UNITED KINGDOM STATUTORY INSTRUMENT
1996 No. 2194
MEDICINES
The Animal Test Certificates Regulations 1996
Made 21th August 1996
Laid before Parliament 23th August 1996
Coming into force 13th September 1996
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Scotland and in Wales, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 36(1), 38(3) (as read with section 36(1)), 47(1), 85(1) and (4), 86(1), 91(2) and (3) and 129(1) and (5) of the Medicines Act 1968and now vested in them, and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food, the Secretaries of State concerned with agriculture in Scotland and in Wales and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 85(1), (2) and (4), 86(1), 91(2) and (3) (as read with section 90(1)) and 129(5) of that Actand now vested in them, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following Regulations in accordance with section 129(6) of that Act, hereby make the following Regulations:
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Title and commencementTitle and commencement
1. These Regulations may be cited as the Animal Test Certificates Regulations 1996 and shall come into force on 13th September 1996.
Interpretation
2.—(1) In these Regulations, unless the context otherwise requires—
“the Act” means the Medicines Act 1968;
“approved dossier” means all the particulars submitted in an application for a certificate, or at any subsequent time in connection with a certificate, which have been or which are deemed to have been approved by the licensing authority;
“certificate” means an animal test certificate;
“biological product” includes an antigen, toxin, antitoxin, toxoid, serum, antiserum or vaccine or a fraction of any such product;
“new molecule” means an active ingredient which has not at any time been included in a product in respect of which a product licence under the Act, or marketing authorisation within the meaning of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994has been granted;
“suspected adverse reaction” means—
(a) a reaction in an animal treated with a product during a test which is suspected to have been caused by the product, and which has resulted in harm to the animal, or
(b) a suspected lack of efficacy of a product in an animal so treated; and
“test” means a medicinal test on animals the subject of a certificate or of an application for the grant thereof.
(2) Any reference in these Regulations to a numbered regulation or Schedule shall, unless the context otherwise requires, be construed as a reference to the regulation or Schedule bearing that number in these Regulations.
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Applications for certificatesApplications for certificates
3.—(1) An application for a certificate shall be made to the licensing authority in writing in the English language and be signed by the applicant.
(2) A separate application shall be made in respect of each product, except that one application may be made in respect of more than one product if—
(a)
(a) those products are to be administered in the same test, or
(b)
(b) they have the same pharmaceutical form and contain the same active ingredient or ingredients which differ only as to their strengths, or
(c)
(c) they are preparations of allergen extracts for the treatment of allergies, and they consist of two or more dilutions of the same allergen extract or of the same mixture of allergen extracts, or
(d)
(d) they are products for testing for allergic responses to specific substances, and they consist of two or more allergen extracts manufactured by the same method, and the application states the substances from which the extracts are prepared.
(3) The applicant shall supply four copies of the application, in a bound form, with the pages of each copy serially numbered.
(4) The application shall contain the particulars specified in Schedule 1.
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Renewal of certificatesRenewal of certificates
4.—(1) An application for renewal of a certificate shall be made to the licensing authority in writing in the English language and be signed by the applicant.
(2) The applicant shall supply four copies of the application.
(3) Every renewal application shall contain particulars of—
(a)
(a) the holder of the certificate,
(b)
(b) the product to which the certificate relates,
(c)
(c) the certificate held, together with details of any variation thereof and any notification given in accordance with the provisions of the certificate, since the issue of the certificate, or, if it has been renewed, since its last renewal,
(d)
(d) any proposed alterations to the approved dossier in respect of which a provision of the certificate requires an application for variation,
(e)
(e) a summary of all suspected adverse reactions occurring during the test, and
(f)
(f) the reason why the renewal is needed, including up to date particulars of the progress of tests already conducted.
(4) In the case of an application for the renewal of a certificate issued in respect of an application made in accordance with the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971, the application shall also contain any of the particulars specified in Schedule 1 which have not been submitted before, and particulars of the current labelling, and any leaflet or package insert used for the product.
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Standard provisions for certificatesStandard provisions for certificates
5.—(1) The standard provisions for certificates for the purposes of Part II of the Act shall be the provisions set out in Schedule 2.
(2) The standard provisions for certificates prescribed by regulation 3(3) of and Part III of Schedule 1 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971shall be superseded by the preceding paragraph except in relation to a certificate issued in respect of an application made in accordance with the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971.
Revocations
6. The Regulations listed in the first and second columns of Schedule 3 are hereby revoked to the extent specified in the third column of that Schedule.
Gerald Malone
Minister of State,
Department of Health
16th August 1996
Jonothan Evans
Parliamentary Under Secretary of State,
Welsh Office
21st August 1996
Lindsay
Parliamentary Under Secretary of State,
Scottish Office
12th August 1996
Tony Baldry
Minister of State,
Ministry of Agriculture,
Fisheries and Food
7th August 1996
F A Elliott
Permanent Secretary
J Murray
Permanent Secretary
SCHEDULE 1
Regulation 3(4)
PARTICULARS TO BE CONTAINED IN AN APPLICATION FOR A CERTIFICATE
Part I—
Standard particulars
1. The name or proposed name of the product, or, if there is no name, some other designation which will adequately identify it.
2. The name and address of the applicant, and of the proposed certificate holder, if different, and any other name under which the applicant or proposed holder carries on business.
3. Details of the manufacturer of the product, which—
(a) for products which have not been imported, shall include the name and address of the person responsible for each stage of its manufacture and assembly, and the sites where manufacture and assembly takes place, or
(b) for imported products, shall mean the name and address of the manufacturer and assembler of the product in its imported form.
4. The proposed duration of the certificate, if less than two years.
5. Details of any certificate previously granted in respect of the product.
6. Details of any application for, or grant of, a product licence under the Act, or a marketing authorisation within the meaning of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994, in respect of the product.
7. For applications in respect of new molecules only, details of any application made and any approval given in respect of the testing or marketing of the product in another country.
8. Drafts of the proposed labelling, and any proposed...
