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    • 19/03/2021
    • Articles

    Brexit - Medicinal Products - Commission Temporarily Redesigns Supply Chains to Cyprus, Ireland, Malta and Northern Ireland

    On 17 March 2021, the Official Journal of the European Union published Commission Delegated Regulation (EU) 2021/457 of 13 January 2021 “amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom” (see, attached copy; the Delegated Regulation). The Delegated Regulation gives effect to a Commission Notice of 23 December 2020 in which the European Commission addressed the issues faced by market operators in Cyprus, Ireland, Malta and Northern Ireland, which are historically dependent on the United Kingdom for their medicine supplies, in complying with the EU’s pharmaceutical acquis following Brexit (see, Van Bael & Bellis Life Sciences News Alert of 23 December 2020). One of the issues identified was that there are currently no importers holding a manufacturing authorisation in Cyprus, Ireland, Malta and Northern Ireland. However, a manufacturing authorisation is required to affix a unique identifier on medicinal products which are imported from outside the EU and placed on the market in the EU. As there are currently no wholesalers in Cyprus, Ireland, Malta and Northern Ireland which can affix a unique identifier on medicinal products that are imported from the United Kingdom, the Delegated Regulation makes it possible for medicinal products which are exported from the EU to the United Kingdom to maintain their initial unique identifier. More precisely, the Delegated Regulation introduces a temporary derogation from the obligation of EU wholesalers to decommission the unique identifier of any medicinal products which they distribute in the United Kingdom. This will facilitate onward distribution of the medicines from the United Kingdom to the cited EU Member States and Northern Ireland. The exemption applies retroactively from 1 January 2021 and will apply until 31 December 2021. The unique identifier was introduced by the Falsified Medicines Directive (Directive 2011/62/EU) with a view to allowing wholesalers and healthcare professionals to verify the authenticity of medicinal products and to identify individual packs.

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    • 04/02/2021
    • Articles

    Brexit Implications for Data Protection in 8 Questions | Q&A Update under Brexit Trade Deal

    On 24 December 2020, the UK and the EU agreed a Trade and Cooperation Agreement regulating relations between both parties after Brexit. The TCA covers several topics, including data protection. Meanwhile, Brexit continues to raise many legal questions and uncertainties, not least as regards protecting personal data that flows between the UK and the rest of Europe. Do organisations in the UK still have to comply with the General Data Protection Regulation (GDPR)? Can they still transfer personal data to the European Economic Area (EEA)? Do they need to appoint a representative in the EU? And what happens with the “one-stop-shop”? Based on eight frequently asked questions, we provide an overview of issues to consider and steps to take to be compliant with data protection rules in the EEA and the UK. Please read our updated Q&A on the topic.

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    • 17/11/2020
    • Articles

    Brexit Implications for Data Protection in 8 Questions after the end of Brexit transition

    The end of the Brexit transition period is only six weeks away and from that moment on, the GDPR will no longer be applicable in the UK and the UK will be considered a third country. Brexit continues to raise many legal questions and uncertainties, not least for the protection of personal data which flows between the UK and the rest of Europe. Will organisations in the UK still have to comply with the General Data Protection Regulation (GDPR)? Can they still transfer personal data to the EU? Will they need to appoint a representative in the EU? And what will happen with the one-stop-shop? On the basis of eight frequently asked questions, we provide an overview of issues to consider and steps to take in order to be compliant with data protection rules during and after the transition period. Please read our Q&A on the topic.

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    • 30/12/2019
    • Articles

    Brexit’s Implications for Data Protection in 8 Questions

    The UK is set to leave the EU on 31 January 2019. As the EU and the UK prepare for Brexit, companies should too. Brexit continues to raise many legal questions and uncertainties, not the least for the protection of personal data which flows between the UK and the rest of Europe. Will organisations in the UK still have to comply with the General Data Protection Regulation (GDPR)? Can they still transfer personal data to the EU? Will they need to appoint a representative in the EU? And what will happen with the one-stop-shop? On the basis of eight frequently asked questions, we provide an overview of issues to consider and steps to take to start preparing now in order to be ready for Brexit. Please find enclosed our memorandum on the topic.

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