Please be advised that EMA London offices has moved to Amsterdam, The Netherlands.
See full details on our website:
https://www.ema.europa.eu/en/about-us/contact/how-find-us#official-address-from-4-march-2019-section
Please note our email addresses will not change.
EMA has published a questions-and-answers (Q&A) document for patients, healthcare professionals and the general public on the preparatory work that European Union authorities are doing to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU.
It explains that in case of a withdrawal agreement, there will be a transition period during which EU law will continue to apply in the United Kingdom. This means that access to medicines will not be affected.
If the UK leaves without a withdrawal agreement or deal (‘no-deal scenario’), EU law will cease to apply in the UK. In this case, in order to be able to continue to supply medicines in the EU, companies carrying out certain activities in the UK will need to make changes to comply with EU law.
The Q&As explain how EMA, the European Commission and EU/EEA Member States have been working closely together since May 2017 to advise companies on how to apply for the necessary changes in order to minimise the impact on the supply of medicines, if the UK leaves the EU without a withdrawal agreement.
The document underlines that Brexit will not impact the safety of medicines, nor the way they are evaluated. EMA and the Member States will continue to monitor the safety and efficacy of medicines without any changes.
This document applies to both human and veterinary medicines and will be updated as necessary.
Industry preparations for new Brexit deadlines
In view of the conclusion of the European Council on 22 March to extend the date of the withdrawal of the UK from the EU, EMA calls on all pharmaceutical companies in the EU to continue their preparedness activities, taking into account all possible outcomes. Based on the European Council conclusions, the deadline of 29 March referred to in EMA’s published Brexit-related guidance should be understood to be replaced by 12 April 2019 until further notice.
Further information is available by clicking here.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
The European Medicines Agency has published for public consultation one European Union herbal monograph on:
Deadline for comments: 15 May 2019.
Please send your comments to hmpc.secretariat@ema.europa.eu by using the standard template.
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
The European Medicines Agency has released for public consultation a procedure on management of proposals submitted by Interested Parties for European Union List Entries or European Union herbal monographs.
The purpose of this document is to enable consistent management of proposals submitted by interested parties for:
- Entries into the ‘European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’ (thereafter called the ‘European Union list entries’);
- European Union herbal monographs on traditional herbal medicinal products;
- European Union herbal monographs on well-established herbal medicinal products.
The Committee on Herbal Medicinal Products establishes draft entries to the European Union list and European Union herbal monographs following assessment of scientific publications/data and in accordance with adopted procedures.
The procedure is available by clicking here.
Comments should be provided using this template and sent to hmpc.secretariat@ema.europa.eu by 30 July 2019.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
The European Medicines Agency has released for public consultation the following documents:
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 31 March 2019.
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 30 April 2019.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
The European Medicines Agency has published the following reflection papers for consultation:
- Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances – Deadline 31 August 2019
- Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats – Deadline 31 August 2019
- Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market – Deadline 31 August 2019
Please send your comments to vet-guidelines@ema.europa.eu by using the standard template.
For more information on the European regulatory system for medicines, please consult our brochure.
EMA has published its draft ‘Regulatory Science to 2025’ strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines.
The strategy will help shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025). It seeks to offer informed guidance on modern medicines development, facilitate the optimisation of regulatory science and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.
We are inviting all our stakeholders to send their comments via an online questionnaire by 30 June 2019.
As a valued EMA stakeholder we are particularly interested in receiving your input to this consultation. We would also appreciate your support in further cascading information about this consultation amongst your networks.
You can read more about the public consultation in today’s press release.
The European Medicines Agency has published the following reflection papers for consultation:
- Reflection paper on resistance in ectoparasites – Deadline 31 August 2019
Please send your comments to vet-guidelines@ema.europa.eu by using the standard template.
For more information on the European regulatory system for medicines, please consult our brochure.
We are pleased to send you our latest edition of the monthly Newsletter which includes decisions by our Scientific Committees and updates on medicines safety. We hope that you will find this useful and welcome any feedback.
You can access the Newsletter by clicking here. Previous editions can also be found on this page.
