Medicines
(Applications for Clinical Trial Certificates) (Jersey) Order 1997[1]
THE HEALTH AND
SOCIAL SERVICES COMMITTEE after consultation with
the Medicines Advisory Council, in
pursuance of Articles 37 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 –
“approved name”,
in respect of a constituent, means –
(a) the
name of the substance or article that appears in the current edition of the
list prepared in accordance with section 100 of the Medicines Act and published
under that section by the Ministers (within the meaning of subsection (1) of
section 1 of the Act); or
(b) the
international non-proprietary name recommended by the World Health
Organisation;
“Law” means the Medicines (Jersey) Law
1995;
“monograph”
means a monograph, in the current edition of–
(a) the
European Pharmacopoeia;
(b) any
compendium published under section 99 of the Medicines Act by the Health
Ministers or the Agriculture Ministers (within the meaning of subsection (1) of
section 1 of the Act);
(c) the
British Pharmacopoeia; or
(d) the British
Pharmaceutical Codex;
“monograph name”
means the name that appears at the head of a monograph;
“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 clinical trial certificate for which application is made.
(2) 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
to an application to renew a clinical trial certificate.
3 Applications for certificates
(1) An
application for a clinical trial certificate shall be in writing.
(2) The
application shall include the information in the Schedule to this Order.
(3) A
separate application shall be made for each description of medicinal product.
(4) Notwithstanding
paragraph (3), one application may be made for any medicinal products that
are to be administered in the course of the same clinical trial.
4 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.
5 Explanation of omissions
Where the application
omits information that is required by Article 3 –
(a) if
the information is not applicable, it shall state that it is not applicable;
and
(b) if
the information is applicable, it shall explain the reason for the omission.
6 Layout
(1) The
application shall be laid out so that those parts relating to –
(a) chemical
and pharmaceutical studies;
(b) experimental
and biological studies;
(c) clinical
studies; and
(d) precautions
and contra-indications,
are each appended, in
sequence, in a separate section or volume.
(2) The
pages of the application shall be numbered in sequence, except that each
appendix –
(a) shall
have on its first page a reference that identifies the application of which it
forms part; and
(b) shall
have its own pages numbered separately, in their own sequence.
(3) The
body of the application shall itself identify the appendices, in sequence, by their
references.
7 Signature
(1) The
applicant shall sign the application.
(2) Where
the proposed holder of the certificate is not the applicant, the proposed
holder shall also sign the application.
8 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.
9 Samples
If so requested by the
Minister, the applicant shall provide a sample of any medicinal product to
which the application relates.
10 Citation
This Order may be cited
as the Medicines (Applications for Clinical Trial Certificates) (Jersey) Order
1997.
SCHEDULE
(Article 3(2))
Information required on
application for clinical trial certificate
1 (1) The name and address
of the applicant.
(2) The name and address of the proposed holder
of the certificate (if the proposed holder is not the applicant).
2 The
period for which the certificate is desired (if less than 2 years).
3 (1) A statement of the
activities to which the certificate is to relate.
(2) In
respect of each medicinal product to which the certificate is to relate,
whether it is for one or more of the following purposes, namely –
(a) the sale or supply of
the medicinal product for the purposes of a clinical trial;
(b) the procurement of its
sale or supply, for the purposes of a clinical trial;
(c) the procurement of its
manufacture or assembly, for sale or supply, for the purposes of a clinical
trial; or
(d) its importation into Jersey
for the purposes of a clinical trial.
4 Where
any medicinal product is to be sold or supplied, for the purposes of the
trial –
(a) to
practitioners;
(b) to
persons providing hospital services; or
(c) in
any other way,
a statement of each of
those ways in which it is to be sold or supplied.
5 A
statement of –
(a) the
name and address of each person in the United Kingdom or Jersey (other than the
proposed holder of the certificate) who will take part in the manufacture or
assembly of each medicinal product;
(b) the
manufacturing and assembling operations;
(c) the
address of each place of manufacture or assembly; and
(d) in
the case of an imported medicinal product, the name and address of each person
who manufactures or assembles the medicinal product in the form in which it is
to be imported.
6 Where
the activity is to procure the sale or supply of any medicinal product, the
name and address of the person selling or supplying the medicinal product for
the purposes of the clinical trial.
7 The
name of each medicinal product or, if it does not have a name, the code
designation that the proposed holder of the certificate has given to it.
8 A
statement of the specification of each medicinal product (apart from the
information required under paragraphs 9, 10 and 12 of this Schedule).
9 A
description of the pharmaceutical form in which each medicinal product is to be
administered to human beings.
10 A
statement of the qualitative and quantitative composition of each medicinal
product, dealing with –
(a) its
constituents (whether active or not); and
(b) all
colouring matter, flavouring agents and perfumes.
11 In
respect of each constituent (whether active or not) –
(a) its
approved name or monograph name;
(b) if it
does not have an approved name or monograph name, the non-proprietary
designation or other descriptive appellation by which it can be readily
identified; or
(c) if
there is no such name, designation or descriptive appellation, the proprietary
designation.
12 The
specification of all constituents (whether active or not) or, at the option of
the applicant in respect of a constituent that is the subject of a monograph, a
reference to the monograph name instead of the specification.
13 The
chemical structural formula for each active constituent (where known) or, at
the option of the applicant in the case of an active constituent that is the
subject of a monograph, a reference to the monograph name instead of the
formula.
14 A
description in detail of the method of manufacture of each medicinal product.
15 A
description of the method of manufacture of each active constituent or, at the
option of the applicant in the case of an active constituent that is the
subject of a monograph, a reference to the monograph name instead of a description.
16 In
the case of every constituent (whether active or not), a description of the
procedures and methods, for the control of its quality, that are to be applied
to ensure compliance with the specification.
17 A
description of the procedures and methods to be used to ensure the uniformity
of each medicinal product in the processes of manufacture and assembly, and
evidence of the stability of the product.
18 A
description of the methods to be employed during manufacture for determining
the identity, purity and potency of each medicinal product, and the address of
the premises where the procedures for those purposes are to be carried out.
19 A
description of the containers to be used for each description of medicinal
product, and a statement of any special directions that are necessary for
storage and transport.
20 A
description of the clinical use to be investigated and an outline of the
proposed trial.
21 The
proposed dosage, duration of dosage and methods and routes of administration of
each medicinal product.
22 A
statement of the directions, contra-indications and warnings proposed by the
applicant in relation to the trial of each medicinal product.
23 Copies
of the reports and evaluations of experimental and biological studies and other
preclinical, clinical and laboratory studies carried out with each medicinal
product or its constituents, where, in the view of the applicant, they are
relevant to the assessment of the safety, quality or efficacy of the medicinal
product.
24 References
to all relevant publications and other clinical trials.