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Article 41 Withdrawal Agreement

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Sep 11

In this statement, the Commission also explains that a batch release site in the EU-27 must be identified from 29 March 2019, in order to ensure ongoing EU compliance after withdrawal. (*1) The Union shall inform the other Parties to this Agreement that the United Kingdom is to be treated as a Member State during the transition period for the purposes of this Agreement. Regulation (EU) 2015/936 of the European Parliament and of the Council of 9 June 2015 on common rules for imports of textile products from certain third countries which are not covered by bilateral agreements, protocols or other arrangements or other union import-specific provisions (11) It specifies that in the event of a withdrawal agreement, there will be a transition period during which EU law will continue to apply to the United Kingdom. This means that access to medicines is not compromised. Since the conclusion of the Withdrawal Agreement, attention has focused on the negotiations on the future relationship between the EU and the UK, which will apply from the end of the transitional period. However, the UK is also at risk of leaving the transition period without an agreement on the future relationship. In this case, the consequences will be to some extent the same as if negotiations on a withdrawal agreement fail. 4. Notwithstanding paragraph 3, the United Kingdom may negotiate, sign and ratify, during the transitional period, international agreements concluded in its own capacity in areas falling within the exclusive competence of the Union, unless such agreements enter into force or apply during the transitional period, unless the Union has approved it. The EMA has published a Q&A document for patients, healthcare professionals and the general public on the preparatory work of European Union authorities to prevent drug shortages due to the UK`s exit from the EU. The European Commission and the EMA today published an updated list of questions and answers on the UK`s withdrawal from the EU.

This Q&A focuses on the regulation of medicinal products for human and veterinary use under the centralised procedure. The agreement defines the goods, services and processes related to them. It argues that any product or service lawfully placed on the market before leaving the Union may continue to be made available to consumers in the United Kingdom or in the Member States of the Union (Art. 40 & 41). 2. The obligations under Union industrial safety law shall apply to the United Kingdom in cases where the tendering, tendering or grant procedure has been initiated for the classified contract, subcontract or classified grant agreement before the end of the transitional period. Accordingly, this Protocol shall not prevent the United Kingdom from including Northern Ireland in the scope of any agreement with third countries, provided that such agreements do not affect the application of this Protocol. A medicinal product is `placed on the market` when it is available for sale or delivery and there is a written or oral agreement (or offer of agreement) to transfer ownership of the medicinal product to another legal person.

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