UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products A medicinal product may only be placed on the UK market if it has been granted a marketing authorisation (MA). Biological medicinal prod- ucts must meet the same quality, safety and efficacy criteria to obtain an MA as those for non-biological medicinal products. However, since biological medicinal products are espe- cially sensitive to change in starting materials or manufacturing conditions, they are subject to specific requirements, as set out in Annex I to EU Directive 2001/83, as amended by Schedule 8B of the HMRs. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices MAs for medicinal products in the UK are valid for an initial period of five years. However, an MA ceases to be valid if the product is not placed on the market within three years of the date of authorisation (known as the “sunset” clause). The renewal application should be submitted to the MHRA six months before expiry. The authorisation may be renewed on the basis of a re-evaluation of the risk-benefit balance. Once renewed, the MA will be valid for an unlimited period, unless there are justified grounds relat- ing to pharmacovigilance to proceed with one additional five-year renewal. The MHRA may revoke, vary or suspend a UK MA in certain situations, including if the MHRA believes that the product is harmful or that the positive therapeutic effects of the product do not outweigh its risks to the health of patients or the public, or that the product’s composition is not as described in the application for the MA or the material supplied with it.
• any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or • any substance or combination of substances that may be used by or administered to human beings with a view to: (a) restoring, correcting or modifying a physi- ological function by exerting a pharma- cological, immunological or metabolic action; or (b) making a medical diagnosis. The UK Medical Devices Regulations define a medical device as any instrument, apparatus, appliance, software, material or other article, used alone or combined, for humans to: • diagnose, prevent, monitor, treat or alleviate disease; • diagnose, monitor, treat, alleviate or compen- sate for an injury or handicap; • investigate, replace or modify the anatomy or a physiological process; or • control conception. To distinguish between medical devices and medicinal products, it is important to consider: • the intended purpose of the product, taking into account the way the product is present- ed; and • the method by which the principal intended action is achieved. Where the assessment is not straightforward, or where disagreement arises, the MHRA’s Medi- cines Borderline Section is able to issue deter- minations. Where a product falls into more than one category, a product will be classified as a medicinal product.
364 CHAMBERS.COM
Powered by FlippingBook