25.03.2021
To the attention of interested persons
As announced in the Commission BREXIT Notice on medicines in January this year, the Commission had adopted and published the Delegated Regulation to amend the Falsified Medicines Directive in view of addressing the BREXIT outstanding issues on medicines.
In order to ensure that medicinal products are marketed with a unique identifier in the small markets currently dependent on the United Kingdom for their supplies of medicinal products, it is granted a temporary derogation until 31 December 2021 from the obligation of wholesalers to decommission the unique identifier of the products which they intend to distribute in the United Kingdom as those products may be re-exported to the Union.
This derogation should not affect the application of Union law to and in the United Kingdom in respect of Northern Ireland in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement in conjunction with Annex 2 to that Protocol.
Please find the link of that act:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.091.01.0001.01.ENG&toc=OJ%3AL%3A2021%3A091%3ATOC
This has also been added to the DG SANTE BREXIT webpage:
https://ec.europa.eu/health/human-use/uk_withdrawal_en

22.02.2021
To the attention of Marketing Authorisation Holders
UK withdrawal from the European Unit
On the 31st December 2020, the transitional period in which the EU pharmaceutical legislation stipulated in the ‘Community Acquis’ continued to be applicable in the United Kingdom has come to an end.
Marketing Authorisation Holders (MAHs) are kindly reminded that batch release and testing sites located in the UK should have been removed from medicinal product authorisation dossiers by the 31st of December 2020, through related variations.
The European Commission, the EMA and the CMDh have developed regulatory guidelines and procedures for situations arising from transition of the UK to the third country status.
MAHs are asked to consult the published and constantly updated documents, in order to apply the pharmaceutical legislation in a correct and timely manner. See also “Practical Guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Q/A 37” posted on the HMA website, under the Brexit section (https://www.hma.eu/535.html).
Consequently, MAHs should implement the required actions as soon as possible so that marketing authorisations (MAs) are compliant with the ‘Community Acquis’ and should immediately submit the required variations for removal / replacement / addition.
Failure to meet these conditions could have consequences such as MA suspension (until the situation is remedied) or withdrawal, as appropriate.
Please check the following links on the EMA websites as well: Brexit: the United Kingdom’s withdrawal from the European Union | European Medicines Agency (europa.eu) (https://www.ema.europa.eu/en/about-us/brexit-united-kingdoms-withdrawal-european-union) and HMA, the ‘Brexit’ section: Heads of Medicines Agencies: BREXIT (hma.eu) (https://www.hma.eu/542.html?&L=0).
Moreover, given the dynamics of the information, you are advised to weekly check the National Agency for Medicines and Medical Devices of Romania (NAMMDR) website (https://www.anm.ro/en/) for procedural updates.

04.02.2021
To the attention of interested persons
In order to deal with the consequences described in the opinion issued by the European Commission together with the European Medicines Agency, marketing authorisation holders, manufacturing authorisation holders and wholesale distributors of medicinal products are strongly advised:
− To take all measures in order to take account of the fact that, after the end of the transitional period, the United Kingdom will, in all respects, no longer observe the EU regulatory system for medicinal products (marketing authorisation procedures, import requirements, (co)labelling, medicinal product supply, etc.];
– To take into account, in all trade-related decisions, that after the end of the transitional period all goods, medicinal products included, shipped from the United Kingdom to the EU will be subject to procedures / controls regarding fiscal (customs duties, origin, VAT) and non-fiscal requirements (batch release).
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04.02.2021
To the attention of interested persons
Commission Notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period (2021/C 27/08)
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