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The Veterinary Medicines (Amendment etc.) Regulations 2024

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Amendment to paragraph 6

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86.  In paragraph 6 (inspection of premises)—

(a)in sub-paragraph (1)—

(i)for “premises” (in the first and the third place it appears) substitute “sites”;

(ii)for “registered” substitute “authorised”;

(iii)for “premises’ history” substitute “site’s history”;

(b)for sub-paragraph (2) substitute—

“(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection establishes that the manufacturer has complied with the requirements of these Regulations in respect of the site to which the inspection relates.

(2A) Where the Secretary of State does not consider that compliance is established after inspection in accordance with sub-paragraph (2), the Secretary of State must enter that fact in the register mentioned in paragraph 12(a).

(2B) The Secretary of State may carry out an inspection on a site occupied by a manufacturer established in a country other than the United Kingdom notwithstanding any arrangements that may have been entered into between the United Kingdom and that country.

(2C) The importer of a veterinary medicinal product must ensure before importation that the manufacturer of that product has—

(a)a valid certificate of good manufacturing practice issued by the Secretary of State; or

(b)an equivalent certificate issued by a regulatory authority—

(i)with which the Secretary of State has an agreement or arrangement for such purposes; or

(ii)which the Secretary of State considers to have demonstrated equivalent standards to those in the United Kingdom.”;

(c)for the heading substitute “Good manufacturing practice certificates and inspection of sites”.

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