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The Human Medicines Regulations 2012
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Pharmacovigilance system master file
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1. Regulation 182(2)(b) (obligation to maintain and make available pharmacovigilance system master file) does not apply in respect of a medicinal product granted an authorisation or registration before 21st July 2012 until whichever is the earlier of—
(a)the day on which the authorisation or registration is renewed under regulation 66 (application for renewal of UK marketing authorisation) or 133 (application for renewal of traditional herbal registration) for the first time after Part 11 has come into force; or
(b)21st July 2015.
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