Title 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 1994(5) has been granted;

"suspected adverse reaction" means-

"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.

Applications 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)those products are to be administered in the same test, or

(b)they have the same pharmaceutical form and contain the same active ingredient or ingredients which differ only as to their strengths, or

(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)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.

Renewal 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)the holder of the certificate,

(b)the product to which the certificate relates,

(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)any proposed alterations to the approved dossier in respect of which a provision of the certificate requires an application for variation,

(e)a summary of all suspected adverse reactions occurring during the test, and

(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(6), 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.

Standard 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 1971(7) shall 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.

Regulation 3(4)

SCHEDULE 1PARTICULARS 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 leaflet or package insert, for the product.

9. A description of the proposed test including details of-

(a) the nature and purpose of the test,

(b) the species and maximum number of animals to be included in the test,

(c) the criteria to be used in the selection of animals for, or exclusion or withdrawal of animals from, the test,

(d) the proposals for monitoring the safety of the product during the test, including details of precautions to be followed by users of the product, and when the product is to be disposed of,

(e) the arrangements for the disposal of animals involved in the test,

(f) the proposed dosage for the product, and its duration, and the method, route and frequency of administration,

(g) the name and qualifications of the person who is to be responsible for the overall supervision of the test, and

(h) the address of every site at which the test is to be carried out and the number of animals involved in the proposed test at each site, but if these particulars are not known to the applicant at the time of application, they may be omitted, so long as the applicant gives an explanation why they are not known.

Part II-Analytical information

1. Qualitative and quantitative particulars relating to the product, which shall include-

(a) the monograph name, or if none the specification, of each ingredient, whether active or not, but if there is no name or specification, details sufficient to identify and characterise each batch of each ingredient used in the product shall be given,

(b) a description of the product's container and its closures, and any special directions for storage or transport of the product, and

(c) the specification of the product, giving its qualitative and quantitative composition.

2. The method of preparation of the product and of its ingredients whether active or not.

3. Details of any substances of animal origin used in the manufacture of the active ingredient, including, for a biological product, details of the master seed and master cell-bank.

4. Details of the in-process control tests to be carried out during the manufacture of the product, and of the control tests to be carried out on the finished product.

5. Proposals for a shelf-life and in-use shelf-life for the product.

Part III-Safety information

1. Details of any information relevant to the safety of the product, including a summary and evaluation of any studies carried out with the product or its ingredients which are necessary to establish the safety of the product for the purposes of the test.

2. In the case of a product intended for administration in the test to food-producing animals-

(a) details of any entry in Annexes I to IV of Council Regulation (EEC) No. 2377/90(8), in relation to the product or any of its ingredients, and

(b) a proposal and justification for a withdrawal period.

Regulation 5

SCHEDULE 2STANDARD PROVISIONS FOR CERTIFICATES

1. The test shall be carried out in accordance with the approved dossier.

2. Where such details were not submitted at the time of the application, the certificate holder shall notify the licensing authority as soon as reasonably practicable of the address of every site at which the test is to be carried out and the number of animals involved in the proposed test at each site, and such details will be deemed to have been approved if the licensing authority has acknowledged the notification and has not notified the holder that it has not been approved within 30 days of the date of his notification.

3. If the certificate holder wishes to alter any part of the approved dossier described in paragraph 4 below, he shall make a written application to the licensing authority for a variation, which includes a justification for the alteration, and he shall not make the alteration proposed until approval of the application has been given.

4. The parts of the approved dossier referred to in the preceding paragraph are:

(a) the maximum number of animals included in the test, where this is to be increased,

(b) the arrangements for disposal of treated animals, if the new arrangements involve the commencement of, or an increase in, animals or animal products being sent for human consumption,

(c) the approved withdrawal period,

(d) the dosage for the product, and its duration, and the frequency of administration, where any of these are to be increased, and

(e) the product's labelling, leaflet or package insert, where changes are required consequent on the alterations referred to in the preceding sub-paragraphs.

5. If the certificate holder wishes to alter any part of the approved dossier described in paragraph 6 below, he shall make a written application to the licensing authority for a variation, and his application will be deemed to have been approved if the licensing authority has acknowledged it and has not notified him that it has not been approved within 30 days of the date of the application.

6. The parts of the approved dossier referred to in the preceding paragraph are:

(a) any of the particulars referred to in paragraphs 1, 2, 3 or 9(a), (c), (d), (g) or (h) of Part I of Schedule 1,

(b) the species of animal included in the test,

(c) any of the particulars referred to in Part II of Schedule 1 where the proposed alteration will affect the product's bioavailability or stability, or the range or level of impurities it contains, and

(d) the product's labelling, leaflet or package insert, where changes are required other than as referred to in paragraph 4(e) above.

7. The certificate holder shall notify the licensing authority if the test is discontinued, giving an explanation for its discontinuance.

8. The certificate holder shall notify the licensing authority-

(a) within 15 days of his becoming aware of it of any suspected adverse reaction occurring during the test, which in the view of the holder was the cause of any increase in mortality or serious ill-health in the treated animals, and

(b) immediately of any other matter of which he becomes aware which may affect the safety of the product for the purposes of the test.

Regulation 6

SCHEDULE 3REVOCATIONS

Explanatory Note

(This note is not part of the Regulations)

These Regulations prescribe requirements in relation to applications for, and applications for renewal of, animal test certificates under the Medicines Act 1968, and prescribe standard provisions for such certificates (regulations 3, 4 and 5(1) and Schedules 1 and 2). The relevant standard provisions prescribed by the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971, as amended, are superseded by these Regulations 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 ("the 1971 Applications Regulations"), as amended (regulation 5(2)). The 1971 Applications Regulations, as amended, and the Medicines (Veterinary Drugs) (Renewal Applications for Licences and Animal Test Certificates) Regulations 1994 are revoked in so far as they respectively relate to applications for, and applications for the renewal of, animal test certificates. The Medicines (Labelling) Regulations 1976, as amended, and the Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988 ("the 1988 Regulations"), are revoked in so far as they relate to the labelling of containers and packages of medicinal products for administration in medicinal tests on animals, except for any such test the subject of a certificate issued in respect of an application made in accordance with the 1971 Applications Regulations. The 1988 Regulations also continue to apply to the labelling of containers and packages of medicated feeding stuffs (regulation 6 and Schedule 3).

A Compliance Cost Assessment has been prepared and a copy has been placed in the library of each House of Parliament and copies can be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey KT15 3NB.