Regulation 3 Amendment of regulation 2 of the principal Regulations

after the definition of “the Act”, there shall be inserted the following–

• ““blood product” means any medicinal product derived from human blood or human plasma and shall include albumin, coagulating factor and immunoglobulin of human origin;”;

after the definition of “capital fee”, there shall be inserted the following–

• ““change of ownership application” means an application for a product licence for a medicinal product in respect of which a person other than the applicant is already the holder of a product licence and which–

  1. (a)

     includes a statement to the effect that that other person intends to cease selling or supplying that product pursuant to that licence;

  2. (b)

     is signed by or on behalf of that other person, as well as by or on behalf of the applicant; and

  3. (c)

     except for the name and address of the applicant and particulars in relation to the labelling of the product, contains or is accompanied by, particulars which are in all material respects identical to the particulars referred to in the product licence already held by that other person;

• “immunological product” means any medicinal product which is a vaccine, toxin, serum or an allergen product;”;

after the definition of “product licence (parallel import)”, there shall be inserted the following–

• ““radiopharmaceutical” means any medicinal product which, when ready for use, contains one or more radioactive isotopes which are included for a medicinal purpose;”.