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The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997
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- UK Statutory Instruments
- 1997 No. 322
- PART II
- Regulation 7
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Renewal of registrations
7.—(1) The registration of a product may be renewed on the application of the person responsible for marketing it.
(2) An application under paragraph (1) shall be made to the Ministers at least three months before the expiry of the registration relating to the product and shall be accompanied by an Article 15 dossier relating to it.
(3) Subject to regulations 11 and 12, following the examination of the application, the Ministers shall renew the registration unless, in their opinion, an Article 11 ground has been established in connection with the product.
(4) Where the Ministers refuse to renew a registration, they shall notify the applicant in accordance with the provisions of the first paragraph of Article 40 of Directive 81/851.
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