Regulation 2 Amendment of regulation 2(1) of the principal regulations

immediately after the definition of “advertisement” the following definitions:—

• ““BCG” means the bacillus of Calmette and Guerin;

• “BCG vaccine” means a vaccine that is a preparation of the bacteria in a living pure culture of a strain of the bacillus of Calmette and Guerin; ”;

immediately after the definition of “medicinal product” the following definitions:—

• ““parenteral administration” means administration by breach of the skin or mucous membrane;

• “serum” means a fluid fraction of coagulated blood;

• “smallpox vaccine” means a vaccine that is a preparation of an infective vaccinia virus;

• “toxins” means substances used in the diagnosis, prevention or treatment of disease consisting wholly or partly of poisonous substances derived from specific micro-organisms, plants or animals;

• “vaccines” means antigenic substances which consist wholly or partly of—

  1. (i)

     any micro-organisms, viruses or other organisms in any state,

  2. (ii)

     any toxins of microbial origin which have been detoxified (toxoids), or

  3. (iii)

     any extracts or derivatives of any micro-organisms or of any viruses,

being substances which, when administered to human beings or animals, are used for the prevention or treatment of specific diseases;”