The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Registration of products

6.—(1) Subject to regulations 11 and 12, following the examination of an application to register a product pursuant to regulation 5, the Ministers shall register it in accordance with the provisions of Article 15 of Directive 81/851 unless, in their opinion, an Article 11 ground has been established in connection with that product or application.

(2) On registering a product the Ministers shall—

(a) give it a registration number,

(b) determine whether there is a need to exercise or further exercise the powers conferred by section 51, 57 or 58 of the Act concerning the conditions as to the sale or supply of the product, and

(c) publish details of the registration in accordance with the provisions in the second paragraph of Article 40 of Directive 81/851.

(3) Where the Ministers refuse to register a product, they shall notify the applicant in accordance with the provisions of the first paragraph of Article 40 of Directive 81/851.