Medicines (Prescription Only) (Jersey) Order 1997

Official Consolidated Version

This is an official version of consolidated legislation compiled and issued under the authority of the Legislation (Jersey) Law 2021.

 

Showing the law from 12 August 2022 to Current

 

 

Medicines (Prescription Only) (Jersey) Order 1997

Article

1             Interpretation. 4

2             Prescription only medicines. 6

3             Medicinal products that are not prescription only medicines. 7

4             New medicinal products. 8

5             Appropriate practitioner. 8

6             Conditions for prescriptions relating to sale and supply. 9

6A          Conditions for prescriptions – administration. 10

7             Exemption for highly diluted medicinal products. 11

8             Exemptions for specified categories of persons. 11

9             Exemption for emergency sale or supply. 11

10           Exemption for sale or supply in hospitals or the prison. 13

11           Exemption for authorised needle supply services. 13

12           Exemption for sale or supply in cases involving another’s default. 14

13           Exemption in the case of forged prescription. 14

14           Exemption for parenteral administration to human beings. 14

15           Exemption for non-parenteral administration to human beings. 14

16           Citation. 14

PART 1  16

PRESCRIPTION ONLY MEDICINES  16

PART 2  68

PART 3  69

NAMED PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES  69

TABLE A   69

TABLE B   70

PART 4  71

OTHER MEDICINAL PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES  71

EXEMPTION FOR CERTAIN PERSONS FROM ARTICLE 57(2) OF THE LAW    83

PART 1  83

PART 2  87

PART 3  89

SUBSTANCES THAT MUST NOT BE CONTAINED IN A PRESCRIPTION ONLY MEDICINE EXEMPTED BY ARTICLE 9  92

clinical management plan   94

1             Information to be included in clinical management plan. 94

Table of Legislation History. 95

Table of Renumbered Provisions. 95

Table of Endnote References. 97

 

 

Medicines (Prescription Only) (Jersey) Order 1997[1]

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 any of the following –

(a)     a midwife or nurse, whose entry on the register established and maintained under article 5 of the Nursing and Midwifery Order 2001 of the United Kingdom indicates that he or she is, or may act as, only a supplementary prescriber;

(b)     an optometrist, whose entry on the register established and maintained under section 7(a) of the Opticians Act 1989 of the United Kingdom indicates that he or she is, or may act as, only a supplementary prescriber;

(c)     a pharmacist, whose entry on the register established and maintained under article 19 of the Pharmacy Order 2010 of the United Kingdom indicates that he or she is, or may act as, only a supplementary prescriber;

(d)     a physiotherapist, podiatrist or radiographer, whose entry on the register established and maintained under article 5 of the Health and Social Work Professions Order 2001 of the United Kingdom 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

(c)     the medicinal product is sold or supplied –

(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

(c)     it is sold or supplied –

(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]

(1)     For the purposes of Article 57(1), the following are appropriate practitioners –

(a)     doctors;

(b)     dentists;

(c)     veterinary surgeons;

(d)     nurse independent prescribers;

(e)     optometrist independent prescribers, but only in relation to a medicinal product that is not a controlled drug and that is not for parenteral administration;

(f)      paramedic independent prescribers, but only in relation to a medicinal product that does not contain a controlled drug other than –

(i)      Codeine,

(ii)      Fentanyl,

(iii)     Midazolam, or

(iv)     Morphine; and

(g)     pharmacist independent prescribers;

(h)     physiotherapist independent prescribers, but only in relation to a medicinal product that does not contain a controlled drug other than –

(i)      Dihydrocodeine,

(ii)      Fentanyl,

(iii)     Morphine,

(iv)     Oxycodone, or

(v)     Temazepam;

(i)      podiatrist independent prescribers, but only in relation to a medicinal product that does not contain a controlled drug other than Dihydrocodeine or Temazepam;

(j)      supplementary prescribers;

(k)     therapeutic radiographer independent prescribers, but only in relation to a medicinal product that does not contain a controlled drug other than –

(i)      Codeine,

(ii)      Fentanyl,

(iii)     Midazolam,

(iv)     Morphine,

(v)     Oxycodone,

(vi)     Temazepam, or

(vii)    Tramadol.

(2)     In this Article, a reference to the following occupations is taken to be a reference to a person registered in respect of that occupation under the Health Care (Registration) (Jersey) Law 1995 –

(a)     nurse independent prescriber;

(b)     optometrist independent prescriber;

(c)     paramedic independent prescriber;

(d)     pharmacist independent prescriber;

(e)     physiotherapist independent prescriber;

(f)      podiatrist independent prescriber;

(g)     therapeutic radiographer independent prescriber.

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;

(c)     the prescription shall contain the following information –

(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

(C)     the supplementary prescriber, 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;

(c)     the prescription only medicine is sold or supplied in accordance with the directions of the doctor requesting it;

(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]

 

 

PART 2

(Articles 1(2), 3(2) and 7)

 

 

PART 3

(Article 3(4))

NAMED PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES

 

 

 

 

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;

(c)     the container or package is labelled to show a maximum period of use of 7 days; and

(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;

(c)     the container or package is labelled to show a maximum period of use of 7 days; and

(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;

(c)     the medicinal product is sold or supplied in a container, or package, containing –

(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;

(c)     the medicinal product is sold or supplied in a container, or package, containing –

(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

(c)     the route of administration of the medicinal product is external; and

(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;

(c)     the container or package is labelled to show a maximum period of use of 7 days; and

(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;

(c)     the medicinal product is sold or supplied in a container, or package, containing not more than 8 tablets; and

(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

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

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))

 

PART 2

(Articles 1(2) and 8(1))

 

 

PART 3[14]

(Articles 1(2) and 8(2))

SCHEDULE 3

(Articles 9(3)(c) and (4)(a))

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

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.