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Regulation 3 Marketing authorizations for relevant medicinal products

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

(1)

Except in accordance with any exception or exemption set out in the relevant Community provisions and subject to paragraphs 1 and 3 of Schedule 1—

(a)

no relevant medicinal product shall be placed on the market; and

(b)

no such product shall be distributed by way of wholesale dealing,

unless a marketing authorization in respect of that product has been granted in accordance with the relevant Community provisions by the licensing authority or the European Commission, and is for the time being in force in accordance with those provisions.

(2)

Schedule 1 shall have effect for the purpose of making certain exceptions or exemptions from paragraph (1), and for imposing certain obligations in connection with such exceptions and exemptions.