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The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

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20.  In the Medicines (Advertising) Regulations 1994(1)—

(a)in paragraph (1) of regulation 2, after the definition of “essential information” there shall be inserted the following definition—

“marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or by the licensing authority under the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 and includes a product licence granted by the licensing authority under Part II of the Act;;

(b)in paragraph (1) of regulation 3, for the words “product licence” there shall be substituted the words “marketing authorization”; and

(c)in regulation 4 for the words “product licence” there shall be substituted the words “marketing authorization”;

(d)in sub-paragraph (l) of paragraph (1) of regulation 9, for the words “product licence” there shall be substituted the words “marketing authorization”;

(e)in regulation 12, for the words “product licence” there shall be substituted the words “marketing authorization”; and

(f)in Schedule 2—

(i)in paragraph 1, for the word “licence” there shall be substituted the word “authorization”;

(ii)in paragraph 2, for the words “product licence” there shall be substituted the words “marketing authorization”; and

(iii)in paragraph 5, for the word “licence” there shall be substituted the word “authorization”; and

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