Medicines (Pharmacy and General Sale - Exemption) Order 1980
| Jurisdiction | UK Non-devolved |
| Citation | SI 1980/1924 |
| Year | 1980 |
1980 No. 1924
MEDICINES
The Medicines (Pharmacy and General Sale— Exemption) Order 19808thDecember 1980
29thDecember 1980
30thJanuary 1981
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 57(1) and (2) and 129(4) of the Medicines Act 1968(a) and now vested in them(b) and the Secretaries of State concerned with health in England, in Wales and in Scotland and the Department of Health and Social Services for Northern Ireland, acting jointly, in exercise of powers conferred by sections 55(2)(b) and 129(4) of that Act and now vested in them(b) and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following order, and after taking into account the advice of the Medicines Commission, hereby make the following order:—
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(c);
"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 purpose of perfuming them, cleansing them, protecting them, caring for them or keeping
(a) 1968 c. 67.
(b) In the case of the Secretaries of State concerned with health in England and in Wales by virtue of Article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388), in the case of the Secretary of State concerned with agriculture in Wales by virtue of Article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and Section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).
(c) 1971 c. 38.
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—
(i) in relation to England and Wales, under the Nurses Act 1957(a),
(ii) in relation to Scotland, under the Nurses (Scotland) Act 1951 (b), and
(iii) in relation to Northern Ireland, under section 17 of the Nurses and Midwives Act (Northern Ireland) 1970(c);
"external use" means—
(i) 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,
(ii) 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"—
(i) in relation to England and Wales, has the same meaning as in the National Health Service Act 1977(d),
(ii) in relation to Scotland, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978(a), and
(iii) 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(f);
"master" has the same meaning as in the Merchant Shipping Act 1894(g);
"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;
(a) 1957 c. 15.
(b) 1951 c. 55.
(c) 1970 c. 11 (N.I.).
(d) 1977 c. 49; the definition of health authority was amended by the Health Services Act 1980 (c. 53), section 1(7) and Schedule 1, Part I, paragraph 77(b).
(e) 1978 c. 29.
(f) S.I. 1972/1265 (N.I. 14).
(g) 1894 c. 60.
"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 or falling within a class specified in Article 3 of the Medicines (Prescription Only) Order 1980(a);
"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(b);
"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(c) 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 purpose 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.
(a) S.I. 1980/1921.
(b) 1958 c. 32.
(c) 1960 c. 66.
(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 sale 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...
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