# The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1977, Regulation 2: Amendment of regulation 2(1) of the principal regulations


Regulation 2(1) of the principal regulations (interpretation) shall be amended by adding—
(a) 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; ”;
(b) 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—
(i) any micro-organisms, viruses or other organisms in any state,
(ii) any toxins of microbial origin which have been detoxified (toxoids), or
(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;”

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Source: https://www.legislation.gov.uk/uksi/1977/675/regulation/2 (the official version)
Page: https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1977/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.