Unlicensed medicine supply particular

This provision allows Member States if they wish (there is no obligation to do so) to make national arrangements for the supply of unlicensed medicines for particular use, but only in the very limited circumstances specified by the Directive. 

This provision allows Member States if they wish (there is no obligation to do so) to make national arrangements for the supply of unlicensed medicines for particular use, but only in the very limited circumstances specified by the Directive. As part of the 2001 review process, the European Commission recently issued proposals to regulate the compassionate use of medicinal products falling within the scope of Regulation 2309/93/EC (the centralised procedure). However, these proposals are unlikely to come into force for several years. 

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. 

At the operational level, manufacturers must apply proper care and rigorous quality control during production, to ensure that they supply unlicensed medicinal products of the highest quality. They must also have in place proper systems for dealing with requests for particular patient supply and for keeping all the necessary records. 

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. ... 

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