UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The importing and exporting of medicinal prod- ucts are governed by the HMRs (or EU Direc- tive 2001/83 in relation to Northern Ireland). A Certificate of Pharmaceutical Product may be required. The importing of medical devices is governed by the UK Medical Devices Regula- tions (or the relevant EU Directive in relation to Northern Ireland). The UK government plans to introduce new regulations for medical devices over the course of 2025 and 2026. These regu- lations are expected 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 import- ing country. HM Revenue and Customs 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 Registra- tion and Identification number, which is entered onto all UK customs 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 regula- tory perspective. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Importing medicinal products into the UK from countries outside the EEA for use in the UK or to supply to an EEA country requires a manu- facturer’s import authorisation granted by the MHRA. Importing QP-certified medicines into Great Britain from the EEA may be performed under a WDA that authorises import. No authorisation is required to import medical devices, but importers should notify the UK Responsible Person or the Northern Ireland- based Authorised Representative (as described in 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceutical and Medi- cal Devices ), as they are required to provide the MHRA with a list of device importers. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Details of specific tariff duties and measures that apply to particular goods in the UK are contained in the Integrated Tariff of the UK. An importer or exporter is responsible for the correct tariff classification of goods. His Majesty’s Revenue and Customs (HMRC) has developed an online trade tariff tool to assist in product classification. 7.5 Trade Blocs and Free Trade Agreements Under the EU–UK Trade and Co-operation Agreement, and the UK’s free trade deal with Norway, Iceland and Liechtenstein, there are no tariffs or quotas on trade in medicinal products and medical devices between the UK and the EU and EEA countries, and mutual recogni- tion of GMP inspections and certificates. The UK has also entered into an economic partner-
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