MEDICINES Citation, commencement and interpretation 1 1 These regulations may be cited as the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Amendment Regulations 1977 and shall come into operation on 15th July 1977. 2 These regulations shall be read as one with the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971 as amended (hereinafter referred to as “ the principal regulations ”). Amendments of Schedule 1 to the principal regulations 2 1 After paragraph 27 of Part I of Schedule 1 to the principal regulations (particulars required on applications) there shall be inserted the following paragraphs— 28 A specimen or mock-up of the labelled container and package in which the medicinal product is to be sold or supplied and a specimen or mock-up of any leaflet relating to the medicinal product which is to be supplied with the product by being enclosed in containers or packages of the product. 29 Where manufacturing or assembling operations relating to the medicinal product are to be carried out in a place other than in the United Kingdom, documentary evidence that every person taking part in the manufacture or assembly in the course of a business carried on by him is authorised to carry out such operations by the appropriate authority of the country in which such operations are to be carried out. 30 Where an authorisation to sell or supply the medicinal product or to place the product on the market in another country has been obtained, a copy of such authorisation. . 2 After paragraph 28 of Part II of Schedule 1 to the principal regulations there shall be inserted the following paragraphs— 29 A specimen or mock-up of the labelled container and package in which the medicinal product is to be sold or supplied and a specimen or mock-up of any leaflet relating to the medicinal product which is to be supplied with the product by being enclosed in containers or packages of the product. 30 Where manufacturing or assembling operations relating to the medicinal product are to be carried out in a place other than in the United Kingdom, documentary evidence that every person taking part in the manufacture or assembly in the course of a business carried on by him is authorised to carry out such operations by the appropriate authority of the country in which such operations are to be carried out. 31 Where an authorisation to sell or supply the medicinal product or to place on the product on the market in another country has been obtained, a copy of such authorisation. . David Ennals Secretary of State for Social Services 13th June 1977 John Morris Secretary of State for Wales 14th June 1977 Bruce Millan Secretary of State for Scotland 16th June 1977 In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 17th June 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 20th day of June 1977. N. Dugdale Permanent Secretary Sealed with the official seal of the Department of Agriculture for Northern Ireland this 21st day of June 1977. J. A. Young Permanent Secretary