Medicines Exemption from

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). 

There are a number of other scenarios where medicinal products may be brought to market exempt from the requirement to submit applications supported by full pre-dinical and clinical data. 

If products under patent are exempted from the RP system, do the negative effects on the R D of the pharmaceutical sector disappear The exclusion of medicines with a current patent may reduce the economic erosion of the rights granted by the patent, and also the disincentive to invest in R D. But negative effects on innovation are not totally eradicated, as (a) RP increases the uncertainty on the expected return on the investment, (b) incentives for innovation will be damaged due to the fact that the R D process is a joint production process, since the overall return is reduced when RP is applied, and (c) the exclusion of patented products has proved to be only partial in some cases (for example, not excluding drags under a process patent). 

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. 

Substances used only for process-orientated research and development are exempt from registration for 5 years. The exemption can be extended for a further 5 years in exceptional circumstances, or 10 years for substances used exclusively to develop human or veterinary medicines. The manufacturer or importer has to inform the ECA of the substance identity, labelling and quantity, justify the quality, summarise the research programme and list the customers. 

The schedule only provides exemptions from the requirement to hold a marketing authorisation. Other activities involved in the supply of medicines on a particular patient basis need to be carried out under the appropriate authorisations. 

Section 8(2) of the Medicines Act 1968 requires those involved in the manufacture or assembly of a medicinal product to hold a manufacturer s licence. In fact. Schedule 1 to 1994 Regulations requires the manufacturer/assembler in the United Kingdom of an unlicensed product for particular patient supply to hold a particular type of manufacturer s licence (a manufacturer s special licence). It should also be noted that Section 23 of the act prohibits the manufacture of a medicinal product unless that product has a marketing authorisation, or is exempt from the marketing authorisation requirement. 

There are illogicalities in the system, as a patient who is exempt from paying a prescription charge gets all medicines free, even if the... 

Abbreviated advertisements are advertisements which are exempt from the requirement to include prescribing information for the advertised medicine, provided that they meet with the requirements of this clause. 

The provision of samples is not permitted for any medicine which contains a substance listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the medicine is not a preparation listed in Schedule III to that Convention) or a substance listed in any of Schedules I to IV of the Psychotropic Substances Convention (where the medicine is not a preparation which may be exempted from measures of control in accordance with Paragraphs 2 and 3 of Article 3 of that Convention). 

Substances used in human medicines, including excipients, are exempt from many of the provisions of REACH, including Authorization, but they are not exempt from the Restriction provisions in REACH Title VIII. This enables the European Commission to restrict the manufacture, marketing, and use of any substance including pharmaceuticals. 

In review, alternative medicines have been exempted from demonstrating efficacy (Kefauver-Harris Amendment) by being classified as dietary supplements (Dietary Supplement Health and Education Act). This means that herbal products cannot make therapeutic... 

In 1997, a Ministerial Decree gave the possibility for exemption from the price for reimbursement acceptance negotiations for medicines with no reimbursement or list claim. The situation is explained as follows. 

Radioactive matericils used for a therapeutic purpose are specifically exempted from the medicines legislation. 

Certain groups of medicinal products are exempted from registration. They are ... 

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