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.
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 30th of March 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 29.03.2019:
- 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 at https://www.basg.gv.at/en/medicines/marketing-authorisation-procedure/austria-as-rms/rms-transfer/.
- 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 at https://www.basg.gv.at/en/medicines/change-of-ownership-acc-to-art-25-amg/.
- 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 29 March 2019.
Please see the following documents for further information on the procedure:
human medicinal products question 32 (http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_373_2018_Rev3_2019_02_clean_-_Practical_guidance_for_Brexit.pdf)
veterinary medicinal products question 24 (http://www.hma.eu/fileadmin/dateien/Veterinary_medicines/CMDv_Website/Brexit/Practical_guidance_for_procedures_related_to_Brexit_for_veterinary_medicinal_
For the respective requirements see: https://ec.europa.eu/health/sites/health/files/files/documents/brexit_batchtesting_medicinalproducts_en.pdf.
The templates for application can be found here:
human medicinal products (http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_391_2019_2019_02_Rev0_-_Template_of_request_for_batch_control_exemption_-_MR_DCP.docx)
veterinary medicinal products (http://www.hma.eu/fileadmin/dateien/Veterinary_medicines/CMDv_Website/Brexit/Template_of_request_for_batch_control_exemption_-_MRP_DCP_VET.docx)
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 29.03.2019).
Brexit-associated variations can be grouped, further information is available at
Further information regarding RMS transfers can be found on the homepage of the BASG (https://www.basg.gv.at/en/medicines/marketing-authorisation-procedure/austria-as-rms/rms-transfer/), respective Guidance Documents of CMDh and CMDv should be consulted (http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/01_General_Info/CMDh_039_2002-Rev5-2017_03-Clean.pdf resp. http://www.hma.eu/fileadmin/dateien/Veterinary_medicines/CMDv_Website/Procedural_guidance/General_info_on_applications/BPG-021_Changing_RMS.pdf).
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 March 2019. In case you are interested to choose AT as RMS for new applications within DCP und MRP, please find further information regarding applications and how to book a slot under:
Further information and FAQs regarding BREXIT are available on the following websites:
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 authorization 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 https://www.basg.gv.at/en/lab/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 30 March 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:
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: https://www.ages.at/service/ages-akademie/programm-detail/kalender/detail/event/ages-gespraech-brexit-chancen-und-herausforderungen/archiv/
„BASG-Gespräch „Aktuelle BREXIT Herausforderungen für die EU-27““ on 26.06.2018:
„BASG-Gespräch „Versorgungssituation - Lieferengpässe““ on 12.02.2019:
Informations on fees can be found here: https://www.basg.gv.at/en/about-us/fees/
BREXIT-related guidance for companies
Created: 16.03.2018 | Page last modified: 22.03.2019