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Excluded from the MRA zone are innovative therapy drugs (ATMPs), human blood, human plasma, human tissues and organs, as well as veterinary immunologies. On 1 November 2017, the EU and the US first signed the MRA for current products, with eight EU countries benefiting immediately from the agreement. After that date, there were many progressive authorisations, with Ireland approved on 1 June 2018. The 28 EU countries are now included in the scope of this agreement. The agreement does not currently apply to veterinary medicines, but the EU and FDA have agreed that veterinary drugs will be included by 15 December 2019 and discussions have already taken place between technical experts. “I particularly hope that this will reassure the Community in Northern Ireland, given that many of its vets are trained in Dublin, so it is essential to ensure that, whatever happens with the UK`s withdrawal from the EU, it will remain a viable source of veterinary talent for the region.” What exactly does this mean for veterinary drug manufacturers? This means that the MRA between the FDA and the EU will allow drug inspectors to rely on information from veterinary inspections carried out in the affected areas. Using the results of inspections and related information, the FDA and the EU will be able to redeploy resources for the inspection of veterinary drug manufacturing facilities with potentially higher risks worldwide. This extension of the GPA should benefit patients and reduce negative public health concerns, while reducing the regulatory workload of the relevant authorities. This in turn will reduce costs and avoid double inspections. Dr Niall Connell, President of RCVS, said: “We are pleased to sign this agreement with the VCI, which is an essential part of the guarantee of the future, to ensure that Dublin graduates can be recognised as having the registration capacity as a UK regulator, regardless of our future relationship with the EU. The scope and relevance of ARM is easy to understand when you consider that 80% of the drugs marketed worldwide are produced either in the EU or in the United States, based on the adoption by pharmaceutical companies of rigorous good manufacturing practices that regulate all stages of production processes.

The implementation of the agreement on the sharing of the results of the BMP inspection is based on the assumption that the procedures applied by regulatory authorities (central or national) are also comparable. The provisions of the MRA have asked the FDA to carry out a formal evaluation of the procedures followed by each relevant European authority, an exercise that is coming to an end with Slovakia. The agreement, initially announced in 2017, represents a three-year cooperation between the FDA and the EU and will allow all partners to recognise inspections carried out by each other. The European Union (EU) has signed Mutual Recognition Agreements (MRA) with third-country authorities on the assessment of compliance of regulated products. These agreements contain a sectoral annex on mutual recognition of good manufacturing practice inspections (GMPs) and certification of batches of medicines for human and veterinary use. The evaluation of GMP inspectors for veterinary medicines is ongoing. We await the final decision to include veterinary medicines in the scope of the mutual recognition agreement currently concluded between the European Community (EU) and the United States, which allows the recognition of GMP inspections in other Member States.