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The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
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- UK Statutory Instruments
- 1994 No. 3144
- Regulation 5
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Consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization.
5.—(1) The licensing authority shall consider every application for the grant, renewal or variation by them of a marketing authorization in accordance with the relevant Community provisions, and shall grant, renew or vary, or refuse to grant, renew or vary the authorization in accordance with those provisions.
(2) The licensing authority shall publish in the Gazette(1) notice of every authorization granted by them.
(3) Schedule 2 shall have effect to regulate the procedure for receiving advice and representations before granting, renewing or varying, or refusing to grant, renew, or vary, a marketing authorization.
(4) A marketing authorization shall, unless previously renewed or revoked, be valid for the period (not exceeding five years) specified in it beginning with the date on which it is granted, but where an application for the renewal of such an authorization is made in accordance with Article 10 of the 1965 Directive the marketing authorization shall remain in force pending the decision of the licensing authority on that application.
(1)
See The Medicines Act 1968, section 132(1) for a definition of “the Gazette”.
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