The 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
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.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
The European Medicines Agency has released today for public consultation two draft consultation papers:
This document provides internationally harmonised recommendations for criteria on data requirements to waive laboratory animal batch safety testing of veterinary vaccines in regions where it is required.
Deadline for comments: 10 April 2020
The CVMP has adopted a draft reflection paper on ‘Promoting the authorisation of alternatives to antimicrobials in the EU’. This draft reflection paper has been developed to identify additional measures that could be implemented to promote the authorisation of alternatives to antimicrobials in the EU
Deadline for comments: 30 April 2020
Comments should be provided using this template and sent to Vet-Guidelines@ema.europa.eu.
The European Medicines Agency has published for public consultation three European Union herbal monographs on:
Deadline for comments: 15 January 2020.
Please send your comments to hmpc.secretariat@ema.europa.eu by using the standard template.
The European Medicines Agency has released for public consultation a draft CVMP Reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU.
Antimicrobial resistance (AMR) is now recognised as a major threat to human and animal health. The European Medicines Network Strategy to 2020 highlights that, with respect to veterinary medicines, controlling the risks of AMR arising from the use of antimicrobials, and particularly arising from the non-prudent use, is one of the highest priorities related to animal and public health.
This reflection paper performs a gap analysis by reviewing the measures currently in place to support the authorisation of alternatives to antimicrobials (ATAm) in veterinary medicine, with particular emphasis given to alternatives to antibiotics, and identifying where and how these could be improved.
The draft paper is available by clicking here.
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 30 April 2020.
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.
The EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022.
On this webpage, stakeholders can find all relevant information regarding EMA’s scientific and technical recommendations to the European Commission that will feed into delegated and implementing acts as part of the implementation of the legislation, as well as updates on other activities such as the preparation for implementation progresses.
The new regulation contains new measures for increasing the availability of veterinary medicines and enhances EU action against antimicrobial resistance, a high priority for the Agency and the European medicines regulatory network. It also aims to reduce administrative burden and encourage medicine innovation and development.
For more details, please click here.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
Further to last year’s workshop and a very successful public consultation, we are pleased to inform you of the upcoming multi-stakeholders workshop entitled “EMA Regulatory Science to 2025” which will take place on 5th - 6th December 2019.
EMA_Agenda_-_5th-6th_December_2019.pdf (259.1 KiB, 5 hits)
The objectives of this workshop are to:
- share the outcome and key messages from the analysis of the public consultation;
- reflect on the likely prioritisation of core recommendations EMA’s Regulatory Science Strategy to 2025; and
- identify concrete actions in order to implement the key goals and core recommendations, addressing expertise development and process evolution.
The Veterinary workshop will take place on Thursday 5th (afternoon) and Friday 6th December 2019, at the European Medicines Agency’s offices in Amsterdam.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
EMA is happy to share the Highlights of patient, consumer, healthcare professional and academia involvement in our activities in 2018 with you.
EMA_2018_highlights.pdf (947.3 KiB, 29 hits)
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).
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.
