Medicines
(Applications for Licences for Products for Human Use) (Jersey) Order 1997[1]
THE HEALTH AND
SOCIAL SERVICES COMMITTEE after consultation
with the Medicines Advisory Council, in
pursuance of Articles 19 and 110 of the Medicines (Jersey)
Law 1995, orders as
follows –
Commencement [see endnotes]
1 Interpretation
(1) In
this Order, unless the context otherwise requires –
“Directives”
means Council Directives 75/318/EEC, 75/319/EEC, 89/342/EEC and 89/381/EEC;
“1965 Directive”
means Council Directive 65/65 EEC of 26th January 1965 on the
approximation of provision laid down by law, regulation or administrative
action relating to medicinal products (as amended by Council Directive
89/341/EEC and as it applies in accordance with Council Directives 75/319/EEC,
89/342/EEC, 89/343/EEC, 89/381/EEC and Article 9(1) of Council Directive
92/73/EEC);
“expert” means
an expert with suitable technical or professional qualifications and experience
for the purposes of drawing up any description or particulars to which paragraph
7 or 8 of Schedule 1 refers, or of drawing up any report to which paragraph
12 of that Schedule refers;
“Law” means
the Medicines
(Jersey) Law 1995;
“standard provisions”
means the standard provisions that are for the time being prescribed by the Medicines (Standard
Provisions for Licences and Certificates) (Jersey) Order 1997 in
respect of the product licence for which application is made.
(2) In
this Order, unless the context otherwise requires, a reference to a Directive
is to a Directive as it was in force immediately before the date on which this Order
is made.
(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 Scope of Order
This Order does not
apply –
(a) to
an application to renew a licence; or
(b) to
an application for a licence for a medicinal product that is not for human use.
3 Applications for licences
(1) An
application for a product licence shall be in writing.
(2) Subject
to Schedules 2 and 3 –
(a) the
application shall, for each medicinal product, include the information,
documents, samples and other material specified in Schedule 1; and
(b) they
shall in every case be prepared and presented in accordance with the
requirements of the Directives in respect of medicinal products to which
Chapters II to V of the 1965 Directive apply.
4 Separate applications
A separate application
shall be made for each description of medicinal product, except that one
application may be made in any of the following cases –
(a) in
respect of any medicinal products that have the same pharmaceutical form, and
either consist of the same single active constituent in different strengths or
consist of a mixture in different strengths of the same 2 or more active
constituents in the same proportion;
(b) in
respect of any substances or articles that have the same physical form, and
either have the same single active constituent in different strengths or are a
mixture in different strengths of the same 2 or more active constituents in the
same proportion;
(c) in
the case of homeopathic medicinal products and medicinal products using similar
attenuations, in respect of–
(i) any
attenuations of the same mother tincture or other solution or of the same
trituration, or
(ii) any
attenuations of any mother tincture or other solution or trituration having the
same specification and pharmaceutical form apart from the tincture, other
solution or trituration;
(d) in
the case of medicinal products that are preparations of allergen extracts for
the treatment of allergies, in respect of any attenuations of –
(i) the
same allergen extract, or
(ii) the
same mixture of allergen extracts; or
(e) in
the case of medicinal products for testing for allergic responses to specific
substances, in respect of any allergen extracts that are manufactured by one
and the same method (if the application specifies the substances from which the
extracts are prepared).
5 Standard provisions
The application shall
specify –
(a) each
of the standard provisions that it is desired to exclude or modify; and
(b) in
the latter case, the ways in which modification is sought.
6 Signature
(1) The
applicant shall sign the application.
(2) Where
the proposed holder of the licence is not the applicant, the proposed holder
shall also sign the application.
7 Copies
The applicant shall
supply to the Minister –
(a) 10
copies of the application, or such lesser number as the Minister may require, in
the English language; and
(b) where
it has been translated from another language, one copy in that language.
8 Citation
This Order may be cited
as the Medicines (Applications for Licences for Products for Human Use)
(Jersey) Order 1997.
SCHEDULE
1
(Articles 1(1) and
3(2)(a))
Information required on
application for product licence
1.
(1) The
names or corporate names, and the permanent addresses, of –
(a) the person
responsible for placing the medicinal product on the market in Jersey;
(b) the manufacturers
and the sites involved in the different stages of manufacture (including the
manufacturer of the finished medicinal product and the manufacturers of the
active ingredients); and
(c) where
relevant, the importer.
(2) Where
the licence is required solely for the purpose of exporting a medicinal product
the name or corporate name, and the permanent address, of the exporter.
(3) In
relation to a substance or article in respect of which Article 8(2) of the
Law has effect by virtue of Article 42 of the Law, where any seller,
supplier or exporter of the medicinal product is not named under paragraph (1)
of this paragraph, a description of the circumstances in which that person will
sell, supply or export it.
2. The
name of the medicinal product, that is to say –
(a) the
brand name;
(b) the
common name, together with a trade mark;
(c) the
name of the manufacturer; or
(d) the
scientific name, together with a trade mark or name of the manufacturer.
3. The
qualitative and quantitative particulars of each constituent of the medicinal
product, together with –
(a) details
of any relevant data concerning its container and, where appropriate, its
manner of closure; and
(b) details
of each device, for its use or administration, that will be delivered with it.
4. A
brief description of the method of preparation.
5. Particulars
of the therapeutic indications, contraindications and side effects.
6. Particulars
of the posology, pharmaceutical form, method and route of administration and
expected shelf-life.
7. A
description, drawn up and signed by experts, of the control methods employed by
the manufacturer (indicating the qualitative and quantitative analysis
of –
(a) each
constituent;
(b) the
finished medicinal product; and
(c) all
special tests that have been carried out (including sterility tests, tests for
the presence of pyrogenic substances and for the presence of heavy metals,
stability tests, biological and toxicity tests, and controls carried out at any
intermediate stages of the manufacturing process).
8. Particulars,
drawn up and signed by experts, of the results of all –
(a) physico-chemical,
biological and microbiological tests;
(b) pharmacological
and toxicological tests; and
(c) clinical
trials,
including all relevant
details of each incomplete or abandoned pharmacotoxicological or clinical test
or trial.
9. A
summary of the characteristics of the medicinal product, containing the
following information –
(a) its
name;
(b) by
reference to its international non-proprietary name or (where there is no such
name) the usual common name or chemical description, the qualitative and
quantitative composition of the medicinal product, in terms of the active
ingredients of which knowledge is essential for its proper administration;
(c) its
pharmaceutical form;
(d) clinical
particulars in respect of –
(i) therapeutic
indications,
(ii) posology
and methods of administration for adults and, where necessary, for children,
(iii) contra-indications,
(iv) special
warnings,
(v) special precautions for
use and, in relation to an immunological medicinal product to which Council
Directive 89/342/EEC applies, information regarding any special precautions to
be taken by persons handling the medicinal product and persons administering it
to patients, together with any precautions to be taken by the patient,
(vi) interaction
with other medicaments and other forms of interaction,
(vii) use during
pregnancy and lactation,
(viii) effects on the
ability to drive and to use machines,
(ix) undesirable
effects (including their frequency and seriousness), and
(x) overdoses (including
symptoms, emergency procedures and antidotes);
(e) its
pharmacological properties and, where such information is useful for
therapeutic purposes, pharmacokinetic particulars;
(f) pharmaceutical
particulars in respect of –
(i) qualitative
composition in terms of the excipients used,
(ii) major
incompatibilities,
(iii) shelf-life,
where relevant after reconstitution of the medicinal product and after the
container is opened for the first time,
(iv) special
precautions for storage,
(v) the nature and
composition of the container,
(vi) special
precautions for the disposal of unused medicinal products and waste materials
derived from the medicinal products, if appropriate, and
(vii) the name or
style, and the permanent address or registered place of business, of the holder
of the licence;
(g) in
relation to any radiopharmaceutical to which Council Directive 89/343/EEC
applies –
(i) full details of
internal radiation dosimetry, and
(ii) additional
detailed instructions for the extemporaneous preparation and control of the
quality of the preparation and, where appropriate, details of the maximum
storage time during which any intermediate preparation such as an eluate, or
the pharmaceutical as it is ready to use, will conform with its specifications;
and
(h) in
relation to any indications to which paragraph 22 of this Schedule applies, a
statement drawing to the attention of persons who may lawfully prescribe or
supply the medicinal product the fact that the particulars available concerning
the medicinal product are as yet inadequate in specified respects.
10. A
copy of the manufacturing authorization as defined in Article 16 of
Council Directive 75/319/EEC, and any other relevant document showing that the
manufacturer is authorized in the manufacturer’s own country to produce
medicinal products.
11. Copies
of the following documents –
(a) each authorization
obtained in –
(i) a member State of
the European Communities (other than the United Kingdom), or
(ii) a
country that is not a member of the European Communities,
to place the relevant
medicinal product on the market;
(b) each
of the summaries of the characteristics of the medicinal product in accordance
with Article 4a of the 1965 Directive as approved by member States;
and
(c) a
list of the countries in which an application has been submitted in respect of
the medicinal product.
12.
(1) An
expert’s report on –
(a) the
chemical, pharmaceutical and biological documentation;
(b) the
pharmacotoxicological documentation; and
(c) the
clinical documentation,
in respect of the
medicinal product stating, where applicable, the grounds on which the applicant
claims to be entitled to use published references in accordance with paragraphs
1, 2, 3 and 4 of Schedule 2.
(2) The
report shall be signed and dated by the expert.
13. Brief
information about the educational background, training and occupational
experience of each expert, and a declaration as to the expert’s
professional relationship to the applicant.
14. One
or more samples or mock-ups of the presentational material to be used for
marketing, the outer packaging, the immediate packaging, the labels, and the
package leaflet (if any).
15. A
statement indicating the number of volumes of documentation submitted in
support of the application.
16. A
statement indicating any samples provided.
17. Where
the applicant is required to provide, under paragraph 8 of this Schedule,
particulars of the results of any safety test falling within Part 3, paragraph
1.1, second sub-paragraph of the Annex to Council Directive 75/318/EEC, a copy
of any certificate issued by the laboratory that carried out the test to the
effect that the test was carried out in conformity with the principles of good
laboratory practice to which that sub-paragraph refers.
18. Where
the applicant is required to provide, under paragraph 8 of this Schedule,
particulars of the results of any clinical trial, a summary of the arrangements
proposed for the keeping in archives of documentation of the trial in
accordance with Part 4, paragraph B.2 of the Annex to Council Directive
75/318/EEC, including the arrangements proposed for ensuring that any change of
ownership in the relevant data is recorded in writing and that all relevant
data and documents will be made available to the Minister if required.
19. A
statement indicating –
(a) whether
the medicinal product should be available –
(i) on prescription
only (that is to say, that it should be subject to the restrictions described
in Article 57(2)(a) or 59(1) of the Law),
(ii) only
from a pharmacy (that is to say, that it should be subject to a restriction
under Article 51 or 52 of the Law to the effect that it may be sold
only at a registered pharmacy, but not subject to the restrictions described in
Article 57(2)(a) or 59(1) of the Law), or
(iii) on
general sale (that is to say, that it should not be subject to any of the
restrictions to which clauses (i) and (ii) of this sub-paragraph refer);
and
(b) what
provisions (if any) in the licence are proposed in respect of the methods of
sale and supply of the medicinal product (including any proposed restrictions
affecting the circumstances that relate to the promotion and use of the
medicinal product).
20. If
the medicinal product is in use lawfully in other countries –
(a) information
in respect of adverse drug reactions to the medicinal product and to other
medicinal products containing the same active ingredient (in each case, where
possible, in relation to the rates of usage) and information from worldwide
studies that is relevant to the safety of the medicinal product;
(b) in
the case of any vaccine, information on the monitoring of vaccinated subjects
to evaluate the prevalence of the disease in question by comparison with
non-vaccinated subjects, when that information is available; and
(c) in
the case of allergen medicinal products, details of response in periods of
increased antigen exposure.
21. In
relation to each generator to which Article 3 of Council Directive
89/343/EEC applies –
(a) a
general description of the system, together with a detailed description of each
component of the system that may affect the composition or quality of the
daughter nuclide preparation; and
(b) qualitative
and quantitative particulars of each eluate and each sublimate.
22. Where
the applicant, in relation to any particular therapeutic indications, omits any
information by reason of paragraph 5 of Schedule 2 –
(a) detailed
proposals for the programme of studies to which that paragraph refers
(including a proposed period for carrying them out) for the purposes of a
reassessment of the profile of benefits and risks in relation to those
indications; and
(b) a
statement as to each proposal that the medicinal product in question should be
administered for those indications only under strict medical supervision or in
a hospital or, for a radiopharmaceutical to which Council Directive 89/343/EEC
applies, by an authorized person.
23. Where
the licence is required solely for the purpose of exporting a medicinal
product, a statement to that effect.
24. All
other information that is relevant to the evaluation of the medicinal product,
whether the information is favourable or unfavourable.
SCHEDULE
2
(Article 3(2))
Exceptions to requirements
of paragraph 8 of Schedule 1
1. Subject
to paragraphs 2, 3 and 4 of this Schedule, the applicant shall not be required
under paragraph 8 of Schedule 1 to provide particulars of the results of
pharmacological and toxicological tests, or of the results of clinical trials,
where the applicant can demonstrate –
(a) that the medicinal product is similar in all
material respects to a medicinal product to which an existing product licence
applies (not being a licence relating solely to importation), and that the person
responsible for placing that medicinal product on the market in Jersey consents
to the pharmacological, toxicological or clinical references (as the case may
be) that are contained in the file on the original medicinal product being used
for the purpose of examining the medicinal product in question; or
(b) by
detailed references to published scientific literature presented in accordance
with the second paragraph of Article 1 of Council Directive 75/318/EEC,
that each constituent of the medicinal product has a well-established medical
use, with recognized efficacy and an acceptable level of safety.
2. The
applicant shall provide particulars of the results of appropriate
pharmacological and toxicological tests, and of clinical trials,
where –
(a) the
medicinal product is intended for a different therapeutic use from that of the
other medicinal products marketed; or
(b) is to
be administered by any different route or in any different dose than those
other medicinal products.
3. Where
the medicinal product is a new medicinal product containing known constituents that
have not been used in combination for therapeutic purposes, the applicant shall
provide particulars of the results of appropriate pharmacological and
toxicological tests and of clinical trials in relation to that combination, but
it shall not be necessary to provide references relating to each individual
constituent.
4. The
applicant shall not omit any particulars or results if, without them, proper
consideration of the application could not be carried out without prejudicing
any rights that –
(a) arise
under any law relating to the protection of industrial or commercial property;
and
(b) are
enforceable in Jersey.
5. The
applicant shall not be required under paragraph 8 of Schedule 1 to
provide, in relation to particular therapeutic indications, the results of any
tests or trials where –
(a) in
respect of those indications the applicant can show that he or she is unable to
provide comprehensive information as to quality, efficacy and safety under
normal conditions of use because –
(i) the indications
for which the medicinal product is intended are encountered so rarely that the
applicant cannot reasonably be expected to provide comprehensive evidence,
(ii) in
the present state of scientific knowledge, comprehensive information cannot be
provided, or
(iii) it
would be contrary to generally accepted principles of medical ethics to collect
such information;
(b) if
the applicant wishes the Minister to consider granting the licence on the basis
that the applicant would be required to carry out a programme of studies for
the purposes of reassessing the profile of benefits and risks, the applicant
can show –
(i) that the
medicinal product would be supplied on medical prescription only (and subject
to any other relevant restrictions), and
(ii) that
the applicant would be required to provide relevant information in the package
leaflet and medical information; and
(c) the
applicant provides a statement that complies with paragraph 19(a) of Schedule 1
and paragraph 22(a) and (b) of that Schedule.
6. The
applicant shall not be required under paragraph 8 of Schedule 1 to provide
any material that –
(a) has
been or is provided in connection with another application made by the
applicant previously or at the same time (whether or not that other application
is made under this Order);
(b) is
identified in the application, or in any document accompanying it, by reference
to its provision in connection with that other application; and
(c) would
meet the requirements of this Order if it had been provided in connection with
the application that is under consideration.
SCHEDULE
3
(Article 3(2))
Information that may be
provided by manufacturer
1. In
the case of an active ingredient that is manufactured by a person other than
the applicant, and –
(a) is not described in the European
Pharmacopoeia or in the pharmacopoeia of a member State of the European
Communities; or
(b) although
described in the European Pharmacopoeia or in the pharmacopoeia of a member
State, is an ingredient prepared by a method liable to leave impurities that
are not mentioned in the pharmacopoeial monograph and for which the monograph
is inappropriate to control its quality adequately,
the applicant may arrange
for the detailed descriptions of the manufacturing method, control of quality
during manufacture and validation of the processes used to be supplied directly
to the Minister by the manufacturer of the active ingredient.
2. Paragraph
1 shall not apply unless –
(a) the
manufacturer provides the applicant with the data that is necessary to enable
the latter to take responsibility for the medicinal product;
(b) the
manufacturer confirms in writing to the applicant that the manufacturer will
ensure batch to batch consistency and will not modify the manufacturing process
or specifications without informing the applicant; and
(c) the
application is accompanied by –
(i) the documents and
other material that are reasonably necessary to enable the Minister to be
satisfied that the manufacturer has complied with sub-paragraph (a),
(ii) a
copy of the confirmation required by sub-paragraph (b), and
(iii) the
other documents and material that are reasonably necessary to enable the
Minister to be satisfied that the applicant has made adequate arrangements,
with the manufacturer, for the provision to the Minister of appropriate
documents and particulars supporting any application to make any modification
to which sub-paragraph (b) refers.