MEDICINES Citation, commencement and interpretation 1 1 This order may be cited as the Medicines (Pharmacy and General Sale—Exemption) Order 1980 and shall come into operation on 30th January 1981. 2 In this order, unless the context otherwise requires,— a “ the Act ” means the Medicines Act 1968; “ controlled drug ” has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971; “ cosmetic ” means any substance or preparation intended to be applied to the various surfaces of the human body including epidermis, pilary system and hair, nails, lips and external genital organs, or the teeth and buccal mucosa wholly or mainly for the purposes of perfuming them, cleaning them, protecting them, caring for them or keeping them in condition, modifying their appearance (whether for aesthetic purposes or otherwise) or combating body odours or normal body perspiration; “ enrolled nurse ” means a person for the time being enrolled as a nurse— in relation to England and Wales, under the Nurses Act 1957, in relation to Scotland, under the Nurses (Scotland) Act 1951, and in relation to Northern Ireland, under section 17 of the Nurses and Midwives Act (Northern Ireland) 1970; “ external use ” means — in relation to medicinal products for use by being administered to human beings, application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal, in relation to veterinary drugs, application to the skin, hair, fur, feathers, scales, hoof, horn, ear, eye, mouth or mucosa of the throat or prepuce, in either case when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that in relation to paragraph (i) in this definition such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations; “ food ” includes beverages, confectionery and articles and substances used as ingredients in the preparation of food and includes any manufactured substance to which there has been added any vitamin and which is advertised (within the meaning of section 92) as available and for sale to the general public as a dietary supplement; “ health authority ” — in relation to England and Wales, has the same meaning as in the National Health Service Act 1977 in relation to Scotland, means a Health Board Constituted under section 2 of the National Health Service (Scotland) Act 1978, and in relation to Northern Ireland, means a Health and Social Services Board established under Article 16 of the Health and Personal Social Services (Northern Ireland) Order 1972; “ master ” has the same meaning as in the Merchant Shipping Act 1894; “ occupational health scheme ” means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease; “ operator ”, in relation to an aircraft, means the person for the time being having the management of the aircraft; “ parenteral administration ” means administration by breach of the skin or mucous membrane; “ pharmacy medicine ” means a medicinal product which is not a prescription only medicine or a medicinal product on a general sale list; “ pre-school dental scheme ” means a scheme supervised by a doctor or dentist in which medicinal products are supplied to parents or guardians of children under five, for use by such children for the purpose of preventing dental caries; “ prescription only medicine ” means a medicinal product of a description for falling within a class specified in Article 3 of the Medicines (Prescription Only) Order 1980; “ registered nurse ” has the same meaning as in section 11; “ registered ophthalmic optician ” means a person who is registered in either of the registers of ophthalmic opticians established and maintained under section 2(a) of the Opticians Act 1958; “ school dental scheme ” means a scheme supervised by a doctor or dentist in which medicinal products are supplied at a school to pupils of that school for the purpose of preventing dental caries; “ sell ” means sell by retail as defined in section 131 and “ sale ” has a corresponding meaning; “ state registered chiropodist ” means a person who is registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960 by the Chiropodists Board; “ supply ” means supply in circumstances corresponding to retail sale as defined in section 131; “ unit preparation ” means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders, or other inert substances for the purposes of being administered to human beings; and b a reference to a numbered section is to the section of the Act which bears that number, a reference to a numbered Article or Schedule is to the Article of or Schedule to this order which bears that number and a reference in an Article or Schedule to a numbered paragraph is to the paragraph which bears that number in that Article or Schedule. Temporary exemption for certain products for human use 2 1 The restrictions imposed by section 52 shall not apply during the period set out in paragraph (2) to the sale, offer or exposure for sale or supply of any medicinal product which is for use by being administered to human beings and in respect of which a product licence has been granted containing, or has been varied so as to contain, a provision to the effect that the method of sale or supply of that product may be otherwise than by or under the supervision of a pharmacist (whether the grant or variation is made before, on or after the date on which this order comes into operation), if and so long as the conditions specified in section 53 are fulfilled. 2 The period referred to in paragraph (1) is— a where the product licence is granted containing the provision referred to in paragraph (1), that of two years from the date of the grant of that licence, and b where the product licence is varied so as to contain the provision referred to in paragraph (1), that of one year from the date of that variation of that licence. Exemption in cases involving another's default 3 The restrictions imposed by section 52 shall not apply to the sale, offer or exposure for sale or supply of a medicinal product by a person who, having exercised all due diligence, believes on reasonable grounds that the product is a medicinal product— a on a general sale list, or b which he may lawfully sell, offer or expose for sales or supply, as the case may be, free from the restrictions imposed by section 52, by reason of the exemption conferred by Article 2, where, due to the act or default of another person, that product is not such a medicinal product, if and so long as the conditions specified in section 53 are fulfilled. Exemption for products used by midwives in the course of their professional practice 4 There are hereby specified for the purposes of section 55(2)(b) (exemptions for certified midwives) the following classes of medicinal products— a all medicinal products that are not prescription only medicines, and b prescription only medicines which, by virtue of an exemption conferred by an order made under section 58(4)(a), may be sold or supplied by a certified midwife otherwise than in accordance with a prescription given by a practitioner. Exemption for certain persons 5 1 The restrictions imposed by section 52 shall not apply— a to the sale, offer or exposure for sale or supply by any person listed in column 1 of Part I of Schedule 1, or b to the supply by any person listed in column 1 of Part II of Schedule 1, of the prescription only medicines and the pharmacy medicines referred to in column 2 of Part I or Part II, as the case may be, of Schedule 1 in relation to that person, if and so long as the conditions specified in the corresponding paragraphs in column 3 of Part I or Part II, as the case may be, of Schedule 1 are fulfilled. 2 The restrictions imposed by section 53 shall not apply to the sale, offer or exposure for sale or supply by any person listed in column 1 of Part I or Part II of Schedule 1 of any medicinal product on a general sale list referred to in column 2 of Part I or Part II, as the case may be, of Schedule 1 in relation to that person if and so long as the conditions specified in the corresponding paragraphs in column 3 of Part I or Part II, as the case may be, of Schedule 1 are fulfilled. 3 For the purposes of the sale, offer or exposure for sale or supply of any veterinary drug on a general sale list, section 53 shall have effect without the conditions in subsection (3) of that section being required to be fulfilled if and so long as the sale or supply is by the holder of a product licence granted under Part II of the Act in respect of the veterinary drug in question and is to a person who has in his charge or maintains animals for the purposes of and in the course of carrying on a business, either as his sole business activity or as a substantial part of his business activities. Exemption for medicinal products at high dilutions 6 1 The restrictions imposed by sections 52 and 53 shall not apply to the sale, offer or exposure for sale or supply of a medicinal product which is neither for parenteral administration nor a controlled drug and which consists solely of one or more unit preparations of— a any substance where the unit preparation has been diluted to at least one part in a million (6x), or b any substance listed in Part I of Schedule 2 where the unit preparation has been diluted to at least one part in a thousand (3x), or c any substance listed in column 1 of Table A of Schedule 3 to the Medicines (General Sale List) Order 1980 or in Part III of Schedule 2 to this order or, if the medicinal product in question is for external use only, any substance listed in column 1 of Table B of Schedule 3 to the Medicines (General Sale List) Order 1980 or in Part IV of Schedule 2 to this order, in each case where the unit preparation has been diluted to at least one part in ten (1x), if and so long as the person selling or supplying the medicinal product has been requested by or on behalf of a particular person and in that person's presence to use his own judgment as to the treatment required. 2 The restrictions imposed by section 52 shall not apply to the sale, offer or exposure for sale or supply of a medicinal product which is neither for parenteral administration nor a controlled drug and which consists solely of one or more unit preparations of— a any substance where the unit preparation has been diluted to at least one part in a million (6c), or b any substance listed in Part II of Schedule 2 where the unit preparation has been diluted to at least one part in a million (6x), or c any substance listed in column 1 of Table A of Schedule 3 to the Medicines (General Sale List) Order 1980 or in Part III of Schedule 2 to this order or, if the medicinal product in question is for external use only, any substance listed in column 1 of Table B of Schedule 3 to the Medicines (General Sale List) Order 1980 or in Part IV of Schedule 2 to this order, in each case where the unit preparation has been diluted to at least one part in ten (1x), if and so long as the conditions specified in section 53 are fulfilled. Exemption for foods and cosmetics 7 For the purposes of the sale, offer or exposure for sale or supply of any medicinal product on a general sale list which is for sale either for oral administration as a food or for external use as a cosmetic, section 53 shall have effect without the condition in subsection (2) of that section being required to be fulfilled. Revocations 8 The Medicines (Pharmacy and General Sale—Exemption) Order 1977 and the Medicines (Pharmacy and General Sale—Exemption) Amendment Order 1978 are revoked. Patrick Jenkin Secretary of State for Social Services 27th November 1980 Nicholas Edwards Secretary of State for Wales 27th November 1980 George Younger Secretary of State for Scotland 1st December 1980 In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 3rd December 1980. Peter Walker Minister of Agriculture, Fisheries and Food Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 8th day of December 1980. N. Dugdale Permanent Secretary Sealed with the official seal of the Department of Agriculture for Northern Ireland this 5th day of December 1980. J. A. Young Permanent Secretary