Mutual Recognition Agreement Testing

Although there has been little progress in accession negotiations, Turkey has gradually expanded its legislation on EU legislation to remove technical barriers. The results of THE CAB tests notified by Turkey are mutually recognised in the EU (and vice versa). If the EU refuses to negotiate a similar system of mutual recognition with the UK, this may violate the most favoured nation obligation (MPF) under WTO law. The MFN is a non-discrimination rule that requires that any benefit granted to products originating in one country be granted to similar products originating in other countries. In the Brexit negotiations, the UK government called for mutual recognition of the rules, including in Theresa May`s florence speech and as an option for future regulation of financial services, but refused by the EU. The Johnson government has moved away from these approaches. In its proposal for a comprehensive free trade agreement with the EU, the UK proposes an agreement on mutual recognition of compliance assessment that is „consistent“ with the provisions of the EU agreement with Canada. A separate agreement on the certification of marine equipment is also proposed as part of the agreement between the EU and the United States. What kind of mutual recognition agreements has the EU concluded? Health Canada considers the requirements for good manufacturing practices in the EU to be equivalent to those set out in the regulations for natural health products. As a result, Health Canada accepts valid GMP certificates issued by the regulator within the EC- Canada MRA as proof of compliance with NHP GMP. In addition, all products manufactured at these sites are considered acceptable and do not require further testing to confirm finished products in Canada. Market authorization holders can continue to rely on QC testing in the UK, where Covance has sites in Harrogate, York and Huntingdon.

We believe that during this potential transition period, it is likely that a similar MRA will be formed between the EU and the UK. Both sides have, for more than 40 years, put in place the same LDC rules and have strong ethical motivations to continue the free movement of medicines. One of the main benefits that the agreement will bring to European companies is the abandonment of batch testing for the importation of medicines from the United States. In the EU, the qualified person (PQ) is relieved of his responsibility for carrying out the checks in accordance with Article 22, paragraph 1, paragraph b), directives 75/319/EEC of the Council, provided these checks have been carried out in the United States.