# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 44B: Variation of POC (IMP) master file


Subject to regulation 45(6), the holder of a manufacturing authorisation (POC) may amend the information in the POC (IMP) master file provided in accordance with paragraph 11(a), (b) and (g) to (i) of Schedule 6 and paragraph 14M(a) of Schedule 7 without applying to the licensing authority for a variation under regulation 44.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/44B (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-44B
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.