Marketing authorisations United Kingdom

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. 

In the United Kingdom, manufacturers who provide special products must have an authorisation allowing special manufacture. A wholesale distributor will not be in breach of wholesale distribution rules and conditions if he handles a special product, provided that there is no departure from the terms of the rules. The exclusions facilitate compassionate use programmes where product is not authorised, either because it is still at the experimental stage or because it has been withdrawn from the market (for commercial or for safety reasons) or the product may simply never have been intended for full-scale... 

Where a clinical trial was proposed with a marketed product then the CTMP scheme could be used. This was a streamlined process based on the fact that there were no quality issues with a product that had already been granted a marketing authorisation. The applicant submitted a copy of the trial protocol, provided information on the investigators and, depending on whether or not the applicant was the MAH, information on the procedures for reporting adverse drug reactions. It was only possible to use this procedure for UK marketed products. It did not apply to unauthorised products manufactured specifically for trial or to products, which were licensed only in countries other than the United Kingdom. 

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