European Community Mutual Recognition Agreement

The subsequent amendments to the Agreement have been inserted in the original text. This consolidated version is only documentary. Mutual recognition agreements define the conditions under which one Party (third country) accepts the results of conformity assessment (e.B.g. tests or certifications) carried out by conformity assessment bodies (CABs) designated by the other Party (EU) to demonstrate compliance with the requirements of the first Party (third country), and vice versa. The transition period for medicinal products for human use covered by the Agreement ended on 11 July 2019: Agreement on Mutual Recognition of Conformity Assessment of Products between Turkey and EFTA (entered into force on 5 July 2011). Protocol E to the EFTA-Turkey Free Trade Agreement covers all harmonised product sectors in trade between the EEA-EFTA States and Turkey. As regards trade between Turkey and Switzerland, this Protocol shall apply to the sectors covered by the EU-Switzerland MRI in which the respective legislation of this Agreement is considered equivalent. Here you will find an overview of the sectors covered as well as links to the relevant conformity assessment bodies (CABs). Agreement on the Mutual Recognition of Conformity Assessments, Certificates and Markings between New Zealand and Iceland, Liechtenstein and Norway (entered into force on 1 March 2000). Sectors covered: pharmaceuticals (Good Manufacturing Practices, GMP), medical devices, telecommunications terminals, low-voltage devices, electromagnetic compatibility (ELECTROMAGNETIC), machinery and pressure equipment.

Agreement on the Mutual Recognition of Conformity Assessments, Certificates and Markings between Canada and Iceland, Liechtenstein and Norway (entered into force on 1 January 2001). Sectors covered: telecommunications terminal equipment, electromagnetic compatibility (ELECTROMAGNETIC), electrical safety, recreational craft, medicines (good manufacturing practices, GMP) and medical devices. The EU-Australia Agreement covers the following sectors The European Union (EU) has signed mutual recognition agreements (MRAs) with third country authorities on conformity assessment of regulated products. These agreements contain a sectoral annex on the mutual recognition of GMP (Good Manufacturing Practice) inspections and the certification of batches of medicinal products for human and veterinary use. Recognition as a conformity assessment body can be applied for from the Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railways (formerly the Telecommunications and Postal Regulatory Authority). See, in this context, Official Journal No 19/2001 of the regulatory authority, page 2950, Communication No 555/2001. During a transitional period, the authorities shall assess mutually, within the framework of the Agreement, pharmaceutical legislation, guides and regulatory systems. List of CABs designated under the MRA between the European Community and the United States Mutual Recognition Agreement between the European Community and Australia Protocol 12 to the EEA Agreement ensures the proper functioning and homogeneity of the EEA.

. . .