07 Apr 2021

Agreement On Mutual Recognition Between The European Community And Japan

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The United States, for example, has been particularly interested in extending its mutual agreements with the EU. Mutual recognition agreements (MRAs) promote trade in goods between the European Union and third countries and facilitate market access. These are bilateral agreements designed to facilitate industry access to compliance assessment. The European Union has concluded negotiations for an agreement with Japan to facilitate trade and facilitate access for European companies to the large Japanese market. The new agreement extends it to certain biologic drugs, including immunologies and vaccines, which no longer need to be verified once delivered to each other`s territory. This agreement allows mutual recognition, promotes trade and facilitates market access between the two countries for certain types of marine equipment. The EMA announcement comes just a day after the EU and Japan completed their 25th summit. At the meeting, the two countries concluded a major free trade agreement between two of the world`s largest economic regions. The European Medicines Agency (EMA) explained the benefits of the agreement in a statement: “With this agreement, EU and Japanese regulators will be able to make better use of their inspection resources by reducing double controls on the territory of the other quarter.” This agreement reiterates the impact of the EU-Australia MRA, as it would apply to the relationship between the UK and Australia. It allows mutual recognition, promotes trade and facilitates market access between the two countries.

6 – The parties cooperate in the area of mutual recognition in accordance with the mutual recognition agreement between the European Community and Japan, concluded in Brussels on 4 April 2001. Contracting parties may also decide, in accordance with the relevant provisions of this agreement, to expand product coverage, applicable regulatory requirements and recognized compliance assessment agencies. 4 – The parties exchange information on the mechanisms covered in paragraph 3. One party communicates, at the request of the other party, information on: (a) the mechanisms covered by paragraph 3 and similar mechanisms to facilitate the adoption of the results of compliance assessment procedures; (b) factors, including risk assessment and risk management, that are taken into account in selecting appropriate compliance assessment procedures for certain products; and (c) accreditation policy, including international accreditation standards, and international accreditation agreements and arrangements, including laboratory accreditation cooperation (ILAC) and the International Accreditation Forum (IAF), where possible and used by a party in a given area.

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