FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The import of products into the EU is governed by a standardised classification system that categorises products based on their tariff codes (Harmonised Sys- tem, Union Combined Nomenclature and Community Customs Tariff). This classification helps to identify and regulate products that are being imported, ensur- ing that duties, taxes and restrictions are properly applied. Additionally, the applicable non-tariff regula- tions depend on whether an imported product meets the statutory product definition (medical devices or pharmaceuticals). The types of products subject to import regulations in the EU are outlined in various laws and regulations such as EU Regulation No 952/2013 laying down the Union Customs Code or Regulation No 952/2013 lay- ing down the Union Customs 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 services 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 reim- bursed by SHI. The rules governing price setting are mainly outlined in the French Social Security Code and Framework Agreements entered into between the governmental body in charge of fixing prices ( Comité économique des produits de santé or CEPS) and industry trade associations. Pharmaceuticals The price of products used in hospitals is negotiated between the pharmaceutical company and the hos- pital, within the framework of the Public Procurement
Import authorisation requests must be submitted via an online platform (Impexweb). If the ANSM does not respond within 45 days, the request is consid- ered rejected. The ANSM may suspend or revoke an authorisation at any time. Except in urgent cases, such decisions can only be taken after allowing the authorisation holder to submit observations. However, there are exemptions from the prior authori- sation requirement, namely for: • individuals importing medicines for personal use; • medicines with a valid marketing authorisation in France, provided they are presented in compliance with the approved authorisation (see 3.4 Procedure for Obtaining a Marketing Authorisation ); • homeopathic and traditional herbal medicines registered in France, provided they are presented in compliance with their registration; • medicines authorised under early access or com- passionate use; • medicines required for an authorised biomedical research study in France; • medicines imported from an EU member state and stored in a licensed pharmaceutical facility, pro- vided they are intended exclusively for export to non-EU countries; • medicines imported by a sports team physician 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 govern- mental 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 essen- tial safety and performance 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 ensur- ing the device’s conformity, traceability and compli- ance with post-market obligations.
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