Brexit

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 fullfil 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 29.3.19:

 

  • 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) – currently this holds for 409 human and 291 veterinary medicinal products. Further information can be found at https://www.basg.gv.at/en/medicines/marketing-authorisation-procedure/austria-as-rms/rms-transfer/. Austria overtakes a leading role here within EU, being among TOP 5 most active states and having finalised already 70 transfers from UK=RMS to AT=RMS.
  • If the address of Marketing Authorisation Holder/Holders of a Registration is established within UK, marketing authorization/registration needs to be transferred to a site within EU/EEA  – currently this holds for 273 human and 149 veterinary medicinal products. 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 state within EU/EEA – currently this holds for 192 human and 117 veterinary medicinal products. For further information regarding batch control and import please consult FAQs of CMDh/CMDV below.
  • Also if QPPV resides and/or PSMF are located in UK, these need to be transferred.


Brexit-associated variations can be grouped, further information is available at
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/1_CMDh_173_2010_Rev17_2017_06_clean.pdf


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:
https://www.basg.gv.at/en/medicines/marketing-authorisation-procedure/austria-as-rms/dcpmrprup-slots/ resp.
https://www.basg.gv.at/en/news-center/public-information-campaigns/austria-as-rms/rms-flyer/

Further information and FAQs regarding BREXIT are available on the following websites:
EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7
CMDh: http://www.hma.eu/535.html
CMDv: http://www.hma.eu/542.html

Takeover of Batch Release by BASG

The Official Medicines Control Laboratory (OMCL) of BASG belongs to the leading OMCLs within the EU/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:
https://ec.europa.eu/health/blood_tissues_organs/overview_en

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 offered already information campaigns regarding BREXIT and is planning information talks in future:
„AGES-Gespräch „Brexit – Chancen und Herausforderungen““ from 13.09.2017: https://www.ages.at/service/ages-akademie/programm-detail/kalender/detail/event/ages-gespraech-brexit-chancen-und-herausforderungen/archiv/
SAVE THE DATE: The „BASG-Gespräch „Aktuelle BREXIT Herausforderungen für die EU-27““ will take place on 26.06.2018:

https://www.ages.at/service/ages-akademie/programm-detail/kalender/detail/event/aktuelle-brexit-herausforderungen-fuer-die-eu-27/

Informations on fees can be found here: https://www.basg.gv.at/en/about-us/fees/

Created: 16.03.2018 | Page last modified: 18.10.2018

© Austrian Federal Office for Safety in Health Care
to top