BREXIT – Impact for Marketing Authorisation Holders and for Agencies
The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (“BREXIT”). This means that UK will leave the European Union on 30 March 2019, and national agencies MHRA (Medicines and Healthcare Products Regulatory Agency) and VMD (Veterinary Medicines Directorate) will presumably no longer be able to lead any EU procedures anymore.
Till the end of March 2019 UK remains a full member of the EU and continues to fulfill all tasks within the union. A future cooperation or a respective transition period is currently not foreseeable.
UPDATE (on 12.04.2019): The date for UK’s withdrawal from the European Union has been furthermore extended by the European Council at its meeting on 10-11 April 2019. The extension will now last until 31.10.2019 at latest.
- If the UK has not held elections to the European Parliament in accordance with applicable Union law and has not ratified the withdrawal agreement by 22 May 2019 the withdrawal will take place on 1 June 2019.
- If the UK ratifies the withdrawal agreement at any stage before 31 October 2019, the withdrawal will take place on the first day of the month following the completion of the ratification procedures.
In accordance with this decision, the deadline of 29 March 2019 referred to in Brexit related guidance documents should be understood to be replaced by 31.10.2019.
However, Marketing Authorisation Holders are strongly encouraged to continue their necessary arrangements for the UK’s withdrawal (latest until 31 October 2019) to be appropriately prepared also in case of a “hard Brexit”.
The NIBSC is currently the Official Medicines Control Laboratory (OMCL) responsible for batch release of plasma products and vaccines and for testing of plasma pools. From today’s perspective, the validity of certificates granted after 1st of November 2019 cannot be guaranteed. Thus, a mutual recognition of batch release would not be possible anymore.
In case of a “hard Brexit” loss of these highly active UK agencies within the network needs to be compensated by other agencies and the availability of medicines and medical devices to all patients needs to be ensured. Therefore, BASG plans to further increase its active role within the EU and to take over additional tasks.
Already now BASG is very active as competent partner in a huge range of activities comprising the whole lifecycle of medicinal products, as for example provides expertise in Scientific Advices, performs GMDP- and GCP-inspections, acts as Reference Member State (RMS) within Decentralised (DCP) and Mutual Recognition Procedures (MRP), acts as (Co-)Rapporteur within Centralised Procedures (CP) as well as OMCL.
Impact on Marketing Authorisations
In the following cases Marketing Authorisation Holders/Holders of a Registration need to act, these tasks have to be finalised until 31.10.2019:
- If your medicinal product was authorized/registered within MRP/DCP with UK as RMS, a transfer to a new RMS needs to be performed (RMS switch). Further information can be found here .
- If the address of Marketing Authorisation Holder/Holders of a Registration is established within UK, marketing authorisation/registration needs to be transferred to a site within EU27/EEA. Further informationen can be found here .
- If your batch release site is located within UK, this needs to be changed via variation to a member state within EU27/EEA. For further information regarding batch control and import please consult FAQs of CMDh/CMDv below.
UPDATE MARCH 2019: If the transfer of the batch control site to a site within the EU27/EEA may not be completed before the withdrawal date, it is possible to apply for a temporary exemption in justified cases (in principal until the end of 2019). The respective notification has to be submitted in no case later than on 31 October 2019.
Please see the following documents for further information on the procedure:
human medicinal products question 32
veterinary medicinal products question 24.
For the respective requirements see European Commission.
The templates for application can be found here:
human medicinal products
veterinary medicinal products
Please submit respective inquiries/applications (for AT=RMS or purely national authorisations) to cmdh-contactbasg.gvat.
- Also if the QPPV resides and/or the PSMF is located in UK, these need to be transferred. Marketing Authorisation Holders have to implement these changes via the Article 57 database in due time (no later than 31.10.2019).
Brexit-associated variations can be grouped, further information is available at CMDh.
Further information regarding RMS transfers can be found on the homepage of the BASG RMS transfer respective Guidance Documents of CMDh and CMDv should be consulted.
For questions and applications regarding RMS transfers please contact rmsagesat.
BASG is also prepared to act as RMS for new applications
Presumably, UK will not be able to act as RMS for new MR- and DC-applications, which will not be finalised before 31.10.2019. In case you are interested to choose AT as RMS for new applications within DCP und MRP, please find further information regarding applications here and how to book a slot here.
Further information and FAQs regarding BREXIT are available on the following websites:
EMA, CMDh, CMDv.
Takeover of Batch Release by BASG
The Official Medicines Control Laboratory (OMCL) of BASG belongs to the leading OMCLs within the EU27/EEA. We are a full-service provider for batch release of plasma products (including plasma pool testing). The necessary expertise and capacity for taking over batch release activities from the NIBSC are available for all kinds of products and testing methods.
Marketing Authorisation Holders who want to transfer official control authority batch release from the NIBSC to our OMCL are kindly asked to contact BASG at least 3 months before the exit of UK.
We do also have a very long history and expertise in batch release of vaccines therefore we are prepared to take over the batch release for those products. As not all types of products and methods are part of our routine operations for vaccines please be aware that for those products a longer lead time of 6-9 months before BREXIT will be necessary.
For further information please refer to batch release.
Impact on substances of human origin (Blood and Tissues/Cells)
Unless otherwise agreed between the member states, the EU rules in the field of substances of human origin will no longer apply to the UK from 1 November 2019. From that date, any exchange of blood and blood components, tissues and cells, (and organs), between the member states and the UK will be considered as import/export from/to a third country.
For further information and updates please refer to European Commission.
Impact on GMP inspections of centrally authorized medicinal products
Following the rules of Regulation 726/2004, the supervisory authorities are
the competent authorities of the Member State or of the Member States granting the authorization pursuant to Article 40 (1) or (3) of Directive 2001/83 / EC or Article 44 (1) or (3) of Directive 2001/82 / EC. Therefore, the inspection competence lies with the inspection authority of the Member State in which the establishment of the batch certification for the transport in the EEA is located. The Austrian Inspectorate is prepared with additional capacity to carry out any possible inspections in third countries in a timely and competent manner.
BASG held already the following informative talks about BREXIT:
„AGES-Gespräch „Brexit – Chancen und Herausforderungen“" on 13.09.2017
„BASG-Gespräch „Aktuelle BREXIT Herausforderungen für die EU-27““ on 26.06.2018
„BASG-Gespräch „Versorgungssituation - Lieferengpässe““ on 12.02.2019:
Information on fees can be found here.
BREXIT-related guidance for companies
Created: 16.03.2018 | Page last modified: 12.04.2019