Prescription Only Medicines (Human Use) Order 1997
| Jurisdiction | UK Non-devolved |
| Citation | SI 1997/1830 |
(1) This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997 and shall come into force on 18th August 1997.(2) In this Order, unless the context otherwise requires–
- “the Act” means the Medicines Act 1968;
- “aerosol” means a product which is dispersed from its container by a propellent gas or liquid;
- “appropriate nurse practitioner” means–
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(a) a person who–
- (i) is registered in Part 1 or 12 of the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979 (referred to below in this definition as “the professional register”) , and
- (ii) has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 1983; or
- (b) a person who is registered in Part 11 of the professional register as a health visitor;
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(a) a person who–
- “controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971 ;
- “cyanogenetic substances” means preparations which–
- (a) are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17, or
- (b) contain more than 0.1 per cent by weight of any substance having the formula either α-Cyanobenzyl-6-O-β-d-glucopyranosyl-β-d-glucopyranoside or α-Cyanobenzyl-β-d-glucopy ranosiduronic acid;
- “dosage unit” means–
- (a) where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or
- (b) where a medicinal product is not in any such form, the unit of measurement which is used as the unit by reference to which the dose of the medicinal product is measured;
- “external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal 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 such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;
- “health prescription” means a prescription issued by a doctor, dentist or nurse prescriber under or by virtue of–
- (a) in England and Wales, the National Health Service Act 1977,
- (b) in Scotland, the National Health Service (Scotland) Act 1978, and
- (c) in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972;
- “inhaler” does not include an aerosol;
- “master” has the same meaning as in section 313(1) of the Merchant Shipping Act 1995 ;
- “maximum daily dose” or “MDD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered in a period of 24 hours;
- “maximum dose” or “MD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered at any one time;
- “maximum strength” means–
- (a) the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;
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(b) the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–
- (i) weight in weight,
- (ii) weight in volume,
- (iii) volume in weight, or
- (iv) volume in volume,
- “medicinal product” includes any article or substance in respect of which section 58 of the Act has effect by virtue of an order made under section 104 of the Act, but does not include–
- (a) a medicinal product which is a veterinary drug as defined in section 132(1) of the Act or
- (b) an article or substance in respect of which section 58 has such effect where that article or substance is only to be administered to animals;
- “the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 1985 and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986;
- “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;
- “offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 1971 which is within–
- (a) tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward limits of territorial waters;
- (b) waters in any area designated under section 1(7) of the Continental Shelf Act 1964;
- “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;
- “prescription only medicine” means a medicinal product of a description or falling within a class specified in article 3 of this Order;
- “prolonged release” in relation to a medicinal product means a formulation of that product which–
- (a) is used to reduce the...
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