MEDICINES Citation, interpretation and commencement 1 These regulations, which may be cited as the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1977, shall be read as one with the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 as amended (hereinafter referred to as “ the principal regulations ”) and shall come into operation on 12th May 1977. Amendment of regulation 2(1) of the principal regulations 2 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— any micro-organisms, viruses or other organisms in any state, any toxins of microbial origin which have been detoxified (toxoids), or 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; Additional regulations 3 The principal regulations shall be amended by adding after Regulation 3 the following regulations:— “Standard provisions for manufacturer's licences and manufacturer's licences of right for vaccines, toxins and sera 4 1 In addition to the standard provisions for manufacturer's licences set out in Schedule 2 to these regulations, the standard provisions for manufacturer's licences, including manufacturer's licences of right, relating to vaccines for human use shall be the following— a for all vaccines, including smallpox vaccine and BCG vaccine, those provisions set out in Part I of Schedule 4 to these regulations, b for smallpox vaccine, those provisions set out in Part II of Schedule 4 to these regulations, and c for BCG vaccine, those provisions set out in Part III of Schedule 4 to these regulations. 2 In addition to the standard provisions for manufacturer's licences set out in Schedule 2 to these regulations, the standard provisions for manufacturer's licences, including manufacturer's licences of right, relating to toxins and sera for human use shall be the following— a for toxins, those provisions set out in Part IV of Schedule 4 to these regulations, and b for sera, those provisions set out in Part V of Schedule 4 to these regulations. Standard provisions for product licences including product licences of right for certain medicinal products 5 1 In addition to the standard provisions for product licences set out in Part I of Schedule 1 to these regulations, the standard provisions for product licences, including product licences of right, relating to medicinal products to which this regulation applies shall be those provisions set out in Schedule 5 to these regulations. 2 The standard provisions contained in this regulation shall only apply to medicinal products which include a substance or substances specified in paragraphs 1 to 35 in column 1 of Schedule 1 to the Medicines (Control of Substances for Manufacture) Order 1971 in the circumstances set out in column 2 of the said Schedule other than medicinal products as aforesaid manufactured, assembled, sold, supplied, imported or exported for use as veterinary drugs. . Additional schedules 4 After Schedule 3 to the principal regulations, there shall be added as Schedules 4 and 5, the Schedules set out in the Schedule to these regulations. David Ennals Secretary of State for Social Services 4th March 1977 John Morris Secretary of State for Wales 25th March 1977 Bruce Millan Secretary of State for Scotland 31st March 1977 In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 4th April 1977. John Silkin Minister of Agriculture, Fisheries and Food Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 5th day of April 1977. N. Dugdale Permanent Secretary Sealed with the official seal of the Department of Agriculture for Northern Ireland this 6th day of April 1977. J. A. Young Permanent Secretary