UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices A wholesale distribution authorisation (WDA) issued by the MHRA is required in order to: • sell, supply, offer for sale, procure, hold or export POM, P/OTC, traditional herbal and GSL medicines on a wholesale basis in the UK; • import QP-certified medicinal products into Great Britain from EEA countries; and • export medicinal products to EEA and non- EEA countries. WDA holders located in Northern Ireland can still bring medicinal products into Northern Ireland from Great Britain, provided certain additional conditions are met. The facility involved in wholesale distribution is subject to inspection by the MHRA before a licence is granted. A WDA remains in force until it is revoked or surrendered. Distributors of medical devices are not required to obtain an authorisation to engage in whole- sale trade. 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Different Categories of Pharmaceuti - cals and Medical Devices .
criteria will need to be fulfilled. The proposed framework would provide a certificate of interna- tional recognition that will grant devices access to the Great Britain market. It is anticipated that certain devices, for example custom-made and certain software devices, will be excluded from eligibility. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices A manufacturer licence issued by the MHRA is required in order to manufacture, assemble or import licensed, unlicensed or investigational medicinal products. The process involves the submission of an application and the inspec- tion of the designated manufacturing site by the MHRA to verify compliance with good manufac- turing practice (GMP). A manufacturer licence remains in force until it is revoked or surrendered. Manufacturers of medical devices are not required to obtain a specific authorisation for the manufacture of their products, but are required to register the medical devices with the MHRA in order to place them on the market in Great Britain and (for certain medical devices, includ- ing IVD medical devices) Northern Ireland. As previously noted, the MHRA will only register medical devices where the manufacturer or their UK Responsible Person has a registered place of business in the UK.
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