Regulation 5 Consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization.

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

reg 5 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 2(3)
reg. 5(4) substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(7)(a)
reg. 5(5)-(9) inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(7)(b)
reg. 5(3) words inserted by Medicines (Advisory Bodies) 2005 Sch. 2 para. 2
reg. 5(4) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(d)
reg 5 rev in pt by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 3(1), (2)

(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^f1 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.

Annotations

Footnotes

f1: See The Medicines Act 1968, section 132(1) for a definition of “the Gazette”.