoprofen Calcium
Fenoterol Hydrobromide
Fenticonazole Nitrate		External use (but, in the case of vaginal use, only for the treatment of vulvovaginal candidiasis)
Feprazone
Ferrous Arsenate
Ferumoxsil
Fexofenadine Hydrochloride
Filgrastim
Finasteride
Flavoxate Hydrochloride
Flecainide Acetate
Flosequinan
Fluanisone
Flubendazole
Fluclorolone Acetonide
Flucloxacillin Magnesium
Flucloxacillin Sodium
Fluconazole
Flucylosine
Fludrocortisone Acetate
Flufenamic Acid
Flumazenil
Flumethasone
Flumethasone Pivalate
Flunisolide
Fluocinolone Acetonide
Fluocinonide
Fluocortin Butyl
Fluocortolone
Fluocortolone Hexanoate
Fluocortolone Pivalate
Fluorescein Dilaurate
Fluorometholone
Fluorouracil
Fluorouracil Trometamol
Fluoxetine Hydrochloride
Fluoxymesterone
Flupenthixol Decanoate
Flupenthixol Hydrochloride
Fluperolone Acetate
Fluphenazine Decanoate
Fluphenazine Enantate
Fluphenazine Hydrochloride
Fluprednidene Acetate
Fluprednisolone
Fluprostenol Sodium
Flurandrenolone
Flurbiprofen	8.75 mg	throat lozenges	43.75 mg (MDD)
Flurbiprofen Sodium
Fluspirilene
Flutamide
Fluticasone Propionate		Aqueous nasal sprays for the treatment of allergic rhinitis in persons not less than 18 years
Flutrimazole
Fluvastatin Sodium
Fluvoxamine Maleate
Folic Acid			500 mcg (MDD)
Formestane
Formocortal
Formoterol Fumarate
Foscarnet Sodium
Fosfestrol Sodium
Fosfomycin Trometamol
Fosinopril Sodium
Framycetin Sulphate
Frusemide
Furazolidone
Fusafungine
Fusidic Acid
Gabapentin
Gadolinium
Gadoteridol
Gallamine Triethiodide
Ganciclovir
Ganciclovir Sodium
Gelsemine	0.1%
Gelsemium			25 mg (MD) 75 mg (MDD)
Gemeprost
Gemfibrozil
Gentamicin
Gentamicin Sulphate
Gestodene
Gestrinone
Gestronol
Gestronol Hexanoate
Glibenclamide
Glibornuride
Gliclazide
Glimepiride
Glipizide
Gliquidone
Glisoxepide
Glucagon
Glycopyrronium Bromide			1 mg (MD) 2 mg (MDD)
Glymidine
Gonadorelin
Goserelin Acetate
Gramicidin	0.2%	External
Granisetron Hydrochloride
Griseofulvin
Growth Hormone
Guanethidine Monosulphate
Guanfacine Hydrochloride
Guanoclor Sulphate
Guanoxan Sulphate
Halcinonide
Halofantrine Hydrochloride
Haloperidol
Haloperidol Decanoate
Heparin		External
Heparin Calcium		External
Hexachlorophane		External:
	(a) 2.0% (b) 0.1% (c) 0.75%	(a) soaps (b) aerosols (c) preparations other than soaps and aerosols
Hexamine Phenylcinchoninate
Hexobarbitone
Hexobarbitone Sodium
Hexoestrol
Hexoestrol Dipropionate
L-Histidine Hydrochloride		Dietary or nutritive use
Homatropine		(1) Internal	(1) 0.15 mg (MD) 0.45 mg (MDD)
		(2) External (except local ophthalmic use)
Homatropine Hydrobromide			0.2 mg (MD) 0.6 mg (MDD)
Homatropine Methylbromide			2 mg (MD) 6 mg (MDD)
Hydralazine Hydrochloride
Hydrargaphen		Local application to skin
Hydrobromic Acid
Hydrochlorothiazide
Hydrocortisone
Hydrocortisone Acetate
Hydrocortisone Butyrate
Hydrocortisone Caprylate
Hydrocortisone Hydrogen Succinate
Hydrocortisone Sodium Phosphate
Hydrocortisone Sodium Succinnate
Hydrocyanic Acid
Hydroflumethiazide
Hydroxychloroquine Sulphate		Prophylaxis of malaria
Hydroxyprogesterone
Hydroxyprogesterone Enanthate
Hydroxyprogesterone Hexanoate
Hydroxyurea
Hydroxyzine Embonate
Hydroxyzine Hydrochloride
Hyoscine	(1) 0.15%	(1) Internal
		(2) External (except local ophthalmic use)
Hyoscine Butylbromide		(1) Internal: (a) by inhaler	(MDD) (x)
		(2) External
Hyoscine Hydrobromide		(1) Internal: (a) by inhaler (b) otherwise than by inhaler	(b) 300 mcg (MD) 900 mcg (MDD)(x)
		(2) External (except local ophthalmic use)
Hyoscine Methobromide		(1) Internal: (a) by inhaler
		(b) otherwise than by inhaler	(b) 2.5 mg (MD) 7.5 mg (MDD)(x)
		(2) External
Hyoscine Methonitrate		(1) Internal: (a) by inhaler
		(b) otherwise than by inhaler	(b) 2.5 mg (MD) 7.5 mg (MDD)(x)
		(2) External
Hyoscyamine		(1) Internal: (a) by inhaler
		(b) otherwise than by inhaler	(b) 300 mcg (MD) 1 mg (MDD)(x)
		(2) External
		(3) Preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants which contain Hyoscyamine as an alkaloid of Stramonium
Hyoscyamine Hydrobromide		(1) Internal: (a) by inhaler
		(b) otherwise than by inhaler	(b) Equiva-lent of 300 mcg of Hyoscyamine (MD) Equi-valent of 1 mg of Hyos-cyamine (MDD)(x)
		(2) External
Hyoscyamine Sulphate		(1) Internal: (a) by inhaler
		(b) otherwise than by inhaler	(b) Equiva-lent of 300 mcg of Hyoscyamine (MD) Equivalent of 1 mg of Hyoscyamine (MDD)(x)
		(2) External
Ibuprofen
Ibuprofen Lysine		Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza
		Internal	(a) In the case of a prolonged release preparation 600 mg (MD) 1,200 mg (MDD)
			(b) In any other case 400 mg (MD) 1,200 mg (MDD)
Idarubicin Hydrochloride
Idoxuridine
Ifosfamide
Ignatius Bean
Imidapril Hydrochloride
Imipenem Hydrochloride
Imipramine
Imipramine Hydrochloride
Imipramine Ion Exchange Resin Bound Salt or Complex
Indapamide Hemihydrate
Indinavir
Indomethacin
Indomethacin Sodium
Indoramin Hydrochloride
Indoprofen
Inosine Pranobex
Insulin
Iodamide
Iodamide Meglumine
Iodamide Sodium
Iohexol
Iomeprol
Iopamidol
Iopentol
Iothalamic Acid
Ioversol
Ioxaglic Acid
Ipratropium Bromide
Iprindole Hydrochloride
Iproniazid Phosphate
Irbesartan
Isoaminile
Isoaminile Citrate
Isocarboxazid
Isoconazole Nitrate		External, but in the case of vaginal use, only for the treatment of vaginal candidiasis
Isoetharine
Isoetharine Hydrochloride
Isoetharine Mesylate
Isoniazid
Isoprenaline Hydrochloride
Isoprenaline Sulphate
Isopropamide Iodide			Equivalent of 2.5 mg of Isoprop-amide ion (MD) Equivalent of 5.0 mg of Isoprop-amide ion (MDD)
Isotretinoin
Isradipine
Itraconazole
Jaborandi		External
Kanamycin Acid Sulphate
Kanamycin Sulphate
Ketamine Hydrochloride
Ketoconazole
Ketoprofen
Ketorolac Trometamol
Ketotifen Pumarate
Labetalol Hydrochloride
Lachesine Chloride
Lacidipine
Lamivudine
Lamotrigine
Lanatoside C
Lanatoside Complex A, B and C
Lanzoprazole
Latamoxef Disodium
Latanaprost
Lercanidipine Hydrochloride
Letrozole
Levallorphan Tartrate
Levobunolol Hydrochloride
Levocabastine Hydrochloride
Levocarnitine		For dietary supplementation
Levodopa
Levofloxacin Hemihydrate
Levonorgestrel
Lidoflazine
Lignocaine		Any use (except local ophthalmic use)
Lignocaine Hydrochloride		Any use (except local ophthalmic use)
Lincomycin
Lincomycin Hydrochloride
Liothyronine Sodium
Lisinopril
Lithium Carbonate			Equivalent of 5 mg of Lithium (MD) Equivalent of 15 mg of Lithium (MDD)
Lithium Citrate
Lithium Sulphate			Equivalent of 5 mg of Lithium (MD) Equivalent of 5 mg of Lithium (MDD)
Lithium Succinate
Lobeline		(1) Internal	(1) 3 mg (MD) 9 mg (MDD)
		(2) External
Lobeline Hydrochloride		(1) Internal	(1) Equiva-lent of 3 mg of Lobeline (MD)
			Equivalent of 9 mg of Lobeline (MDD)
		(2) External
Lobeline Sulphate		(1) Internal	(1) Equiva-lent of 3 mg of Lobeline (MD) Equivalent of 9 mg of Lobeline (MDD)
		(2) External
Lodaximide Trometamol	equivalent of 0.1% Lodoxamide	For the treatment of ocular signs and symptoms of allergic conjunctivitis, in adults and in children aged 4 years and over
Lofepramine
Lofepramine Hydrochloride
Lofexidine Hydrochloride
Lomefloxacin Hydrochloride
Lornoxicam
Lomustine
Loperamide Hydrochloride		Treatment of acute diarrhoea
Loratidine
Losartan Potassium
Loxapine Succinate
Lung Surfactant Porcine
Luteinising Hormone
Lymecycline
Lynoestrenol
Lypressin
Lysuride Maleate
Mafenide
Mafenide Acetate
Mafenide Hydrochloride
Mafenide Propionate	5.0%	Eye drops
Magnesium Fluoride
Magnesium Metrizoate
Mandragora Autumnalis
Mannomustine Hydrochloride
Maprotiline Hydrochloride
Mebanazine
Mebendazole
Mebeverine Hydrochloride		(a) For the symptomatic relief of irritable bowel syndrome (b) For uses other than the symptomatic relief of irritable bowel syndrome	(a) 135mg (MD) 405mg (MDD) (b) 100 mg (MD) 300mg (MDD)
Mebeverine Pamoate
Mebhydrolin
Mebhydrolin Napadisylate
Mecamylamine Hydrochloride
Mecillinam
Meclofenoxate Hydrochloride
Medigoxin
Medrogestone
Medroxyprogesterone Acetate
Mefenamic Acid
Mefloquine Hydrochloride
Mefruside
Megestrol
Megestrol Acetate
Meglumine Gadopentetate
Meglumine lodoxamate
Meglumine loglycamate
Meglumine lothalamate
Meglumine lotroxate
Meglumine loxaglate
Meloxicam
Melphalan
Melphalan Hydrochloride
Menotrophin
Mepenzolate Bromide			25 mg (MD) 75 mg (MDD)
Mephenesin
Mephenesin Carbamate
Mepivacaine Hydrochloride		Any use (except local ophthalmic use)
Meptazinol Hydrochloride
Mequitazine
Mercaptamine Bitartrate
Mercaptopurine
Mersalyl
Mersalyl Acid
Mesalazine
Mesna
Mesterolone
Mestranol
Metaraminol Tartrate
Metergoline
Metformin Hydrochloride
Methacycline
Methacycline Calcium
Methacycline Hydrochloride
Methallenoestril
Methandienone
Methicillin Sodium
Methixene
Methixene Hydrochloride
Methocarbamol
Methocidin		Throat lozenges and throat pastilles
Methohexitone Sodium
Methoin
Methoserpidine
Methotrexate
Methotrexate Sodium
Methotrimeprazine
Methotrimeprazine Hydrochloride
Methotrimeprazine Maleate
Methoxamine Hydrochloride	0.25%	Nasal sprays, or nasal drops, not containing in either case liquid paraffin as a vehicle
Methsuximide
Methyclothiazide
Methyldopa
Methyldopa Hydrochloride
Methylephedrine Hydrochloride			30 mg (MD) 60 mg (MDD)
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Sodium Succinate
Methyltestosterone
Methylthiouracil
Methysergide Maleate
Metipranolol
Metirosine
Metoclopramide Hydrochloride
Metolazone
Metoloprolol Tartrate
Metoprolol Fumarate
Metoprolol Succinate
Metronidazole
Metronidazole Benzoate
Metyrapone
Mexiletine Hydrochloride
Mezlocillin Sodium
Mianserin Hydrochloride
Mibefradil Dihydrochloride
Miconazole		External
Miconazole Nitrate		External, but in the case of vaginal use, only for the treatment of vaginal candidiasis
Mifepristone
Miglitol
Milrinone
Milrinone Lactate
Minocycline
Minocycline Hydrochloride
Minoxidil	(1) 2.0%	External
	(2) 5.0%	External, for the treatment of alopecia androgenetica in men who have attained the age of 18 years but have not attained the age of 65 years
Mirtazapine
Misoprostol
Mitobronitol
Mitomycin C
Mitozantrone Hydrochloride
Mivacurium Chloride
Mizolastine
Moclobemide
Modafinil
Moexipril Hydrochloride
Molgramostim
Molindone Hydrochloride
Mometasone Furoate
Moracizine Hydrochloride
Morazone Hydrochloride
Moxisylyte Hydrochloride
Moxonidine
Mupirocin
Mupirocin Calcium
Mustine Hydrochloride
Mycophenolate Mofetil
Nabilone
Nabumetone
Nadolol
Nafarelin Acetate
Naftidrofuryl Oxalate
Naftifine Hydrochloride
Nalbuphine Hydrochloride
Nalidixic Acid
Nalorphine Hydrobromide
Naloxone Hydrochloride
Naltrexone Hydrochloride
Nandrolone Decanoate
Nandrolone Laurate
Nandrolone Phenylpropionate
Naphazoline Hydrochloride	(1) 0.05%	(1) Nasal sprays, or nasal drops, not containing in either case liquid paraffin as a vehicle
	(2) 0.015%	(2) Eye drops
Naphazoline Nitrate	0.05%	Nasal sprays, or nasal drops, not containing in either case liquid paraffin as a vehicle
Naproxen
Naproxen Sodium
Naratriptan Hydrochloride
Natamycin
Nebivolol Hydrochloride
Nedocromil Sodium
Nefazadone Hydrochloride
Nefopam Hydrochloride
Neomycin
Neomycin Oleate
Neomycin Palmitate
Neomycin Sulphate
Neomycin Undecanoate
Neostigmine Bromide
Neostigmine Methylsulphate
Netilmicin Sulphate
Nicardipine Hydrochloride
Nicergoline
Niceritrol
Nicotinic Acid		Any use (except for the treatment of hyperlipid-aemia)	600 mg (MDD)
Nicoumalone
Nifedipine
Nifenazone
Nikethamide
Nilutamide
Nimodipine
Niridazole
Nisoldipine
Nitrendipine
Nitrofurantoin
Nitrofurazone
Nizatidine
Nomifensine Maleate
Noradrenaline
Noradrenaline Acid Tartrate
Norethandrolone
Norethisterone
Norethisterone Acetate
Norethisterone Heptanoate
Norethynodrel
Norfloxacin
Norgestimate
Norgestrel
Nortriptyline Hydrochloride
Noscapine
Noscapine Hydrochloride
Novobiocin Calcium
Novobiocin Sodium
Nux Vomica Seed
Nystatin
Octacosactrin
Octreotide
Oestradiol
Oestradiol Benzoate
Oestradiol Cypionate
Oestradiol Dipropionate
Oestradiol Diundecanoate
Oestradiol Enanthate
Oestradiol Phenylpropionate
Oestradiol Undecanoate
Oestradiol Valerate
Oestriol
Oestriol Di-Hemi Succinate
Oestrogenic Substances, Conjugated
Oestrone
Ofloxacin
Olanzapine
Olsalazine Sodium
Omeprazole
Omeprazole Magnesium
Ondansetron
Ondansetron Hydrochloride
Orciprenaline Sulphate
Orphenadrine Citrate
Orphenadrine Hydrochloride
Ouabain
Ovarian Gland, Dried
Oxamniquine
Oxandronolone
Oxantel Pamoate
Oxaprozin
Oxatomide
Oxedrine Tartrate
Oxethazaine
Oxidronate Sodium
Oxitropium Bromide
Oxolinic Acid
Oxpentifylline
Oxprenolol Hydrochloride		Any use (except local ophthalmic use)
Oxybuprocaine Hydrochloride
Oxybutynin Hydrochloride
Oxymetholone
Oxypertine
Oxypertine Hydrochloride
Oxyphenbutazone
Oxyphencyclimine Hydrochloride
Oxyphenonium Bromide			5 mg (MD) 15 mg (MDD)
Oxytetracycline
Oxytetracycline Calcium
Oxytetracycline Dihydrate
Oxytetracycline Hydrochloride
Oxytocin, Natural
Oxytocin, Synthetic
Pamidronate Disodium
Pancreatin	(1) 21,000 European Pharmacopoeia units of lipase per capsule		(1) Capsules
	(2) 25,000 European Pharmacopoeia units of lipase per g		(2) Powder
Pancuronium Bromide
Pantoprazole
Pantoprazole Sodium
Papaverine		(1) By inhaler
		(2) Otherwise than by inhaler	(2) 50 mg (MD) 150 mg (MDD)
Papaverine Hydrochloride		(1) By inhaler
		(2) Otherwise than by inhaler	(2) Equivalent of 50 mg of Papaverine (MD) Equivalent of 150 mg of Papaverine (MDD)
Paracetamol		Any form (except non-effervescent tablets and capsules)
Paraldehyde
Paramethadione
Paramethasone Acetate
Parathyroid Gland
Pargyline Hydrochloride
Paroxetine Hydrochloride
Pecilocin
Penamecillin
Penbutolol Sulphate
Penciclovir
Penicillinamine
Penicillinamine Hydrochloride
Pentamidine Isethionate
Pentamidronate Disodium
Penthienate Methobromide			5 mg (MD) 15 mg (MDD)
Pentolinium Tartrate
Perfluamine
Pergolide Mesylate
Perhexiline Maleate
Perindopril
Pericyazine
Perindopril Erbumine
Perphenazine
Phenacetin	0.1%
Phenazone		External
Phenazone and Caffeine Citrate
Phenazone Salicylate
Phenbutrazate Hydrochloride
Phenelzine Sulphate
Phenethicillin Potassium
Phenformin Hydrochloride
Phenglutarimide Hydrochloride
Phenindione
Phenolphthalein
Phenoxybenzamine Hydrochloride
Phenoxymethylpenicillin
Phenoxymethylpenicillin Calcium
Phenoxymethylpenicillin Potassium
Phenprocoumon
Phensuximide
Phentolamine Hydrochloride
Phentolamine Mesylate
Phenylbutazone
Phenylbutazone Sodium
Phenylpropanolamine Hydrochloride		Internal: (a) all preparations (except controlled release capsules, nasal sprays or nasal drops)	(a) 25 mg (MD) 100 mg (MDD)
		(b) controlled release capsules	(b) 50 mg (MD) 100 mg (MDD)
	(c) 2.0%	(c) nasal sprays or nasal drops
Phenytoin
Phenytoin Sodium
Phthalylsulphathiazole
Physostigmine
Physostigmine Aminoxide Salicylate
Physostigmine Salicylate
Physostigmine Sulphate
Phytomenadine		Any use except the prevention or treatment of haemorrhagic disorders
Picrotoxin
Pilocarpine
Pilocarpine Hydrochloride
Pilocarpine Nitrate
Pimozide
Pindolol
Pipenzolate Bromide			5 mg (MD) 15 mg (MDD)
Piperacillin Sodium
Piperazine Oestrone Sulphate
Piperidolate Hydrochloride			50 mg (MD) 150 mg (MDD)
Pipothiazine Palmitate
Piracetam
Pirbuterol Acetate
Pirbuterol Hydrochloride
Pirenzepine Dihydrochloride Monohydrate
Pirenzepine Hydrochloride
Piretamide
Piroxicam
Piroxicam Beta-Cyclodextrin
Pituitary Gland (Whole Dried)		By inhaler
Pituitary, Powdered (Posterior Lobe)		By inhaler
Pivampicillin Hydrochloride
Pivmecillinam
Pivmecillinam Hydrochloride
Pizotifen
Pizotifen Malate
Plicamycin
Podophyllotoxin
Podophyllum
Podophyllum Indian
Podophyllum Resin	20.0%	External: ointment or impregnated plaster
Poldine Methylsulphate			2 mg (MDD) 6 mg (MDD)
Polidexide
Polymyxin B Sulphate
Polyestradiol Phosphate
Polythiazide
Poppy Capsule
Potassium Arsenite	0.0127%
Potassium Bromide
Potassium Canrenoate
Potassium Clavulanate
Potassium Perchlorate
Practolol
Pralidoxime Chloride
Pralidoxime lodide
Pralidoxime Mesylate
Pramipexole Dihydrochloride
Pravastatin Sodium
Prazosin Hydrochloride
Prednisolone
Prednisolone Acetate
Prednisolone Butylacetate
Prednisolone Hexanoate
Prednisolone Pivalate
Prednisolone Sodium Phosphate
Prednisolone Sodium m-Sulphobenzoate
Prednisolone 21-Steaglate
Prednisolone m-Sulphobenzoate
Prednisone
Prednisone Acetate
Prenalterol Hydrochloride
Prenylamine Lactate
Prilocaine Hydrochloride		Any use (except local ophthalmic use)
Primidone
Probenecid
Probucol
Procainamide Hydrochloride
Procaine Hydrochloride		Any use (except local ophthalmic use)
Procaine Penicillin
Procarbazine Hydrochloride
Prochlorperazine
Prochlorperazine Edisylate
Prochlorperazine Maleate
Prochlorperazine Mesylate
Procyclidine Hydrochloride
Progesterone
Prolactin
Proligestone
Prolintane Hydrochloride
Promazine Embonate
Promazine Hydrochloride
Propafenone
Propafenone Hydrochloride
Propanidid
Propantheline Bromide			15 mg (MD) 45 mg (MDD)
Propiverine Hydrochloride
Propofol
Propranolol Hydrochloride
Propylthiouracil
Proquazone
Protamine Sulphate
Prothionamide
Protirelin
Protriptyline Hydrochloride
Proxymetacaine Hydrochloride		Any use (except local ophthalmic use)
Pseudoephedrine Hydrochloride		Internal	In the case of a controlled release preparation: 120 mg (MD) 180 mg (MDD) In any other case: 60 mg (MD) 180 mg (MDD)
Pseudoephedrine Sulphate			60 mg (MD) 180 mg (MDD)
Pyrantel Embonate
Pyrantel Tartrate
Pyrazinamide
Pyridostigmine Bromide
Pyrimethamine
Quetiapine Fumarate
Quinagolide Hydrochloride
Quinapril
Quinapril Hydrochloride
Quinestradol
Quinestrol
Quinethazone
Quinidine
Quinidine Bisulphate
Quinidine Polygalacturonate
Quinidine Sulphate
Quinine			100 mg (MD) 300 mg (MDD)
Quinine Bisulphate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Dihydrochloride			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Ethyl Carbonate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Glycero-phosphate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Hydrobromide			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Hydrocholride			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Iodobismuthate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Phenylcinchoninate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Phosphate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Salicylate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Sulphate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine Tannate			Equivalent of 100 mg of Quinine (MD) Equivalent of 300 mg of Quinine (MDD)
Quinine and Urea Hydrochloride
Ramipril
Ranitidine Bismuth Citrate
Ranitidine Hydrochloride
Rauwolfia Serpentina
Rauwolfia Vomitoria
Reboxetine
Reboxetine Mesilate
Remoxipride Hydrochloride
Reproterol Hydrochloride
Rescinnamine
Reserpine
Rifabutin
Rifampicin
Rifampicin Sodium
Rifamycin
Rimexolone
Rimiterol Hydrobromide
Risperidone
Ritodrine Hydrochloride
Ritonavir
Rolitetracycline Nitrate
Ropinorole Hydrochloride
Sabadilla
Salbutamol
Salbutamol Sulphate
Salcatonin
Salcatonin Hydrated Polyacetate
Salmefamol
Salmeterol Hydroxynaphthoate
Salsalate
Saquinavir
Saralasin Acetate
Selegiline Hydrochloride
Sera and Antisera –
Botulin Antitoxin
Diphtheria Antitoxin
Gas-gangrene Antitoxin (Oedematiens)
Gas-gangrene Antitoxin (Perfringens)
Gas-gangrene Antitoxin (Septicum)
Mixed Gas-gangrene Antitoxin
Leptospira Antiserum
Rabies Antiserum
Scorpion Venom Antiserum
Snake Venom Antiserum
Tetanus Antitoxin
Serum Gonadotrophin
Sermorelin
Sertindole
Sertraline Hydrochloride
Sevoflurane
Sibutramine Hydrochloride
Silver Sulphadiazine
Simvastatin
Sissomicin
Sissomicin Sulphate
Snake Venoms
Sodium Acetrizoate
Sodium Aminosalicylate
Sodium Antimonylgluconate
Sodium Arsanilate
Sodium Arsenate
Sodium Arsenite	0.013%
Sodium Bromide
Sodium Clodronate
Sodium Cromoglycate		Administration through the nose
Sodium Ethacrynate
Sodium Fluoride	(1) 0.33% (y)	(1) Dentifrices
		(2) Other preparations for use in the prevention of dental of dental caries in the form of – (a)tablets or drops;	(a) 2.2 mg (MDD)
	(b) 0.2%	(b) mouth-washes (other than those for daily use);
	(c) 0.05%	(c) mouth-washes for daily use
Sodium Fusidate
Sodium Metrizoate
Sodium Monofluorophosphate	1.14% (y)	Dentifrice
Sodium Stibogluconate
Sodium Valproate
Somatorelin Acetate
Somatrem
Somatropin
Sotalol Hydrochloride
Sparfloxacin
Spectinomycin
Spectinomycin Hydrocloride
Spiramycin
Spiramycin Adipate
Spironolactone
Stannous Fluoride	(1) 0.62% (y)	(1) Dentifrice
	(2) 0.4%	(2) Dental gels for use in the prevention and treatment of dental caries and decalcification of the teeth
Stanolone
Stanozolol
Stavudine
Stilboestrol
Stilboestrol Dipropionate
Streptodornase		External
Streptokinase		External
Streptomycin
Streptomycin Sulphate
Strychnine
Strychnine Arsenate
Strychnine Hydrochloride
Strychnine Nitrate
Styramate
Succinylsulphathiazole
Sucralfate
Sulbactam
Sodium
Sulbenicillin
Sulbenicillin Sodium
Sulbenicillin Tosylate
Sulconazole Nitrate		External (except vaginal use)
Sulfacytine
Sulfadoxine
Sulfamonomethoxine
Sulindac
Sulphabenzamide
Sulphacetamide
Sulphacetamide Sodium
Sulphadiazine
Sulphadiazine Sodium
Sulphadimethoxine
Sulphadimidine
Sulphadimidine Sodium
Sulphafurazole
Sulphafurazole Diethanolamine
Sulphaguanidine
Sulphaloxic Acid
Sulphamerazine
Sulphamerazine Sodium
Sulphamethizole
Sulphamethoxazole
Sulphamethoxydazine
Sulphamethoxypyridazine
Sulphamethoxypyridazine Sodium
Sulphametopyrazine
Sulphamoxole
Sulphanilamide
Sulphaphenazole
Sulphapyridine
Sulphapyridine Sodium
Sulphasalazine
Sulphathiazole
Sulphathiazole Sodium
Sulphaurea
Sulphinpyrazone
Sulpiride
Sultamicillin
Sultamicillin Tosylate
Sulthiame
Sumatriptan
Sumatriptan Succinate
Suprofen
Suxamethonium Bromide
Suxamethonium Chloride
Suxethonium Bromide
Tacalcitol Monohydrate
Tacrine Hydrochloride
Talampicillin
Talampicillin Hydrochloride
Talampicillin Napsylate
Tamoxifen
Tamoxifen Citrate
Tamsulosin Hydrochloride
Tazarotene
Tazobactam Sodium
Teicoplanin
Temocapril Hydrochloride
Temocillin Sodium
Tenoxicam
Terazosan Hydrochloride
Terbinafine
Terbinafine Hydrochloride
Terbutaline
Terbutaline Sulphate
Terfenadine
Terodiline Hydrochloride
Tertipressin
Testosterone
Testosterone Acetate
Testosterone 17B Chloral Hemiacetal
Testosterone Cyclohexyl-propionate
Testosterone Cypionate
Testosterone Decanoate
Testosterone Enanthate
Testosterone Isocaproate
Testosterone Phenylpropionate
Testosterone Propionate
Testosterone Undecanoate
Tetrabenazine
Tetracosactrin
Tetracosactrin Acetate
Tetracycline
Tetracycline Hydrochloride
Tetracycline Phosphate Complex
Tetroxoprim
Thallium Acetate
Thallous Chloride
Thiabendazole
Thiambutosine
Thiethylperazine
Thiethylperazine Maleate
Thiocarlide
Thioguanine
Thiopentone Sodium
Thiopropazate Hydrochloride
Thioproperazine Mesylate
Thioridazine
Thioridazine Hydrochloride
Thiosinamine
Thiotepa
Thiothixene
Thiouracil
Thymoxamine Hydrochloride
Thyroid
Thyrotrophin
Thyroxine Sodium
Tiamulin Fumarate
Tiaprofenic Acid
Tibolone
Ticarcillin Sodium
Ticlopidine Hydrochloride
Tigloidine Hydrobromide
Tiludronate Disodium
Timolol Maleate
Tinidazole
Tinzaparin
Tioconazole	2.0%	(1) External, but in the case of vaginal use only, external use for treatment of vaginal candidiasis
Tizanidine Hydrochloride
Tobramycin
Tobramycin Sulphate
Tocainide Hydrochloride
Tofenacin Hydrochloride
Tolazamide
Tolazoline Hydrochloride		External
Tolbutamide
Tolbutamide Sodium
Tolcapone
Tolfenamic Acid
Tolmetin Sodium
Topiramate
Torasemide
Toremifene
Tramadol Hydrochloride
Trandolapril
Tranexamic Acid
Tranylepromine Sulphate
Trazodone Hydrochloride
Treosulfan
Tretinoin
Triamcinolone
Triamcinolone Acetonide
Triamcinolone Diacetate
Triamcinolone Hexacetonide
Triamterene
Tribavirin
Triclofos Sodium
Trientine Dihydrochloride
Trifluoperazine
Trifluoperazine Hydrochloride
Trifluperidol
Trifluperidol Hydrochloride
Trilostane
Trimeprazine
Trimeprazine Tartrate
Trimetaphan Camsylate
Trimetazidine
Trimetazidine Hydrochloride
Trimethoprim
Trimipramine Maleate
Trimipramine Mesylate
Tropicamide
Tropisetron Hydrochloride
Troxidone
L-Tryptophan		(1) Dietary or nutritive use (2) Any external use
Tubocurarine Chloride
Tulobuterol
Tulobuterol Hydrochloride
Tyrothricin		Throat lozenges or throat pastilles
Uramustine
Urea Stibamine
Urethane
Uridine-5-Triphosphoric Acid
Urofollitrophin
Urokinase
Ursodeoxychloric Acid
Vaccines –
Athrax Vaccine (Bacillus) Anthracis)
Bacillus Calmette- Guerin Vaccine
Bacillus Salmonella Typhi Vaccine
Percutaneous Bacillus Calmette- Guerin Vaccine
Cholera Vaccine
Diphtheria Vaccine
Adsorbed Diphtheria Vaccine
Diphtheria and Tetanus Vaccine
Adsorbed Diphtheria and Tetanus Vaccine
Diphtheria, Tetanus and Pertussis Vaccine
Adsorbed Diphtheria, Tetanus and Pertussis Vaccine
Diphtheria, Tetanus and Poliomyelitis Vaccine
Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine
Eltor Vaccine
Influenza Vaccine
Hepatitis B Vaccine
Measles Vaccine (Live Attenuated)
Meningococcal Polysaccharide Vaccine
Mumps Vaccine
Pertussis Vaccine
Plague Vaccine
Pneumococcal Vaccine (Bacterial Antigen)
Poliomyelitis Vaccine (Inactivated)
Poliomyelitis Vaccine (Live Oral)
Rabies Vaccine
Rubella Vaccine (Live Attenuated)
Rubella, Mumps, Measles Vaccine
Tetanus Vaccine
Adsorbed Tetanus Vaccine
Tetanus and Pertussis Vaccine
Tuberculin Purified Protein Derivative
Old Tuberculin
Typhoid Vaccine
Typhoid – Paratyphoid A and B Vaccine
Typhoid – Paratyphoid A and B and Cholera Vaccine
Typhoid – Paratyphoid A and B and Tetanus Vaccine
Typhus Vaccine
Yellow Fever Vaccine
Valaciclovir
Valaciclovir Hydrochloride
Valproic Acid
Valsartan
Vancomycin Hydrochloride
Vasopressin Injection
Vasopressin Tannate
Vecuronium Bromide
Venlafaxine
Venlafaxine Hydrochloride
Verapamil Hydrochloride
Veratrine
Veratrum (Green and White)
Vidarabine
Vigabatrin
Viloxazine Hydrochloride
Vinblastine Sulphate
Vincristine Sulphate
Vindesine Sulphate
Viomycin Pantothenate
Viomycin Sulphate
Vitamin A		(1) Internal	(1) 7500 iu (2250 mcg Retinol equivalent) (MDD)
		(2) External
Vitamin A Acetate		(1) Internal	(1) Equi-valent to 7500 iu Vitamin A (2250 mcg Retinol equivalent) (MDD)
		(2) External
Vitamin A Palmitate		(1) Internal	(1) Equi-valent to 7500 iu Vitamin A (2250 mcg Retinol equivalent) (MDD)
		(2) External
Warfarin
Warfarin Sodium
Xamoterol Fumarate
Xipamide
Yohimbine Hydrochloride
Zalcitabine
Zidovudine
Zimeldine Hydrochloride
Zolmitriptan
Zolpidem
Zomepirac Sodium
Zopiclone
Zuclopenthixol Acetate
Zuclopenthixol Decanoate
Zuclopenthixol Hydrochloride
Note –	1. In relation to a medicinal product that contains more than one of the substances Atropine, Atropine Methobromide, Atropine Methonitrate, Atropine Oxide Hydrochloride, Atropine Sulphate, Hyoscine, Hyoscine Butylbromide, Hyoscine Hydrobromide, Hyoscine Methobromide, Hyoscine Methonitrate, Hyoscyamine, Hyoscyamine Hydrobromide and Hyoscyamine Sulphate, the maximum daily dose for the purposes of column 4 is 1 mg of the total alkaloids contained in the product that are derived from Belladonna, Hyoscyamus, Stramonium or other solanaceous plant, and there is no maximum dose.
	2. In relation to a medicinal product that contains more than one of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride combined in a dentifrice, the maximum strength of the combination for the purposes of column 2 shall not exceed 0.15% calculated as Fluorine.

PART 2

(Articles 1(2), 3(2) and 7)

Controlled Drugs	Circumstances In Which Controlled Drugs Are Not Prescription Only Medicines
Column 1	Column 2	Column 3	Column 4
Substance	Maximum strength	Pharmaceutical form	Maximum dose
Codeine; its salts	Equivalent of 1.5% of Codeine Monohydrate		Equivalent of 20 mg of Codeine Monohydrate
Dihydrocodeine; its salts	Equivalent of 1.5%of Dihydrocodeine		Equivalent of 10 mg of Dihydroco-deine
Ethylmorphine; its salts	Equivalent of 0.2% of Ethylmorphine		Equivalent of 7.5 mg of Ethyl-morphine
Morphine; its salts	(1) Equivalent of 0.02% of anhydrous Morphine	(1) Liquid	(1) Equivalent of 3 mg of anhydrous Morphine
	(2) Equivalent of 0.04% of anhydrous Morphine; equivalent of 300 mcg of anhydrous Morphine	(2) Solid	(2) Equivalent of 3 mg of anhydrous Morphine
Medicinal Opium	(1) Equivalent of 0.02%of anhydrous Morphine	(1) Liquid	(1) Equivalent of 3 mg of anhydrous Morphine
	(2) Equivalent of 0.04% of anhydrous Morphine	(2) Solid	(2) Equivalent of 3 mg of anhydrous Morphine
Pholcodine; its salts	Equivalent of 1.5% of Pholcodine		Equivalent of 20 mg of Pholcodine

PART 3

(Article 3(4))

NAMED PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES

TABLE A
Name and product licence number of medicinal products that are not prescription only medicines
Adcortyl in Orabase for Mouth Ulcers	0034/0321
Anusol Plus HC Ointment	0018/0223
Anusol Plus HC Suppositories	0018/0224
Beechams Hydrocortisone Cream	0079/0203
Boots Hydrocortisone Ointment	0014/0364
Calacort Cream	12650/0001
Canesten Hydrocortisone Cream	0010/0216
Corlan Pellets	0039/0397
Cortaid Cream 1%	0032/0126
Corteze Cream	0001/0107
Cortiderm	2855/0010
Cortril Topical Ointment 1% (non-greasy)	0057/0251
Dermacort Hydrocortisone Cream	8265/0002
Dioderm Hydrocortisone Cream	0173/0153
Efcortelan Eczema Cream	10949/0234
Efcortelan Eczema Ointment	10949/0235
Eurax HC Cream	0001/5010R
Hc45 Hydrocortisone Cream	0327/0039
Herpetad Cold Sore Cream	4986/0007
Jungle Formula Bite & Sting Relief Cream	2855/0010
Lanacort Cream	3157/0008
Lanacort Ointment	3157/0011
Perinal Spray	0173/0049
Pharmacort Cream 0.5%	0011/0077
Proctocream HC	0036/0065
Soothelip Cold Sore Cream	0142/0426
Timocort Hydrocortisone Cream	0044/0090
Timocort Hydrocortisone Cream 1%	0063/0076
Wasp-Eze Hydrocortisone Cream	8452/0012
Zaclovir Cold Sore Cream	4986/0007
Zenoxone Cream	0181/0033
Zovirax Cold Sore Cream	0003/0304

TABLE B
Relevant product licence holder and name and product licence number of medicinal products that are not prescription only medicines
Leo Laboratories Limited:
Hydrocortisone Acetate Cream BP 0.5%	0043/0150
Hydrocortisone Acetate Cream BP 1.0%	0043/0151
Richard Daniel and Son Limited:
Hydrocortisone Cream BP 1.0%	0842/0011

PART 4[12]

(Article 3(4))

OTHER MEDICINAL PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES

1 A medicinal product shall not be a prescription only medicine by reason that it contains the substance aciclovir, where –

(a) the maximum strength of the aciclovir in the medicinal product does not exceed 5%;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 2 g of the medicinal product; and

(c) the medicinal product is indicated only for external application for the treatment of herpes simplex virus infections of the lips and face (Herpes labialis).

2 A medicinal product shall not be a prescription only medicine by reason that it contains the substance acrivastine, where –

(a) the medicinal product is sold or supplied in a container, or package, containing not more than 240 mg of acrivastine; and

(b) the container or package is labelled to show a maximum daily dose of 24 mg of acrivastine.

3 A medicinal product shall not be a prescription only medicine by reason that it contains the substance aloxiprin, where –

(a) the medicinal product is in the form of non-effervescent tablets or capsules;

(b) the maximum strength of the medicinal product in each tablet or capsule does not exceed 620 mg;

(c) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied in one container or package does not exceed 32; and

(d) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied to a person at any one time does not exceed 100.

4 A medicinal product shall not be a prescription only medicine by reason that it contains the substance aloxiprin, where it is not in the form of a non-effervescent tablet or capsule.

5 A medicinal product shall not be a prescription only medicine by reason that it contains the substance aspirin, where –

(a) the medicinal product is in the form of non-effervescent tablets or capsules;

(b) the maximum strength of the medicinal product in each tablet or capsule does not exceed 75 mg;

(c) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied in one container or package does not exceed 100; and

(d) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied to a person at any one time does not exceed 100.

6 A medicinal product shall not be a prescription only medicine by reason that it contains the substance aspirin, where –

(a) the medicinal product is in the form of non-effervescent tablets or capsules;

(b) the maximum strength of the medicinal product in each tablet or capsule does not exceed 325 mg;

(c) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied in one container or package does not exceed 32; and

(d) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied to a person at any one time does not exceed 100.

7 A medicinal product shall not be a prescription only medicine by reason that it contains the substance azelastine hydrochloride, where –

(a) the medicinal product is in non-aerosol, aqueous form for nasal administration;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 36 doses each of which contains not more than 140 mcg of azelastine hydrochloride;

(c) the container or package is labelled to show a maximum dose of 140 mcg per nostril and a maximum daily dose of 280 mcg per nostril of azelastine hydrochloride; and

(d) the medicinal product is indicated only for the treatment of seasonal allergic rhinitis or perennial allergic rhinitis, in persons aged not less than 5 years.

8 A medicinal product shall not be a prescription only medicine by reason that it contains the substance azelastine hydrochloride, where –

(a) the medicinal product is in the form of eye drops; and

(b) it is indicated only for the treatment of allergic conjunctivitis, in persons aged not less than 12 years.

9 A medicinal product shall not be a prescription only medicine by reason that it contains the substance beclomethasone dipropionate, where –

(a) the medicinal product is in non-aerosol form for nasal administration;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 5,600mcg of beclomethasone diopropionate;

(c) the container or package is labelled to show a maximum dose of 100 mcg per nostril and a maximum daily dose of 200 mcg per nostril of beclomethasone dipropionate; and

(d) the medicinal product is indicated only for the prevention of treatment of allergic rhinitis, in persons aged not less than 12 years.

10 A medicinal product shall not be a prescription only medicine by reason that it contains the substance budesonide, where –

(a) the medicinal product is in non-aerosol, aqueous form for nasal administration;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 10 mg of the medicinal product;

(c) the container or package is labelled to show a maximum dose, and a maximum daily dose, of 200 mcg per nostril of budesonide; and

(d) the medicinal product is indicated only for the prevention of treatment of seasonal allergic rhinitis, in persons aged not less than 12 years.

11 A medicinal product shall not be a prescription only medicine by reason that it contains the substance carbenoxolone sodium, where –

(a) the medicinal product is in the form of granules;

(b) the maximum strength of the carbenoxolone sodium in the medicinal product does not exceed 1%, calculated in terms of weight in weight;

(c) the medicinal product is sold or supplied in a container, or package, containing not more than 560 mg of carbenoxolone sodium;

(d) the container or package is labelled to show a maximum dose of 20 mg and a maximum daily dose of 80 mg of carbenoxolone sodium; and

(e) the medicinal product is indicated only for treatment by mouthwash, in persons aged not less than 12 years.

12 A medicinal product shall not be a prescription only medicine by reason that it contains the substance cetirizine, where –

(a) the medicinal product is sold or supplied in a container, or package, containing not more than 100 mg of cetirizine; and

(b) the container or package is labelled to show a maximum daily dose of 10mg of cetirizine.

13 A medicinal product shall not be a prescription only medicine by reason that it contains the substance cimetidine, where –

(a) the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose of 200 mg and a maximum daily dose of 800 mg of cimetidine for a maximum period of 14 days; and

(b) the medicinal product is indicated for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity and for the prophylaxsis of meal-induced heartburn.

14 A medicinal product shall not be a prescription only medicine by reason that it contains the substance cimetidene, where –

(a) the medicinal product is for the prophylactic management of nocturnal heartburn; and

(b) the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose of 100 mg of cimetidine to be taken once daily at night for a maximum period of 14 days.

15 A medicinal product shall not be a prescription only medicine by reason that it contains the substance clobetasone butyrate, where –

(a) the medicinal product is in the form of a cream;

(b) the maximum strength of the clobetasone butyrate in the medicinal product does not exceed 0.05%;

(c) the medicinal product is sold or supplied in a container, or package, containing not more than 15 g of the medicinal product; and

(d) the medicinal product is indicated only for external application for the short-term treatment of eczema and dermatitis, in persons aged not less than 12 years.

16 A medicinal product shall not be a prescription only medicine by reason that it contains the substance diclofenac diethylammonium, where –

(a) the maximum strength of the diclofenac diethylammonium in the medicinal product does not exceed 1.16%, calculated in terms of weight in weight;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 30 g of the medicinal product;

(d) the medicinal product is indicated for external application for the local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints and in localized forms of soft tissue rheumatism, in persons aged not less than 12 years.

17 A medicinal product shall not be a prescription only medicine by reason that it contains the substance domperidone, where –

(a) the medicinal product is indicated for the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn;

(b) the medicinal product is sold or supplied in a container or package containing not more than 200 mg of domperidone; and

(c) the container or package is labelled to show a maximum dose of 10 mg of domperidone and a maximum daily dose of 40 mg of domperidone.

18 A medicinal product shall not be a prescription only medicine by reason that it contains the substance domperidone maleate, where –

(a) the medicinal product is sold in a container, or package, containing not more than 200 mg of domperidone maleate;

(b) the container or package is labelled to show a maximum dose of 10 mg and a maximum daily dose of 40 mg; and

(c) the medicinal product is indicated for use for the relief of postprandial symptoms of excessive fullness, nausea, epigastric bloating and belching, accompanied by epigastric discomfort and heartburn.

19 A medicinal product shall not be a prescription only medicine by reason that it contains the substance famotidine, where –

(a) the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose of 10 mg and a maximum daily dose of 20 mg of famotidine for a maximum period of 14 days; and

(b) the medicinal product is indicated for –

(i) the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion or hyperacidity, or

(ii) the prevention of the symptoms of heartburn, dyspepsia, indigestion, acid indigestion or hyperacidity where they are associated with the consumption of food or drink, including the prevention of sleep disturbance because of those symptoms.

20 A medicinal product shall not be a prescription only medicine by reason that it contains the substance felbinac, where –

(a) the maximum strength of the felbinac in the medicinal product does not exceed 3.17%, calculated in terms of weight in weight;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 50 g of the medicinal product;

(d) the medicinal product is indicated for external application for the relief of symptoms associated with soft tissue injury such as strains, sprains and contusions, in persons aged not less than 12 years.

21 A medicinal product shall not be a prescription only medicine by reason that it contains the substance fluconazole, where –

(a) the medicinal product is sold or supplied in a container, or package, containing not more than 150 mg of the medicinal product;

(b) the container or package is labelled to show a maximum dose of 150 mg of fluconazole; and

(c) the medicinal product is indicated for oral administration for the treatment of vaginal candidiasis or associated candidal balanitis, in persons aged not less than 16 years but less than 60 years.

22 A medicinal product shall not be a prescription only medicine by reason that it contains the substance flunisolide, where –

(a) the medicinal product is in the form of a non-pressurized nasal spray;

(b) the maximum strength of the flunisolide in the medicinal product does not exceed 0.025%, calculated in terms of weight in volume;

(c) the medicinal product is sold or supplied in a container, or package, containing not more than 240 metered doses of the medicinal product;

(d) the container or package is labelled to show a maximum dose of 50 mcg per nostril and a maximum daily dose of 100 mcg per nostril of flunisolide in the case of persons aged not less than 16 years, and a maximum dose of 25 mcg per nostril and a maximum daily dose of 75 mcg per nostril in the case of children aged not less than 12 years but less than 16 years; and

(e) the medicinal product is indicated for the prevention and treatment of seasonal allergenic rhinitus, including hay fever, in persons aged not less than 12 years.

23 A medicinal product shall not be a prescription only medicine by reason that it contains the substance hydrocortisone, where –

(a) the maximum strength of the hydrocortisone in the medicinal product does not exceed 0.5%, calculated in terms of weight in weight;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 15 g of the medicinal product; and

(c) the medicinal product is indicated for external use in combination with nystatin of a maximum strength of 3.0%, for intertrigo, in persons aged not less than 10 years.

24 A medicinal product shall not be a prescription only medicine by reason that it contains the substance hydrocortisone, where –

(a) the medicinal product is in the form of a cream, ointment or spray;

(b) the maximum strength of the hydrocortisone in the medicinal product does not exceed 1.0%, calculated in terms of weight in weight;

(i) where the medicinal product is in the form of a cream or ointment, not more than 15 g of the medicinal product, or

(ii) where the medicinal product is in the form of a spray, not more than 30 ml of the medicinal product;

(d) the medicinal product is indicated for external use, either alone or in conjunction with crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions or mild to moderate eczema, and either in combination with clotrimazole or miconazole nitrate for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids; and

(e) the medicinal product is indicated for use in persons aged not less than 10 years.

25 A medicinal product shall not be a prescription only medicine by reason that it contains the substance hydrocortisone acetate, where –

(a) the medicinal product is in the form of a cream or ointment, or suppositories;

(b) the maximum strength of the hydrocortisone acetate in the medicinal product is equivalent to 1.0% of hydrocortisone, calculated in terms of weight in weight;

(i) where the medicinal product is in the form of a cream or ointment, not more than 15 g of the medicinal product, or

(ii) where the medicinal product is in the form of suppositories, not more than 12 suppositories;

(d) the medicinal product is indicated for external use -

(i) for irritant dermatitis, contact allergic dermatitis, insect bite reactions or mild to moderate eczema,

(ii) in combination with one or more of the following, namely benzyl benzoate, bismuth oxide, bismuth subgallate, peru balsam, pramoxine hydrochloride and zinc oxide, for haemorrhoids, or

(iii) in combination with miconazole nitrate, for tinea pedis or candidal intertrigo; and

(e) the medicinal product is indicated for use in persons aged not less than 10 years.

26 A medicinal product shall not be a prescription only medicine by reason that it contains the substance hydrocortisone sodium succinate, where –

(a) the medicinal product is in the form of pellets;

(b) the maximum strength of the hydrocortisone sodium succinate in the medicinal product is equivalent to 2.5 mg of hydrocortisone, calculated in terms of weight in weight;

(c) the medicinal product is sold or supplied in a container, or package, containing the equivalent of 50 mg of hydrocortisone; and

(d) the medicinal product is indicated for external use for aphthous ulceration of the mouth, in persons aged not less than 12 years.

27 A medicinal product shall not be a prescription only medicine by reason that it contains the substance hydroxyzine hydrochloride, where –

(a) the medicinal product is sold or supplied in a container, or package, containing not more than 750 mg of the medicinal product;

(b) the container or package is labelled to show a maximum dose of 25 mg, and to show a maximum daily dose of 75 mg in the case of persons aged not less than 12 years and a maximum daily dose of 50 mg in the case of children aged not less than 6 years but less than 12 years; and

(c) the medicinal product is indicated for the management of pruritus associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in persons aged not less than 6 years.

28 A medicinal product shall not be a prescription only medicine by reason that it contains the substance hyoscine butylbromide, where –

(a) the route of administration of the medicinal product is internal and is otherwise than by means of an inhaler;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 240 mg of the medicinal product; and

(c) the container or package is labelled to show a maximum dose of 20 mg and a maximum daily dose of 80 mg of the medicinal product.

29 A medicinal product shall not be a prescription only medicine by reason that it contains the substance Ibuprofen, where –

(a) the medicinal product is indicated for the relief of rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza; and either

(b) the route of the administration of the medicinal product is internal; and –

(i) in the case of a prolonged release preparation the container or package is labelled to show a maximum dose of 600 mg and a maximum daily dose of 1200 mg, or

(ii) in any other case the container or package is labelled to show a maximum dose of 400 mg and a maximum daily dose of 1200 mg; or

(i) the maximum strength of the Ibuprofen in the medicinal product does not exceed 5%, or

(ii)

(A) the maximum strength of the Ibuprofen in the medicinal product does not exceed 10%, and

(B) the medicinal product is sold or supplied in a container or package containing not more than 50 g of medicinal product which is labelled to show a maximum dose of 125 mg and a maximum daily dose of 500 mg.

30 A medicinal product shall not be a prescription only medicine by reason that it contains the substance ketoconazole, where –

(a) the medicinal product is in the form of a shampoo;

(b) the maximum strength of the ketoconazole in the medicinal product does not exceed 2%, calculated in terms of weight in weight;

(c) the medicinal product is sold or supplied in a container, or package, containing not more than 120 ml of the medicinal product and containing in the medicinal product not more than 2,400 mg of ketoconazole;

(d) the container or package is labelled to show a maximum frequency of application of once every 3 days; and

(e) the medicinal product is indicated for the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp.

31 A medicinal product shall not be a prescription only medicine by reason that it contains the substance ketoprofen, where –

(a) the maximum strength of the ketoprofen in the medicinal product does not exceed 2.5%, calculated in terms of weight in weight;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 30 g of the medicinal product; and

(c) the medicinal product is indicated only for treatment by external topical application, for rheumatic and muscular pain, in persons aged not less than 12 years, for a maximum period of 7 days.

32 A medicinal product shall not be a prescription only medicine by reason that it contains the substance levocabastine hydrochloride, where –

(a) the medicinal product is in the form of a nasal spray;

(b) the maximum strength of the medicinal product does not exceed the equivalent of 0.05% levocabastine;

(c) the medicinal product is sold or supplied in a container, or package, containing not more than 10 ml of the medicinal product; and

(d) the medicinal product is indicated for the symptomatic treatment of seasonal allergic rhinitis.

33 A medicinal product shall not be a prescription only medicine by reason that it contains the substance levocabastine hydrochloride, where –

(a) the medicinal product is in the form of aqueous eye drops;

(b) the maximum strength of the medicinal product does not exceed the equivalent of 0.05% levocabastine;

(c) the medicinal product is sold or supplied in a container, or package, containing not more than 4ml of the medicinal product; and

(d) the medicinal product is indicated for the symptomatic treatment of seasonal allergic conjunctivitis.

34 A medicinal product shall not be a prescription only medicine by reason that it contains the substance loratadine, where –

(a) the medicinal product is sold or supplied in a container, or package, containing not more than 100 mg of loratadine; and

(b) the container or package is labelled to show a maximum daily dose of 10 mg of loratadine.

35 A medicinal product shall not be a prescription only medicine by reason that it contains the substance mebendazole, where –

(a) the medicinal product is sold or supplied in a container, or package, containing not more than 800 mg of mebendazole;

(b) the container or package is labelled to show a maximum dose of 100 mg of mebendazole; and

(c) the medicinal product is indicated for oral use in the treatment of enterobiasis, in persons aged not less than 2 years.

36 A medicinal product shall not be a prescription only medicine by reason that it contains the substance nedocromil sodium, where –

(a) the maximum strength of the nedocromil sodium in the medicinal product does not exceed 2.0%, calculated in terms of weight in volume;

(b) the medicinal product is sold in a container, or package, containing not more than 3 ml of the medicinal product; and

(c) the medicinal product is indicated for the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis.

37 A medicinal product shall not be a prescription only medicine by reason that it contains the substance nizatidine, where –

(a) the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose of 75 mg of nizatidine and a maximum of 4 such doses in any period of 14 days; and

(b) the medicinal product is indicated only for the prevention of the symptoms of food-related heartburn, in persons aged not less than 16 years.

38 A medicinal product shall not be a prescription only medicine by reason that it contains the substance nystatin, where –

(a) the maximum strength of the nystatin in the medicinal product does not exceed 3.0%, calculated in terms of weight in weight;

(b) the medicinal product is sold in a container, or package, containing not more than 15 g of the medicinal product; and

(c) the medicinal product is indicated for external use in combination with hydrocortisone of a maximum strength of 0.5% for intertrigo, in persons aged not less than 10 years.

39 A medicinal product shall not be a prescription only medicine by reason that it contains the substance oxethazaine, where –

(a) the medicinal product is sold or supplied in a container, or package, containing not more than 400 ml of oxethazaine; and

(b) the container or package is labelled to show a maximum dose of 10 ml and a maximum daily dose of 30 ml of oxethazaine.

40 A medicinal product shall not be a prescription only medicine by reason that it contains the substance paracetamol, where –

(a) the medicinal product is in the form of non-effervescent tablets or capsules;

(b) the maximum strength of the medicinal product in each tablet or capsule does not exceed 500 mg;

(c) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied in one container or package does not exceed 32;

(d) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied to a person at any one time does not exceed 100; and

(e) the medicinal product is indicated for use by administration wholly or mainly to persons aged not less than 12 years.

41 A medicinal product shall not be a prescription only medicine by reason that it contains the substance paracetamol, where –

(a) the medicinal product is in the form of non-effervescent tablets or capsules;

(b) the maximum strength of the medicinal product in each tablet or capsule does not exceed 250 mg;

(c) the quantity (of tablets or capsules, or of any combination of tablets and capsules) that is sold or supplied in one container or package does not exceed 32; and

(d) the quantity (of tablets and capsules, or of any combination of tablets and capsules) that is sold or supplied to a person at any one time does not exceed 100.

42 A medicinal product shall not be a prescription only medicine by reason that it contains the substance piroxicam, where –

(a) the maximum strength of the piroxicam in the medicinal product does not exceed 0.5%;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 30 mg of the medicinal product;

(d) the medicinal product is indicated for external application for the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains and sports injuries, in persons aged not less than 12 years.

43 A medicinal product shall not be a prescription only medicine by reason that it contains the substance prochlorperazine maleate, where –

(a) the medicinal product is in the form of tablets;

(b) the maximum amount of the prochlorperazine maleate in the medicinal product, in each tablet, does not exceed 3 mg;

(d) the medicinal product is indicated only for nausea, and vomiting, in previously diagnosed migraine, in persons aged not less than 18 years.

44 A medicinal product shall not be a prescription only medicine by reason that it contains the substance pyrantel embonate, where –

(a) the medicinal product is sold or supplied in a container, or package, containing not more than 750 mg of the medicinal product;

(b) the container or package is labelled to show a maximum daily dose (to be taken as a single dose) of pyrantel embonate of 750 mg in the case of persons aged not less than 12 years, of 500 mg in the case of children aged not less than 6 years but less than 12 years, and of 250 mg in the case of children aged not less than 2 years but less than 6 years; and

45 A medicinal product shall not be a prescription only medicine by reason that it contains the substance ranitidine hydrochloride, where –

(a) the container or package in which the medicinal product is sold or supplied is labelled to show a maximum dose equivalent to 75 ml and a maximum daily dose equivalent to 300 ml of ranitidine for a maximum period of use of 14 days; and

(b) the medicinal product is indicated for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, or the prevention of those symptoms when associated with the consumption of food and drink.

46 A medicinal product shall not be a prescription only medicine by reason that it contains the substance sodium cromoglycate, where –

(a) the medicinal product is in the form of aqueous eye drops;

(b) the maximum strength of the sodium cromoglycate in the medicinal product does not exceed 2%, calculated in terms of weight in volume;

(c) the medicinal product is sold or supplied in a container containing not more than 10 ml of the medicinal product; and

(d) the medicinal product is indicated for treatment of acute seasonal allergic conjunctivitis.

47 A medicinal product shall not be a prescription only medicine by reason that it contains the substance sodium cromoglycgate, where –

(a) the medicinal product is in the form of an eye ointment;

(b) the maximum strength of the sodium cromoglycate in the medicinal product is 4%, calculated in terms of weight in weight;

(c) the medicinal product is sold or supplied in a container, or package, containing not more than 5 g of the medicinal product; and

(d) the medicinal product is indicated for the treatment of acute seasonal allergic conjunctivitis or perennial allergic conjunctivitis.

48 A medicinal product shall not be a prescription only medicine by reason of the fact that it contains terbinafine, where –

(a) the maximum strength of the terbinafine in the medicinal product does not exceed 1%;

(b) the medicinal product is sold or supplied in a container, or package, containing not more than 30 g of the medicinal product; and

(c) the medicinal product is indicated for external use as a gel for the treatment of tina corporis, tinea pedis and tinea cruris.

49 A medicinal product shall not be a prescription only medicine by reason of the fact that it contains terbinafine hydrochloride where –

(a) the maximum strength of the terbinafine hydrochloride in the medicinal product does not exceed 1%;

(b) the medicinal product is indicated for external use for the treatment of tinea pedis and tinea cruris; and

(c) the medicinal product is sold or supplied in a container or package containing not more than 15 g of medicinal product.

50 A medicinal product shall not be a prescription only medicine by reason of the fact that it contains terbinafine hydrochloride, where –

(a) the maximum strength of the terbinafine hydrochloride in the medicinal product does not exceed 1%;

(b) the medicinal product is sold or supplied in a container containing not more than 30 ml of the medicinal product; and

(c) the medicinal product is indicated for external use as a spray solution for the treatment of tina corporis, tinea pedis and tinea cruris.

51 A medicinal product shall not be a prescription only medicine by reason of the fact that it contains triamcinolone acetonide where –

(a) the medicinal product is in the form of a non-pressurised nasal spray;

(b) the medicinal product is indicated for the treatment of symptoms of seasonal allergic rhinitis in persons aged 18 years and over for a maximum period of 3 months;

(c) the container or package is labelled to show a maximum dose of 110 mcg per nostril and a maximum daily dose of 110 mcg per nostril; and

(d) the medicinal product is sold or supplied in a container or package containing not more than 3.375 mg of triamcinolone acetonide.

SCHEDULE 2

EXEMPTION FOR CERTAIN PERSONS FROM ARTICLE 57(2) OF THE LAW

PART 1[13]

(Articles 1(2)(a) and 8(1))

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.	1. All prescription only medicines.	1.(1) The sale or supply shall be subject to the presentation of an order, signed by the principal of the institution or the appropriate head of department in charge of a specified course of research.
		(2) The order shall specify–
		(a) the name of the institution for which the prescription only medicine is required;
		(b) the purpose for which the prescription only medicine is required; and
		(c) the total quantity required.
		(3) The sale or supply shall be only for the purposes of the education or research with which the institution is concerned.
2. Persons selling or supplying prescription only medicines to any of the following persons – (a) the Official Analyst appointed under Article 2 of the Food Safety (Jersey) Law 1966, or any person appointed under that Article to deputise for him or her;	2. All prescription only medicines.	2.(1) The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in any of paragraph 2(a), (b) and (c) of column 1 of this Part of this Schedule. (2) The order shall specify the status of the person signing it, and the amount of the prescription only medicine required.
(b) an authorized officer within the meaning of the Food Safety (Jersey) Law 1966; and		(3) The sale or supply shall be only in connection with the exercise by the person of his or her statutory functions.
(c) a person duly authorized by the Minister under Article 96 or 97 of the Law.
3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of drugs and appliances supplied under the Health Insurance (Jersey) Law 1967, or under any subordinate legislation made under that law.	3. All prescription only medicines.	3.(1) The sale or supply shall be subject to the presentation of an order signed by or on behalf of the person so employed or engaged. (2) The order shall specify the status of the person signing it, and the amount of the prescription only medicine required.
		(3) The sale or supply shall be only for the purposes of a scheme to which paragraph 3 of column 1 of this Part of this Schedule refers.
4. Certified midwives.	4. Prescription only medicines containing any of the following substances – Chloral hydrate Dichloral-phenazone Ergometrine maleate Pentazocine hydrochloride Phytomenadrone Triclofos sodium	4. The sale or supply shall be only in the course of the midwife’s professional practice and, in the case of Ergometrine maleate, only when contained in a medicinal product that is not for parenteral administration.
5. Persons lawfully conducting retail pharmacy businesses.	5. Prescription only medicines (not being for parenteral administration) that are of any of the following descriptions –	5. The sale or supply shall be subject to the presentation of an order signed by a registered optometrist.
	(a) eye drops, or eye ointments, that are prescription only medicines by reason only that they contain – (i) 30.0% Sulphacetamide sodium; or (ii) 0.5% Chloramphenicol;

	(b) eye ointments that are prescription only medicines by reason only that they contain – (i) 30.0% Sulpha-cetamide sodium; or (ii) 0.5%Chloramphenicol; or
	(c) medicinal products that are prescription only medicines by reason only that they contain any of the following substances – Atropine sulphate Bethanecol chloride Carbachol Cyclopentolate hydrochloride Homatropine hydrobromide Hyoscine hydrobromide Naphazoline hydrochloride Naphazoline nitrate Neostigmine methyl-sulphate Physostigmine salicylate Physostigmine sulphate Pilocarpine hydrochloride Pilocarpine nitrate Tropicamide.
6. Registered optometrists.	6. Prescription only medicines listed in paragraph 5 of column 2 of this Part of this Schedule.	6.(1) The sale or supply shall be only in the course of the optician’s professional practice. (2) The sale shall be only in an emergency.
7.(1) Holders of product licences.	7. Prescription only medicines to which the licence relates.	7. The sale or supply shall be only –
(2) Holders of manufacturer’s licences.		(a) to a pharmacist, so as to enable that pharmacist to prepare an entry relating to the prescription only medicine in question in a tablet or capsule identifi-cation guide or similar publication; and
(2) Holders of manufacturer’s licences.		(b) of no greater quantity than is reasonably necessary for that purpose.
8. Pharmacists selling or supplying to persons to whom cyanide salts may be sold lawfully under the Poisons (Jersey) Law 1952.	8. Amyl nitrite.	8. The sale or supply shall only be so far as is necessary to enable an antidote to be available to persons at risk of cyanide poisoning.

PART 2

(Articles 1(2) and 8(1))

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1.(1) The Royal National Lifeboat Institution. (2) Certificated first aiders of the Institution.	1. All prescription only medicines.	1. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
2. The owner or the master of a ship that does not carry a doctor on board as part of the ship’s complement.	2. All prescription only medicines.	2. The supply shall be only so far as is necessary for the treatment of persons on the ship.
3. The operator or commander of an aircraft.	3. Prescription only medicines that – (a) are not for parenteral administration; and (b) have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.	3.(1) The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft. (2) The supply shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
4. Persons authorized by licences granted under Article 4 of the Misuse of Drugs (General Provisions) (Jersey) Order 1989 to supply a controlled drug.	4. Prescription only medicines (being controlled drugs) whose supply is authorized by the licence.	4. The supply shall be subject to the conditions, in the circumstances and to the extent specified in the licence.
5. Persons requiring prescription only medicines to enable them, in the course of any business carried on by them, to comply with any requirements under any enactment in respect of the medical treatment of their employees.	5. Prescription only medicines specified in the enactment.	5.(1) The supply shall be only to enable the person to comply with any such requirements. (2) The supply shall be subject to such conditions and in such circumstances as may be specified in the enactment.
6. Persons operating an occupational health scheme.	6. Prescription only medicines sold or supplied to such a person in response to an order in writing signed by a doctor or a registered nurse.	6.(1) The supply shall be only in the course of the scheme. (2) The person supplying the prescription only medicine shall be – (a) a doctor; or
6. Persons operating an occupational health scheme.		(b) a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the scheme.

PART 3[14]

(Articles 1(2) and 8(2))

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Chiropodists, registered under the Health Care (Registration) (Jersey) Law 1995, who hold certificates of competence in the use of analgesics issued by or with the approval of the Chiropodists Board of the United Kingdom.	1. Prescription only medicines for parenteral administration that contain, as the sole active ingredient, not more than one of the following substances –	1. The administration shall be only in the course of the chiropodist’s professional practice.
	Bupivacaine hydrochloride
	Bupivacaine hydrochloride with adrenaline, where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride
	Lignocaine hydrochloride
	Lignocaine hydrochloride with adrenaline, where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride
	Mepivacaine hydrochloride
	Prilocaine hydrochloride
2. Certified midwives.	2. Prescription only medicines for parenteral administration that contain any of the following substances (but no other substance specified in column 1 of Part I of the First Schedule to this Order) –	2. The administration shall be only in the course of the midwife’s professional practice and, in the case of Lignocaine, Lignocaine hydrochloride and Promazine hydrochloride, shall be only while attending on a woman in childbirth.
	Ergometrine maleate
	Levallorphan tartrate
	Lignocaine
	Lignocaine hydrochloride
	Naloxone hydrochloride
	Oxytocins,
	Natural and Synthetic
	Pentazocine lactate
	Pethidine
	Pethidine hydrochloride
	Phytomenadione
	Promazine hydrochloride.
3. The owner or the master of a ship that does not carry a doctor on board as part of the ship’s complement.	3. All prescription only medicines that are for parenteral administration.	3. The administration shall be only so far as is necessary for the treatment of persons on the ship.
4. The operator or commander of an aircraft.	4. Prescription only medicines for parenteral administration that have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.	4.(1) The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft.
		(2) The administration shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
5. Persons operating an occupational health scheme.	5. Prescription only medicines for parenteral administralion that have been sold or supplied to such a person in response to an order in writing signed by a doctor or a registered nurse	5.(1) The administration shall be only in the course of the scheme. (2) The person administering the prescription only medicine shall be – (a) a doctor;
		(b) a person acting in accordance with the directions of a doctor; or
		(c) a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the scheme.
6. Persons who hold certificates of proficiency in ambulance paramedical skills issued by or with the approval of the Secretary of State of the United Kingdom, or persons who are state registered paramedics.	6. The following prescription only medicines for parenteral administration –	6. The administration shall be only for the immediate, necessary treatment of sick or injured persons and, in the case of a prescription only medicine containing Heparin sodium, shall be only for the purpose of cannula flushing.
	(a) Diazemuls (product licence number 10183/00001);
	(b) Gelofusine (product licence number 00183/5025R); and
	(c) medicines containing the substances Ergometrine Maleate 500mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient:
	(d) prescription only medicines that contain one or more of the following substances, (but no other active ingredient)-
	Adrenaline acid tartrate
	Benzylpenicillin
	Frusemide
	Glucose
	Heparin sodium
	Lignocaine hydrochloride
	Metoclopramide
	Morphine Sulphate
	Nalbuphine hydrochloride
	Naloxone hydrochloride
	Polygeline
	Sodium bicarbonate
	Sodium chloride.
	Streptokinase

SCHEDULE 3

(Articles 9(3)(c) and (4)(a))

SUBSTANCES THAT MUST NOT BE CONTAINED IN A PRESCRIPTION ONLY MEDICINE EXEMPTED BY ARTICLE 9

Ammonium Bromide
Amylobarbitone
Amylobarbitone Sodium
Barbitone
Barbitone Sodium
Butobarbitone
Butobarbitone Sodium
Calcium Bromide
Calcium Bromidolactobionate
Cyclobarbitone
Cyclobarbitone Calcium
Embutramide
Fencamfamin Hydrochloride
Fluanisone
Heptabarbitone
Hexobarbitone
Hexobarbitone Sodium
Hydrobromic Acid
Meclofenoxate Hydrochloride
Methohexitone Sodium
Methylphenobarbitone
Pemoline
Pentobarbitone
Pentobarbitone Sodium
Phenobarbitone
Phenobarbitone Sodium
Phenylmethylbarbituric Acid
Piracetam
Potassium Bromide
Prolintane Hydrochloride
Quinalbarbitone
Quinalbarbitone Sodium
Quinidine Phenylethylbarbiturate
Secbutobarbitone
Secbutobarbitone Sodium
Sodium Bromide
Strychnine Hydrochloride
Tacrine Hydrochloride
Thiopentone Sodium
Note (for information):	The restriction in Article 9(3)(c) is subject to Article 9(4), in respect of Phenobarbitone and Phenobarbitone Sodium for use in the treatment of epilepsy.

SCHEDULE 4[15]

(Articles 6(2)(ca) and 6A(2))

clinical management plan

1 Information to be included in clinical management plan

A clinical management plan must include –

(a) the name of the patient to whom the plan relates;

(b) the illness or conditions in relation to which the supplementary prescriber may give a prescription or administer (or direct the administration of) a medicinal product;

(c) the date on which the plan is to take effect and the date or dates when it is subject to review by the doctor or dentist who is a party to the plan;

(d) the class or description of medicinal product that may be prescribed by a supplementary prescriber or administered by, or under the direction of, a supplementary prescriber;

(e) any restrictions or limitations as to the strength or dose, or period of use, of any medicinal product which may be prescribed by or administered by, or under the direction of, the supplementary prescriber;

(f) any relevant warnings about the known sensitivities of the patient to, or known difficulties of the patient with, particular medicinal products;

(g) arrangements for the notification of suspected or known adverse reactions to –

(i) the medicinal product referred to in paragraph (d), and

(ii) any other medicinal product taken at the same time or over the same period;

(h) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist who is a party to the plan.

Endnotes

Table of Legislation History

Legislation	Year and No	Commencement
Medicines (Prescription Only) (Jersey) Order 1997	R&O.9140	1 January 1998
Medicines (Prescription Only) (Amendment) (Jersey) Order 1998	R&O.9326	1 January 1999
Medicines (Prescription Only) (Amendment No. 2) (Jersey) Order 2000	R&O.1/2000	1 February 2000
Medicines (Prescription Only) (Amendment No. 3) (Jersey) Order 2001	R&O.2/2001	1 February 2001
Medicines (Prescription Only) (Amendment No. 4) (Jersey) Order 2002	R&O.94/2002	1 October 2002
Medicines (Prescription Only) (Amendment No. 5) (Jersey) Order 2003	R&O.75/2003	13 August 2003
Medicines (Prescription Only) (Amendment No. 6) (Jersey) Order 2004	R&O.65/2004	12 July 2004
Medicines (Prescription Only) (Amendment No. 7) (Jersey) Order 2005	R&O.174/2005	11 November 2005
States of Jersey (Amendments and Construction Provisions No. 5) (Jersey) Regulations 2005	R&O.45/2005	9 December 2005
Pharmacists and Pharmacy Technicians (Registration) (Jersey) Law 2010	L.6/2010	16 May 2010
Medicines (Prescription Only) (Amendment No. 8) (Jersey) Order 2013	R&O.82/2013	1 July 2013
Opticians (Registration) (Amendment No.2) (Jersey) Law 2017	L.13/2017	19 May 2017
Data Protection (Jersey) Law 2018	L.3/2018	25 May 2018

Table of Renumbered Provisions

Original	Current
3(3)	revoked by R&O.9326
10A	11
11	12
12	13
13	14
14	15
15	16
FIRST SCHEDULE	SCHEDULE 1
PART I	PART 1
PART II	PART 2
PART III	PART 3
PART IV	PART 4
7A	8
8	9
9	10
10	11
11	12
12	13
13	14
13A	15
14	16
14A	17
15	18
16	19
17	20
18	21
19	22
20	23
21	24
22	25
23	26
24	27
25	28
25A	29
26	30
27	31
28	32
29	33
30	34
31	35
32	36
33	37
34	38
35	39
36	40
37	41
38	42
38A	43
39	44
40	45
41	46
42	47
42A	48
43	49
43A	50
44	51
SECOND SCHEDULE	SCHEDULE 2
PART I	PART 1
PART II	PART 2
PART III	PART 3
6(bb)	6(c)
6(c)	6(d)
THIRD SCHEDULE	SCHEDULE 3

Table of Endnote References

[1] This Order has been amended by the States of Jersey (Amendments and Construction Provisions No. 5) (Jersey) Regulations 2005. The amendments replace all references to a Committee of the States of Jersey with a reference to a Minister of the States of Jersey, and remove and add defined terms appropriately, consequentially upon the move from a committee system of government to a ministerial system of government

[2] Article 1(1) amended by R&O.2/2001, R&O.82/2013, L.13/2017, L.3/2018

[3] Article 2 amended by R&O.82/2013

[4] Article 5 substituted by R&O.82/2013

[5] Article 6 heading amended by R&O.82/2013

[6] Article 6(2) amended by R&O.82/2013

[7] Article 6A inserted by R&O.82/2013

[8] Article 9(3) amended by R&O.9326, R&O.1/2000

[9] Article 10 substituted by R&O.82/2013

[10] Article 11 inserted by R&O.65/2004

[11] Schedule 1 Part 1 amended by R&O.9326, R&O.1/2000, R&O.2/2001, R&O.94/2002, R&O.174/2005

[12] Schedule 1 Part 4 substituted by R&O.1/2000, amended by R&O.2/2001, R&O.94/2002,

[13] Schedule 2 Part 1 amended by R&O.1/2000, L.6/2010, L.13/2017

[14] Schedule 2 Part 3 amended by R&O.9326, R&O.1/2000, R&O.2/2001

[15] Schedule 4 inserted by R&O.82/2013

Page Last Updated: 10 Dec 2024

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Medicines (Prescription Only) (Jersey) Order 1997

Showing the law from 01 Jan 2019 to 14 Oct 2019