Paragraph 4
In the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977f1 for paragraph (1) of regulation 2 there shall be substituted the following paragraph—
“(1)In these Regulations, unless the context otherwise requires—
(a)“medicinal product” includes a relevant medicinal product within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 and, where a product licence relates to any substance or article which is not a medicinal product, the substance or article to which the licence relates or is intended to relate;
(b)“product licence” includes a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994; and
(c)other expressions have the same meanings as in the Medicines Act 1968.”.
Annotations
Footnotes
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S.I. 1977/1038. The relevant amending instrument is S.I. 1992/2845.