Below you'll find the highlights that we have selected for you regarding regulatory, pharmacovigilance and quality related matters in the Life Sciences industry in a chronological order
Brexit preparedness: EMA to further temporarily scale back and suspend activities, EMA, 01-08-2018 - General
Following the implementation of phase 1 and 2 of the business continuity plan, in phase 3 EMA will start to temporarily scale back or suspend additional activities through to 2019. This contributes to protecting EMA’s essential public health activities and allows for training of EMA staff who will be re-assigned to new duties ahead of the peak relocation time which will start in early 2019.
Activities initially impacted by phase 3 include (a.o.) collaboration at international level, development and revision of guidelines, holding of non-product related working parties, and clinical data publication.
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure, EMA, 19-06-2018 - General
The below Practical Guidance has been developed taking into consideration that as of 30 March 2019 the United Kingdom will become a third country. As a result, MAHs and applicants of centrally authorised products for human or veterinary use need to ensure that the necessary changes are made by the 30 March 2019, unless indicated otherwise in the guidance below. This document complements the EC-EMA Q&A to provide procedural and practical guidance regarding submission of changes and related fees.
Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to national authorised medicinal products for human use, EMA, 19-06-2018 - General
This list of Q&As has been drafted by the CMDh taking into account the European Commission's and EMA's Questions and Answers on the same issues within the framework of the centralised procedure. This version is an update of the initial list of Q&As as subsequently amended and it replaces all previous versions of Q&As. The new text introduced in this version of Q&As is indicated by the word "NEW". The Q&As may be further updated and complemented in the future.
The European Medicines Agency and Netherlands agree on Seat Agreement, EMA, 24-04-2018 - General
The agreement describes how the Agency, its bodies, and its employees will be treated by the Dutch government after the transition and are operational in the Netherlands. Negotiations between EMA and the Dutch government were wrapped up earlier then expected, which is has a positive affect on EMA staff and their families because they will have clarity sooner and can focus on settlement in the Netherlands. The agreement will come into force once both parties have signed the document.
Completion of redistribution of the UK Centrally Authorised Product portfolio, EMA, 11-04-2018 - General
The methodology for the redistribution of the UK product portfolio for CHMP/CVMP/CAT/PRAC (Co)-Rapporteurships for human and veterinary products was endorsed by the Management Board at its December 2017 meeting. The methodology is flexible, easy to explain and implement, and can be applied equally to human and veterinary medicines. It involves a multifaceted approach for allocation of the UK product portfolio within the Network, which takes into consideration the results of the surveys, the expertise within the Network and workload for each medicinal product. The proposal ensures an optimised and robust allocation of the workload across the Network and guarantees efficiency within the Network, making it sustainable. In addition, it allows NCAs to participate in EMA activities, as per the capacity of each NCA.
MPA Brexit info meeting, Läkemedelsverket, 5-2-2018 - GENERAL
Slide deck from the Swedish Medicinal Products Agency with a brief Brexit introduction and insighto into Brexit from a pharmaceutical perspective, practical aspects, variations, change of RMS – Reference product from UK and a Q&A session.
Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, EC & EMA, 29-1-2018
Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, the EU rules in the field of medicinal products for human and veterinary use no longer apply to the United Kingdom. This has, in particular, the following consequences in the different areas of EU law on medicinal products:
- EU law requires that marketing authorisation holders are established in the EU (or EEA);
- Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.
EMA surveys pharma companies on their preparedness for Brexit, EMA, 23-1-2018 - GENERAL
The European Medicines Agency (EMA) is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.
MHRA update to pharmaceutical companies on exit preparations, MHRA, 16-1-2018 - REGULATORY AFFAIRS
More clarified information on the positioning of the MHRA in its current environment and future Brexit changes to ensure continuity.
Guidance from the Irish authorities on Brexit, HPRA, 20-12-2017 - REGULATORY AFFAIRS
According to the HPRA, there are many areas to consider regarding Brexit - but these also all subject to change depending on the Brexit government discussions. This is explained clearly is this guidance for areas like Reference Member States, MS, generic, Clinical Trials, PhV, import & export. It also reaches out to the Irish HA and stakeholders to be pro-active.
EMA Management Board: highlights of December 2017 meeting: Brexit update and adoption of work programme and budget for 2018, EMA, 15-12-2017 - GENERAL
The Management Board of the European Medicines Agency (EMA) heard from Executive Director Guido Rasi and Deputy Executive Director Noël Wathion how the Agency is preparing for relocation to Amsterdam in the Netherlands, and operationally for the United Kingdom’s (UK) withdrawal from the European Union (EU). This is the first meeting of the Board since the General Affairs Council (Art.50) of 20 November and the decision of the EU 27 Member States to relocate the Agency to Amsterdam. EMA now has just over 15 months to prepare for the move and take up its new seat in Amsterdam by 30 March 2019 at the latest.
EMA management Board meeting, EMA, 15-12-2017 - REGULATORY AFFAIRS
EMA and the Dutch authorities are currently working on a Memorandum of Understanding (MoU). The Board was also informed that EMA’s Brexit preparedness business continuity plan will enter Phase 2 in January 2018.
Brexit related manufacturing and supply, European QP Association, 12-12-2017 - QUALITY MANAGEMENT / QP
This Q&A document explains from the manufacturing, release and distribution perspective and recommends that Life Sciences companies should be pro-active to ensure compliance and efficiency during Brexit.
Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to national authorised medicinal products for human use, CMDh, 1-12-2017 - REGULATORY AFFAIRS
On 2 May 2017, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) published a Notice to marketing authorisation holders of national authorised medicines products for human use. In this regard, marketing authorisation holders of national authorised medicinal products for human use are reminded of certain legal consequences that need to be considered in a timely manner. Preparing for the consequences of the UK’s withdrawal from the Union is not just a matter for European and National administrations, but also for private parties.
Is Brexit a positive for the UK’s pharma sector? Here are seven factors in favour of this, EPM Magazine, 29-11-2017 - GENERAL
Article which shows more intel about how the Brexit will positively influence the UK's pharmaceutical industry.
Procedural guidance to help pharmaceutical companies prepare for Brexit, EMA, 28-11-2017 - GENERAL
The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisationto allow for the continued marketing of their medicine in the European Economic Area after the UK withdraws from the EU. The guidance has been prepared on the basis that the UK will become a third country as of 30 March 2019. It should be read in conjunction with the Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the centralised procedure published in May 2017.
The Netherlands welcome EMA, 20-11-2017 - GENERAL
Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.
The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.
The Dutch Bid for EMA, CGB-MEB - GENERAL
The Dutch Health Authority has promoted its offer to attract the EMA in a nice looking website.
Have a look!
EFPIA Brexit Survey results, EFPIA, 8-11-2017 - GENERAL
A slide deck with the insightful results of a survey performed by the European Association of Pharmaceutical Industries and Associations surrounding the impact that Brexixt will have on the Life Sciences Sector.