The FDA will continue to carry out certain inspections in EU countries with appropriate inspections, for example. B product production evaluation inspections to support marketing authorisation decisions. However, the FDA expects less routine surveillance inspections to be carried out in EU countries, with one capable inspection. Agreement on the 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). “We welcome the implementation of this agreement, which means that authorities on both sides of the Atlantic can now count on each other`s inspection results. This milestone is proof of the importance of our strategic partnership with the United States.
This will allow us to make the most of our inspection capabilities so that patients can count on the quality, safety and efficacy of all medicines, regardless of where they were manufactured,” said Guido Rasi, Executive Director of the EMA. *Restrictions: Capacity rules apply to routine surveillance inspections. In future, the following types of products and inspection may be included in the scope of the Agreement until additional considerations are taken: Protocol 12 to the EEA Agreement ensures the proper functioning and homogeneity of the EEA. The Protocol ensures that, when taking the initiative to negotiate Mutual Recognition Agreements (MRAs), the EU negotiates on the basis of the conclusion by the third countries concerned of a parallel MRA with the EEA EFTA States equivalent to those to be concluded by the EU [Box 1]. This system of parallel agreements allows third countries throughout the EEA to benefit from simplified market access for the sectors covered and vice versa [Box 2]. 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. These agreements benefit regulators by reducing double inspections in any other area, allowing for a greater focus on higher-risk sites, and expanding inspection coverage of the global supply chain.
With the accession of 10 new EU Member States on 1 May 2004, it was decided to assess countries individually. Once all regulatory authorities (usually one or two) are considered equivalent within the same country, the country would be considered equivalent and the exploitation phase would begin. products manufactured in the territories of the EU and Israel and producers in third countries that are controlled by the regulatory authority of one of the Parties, where the product is also subject to re-control in one of the Parties. On 1st The agreement between the European Union and the United States on the recognition of inspections of production sites of medicinal products for human use carried out in their respective territories entered into force on 1 November 2017. . .