The Medicines (Veterinary Medicinal Products) (Renewal Applications for Product Licences Subject to Review) Regulations 1993

• Citation: S.I. 1993/2399
• Sections: 3

Section 1 Title and commencement

These Regulations may be cited as the Medicines (Veterinary Medicinal Products) (Renewal Applications for Product Licences Subject to Review) Regulations 1993 and shall come into force on 29th October 1993.

Section 2 Interpretation

In these Regulations—

“ the Act ” means the Medicines Act 1968;

“Directive 81/851” means Council Directive 81/851/ EEC on the approximation of the laws of the Member States relating to veterinary medicinal products amended by Council Directive 90/676/EEC and extended by Council Directive 90/677/EEC extending the scope of Directive 81/851/EEC and laying down additional provisions for immunological veterinary medicinal products ;

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

“renewal application” means an application for the renewal of a licence under section 24 of the Act in consequence of a notice served on the holder of the licence by the licensing authority under section 24(1A) thereof.

Section 3 Requirements as to renewal application

(1) Subject to paragraph (2) below, every renewal application shall be made in accordance with the provisions of the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993 as if such application were an application to which those Regulations apply.

(2) If the product the subject of the licence for which a renewal application is made is for the time being authorised in accordance with Directive 81/851 for sale or supply in another member state, or is the subject of an application for such authorisation, the requirements of regulation 4 of the Regulations referred to in paragraph (1) above shall be deemed to have been complied with if the renewal application is accompanied by such documents and particulars as have been submitted to that other member State, unless the licensing authority otherwise directs.