Medicines
(Applications for Manufacturer’s and Wholesale Dealer’s Licences)
(Jersey) Order 1997[1]
THE HEALTH AND SOCIAL SERVICES COMMITTEE in pursuance of Articles 19 and 110 of the Medicines (Jersey)
Law 1995, after consultation with the Medicines Advisory Council and
having otherwise complied with Article 110 of the Law, orders as
follows –
Commencement [see endnotes]
1 Interpretation
(1) In
this Order, unless the context otherwise requires –
“imported
proprietary product” means a proprietary medicinal product that is
imported from a place other than a member State of the European Communities and
other than Guernsey;
“Law” means
the Medicines
(Jersey) Law 1995;
“licence”
means a manufacturer’s licence or a wholesale dealer’s licence;
“product to which
Chapters II to V of the 1965 Directive apply” means a medicinal
product to which Chapters II to V of Council Directive 65/65/EEC apply, in
accordance with Article 2 of Council Directive 65/65/EEC as amended, Article 34
of Council Directive 75/319/EEC, Article 1 of Council Directive
89/342/EEC, Article 1 of Council Directive 89/343/EEC; and Article 1
of Council Directive 89/381/EEC;
“proprietary
medicinal product” has the same meaning as it has in Article 8(7)(a)
of the Law;
“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 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
to an application to renew a licence.
3 Applications for licences
(1) An
application for a licence shall be in writing.
(2) An
application for a manufacturer’s licence shall include the information in
Schedule 1.
(3) An
application for a wholesale dealer’s licence shall include the
information in Schedule 2.
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
The pages of the
application shall be numbered in sequence.
7 Signature
(1) The
applicant shall sign the application.
(2) Where
the proposed holder of the licence is not the applicant, he or she shall also
sign the application.
8 Copies
The applicant shall
supply to the Minister –
(a) 6
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 Citation
This Order may be cited
as the Medicines (Applications for Manufacturer’s and Wholesale
Dealer’s Licences) (Jersey) Order 1997.
SCHEDULE
1[2]
(Article 3(2))
Information required on
application for manufacturer’s licence
1
(1) The
name and address of the applicant.
(2) The
name and address of the proposed holder of the licence (if he or she is not the
applicant).
2 The
period for which the licence is desired (if less than 5 years).
3 A
statement of the manufacturing or assembling operations to which the licence is
to relate.
4 A
statement of the uses for which the medicinal products are to be manufactured
or assembled, and whether they are any of the following uses –
(a) by
being administered to human beings;
(b) by
being administered to animals;
(c) in
the form of an ingredient in the preparation of a substance, or of an article,
that is to be administered for a medicinal purpose to human beings or animals;
or
(d) by
incorporation in any animal feeding stuff.
5
(1) The
address of each of the premises where the manufacturing or assembling
operations (including any testing that is associated with manufacture or
assembly) are to be carried out.
(2) The
address of each of the premises where the medicinal products will be stored,
and each of the premises from where they will be distributed.
(3) A
statement describing the facilities and equipment available at each of the
premises for storing the medicinal products, and for distributing them from
those premises and between those premises.
(4) A
separate statement, in respect of each of the premises, of the manufacturing
and the assembling operations that are capable of being carried out at those
premises with their existing facilities. (Each statement shall specify the
kinds of medicinal products to which the operations are relevant.)
(5) A
separate statement, in respect of each of the premises, of the equipment that
is available at those premises for carrying out each stage of the manufacturing
operations and the assembling operations described in sub-paragraph (4).
6 A
statement of –
(a) the manufacturing
operations (other than those to which the licence is to relate) that are
carried on by the proposed holder of the licence on or near each of the
premises to which paragraph 5 refers; and
(b) the
substances and articles that are the subject of such operations.
7
(1) The
following information about the person who will be responsible for supervising
production operations at each of the premises to which paragraph 5
refers –
(a) his
or her name and address;
(b) his
or her qualifications and experience (including any degrees and diplomas);
(c) his
or her designation; and
(d) the
name and function of the person to whom he or she will be responsible.
(2) The
following information about the person who will be responsible for the control
of quality in respect of all of the premises to which paragraph 5
refers –
(a) his
or her name and address;
(b) his
or her qualifications and experience (including any degrees and diplomas);
(c) his
or her designation;
(d) the
extent of the authority to be delegated to him or her to reject unsatisfactory
batches of medicinal products; and
(e) the
name and function of the person to whom that person will be responsible,
and where the holder of
the product licence is to be responsible ultimately for the control of quality,
a statement to that effect.
(3) The
following information about each person who will be responsible for the culture
of living tissue to be used in the manufacture of medicinal
products –
(a) his
or her name and address;
(b) his
or her qualifications and experience (including any degrees and diplomas); and
(c) his
or her designation.
(4) The
following information about the person who is to carry out the functions
specified in paragraph 21(1) of Schedule 3 to the Medicines (Standard
Provisions for Licences and Certificates) (Jersey) Order 1997 –
(a) his
or her name and address;
(b) his
or her qualifications and experience (including any degrees and diplomas); and
(c) his
or her designation.
8 If
the applicant, the proposed holder of the licence or any person to whom paragraph
7 refers –
(a) has
been convicted in Jersey or elsewhere of any offence for which a person is
liable to imprisonment (whether or not a person is also liable to any other
penalty); or
(b) has
been found guilty of professional misconduct in Jersey or elsewhere, by a
professional body to whose disciplinary control he or she was subject at the
time of the conduct on which the finding was based,
the details of that
conviction or finding.
9 A
description, in summary, of the arrangements –
(a) for
the identification and storage of materials and ingredients before and during
manufacture; and
(b) for
the storage of medicinal products after manufacture, and after assembly.
10 A
description, in summary, of the arrangements (whether by maintaining records or
by other means) for ensuring as far as practicable a satisfactory turn-over of
stocks of medicinal products at each of the premises where they will be stored.
11 A
description, in summary, of the arrangements –
(a) for
maintaining production records;
(b) for
maintaining records of analytical and other testing procedures that are applied
in the course of manufacture and of assembly, to ensure that materials used
comply with the specifications of those materials and the medicinal products;
and
(c) for
keeping samples, for purposes of reference, of –
(i) the materials
used in manufacture, and
(ii) the
medicinal products.
SCHEDULE 2[3]
(Article 3(3))
Information required on
application for wholesale dealer’s licence
1
(1) The
name and address of the applicant.
(2) The
name and address of the proposed holder of the licence (if he or she is not the
applicant).
2 The
period for which the licence is desired (if less than 5 years).
3 A
statement of the wholesale dealings to which the licence is to relate,
including (inter alia) the following
matters –
(a) in
respect of the kinds of medicinal products involved –
(i) whether there
will be more than one kind and, if so, whether they will include herbal
remedies,
(ii) whether
they will consist only of herbal remedies,
(iii) whether
they will consist only of medicinal products that may be sold otherwise than at
a registered pharmacy, or otherwise than by a practitioner or otherwise than at
a hospital,
(iv) whether
they will include imported proprietary products, and
(v) where they consist only
of medicinal products that are not referred to in any of clauses (i), (ii)
and (iii), descriptions of the medicinal products; and
(b) whether
any medicinal product is for any of the following uses –
(i) by being
administered to human beings,
(ii) by
being administered to animals,
(iii) in
the form of an ingredient in the preparation of a substance, or of an article, that
is to be administered for a medicinal purpose to human beings or animals, or
(iv) by
incorporation in any animal feeding stuff,
a statement of each of
those uses that it is for.
4 The
address of each of the premises where the medicinal products will be stored,
and each of the premises from where they will be distributed.
5 A
statement describing the general range of medicinal products to be stored at
each of the premises (including, where the licence is to relate to imported
proprietary products, the description of each medicinal product).
6 A
statement describing the facilities and equipment available at each of the
premises for storing the medicinal products, and for distributing them from
those premises and between those premises.
7 Where
the licence is to relate to products to which Chapters II to V of the 1965
Directive apply –
(a) the
following information about the person who is to carry out the functions
specified in paragraph 10(1) of Schedule 4 to the Medicines (Standard
Provisions for Licences and Certificates) (Jersey) Order 1997 –
(i) his or her name
and address,
(ii) his
or her qualifications and experience (including any degrees and diplomas), and
(iii) his
or her designation; and
(b) the
details of an emergency plan that fulfills the requirements of paragraph 5 of
that Schedule.
8 Where
the licence is to relate to a product to which Chapters II to V of
the 1965 Directive apply, a statement of the arrangements for keeping
records (in the form of invoices or on computer or in any other form) in
respect of the receipt and despatch of the product.
9 Where
the licence is to relate to an imported proprietary product and is to be
subject to the provisions of paragraph 13 of Schedule 4 to the Medicines (Standard
Provisions for Licences and Certificates) (Jersey) Order 1997, the
following information about the person who is to carry out the functions
specified in sub-paragraph (1) of that paragraph –
(a) his
or her name and address;
(b) his
or her qualifications and experience (including any degrees and diplomas); and
(c) his
or her designation.
10 Where
the licence is to relate to any dealing in a controlled drug (as defined in Article 3
of the Misuse of
Drugs (Jersey) Law 1978), the following information about each person
who is to handle the drug on behalf of the proposed holder of the licence in
the course of that dealing –
(a) his
or her name and address;
(b) his
or her qualifications and experience (including any degrees and diplomas); and
(c) his
or her designation.
11 If the applicant, the proposed holder of the licence or any person
to whom any of paragraphs 7, 9 and 10 refers –
(a) has
been convicted in Jersey or elsewhere of any offence for which a person is
liable to imprisonment (whether or not a person is also liable to any other
penalty); or
(b) has
been found guilty of professional misconduct in Jersey or elsewhere, by a
professional body to whose disciplinary control he or she was subject at the
time of the conduct on which the finding was based,
the details of that
conviction or finding.
12 A
description, in summary, of the arrangements (whether by maintaining records or
by other means), for ensuring as far as practicable a satisfactory turn-over of
stocks of medicinal products at each of the premises where they will be stored.