UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The importation and exportation of medicinal products are governed by the HMRs (or EU Directive 2001/83 in relation to Northern Ireland). A Certificate of Phar- maceutical Product may be required. The importing of medical devices is governed by the UK Medical Devices Regulations (or the relevant EU Directive in relation to Northern Ireland). In 2025, the UK govern- ment began introducing new regulations for medical devices, and further incremental changes are expect- ed to continue over the course of 2026. Incoming reg- ulations are expected to clarify the requirements for economic operators, including importers. There are no specific rules regarding the exporting of medical devices except that a Certificate of Free Sale may be needed depending on the importing country. HM Revenue and Customs (HMRC) is responsible for border control. The MHRA Enforcement Group is responsible for applying and enforcing the HMRs and the UK Medical Devices Regulations. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Importers of pharmaceuticals and medical devices require an Economic Operator Registration and Iden- tification number, which is entered onto all UK cus- toms declarations. Importers must be a UK-resident business for certain UK customs issues, including the declarations. The designation of a particular entity as the importer of record for customs purposes will not be conclusive in determining who should hold any required import authorisations from a regulatory perspective. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Importing medicinal products into the UK from coun- tries outside the EEA for use in the UK or to supply to an EEA country requires a manufacturer’s import authorisation granted by the MHRA. Importing QP- certified medicines into Great Britain from the EEA
Manufacturers of medical devices are not required to obtain a specific authorisation for the manufacture of their products, but are required to register the medi- cal devices with the MHRA in order to place them on the market in Great Britain and (for certain medical devices, including IVD medical devices) Northern Ire- land. As previously noted, the MHRA will only register medical devices where the manufacturer or their UK Responsible Person has a registered place of busi- ness in the UK. 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 medicinal products 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 sub- ject 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 wholesale trade. 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Categories of Pharmaceuticals and Medical Devices .
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