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The Human Medicines Regulations 2012
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Changes over time for: Section 113
Version Superseded: 31/12/2020
Alternative versions:
- 14/08/2012- Amendment
- 11/11/2013- Amendment
- 09/02/2019
Point in time - 31/12/2020- Amendment
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Obligation to notify placing on the market etcU.K.
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113.—(1) The holder of a certificate of registration must notify the licensing authority of the date on which the product to which the certificate relates is placed on the market in the United Kingdom taking account of the various presentations authorised.
(2) A notification under paragraph (1) must be given before the end of the period of two months beginning with the date on which the product is placed on the market.
(3) The holder of a certificate of registration must notify the licensing authority if the product to which the certificate relates is to be withdrawn from the market in the United Kingdom (whether temporarily or permanently).
[F1(3A) A notification under paragraph (3) must include the reasons for the withdrawal in accordance with article 123(2) of the 2001 Directive.]
(4) A notification under paragraph (3) must be given before the beginning of the period of two months ending with the date on which the product is to be withdrawn from the market unless it is not reasonably practicable to do so.
(5) In that event, the notification must be given as far as is reasonably practicable in advance of the date on which the product is withdrawn from the market.
(6) The licensing authority may require the holder of a certificate of registration to provide information relating to the volume of sales in the United Kingdom of the product to which the certificate relates.
(7) The holder of a certificate of registration must provide the licensing authority with information that it requires under paragraph (6)—
(a)where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or
(b)otherwise, as soon as is reasonably practicable after receipt of the request.
Textual Amendments
F1Reg. 113(3A) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 5
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