The Medicines (Veterinary Drugs) (Renewal Applications for Licences and Animal Test Certificates) Regulations 1994

• Citation: S.I. 1994/3143
• Sections: 5

Section 1 Title and commencement

These Regulations may be cited as the Medicines (Veterinary Drugs) (Renewal Applications for Licences and Animal Test Certificates) Regulations 1994 and shall come into force on 1st January 1995.

Section 2 Interpretation

In these Regulations—

“ the Act ” means the Medicines Act 1968;

“certificate” means an animal test certificate;

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

“renewal application” means an application for the renewal of a licence under section 24 of the Act (other than a renewal application for a product licence to which the Medicines (Veterinary Medicinal Products) (Renewal Applications for Product Licences Subject to Review) Regulations 1993 apply (in consequence of a notice served under section 24(1A)), or an application for the renewal of a certificate under section 38 of the Act.

Section 3 Form and manner of renewal application

(1) Every renewal application shall be made to the licensing authority in writing and shall be signed by the applicant.

(2) The applicant shall supply six copies in the English language of each renewal application and of any accompanying particulars, or such lesser number as the licensing authority may direct, and if any document supplied has been translated from another language, one copy of that document in the original language shall also be supplied if the licensing authority require.

Section 4 Particulars to be contained in or to accompany renewal applications

(1) Every renewal application shall contain or be accompanied by particulars of—

(a) the holder of the licence or certificate in respect of which the renewal application is made,

(b) the product or class of products to which that licence or certificate relates,

(c) the licence or certificate held, any variation thereof, and any notification to the licensing authority in accordance with the provisions of the licence or certificate, made since the grant of the licence or issue of the certificate as the case may be, or, if such licence or certificate has been renewed, since the date of the last renewal, and

(d) any material changes, other than those submitted in accordance with sub-paragraph (c) above, in the information submitted in the application for the grant of the licence or issue of the certificate as the case may be, or, if such licence or certificate has been renewed, any such changes since the date of the last renewal.

(2) In the case of the renewal of a certificate, every renewal application shall be accompanied by up to date particulars of the progress of the medicinal test on animals to which the certificate relates.

Section 5 Revocation

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