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The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002

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Amendment of the Marketing Authorisations RegulationsU.K.

3.—(1) The Marketing Authorisations Regulations are amended as follows.

(2) In regulation 5 (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization), omit paragraph (2).

(3) After regulation 5 (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization) insert the following regulation—

“ Classification of medicinal products

5A.—(1) Each marketing authorization granted by the licensing authority on or after 1st April 2002 shall be granted subject to a condition that the medicinal product to which the authorization relates is to be available—

(a)only on prescription;

(b)only from a pharmacy; or

(c)on general sale.

(2) Where prior to 1st April 2002 a medicinal product is subject to a marketing authorization and that authorization contains a statement that it is to be available on one or more of the following bases—

(a)only on prescription;

(b)only from a pharmacy; or

(c)on general sale,

it is a condition of the marketing authorization from 1st April 2002 that the product is to be available only on that basis or, as the case may be, those bases.”.

(4) In regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products), omit paragraph (8).

(5) Regulation 8 (control of sale or supply of relevant medicinal products) is hereby revoked.

(6) In paragraph 6(2) of Schedule 5 (labels), for head (a) substitute—

“(a)if the product would be subject to restrictions imposed under section 58 of the Act if it contained a higher proportion or level of any substance, except where the product is for external use only or contains any of the substances described in head (c) of this sub-paragraph, the words “Warning. Do not exceed the stated dose”;”.

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