Medicines Exemption from Order

The original provisions date back to the early 1970s. Under section 7(2) of the Medicines Act 1968, it was necessary to hold a product licence in order to sell, supply, export or import a medicinal product to procure those activities or for the manufacture or assembly of the product. However, various exemptions from the licensing requirements, including those relating to particular patient supply, were provided for in the act and in related statutory instruments. The most important exemptions were contained in sections 9 and 13 of the act, the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 and the Medicines (Exemptions from Licences) (Importation) Order 1984. ... 

The Medicines (Exemption from Licences) (Importation) Order 1984 set out additional conditions to be complied with in the case of unauthorised medicinal products imported for particular patient supply but, as noted above, that order was disapplied by the 1994... 

The Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 (SI 1971/1450). 

The legal basis for the CTX scheme is given in SI 1995 No. 2808 The Medicines (Exemption from Licences) (Clinical Trials) Order, and SI 1995 No. 2809 The Medicines Exemption from Licences and Certificates) (Clinical Trials) Order. The MCA provides guidance notes on applications for clinical trial exemptions and clinical trial certificates. Special forms (MLA 164, 165,166, and 168), obtainable from the MCA, are provided for use by applicants in preparing a CTX application, notification of chcinge, and renewal. 

The Medicines (Exemption from Licences) (Importation) Order 1984 set out additional conditions to be complied with in the case of unauthorised medicinal products imported for particular patient supply but, as noted above, that Order was disapplied by the 1994 Regulations. There were no provisions in the 1994 Regulations to parallel the 1984 Order and consequently the controls on imported unlicensed products were reduced to the level of those on products manufactured in the UK. This was clearly the result of an oversight, and additional controls were reinstated in February 1999 by the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999. ... 

Sections 31-39 of the Medicines Act, which set out the general provisions governing the conduct of clinical trials in the UK, are unaffected by the 1994 Regulations. The Act pro sddes that a clinical trial must be authorised before taking place, either by the terms of the marketing authorisation of the product involved, or by a clinical trial certificate ( CTC ) (sections 31(3) and 35(1)). Exemptions, allowing use in clinical trials in other circumstances, are contained in the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Pro visions) Order 1972 (exemption for trials initiated by doctors and dentists - DDX scheme), the Medicines (Exemption from Licences) (Clinical Trials) Order 1995" and the Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995" (exemption for company initiated trials - CTX scheme). Both of these exemptions are subject to certain conditions, such as notification to the MCA. 

The Medicines (Exemption from Licences) (Clinical Trials) Order 1995 (SI 1995/2808). The Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995 (SI 1995/2809). 

The regulation also stipulates that a maximum of three courses of treatment with chemically synthesised allopathic veterinary medical products or antibiotics within one year (or no more than one course of treatment if the productive life cycle is less than one year) is acceptable. These regulations are designed to encourage the use of preventive management and alternative treatments for the control of parasites and diseases. Vaccinations, veterinary medicine treatments for parasites and any compulsory eradication schemes established by Member States are exempt from the treatment maximums, in order to ensure animal welfare. 

The Act makes provision for the legal status of all medicines as either prescription only (POM), general sale (GSL), or by default pharmacy (P) a medicine is Pharmacy status unless listed in the POM or GSL Orders. Some medicines are exempted from POM status (making them P status) if their active substance is within specified limits for strength, dose, pack size, use, route of administration, or dose form. Some medicines may be disallowed from GSL status (making them P status) because their active substance is outside the specified limits for strength, dose, pack size, use, route of administration, or dose form. Pack size of certain GSL medicines is controlled by the Sale and Supply Regulations. 

In the UK in order to sell alcohol a Justice s licence is required. This normally applies to public houses, off licences, supermarkets, etc. A pharmacy would need a licence in order to retail an alcoholic tonic wine but does not need a licence in order to supply or manufacture medicines containing alcohol. A pharmacy would also be exempt from the requirement to hold a licence if selling alcohol to a trader for purposes of trade. 

As a matter of law, there is very little in the European pharmaceutical legislation dealing with licensing exemptions. Directive 65/65 Article 2 merely states that the Member State may in accordance with legislation in force and to fulfil special needs exclude from Chapters II to V medicinal products supplied in response to a bona fide unsolicited order formulated in accordance with the specifications of an authorised healthcare professional and for use by his... 

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