The Veterinary Medicines (Amendment etc.) Regulations 2024
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Change 1
As published
81 Amendment to paragraph 2
For paragraph 2 (time limits) substitute—
Application for authorisation
2. (1) An application for a manufacturing authorisation must be submitted to the Secretary of State electronically and must include the matters mentioned in sub-paragraph (2).
(2) For the purposes of sub-paragraph (1) the matters are—
(a) the name of the person who will hold the manufacturing authorisation and that person’s address or registered place of business;
(b) the names and addresses of the sites (including any site where work is undertaken on behalf of the proposed holder under contract) where—
(i) each stage of the manufacturing process or of bringing a veterinary medicinal product to its final state, including processing, assembling, packaging or repackaging, labelling or relabelling, storing or sterilising, is carried out;
(ii) any imported products are held; or
(iii) any control or batch release is carried out;
(c) a description of the veterinary medicinal products or pharmaceutical forms proposed to be manufactured or imported under the authorisation;
(d) the name of the proposed qualified person (manufacture) for the purposes of paragraph 9;
(e) the name of the person proposed to have responsibility for quality control;
(f) the qualifications and a description of the relevant experience of the person proposed to have responsibility for quality control;
(g) the name of the person proposed to have responsibility for production;
(h) the qualifications and a description of the relevant experience of the person proposed to have responsibility for production;
(i) a declaration that the applicant complies with good manufacturing practice and any relevant legislation; and
(j) a declaration that any site mentioned in paragraph (b) is ready for inspection.
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Your change, as a redline
81 Amendment to paragraph 2
For paragraph 2 (time limits) substitute—
Application for authorisation
2. (1) An application for a manufacturing authorisation must be submitted to the Secretary of State electronically and must include the matters mentioned in sub-paragraph (2).
(2) For the purposes of sub-paragraph (1) the matters are—
(a) the name of the person who will hold the manufacturing authorisation and that person’s address or registered place of business;
(b) the names and addresses of the sites (including any site where work is undertaken on behalf of the proposed holder under contract) where—
(i) each stage of the manufacturing process or of bringing a veterinary medicinal product to its final state, including processing, assembling, packaging or repackaging, labelling or relabelling, storing or sterilising, is carried out;
(ii) any imported products are held; or
(iii) any control or batch release is carried out;
(c) a description of the veterinary medicinal products or pharmaceutical forms proposed to be manufactured or imported under the authorisation;
(d) the name of the proposed qualified person (manufacture) for the purposes of paragraph 9;
(e) the name of the person proposed to have responsibility for quality control;
(f) the qualifications and a description of the relevant experience of the person proposed to have responsibility for quality control;
(g) the name of the person proposed to have responsibility for production;
(h) the qualifications and a description of the relevant experience of the person proposed to have responsibility for production;
(i) a declaration that the applicant complies with good manufacturing practice and any relevant legislation; and
(j) a declaration that any site mentioned in paragraph (b) is ready for inspection.
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