Human medicines regulation schedule 12a
WebIn this Schedule, “the 2012 Regulations” means the Human Medicines Regulations 2012 ( 1 ). Amendment of regulation 15 (amendment of regulation 18 of the 2012 … Web1. — (1) The information in the pharmacovigilance system master file must be accurate and reflect the pharmacovigilance system in place. (2) The holder may, …
Human medicines regulation schedule 12a
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Web— (1) Schedule 12A makes further provision as to the obligations of a holder and the licensing authority in respect of the performance of pharmacovigilance activities … WebIn this Schedule, “the 2012 Regulations” means the Human Medicines Regulations 2012(b). Amendment of regulation 15 (amendment of regulation 18 of the 2012 …
Web1. Citation and commencement. 2. Amendment of the Good Laboratory Practice Regulations 1999. 3. Amendment of the Medicines for Human Use (Clinical Trials) … Webthe Human Medicines Regulations 2012 (HMR) (statutory instrument (SI) 2012 No. 1916, as amended) will be further amended by: • The Human Medicines (Amendment etc.) …
Web31 dec. 2024 · There will be a temporary exemption in place which allows you 12 months from 1 January 2024 to appoint a national contact person for pharmacovigilance that … WebThe Human Medicines (Amendment etc.) (EU Exit) Regulations 2024 UK Draft Statutory Instruments ISBN 978-0-11-117918-5 Table of contents Table of Contents Content Draft Explanatory Memorandum... Amendment of the Human Medicines Regulations 2012. 3. Amendment of the … Amendment Etc - The Human Medicines (Amendment etc.) (EU Exit) Regulations … Amendment of the Human Medicines Regulations 2012. 3. Amendment of the … New Regulation B17 and C17 (Good Manufacturing Practice and Good … 56. For regulation 51 substitute— “ (1) An applicant for a UK marketing … The Human Medicines (Amendment etc.) (EU Exit) Regulations 2024. You are … Amendment of Regulation 45 (Requirement as to Responsible Persons) - The … Amendment of Regulation 45A (Brokering in Medicinal Products) - The Human …
Web8 mrt. 2024 · 177. — (1) This Part and Schedule 33 apply, except to the extent set out in paragraph (4) (b), in relation to medicinal products that are the subject of—. (c) an Article 126a authorisation. [ F1 (1A) Schedule 12A applies in relation to medicinal products that are the subject of a UKMA (GB) ora THR (GB).] [ F2 (1B) Regulations 178 and 179 ...
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