BREXIT – Impact for Marketing Authorisation Holders and for AgenciesNeu
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 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 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 at that time will now last until 31.10.2019 at latest.
It has been agreed at the end of October to further postpone the deadline and that the extension will last as long as necessary and, in any event, no longer than 31 January 2020.
The UK remains a Member State for the duration of the extension. Based on the European Council decision, and until further notice, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31.01.2020.
Please also refer to website of EMA: https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit
Marketing Authorisation Holders are strongly encouraged to continue their necessary arrangements for the UK’s withdrawal (latest until 31.01.2020) 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 issued after 31st of October 2019 cannot be guaranteed, thus, a mutual recognition of batch release would not be possible anymore.
Certificates issued by the NIBSC before 1.11.2019 are still valid, so that in these cases the recognition of batch releases by the NIBSC in Austria is possible.
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 31.01.2020:
- 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.
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).
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 31.01.2020).
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.
The work of the Brexit Task Force of the BASG to prevent potential supply disruptions of medicinal products due to Brexit
By setting up its own Brexit Task Force, the BASG has taken action and promptly endeavored to optimally avert impending supply disruptions of medicinal products critical for the Austrian market. The interdisciplinary Task Force is headed by the BASG and involves internal experts as well as representatives of external interest groups such as the Chamber of Pharmacists, hospital pharmacists, the pharmaceutical industry, wholesalers, the Chamber of Commerce and the Main Association of Austrian Social Security Institutions.
In the spirit of a constructive and transparent cooperation, the actions of the respective institutions were communicated and coordinated in the best possible way.
A decisive measure to ensure the availability of critical medicinal products for the Austrian patients was the proactive establishment of contact between the BASG and the concerned marketing authorisation holders. Through this initiative, the awareness of all stakeholders for the challenges posed by Brexit was increased and the timely implementation of the necessary regulatory measures could be promoted and accelerated.
The commitment of the BASG was very positively received by all institutions concerned and contributes significantly to reducing possible Brexit-related supply disruptions of critical medicinal products to a minimum or, in many cases, to a total prevention.
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.
Medicinal Products Import
In the event of an unregulated withdrawal from the EU, the UK will become a third country from the date of withdrawal. From then on, shipments become subject to authorization, which must comply with the Drug Import Act. Relevant import certificates must be requested from the BASG.
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: 04.11.2019