Ec Mutual Recognition Agreement

Recognition as a compliance assessment agency may be requested from the Federal Electricity, Gas, Telecommunications, Postal and Railway Systems Agency. In this context, see the regulatory authority`s Official Journal 19/2001, page 2950, communication 555/2001. Restrictions: Capacity determination applies to routine inspections. In the future, the following types of products and inspections may be included in the scope of the agreement, pending other considerations: 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 Mutual Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from anti-drug inspections carried out within the other country`s borders. Under the Drug Safety and Safety Act passed in 2012, the FDA has the authority to enter into agreements on the recognition of drug inspections by foreign regulators when the FDA has found that these authorities are able to conduct inspections in accordance with U.S. requirements. The FDA and the EU have been cooperating since May 2014 to assess how they control drug manufacturers and assess the risk and benefits of mutual recognition of inspections. 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. The transition period for medicines for human use, which is covered by the agreement, ended on 11 July 2019: mutual recognition agreements (MRA) 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. For most of the product sectors covered by the agreement, the technical rules of Switzerland and the EU are considered equivalent. The compliance assessments required for the internal market of the European Union can be carried out by a Swiss compliance assessment body recognised under the agreement and in accordance with Swiss technical rules. This applies to all products covered by the agreement, regardless of their origin. In the two product sectors where Swiss and EU legislation are not considered equivalent (hot water boilers and a certain category of measuring instruments), products to be exported to the EU must be manufactured in accordance with EU technical rules. However, the required compliance assessment may continue to be carried out by a Swiss compliance assessment body recognised as part of the agreement. This also explains why recognition regimes are essentially similar, but their practical implementation varies not only from country to country, but also from one sector to another within a single country (e.g.

telecommunications, CEMs, electrical security, medical equipment, food, pressure containers, etc.). The European Union (EU) has signed Mutual Recognition Agreements (MRA) with third-country authorities on the assessment of compliance of regulated products.