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The Human Medicines Regulations 2012
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[F1Obligations of holders of converted EU marketing authorisationsU.K.
This section has no associated Explanatory Memorandum
9.—(1) A holder of a converted EU marketing authorisation must submit to the licensing authority, before the end of the period of one year beginning with IP completion day, the information described in sub-paragraph (3).
(2) The obligation in sub-paragraph (1) is subject to any requirement imposed by the licensing authority to provide that information before the end of a shorter period specified by the licensing authority under paragraph 10(1).
(3) The information which must be submitted in accordance with sub-paragraph (1) (referred to in this paragraph as the “baseline data”) is—
(a)such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing for this purpose and published by the licensing authority on or before IP completion day;
(b)notification of whether or not the product to which the converted EU marketing authorisation relates—
(i)is on the market in the United Kingdom at the time the notification is given, or
(ii)if not, whether the product has been on the market in the United Kingdom at any time on or after IP completion day and if so, the date on which it was withdrawn from the United Kingdom market.
(4) In this Part, the date on which the holder of a converted EU marketing authorisation complies with the obligation in sub-paragraph (1), or with any requirement imposed by the licensing authority under paragraph 10(1) to provide all of the baseline data before the end of a period shorter than the period of one year beginning with IP completion day, is referred to as “the data submission date”.]
Textual Amendments
F1Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)
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