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Medicinal products: manufacture, distribution and sale

Medicinal products are regulated at the EU level by a number of legislative measures including Directive 2001/83/EC Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and other legislation (see for further information:

The Human Medicines Regulations 2012 (2012 No. 1916) ("HMR") come into force on 14 August 2012 (“the Regulations”) and repeal or revoke most existing United Kingdom legislation regulating the authorisation, sale and supply of medicinal products for human and consolidate their effect in one place and in rationalised form.

UK medicines legislation establishes a comprehensive regime for the authorisation of medicinal products for human use, for the manufacture, import, distribution, sale and supply of those products, for their labelling and advertising, and for “pharmacovigilance”, the protection of public health by ensuring that medicines meet appropriate standards of safety, quality and efficacy. Most of the topics covered by the legislation are now the subject of EU enactments, most notably Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (“the Directive”).

The legislation being consolidated comprises the greater part of the Medicines Act 1968 (“the Act”), many principal and amending statutory instruments, some made under the Act and some under the European Communities Act 1972.. This has resulted in a legislative framework that is fragmented, complex, poorly structured and in places obsolete. The Regulations also provide for the enforcement in the UK of Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Regulation (EC) No 726/2004 covers much the same topics as the Directive, but in relation to products based on new active substances for treatment of certain major diseases, and to certain advanced or biological medicines.

The Regulations leave parts of the Act in place. This principally concerns Part IV of the Act, which deals with the registration and conduct of pharmacies. Also retained are certain powers to make secondary legislation in areas that fall outside the scope of the Directive. Enforcement and other ancillary provisions of the Act are retained with appropriate amendments to support these.

Certain pieces of medicines legislation have not been consolidated. Legislation concerning clinical trials, the administration of radioactive medicinal products and fees charged by the MHRA for the administration of procedures under the provisions being consolidated are left in place. They have been, or will be, subject to changes as part of separate policy initiatives, so it would have been unhelpful to consolidate them at this point.

Finally, the Regulations repeal section 10(7) of the Medicines Act 1968 without consolidating it. This exempts pharmacists from the need for a wholesale dealer’s licence if wholesale dealing forms only an inconsiderable part of their business, but is not compatible with the Directive.

Medicinal products
A "medicinal product” means:
(a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or .
(b) any substance or combination of substances that may be used by or administered to human beings with a view to:
(i)restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action; or
(ii)making a medical diagnosis. .
The Regulations do not apply to whole human blood; or any human blood component, other than plasma prepared by a method involving an industrial process.

The MHR recognise a “herbal medicinal product” which is a medicinal product whose only active ingredients are herbal substances or herbal preparations (or both). "Herbal preparation” means a preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, and includes a comminuted or powdered herbal substance, a tincture, an extract, an essential oil, an expressed juice or a processed exudate. A "herbal substance” means a plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of a plant, defined by the plant part used and the botanical name of the plant, either fresh or dried, but otherwise unprocessed.

The MHR also recognise a “homoeopathic medicinal product” which is a medicinal product prepared from homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia, or in the absence of such a description in the European Pharmacopoeia, in any pharmacopoeia used officially in an EEA State.

Manufacturer's and wholesale dealer's licences
The HMR require any person who manufactures, assembles or importss a medicinal product froma non-EEA state to have a licence. A person who distributes a medicinal product by way of wholesale dealing also requires a licence.

Licences are granted by the Secretary of State or Minister of State for Health. The HMR set out the criteria which must be met for the grant of a licence. Tacit consent does not apply as the MHR lay down a 90 day period within which a licence must be granted or refused. There is no specific right of appeal.
Legaleze comment: if the minister acted unlawfully or unreasonably in withholding a licence, it is thought that the action would be subject to the supervisory jurisdiction of the High Court on normal principles of administrative law.

The Regulations provide for licences to be subject to standard conditions and special conditions may be imposed.

Marketing authorisation
A person may not sell or supply, or offer to sell or supply, a medicinal product otherwise than in accordance with the terms of—
(a) a marketing authorisation; .
(b )a certificate of registration; .
(c) a traditional herbal registration; or .
(d) an Article 126a authorisation.

A marketing authorisation under (a) relates to a UK authorisation for marketing a medicinal product. An Article 126a authorisation applies where a medicinal product has been authorised in another EEA member state and is to be imported to the UK. A certificate of registration relates to homoeopathic medicinal products. A traditional herbal registration applies to a herbal medicinal product which has been in continuous use for at least 30 years and in continual medicinal use in the EU for at least 15 years. Certain other requrements are set out in the Regulations.

Prescription only medicine
A person may not sell or supply a prescription only medicine except in accordance with a prescription given by an appropriate practitioner.

Advertising and packaging
The MHR contain requirements relating to the advertising, marketing, labelling and packaging of medicinal products. There are spewcial requirements placed on medical sales representatives and the offer of free samples, inducements and hospitality.

Civil enforcement: there are no specific provisions relating to civil enforcement. [However, it may be that a person who suffers damage due to a breach of the MHR, in particular the sale of an unauthorised mdecine, may be entitled to compensation for breach of statutory duty on general legal principles].
Criminal enforcement: the MHR create a number of offences, notably those of manufaturing or selling by way of wholesale a medicinal product without a valid licence, and of selling or possessing for sale an unauthorised medicinal product. The maximum penalty is in general an unlimited fine or two years' imprisonment.
There is provision for Director's criminal liability.

Further information
Further information on the practical aspects of regulation is available from the The Medicines and Healthcare products Regulatory Agency (MHRA) which is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.



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