Regulation 2 Amendment of regulation 1 of the principal Regulations

in paragraph (2) after the definition of “monograph” the following definitions are inserted—

• ““product information compendium” has the meaning it bears in regulation 2A(1)(b);

• “summary of product characteristics” has the meaning it bears in regulation 2(1) of the Medicines (Advertising) Regulations 1994^f1;”, and

after paragraph (2) the following paragraph is inserted—

“(2A)

In these Regulations unless the context otherwise requires “product licence” includes a marketing authorisation in respect of medicinal products intended for use by being administered to human beings and granted under Council Regulation (EEC) No. 2309/93^f2 or under the Medicines for Human Use (Marketing Authorisations, Etc.) Regulations 1994^f3;”.