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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,—
“the Act” means
“controlled drug”
“cosmetic” means
“enrolled nurse” means
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”
“health authority”
in relation to England and Wales, has the same meaning as in the National Health Service Act 1977(1)
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”
“occupational health scheme” means
“operator”, in relation to an aircraft, means
“parenteral administration” means
“pharmacy medicine” means
“pre-school dental scheme” means
“prescription only medicine” means
“registered nurse”
“registered ophthalmic optician” means
“school dental scheme” means
“sell” means
“state registered chiropodist” means
“supply” means
“unit preparation” means
(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.
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.
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.
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.
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.
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.
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.
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.
L.S.
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.
L.S.
N. Dugdale
Permanent Secretary
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 5th day of December 1980.
L.S.
J. A. Young
Permanent Secretary
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