Mutual Recognition Agreement Pharmaceutical Switzerland

The Chapters of Appendix 1 are systematically divided into five sections. They list the legislation, legislation and regulations in force in the product sectors and define the scope of the agreement. The chapters also contain certain sectoral provisions, such as information exchange, market surveillance cooperation. Trade agreements are trade agreements designed to facilitate market access and promote greater international harmonization of compliance standards while protecting consumer safety. During a transitional period, the authorities assess each other`s pharmaceutical legislation, guidelines and regulatory systems under the agreement. The European Union (EU) has signed Mutual Recognition Agreements (MRA) with third-country authorities on the assessment of compliance of regulated products. These agreements contain a sectoral annex on mutual recognition of good manufacturing practice inspections (GMPs) and certification of batches of medicines for human and veterinary use. With respect to the MRA agreement, products regulated as NHPs in Canada are covered by this MRA if they are manufactured to a GMP standard equivalent to that of drugs. Although not limited to the following, these mainly contain certain commercial herbal, probiotic and vitamin/mineral drug products. Mutual recognition agreement with respect to compliance assessment, certificates and markings between New Zealand and Iceland, Liechtenstein and Norway (which came into force on 1 March 2000). Covered sectors: pharmaceuticals (good manufacturing practices), medical devices, telecommunications terminals, low voltage devices, electromagnetic compatibility (CEM), machinery and equipment under pressure. The agreement consists of a general part and two annexes.

The general part contains several horizontal provisions that apply to all product sectors covered by the agreement. Appendix 1 contains sectoral chapters covering different product sectors, while Schedule 2 contains general rules for the designation of compliance assessment bodies recognized under the agreement. Agreement on mutual product recognition between Turkey and EFTA (entered into force on 5 July 2011). Protocol E of the EFTA-Turkey Free Trade Agreement covers all sectors of products harmonized in trade between the EFTA-EEA states and Turkey. With regard to trade between Turkey and Switzerland, this protocol applies to sectors covered by the EU-Switzerland OPR in which the corresponding legislation is considered equivalent to this agreement. Here you will find an overview of the areas covered as well as links to the relevant compliance assessment agencies (CABs). The MRA with Israel is an agreement on the evaluation of compliance and acceptance of industrial products (ACAA). It is a specific type of MRI based on the alignment of the legal system and infrastructure of the country concerned with that of the EU. Mutual recognition agreement for compliance assessment, certificates and markings between Canada and Iceland, Liechtenstein and Norway (which came into force on January 1, 2001).

Covered sectors: telecommunications terminal equipment, electromagnetic compatibility (CEM), electrical safety, pleasure boats, pharmaceuticals (good manufacturing processes, GMP) and medical devices.