The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
16 Amendment of regulation 50
(1) Regulation 50 (accompanying material) is amended as follows. (2) In paragraph (5), at the beginning insert “Subject to paragraphs (5AA) and (5AB),”. (3) After paragraph (5), insert— (5AA) In addition to the information referred to in Part 1, paragraph 1.2, fourth paragraph of Annex 1 to the 2001 Directive, an applicant for the grant of a UK marketing authorisation for an MM medicinal product must also provide a copy of the MM master file for that product. (5AB) In addition to the information referred to in Part 1, paragraph 1.2, fourth paragraph of Annex 1 to the Directive, an applicant for the grant of a UK marketing authorisation for a POC medicinal product must also provide a copy of the POC master file for that product. .
16 Amendment of regulation 50
(1) Regulation 50 (accompanying material) is amended as follows. (2) In paragraph (5), at the beginning insert “Subject to paragraphs (5AA) and (5AB),”. (3) After paragraph (5), insert— (5AA) In addition to the information referred to in Part 1, paragraph 1.2, fourth paragraph of Annex 1 to the 2001 Directive, an applicant for the grant of a UK marketing authorisation for an MM medicinal product must also provide a copy of the MM master file for that product. (5AB) In addition to the information referred to in Part 1, paragraph 1.2, fourth paragraph of Annex 1 to the Directive, an applicant for the grant of a UK marketing authorisation for a POC medicinal product must also provide a copy of the POC master file for that product. .
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