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”). UK left the European Union on 31 January 2020 and became a third country, and the national agencies MHRA (Medicines and Healthcare Products Regulatory Agency) and VMD (Veterinary Medicines Directorate) are no longer able to lead any EU procedures.
A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. This is due to end on 31 December 2020. Companies have until 31 December 2020 to make the necessary changes to ensure that their authorised medicinal products comply with EU legislation and can remain on the EU market.
Until the end of the transition period, all regulations that apply to member states of the EEA remain applicable to UK, with a few exceptions. The exceptions concern UK's leading role in European procedures and its participation in EU committees. As from 1 February 2020, UK can therefore no longer be an RMS or rapporteur in any procedures.
Please also refer to website of EMA for additional information on the transition period: https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit
Important information for Marketing Authorisation Holders:
If your medicinal product was authorised/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 on the website of the BASG under RMS transfer.
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 contributed 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 transfer.
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 the transfer will be necessary.
For further information please refer to batch release.
Impact on substances of human origin (Blood and Tissues/Cells)
If no agreement is reached between UK and the member states after the end of the transition period, 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
If no agreement is reached between UK and the member states after the end of the transition period, shipments will 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