Jochen Robes über Bildung, Lernen und Trends

Mutual Recognition Agreement Pharmaceutical Switzerland

There are more than 120,000,000,000,000,000,000,000,000,000,000,000,000,000 000 In 2014, Switzerland and the EU began negotiations on a new institutional framework agreement („InstA“) which resulted in a proposal in 2018. The InstA is sometimes referred to as „EEA light“ because it contains many of the points currently included in the EEA framework, but without a central regulatory body. But at the end of 2018, the Swiss rejected this proposal in a public consultation. The main reason was the immigration of EU citizens. This rejection was fuelled by the right-wing Swiss political party SVP, which claimed that these immigrants deprived Swiss workers of jobs and benefited from Swiss social security. As instA is refused, it is not possible to sign new MRAs. This means that the issue of immigration goes much further than allowing the free movement of persons; Swiss stock exchanges no longer have direct access to EU markets and the medical device industry is now seeing the consequences of this vote, since the MDR is not covered by a signed MRA. The Agreement between the Swiss Confederation and the European Community on the mutual recognition of conformity assessment (MRA) entered into force on 1 June 2002 as one of seven agreements concluded under a package called „Bilateral Agreement I“. The MRA is an instrument designed to remove technical barriers to trade in industrial goods between Switzerland and the EU. It applies to the main product sectors (machinery, medical devices, electrical appliances, construction products, lifts, biocidal products). In terms of value, the agreement covers around two-thirds of trade in industrial products between Switzerland and the EU. 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. For most of the product sectors covered by the agreement, the technical rules of Switzerland and the EU are considered equivalent. Conformity assessments necessary for the EU internal market may be carried out by a Swiss conformity assessment body recognised under the Agreement and by Swiss technical regulations. The same applies to all products covered by the Agreement, regardless of their origin. . . .