FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
However, there are exemptions from the prior authorisation requirement, namely for: • individuals importing medicines for personal use; • medicines with a valid marketing authorisa- tion in France, provided they are presented in compliance with the approved authorisation (see 3.4 Procedure for Obtaining a Market- ing Authorisation for Pharmaceuticals and Medical Devices ); • homeopathic and traditional herbal medicines registered in France, provided they are pre- sented in compliance with their registration; • medicines authorised under early access or compassionate use; • medicines required for an authorised biomed- ical research study in France; • medicines imported from an EU member state and stored in a licensed pharmaceutical facility, provided they are intended exclusively for export to non-EU countries; • medicines imported by a sports team phy- sician for team use, whether transported personally or through other means; or • medicines in external transit or moving through French territory as part of intra-EU exchanges. Medical Devices The importation of medical devices from non- EEA countries into France does not require prior governmental authorisation. However, imported devices must fully comply with EU regulatory requirements, including a valid CE marking and an EU Declaration of Conformity, which confirm compliance with essential safety and perfor- mance standards and enable free circulation within the EU. If the manufacturer is based outside the EEA and has not appointed an authorised representative,
the importer assumes regulatory responsibility for ensuring the device’s conformity, traceability and compliance with post-market obligations. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The import of products into the EU is gov- erned by a standardised classification system that categorises products based on their tariff codes (Harmonised System, Union Combined Nomenclature and Community Customs Tariff). This classification helps to identify and regu- late products that are being imported, ensuring that duties, taxes and restrictions are properly applied. Additionally, the applicable non-tariff regulations depend on whether an imported product meets the statutory product definition (medical devices or pharmaceuticals). The types of products subject to import regula- tions in the EU are outlined in various laws and regulations such as EU Regulation No 952/2013 laying down the Union Customs Code or Regu- lation No 952/2013 laying down the Union Cus- toms Code. 7.5 Trade Blocs and Free Trade Agreements France, as a member of the EU, participates in the EU’s free trade agreements and applies the principle of free movement of goods and ser- vices within the EU single market. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Prices for pharmaceuticals and medical devices are strictly controlled in France if such products are reimbursed by SHI.
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