The Medicines (Veterinary Drugs) (Renewal Applications for Licences and Animal Test Certificates) Regulations 1993

Title and commencement

1.  These Regulations may be cited as the Medicines (Veterinary Drugs) (Renewal Applications for Licences and Animal Test Certificates) Regulations 1993 and shall come into force on 31st May 1993.

Interpretation

2.  In these Regulations–

“the Act” means the Medicines Act 1968;

“licence” means a licence for a veterinary drug under Part II of the Act;

“medicinal product” includes, where a licence or certificate relates to any substance or article which is not a medicinal product, that substance or article;

“renewal application” means an application for the renewal of a licence under section 24 of the Act (other than the renewal of a product licence in consequence of a notice served on the licence holder under section 24(1A)), or an application for the renewal of a certificate under section 38 of the Act.

Form and manner of renewal application

3.—(1) Every renewal application shall be made in writing and shall be signed by the applicant.

(2) Where the licensing authority have from time to time approved the form of renewal applications either for use generally or in respect of particular classes of renewal applications, every renewal application shall be made in such approved form.

(3) Subject to paragraph (4) below, six copies, or such lesser number as the licensing authority may direct, of each renewal application and of any accompanying particulars shall be supplied to the licensing authority in the English language and, where the renewal application or accompanying particulars have been translated from another language, also one copy of the renewal application or the accompanying particulars, as the case may be, in the original language, if the licensing authority so require.

(4) In the case of the renewal of a product licence of right, a further 20 copies of the renewal application and of any accompanying particulars shall be supplied to the licensing authority if the licensing authority so require.

(5) Except where the licensing authority otherwise direct, in the case of the renewal of a licence or certificate, a separate renewal application shall be made in respect of each medicinal product of a particular description to which such licence or certificate relates.

Conditions of renewal

4.—(1) Subject to paragraph (2) below, a renewal application shall be made only in respect of a licence or certificate where the licence or certificate is identical in all particulars with the existing licence or certificate.

(2) Notwithstanding paragraph (1) above, a renewal application may be made in respect of a licence or certificate where the only matters which are not identical with the existing licence or certificate relate to–

(a) any variation already incorporated since the date of issue; or

(b) any additional particulars required to be submitted to the licensing authority pursuant to regulation 5(1)(c) below and Part III of the Schedule.

Particulars to be contained in or to accompany renewal applications

5.—(1) Subject to the following provisions of these Regulations every renewal application shall contain or be accompanied by–

(a) the particulars specified in Part I of the Schedule except to the extent that the licensing authority have, in the case of any particular application or any class of renewal applications, otherwise directed;

(b) the particulars specified in Part II of the Schedule in relation to an application to which that Part applies, to the extent that the licensing authority have, in the case of any particular renewal application or any class of renewal applications, directed;

(c) the particulars specified in Part III of the Schedule in relation to an application to which that Part applies, if those particulars have not been submitted to the licensing authority at an earlier date.

(2) Subject to paragraph (3) below, any of the particulars, which by virtue of paragraph (1) above are required to be contained in or to accompany a renewal application, may be omitted if a statement of such omission and the reasons for it are contained in or accompany the renewal application.

(3) Any particulars omitted under paragraph (2) above shall be subsequently furnished to the licensing authority if the licensing authority so direct and such subsequently furnished particulars shall be deemed to have been contained in or to have accompanied the renewal application.

Time for submission of renewal applications

6.  A renewal application for a licence or certificate shall be duly made only if it is made in the period at least 3 months and not more than 5 months before the expiry of the current licence or certificate.

Samples to accompany renewal applications

7.  Every renewal application for a licence or certificate shall be accompanied by such samples of the medicinal product to which such licence or certificate relates, as the licensing authority have, in the case of any particular renewal application or class of renewal applications, directed.

Revocation

8.  The Medicines (Renewal Applications for Licences and Certificates) Regulations 1974(1), the Medicines (Renewal Applications for Licences and Certificates) Amend-ment Regulations 1977(2) and the Medicines (Renewal Applications for Licences and Certificates) Amendment Regulations 1982(3) are hereby revoked to the extent that they relate to renewal applications for licences or certificates for veterinary drugs.

Brian Mawhinney

Minister of State

Department of Health

7th May 1993

Hector Monro

Parliamentary Under Secretary of State, Scottish Office

6th May 1993

David Hunt

Secretary of State for Wales

7th May 1993

In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 6th May 1993.

L.S.

John Selwyn Gummer

Minister of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 7th day of May 1993.

L.S.

F. A. Elliott

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 6th day of May 1993.

L.S.

W. J. Hodges

Permanent Secretary