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The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994
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- UK Statutory Instruments
- 1994 No. 3142
- Regulation 10
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Renewals of authorisations
10.—(1) Every application for renewal of a marketing authorisation by the Ministers shall be made to them in accordance with this regulation.
(2) The application shall be in accordance with article 15 of Council Directive 81/851/ EEC, and shall be submitted not earlier than five months before the expiry date of the existing authorisation.
(3) The application shall include any information required under articles 5, 5a, 6 and 7 of Council Directive 81/851/EEC and the relevant parts of the Annex to Council Directive 81/852/EEC which has not previously been submitted to the Ministers.
(4) Where an application for the renewal of a marketing authorisation has been made under this regulation, the marketing authorisation shall remain in force pending the decision of the Ministers.
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