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Download The Law on Medicines: Volume 3 Distribution and Selling by I. H. Harrison M Pharm, FPS (auth.) PDF

By I. H. Harrison M Pharm, FPS (auth.)

The medications Act 1968 including its delegated laws comprehensively controls the manufacture, packaging, labelling, distribution and merchandising of medications for either human and animal use within the uk. It additionally controls the import and export of such medications. It changed a patchwork of controls which advanced over a century. when you consider that its enactment, greater than a hundred and fifty goods of delegated laws (orders and laws) were made lower than its provisions and approximately a hundred thirty are nonetheless operative. The sheer actual bulk of this mass of fabric explanations hassle, not just in comprehension but additionally find the aspect so frequently required. the placement is exacerbated through the truth that a few items of laws were amended a number of instances. My vital target is to supply a reference booklet which incorporates all the provisions of the Act and its a variety of orders, laws as amended up to now. the cloth is prepared to facilitate the quest for aspect. on the way to help the reader find his manner via this maze, Chaper 1 contains a survey of the location which existed sooner than the Act got here into being, including a synopsis of the current controls. this could let the reader to understand the alterations that have happened and the way the process works.

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27 1. Citation, commencement and interpretation (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 vajrious 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 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, (ii) 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(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, hom, ear, eye, mouth or mucosa of the throat or prepuce, (iii) 31 32 THE LAW ON MEDICINES 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, (ii) in relation to Scotland, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978, 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; '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 or 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; VOLUME 3: DISTRIBUTION AND SELLING 33 '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 a 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) 2.

2. Exemption for certain collection and delivery arrangements (1) The restrictions imposed by sections 52 and 53 of the Act shall not apply to the supply of any medicinal product for human use on premises which are not a registered pharmacy where such supply is in accordance with a prescription given by a doctor or dentist and forms part of a collection and delivery arrangement used by a person who lawfully conducts a retail pharmacy business. (2) In this Article 'collection and delivery arrangement' means any arrangement whereby a person is enabled to take or send a prescription given by a doctor or dentist to premises other than a registered pharmacy and to collect or have collected on his behalf from such premises a medicinal product prepared or dispensed in accordance with such prescription at a registered pharmacy by or under the supervision of a pharmacist if such premises at which the medicinal product is supplied are capable of being closed by the occupier so as to exclude the public.

Further powers to regulate dealings with medicinal products (1) The appropriate Ministers may by regulations prescribe such requirements as they may consider necessary or expedient with respect to any of the following matters, that is to say - (2) (a) the manner in which, or persons under whose supervision, medicinal products may be prepared or may be dispensed; (b) the amount of space to be provided in any premises for persons preparing or dispensing medicinal products, the separation of any such space from the remainder of the premises, and the facilities to be provided in any premises for such persons; (c) the amount of space to be provided in any premises for the sale or supply of medicinal products; (d) the accommodation (including the amount of space) to be provided in any premises for members of the public to whom medicinal products are sold or supplied or for whom medicinal products are being prepared or assembled; (e) the amount of space to be provided in any premises for the storage of medicinal products; (f) the safekeeping of medicinal products; (g) the disposal of medicinal products which have become unusable or otherwise unwanted; (h) precautions to be observed before medicinal products are sold or supplied; (i) the keeping of records relating to the sale or supply of medicinal products; (j) the supply of medicinal products distributed as samples; (k) sanitation, cleanliness, temperature, humidity or other factors relating to the risks of deterioration or contamination in connection with the manufacture, storage, transportation, sale or supply of medicinal products (I) the construction, location and use of automatic machines for the sale of medicinal products.

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