Garrett Security - Canada

The Withdrawal Agreement sets out the conditions for the UK`s withdrawal from the EU, including a transition period. This started on February 1, 2020 and is expected to end on December 31, 2020. The Q&A explains how the EMA, the European Commission and EU/EEA Member States have been working closely since May 2017 to advise companies on how to request the changes needed to minimise the impact on the supply of medicines if the UK leaves the EU without a withdrawal agreement. However, the UK will no longer participate in the EU institutions after its withdrawal from the EU on 31 January 2020. The obligation to notify the cessation of the placing on the market of a medicinal product, to suspend the placing on the market of a medicinal product, to withdraw a medicinal product from the market, to apply for a marketing authorisation and not to apply for the renewal of a marketing authorisation applies to both centralised medicinal products and medicinal products authorised at national level (including those authorised under mutual recognition). and decentralised marketing authorisation). were approved). The notification must clearly indicate the measures to be taken by the breeder (see question 1 “Do I have to notify the cessation, revocation, suspension of my medicinal product/marketing authorisation?”) and the reason for these measures, in particular if they are based on one of the following reasons: Taking into account the conclusion of the European Council of 22. In March, to extend the date of the UK`s withdrawal from the EU, the EMA called on all EU pharmaceutical companies to continue their preparedness measures, taking into account all possible outcomes. Based on the Conclusions of the European Council, the deadline of 29 March set in the EMA`s published Brexit Guidelines should be considered to be replaced by 12 April 2019 until further notice.

The Withdrawal Agreement stipulates that the UK will no longer participate in the EU institutions and their decision-making after its withdrawal from the EU on 31 January 2020. For the EMA, this means that from 1 February 2020, no person representing the United Kingdom or appointed or designated by the United Kingdom will be able to attend the meetings of the Agency`s Scientific Committees, Working Groups or Management Board. .

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