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The Medicines (Veterinary Medicinal Products) (Renewal Applications for Product Licences Subject to Review) Regulations 1993
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- UK Statutory Instruments
- 1993 No. 2399
- Regulation 3
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Requirements as to renewal application
3.—(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(1) 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.
(1)
S.I.1993/2398.
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