EMA and its partners in the European medicines regulatory network are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the European Union (EU). No reports of current shortages or supply disruptions of medicines marketed in the EU due to this outbreak have been received at this point. As the public health emergency develops, shortages or disruptions cannot be excluded.
The EU (EMA, the European Commission and national competent authorities in the Member States) have organised the first meeting of the EU Executive Steering Group on shortages of medicines caused by major events to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU. The mandate of this group is to provide strategic leadership for urgent and coordinated action within the EU in case a crisis caused by major events, such as the COVID-19 outbreak, risks impacting the supply of medicinal products for human and veterinary use.
In the context of COVID-19, the group will identify and coordinate EU-wide actions to protect patients when medicines in the EU are at risk of supply shortage, e.g. due to a temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment. The group will also ensure that patients and healthcare professionals across the EU are kept informed in a consistent and transparent manner about the risks and the remedial actions taken.
For more information on the EU Executive Steering Group and the actions already taken, please click here.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
The call for expression of interest to participate in the European Medicines Agency (EMA) third Awareness Session, focused on science and regulation for animal health and welfare is still open.
The session will be held at the EMA in Amsterdam, on Thursday 2 and Friday 3 April 2020.
This awareness session will give an insight into the Veterinary EU regulatory system and the role of EMA and the EU network, and into specific aspects of the new veterinary medicines regulation. It will address Veterinary topics such as antimicrobial resistance, support for innovation and collaboration with Academia. In addition, there will be parallel sessions on more specific topics, such as animal welfare, food safety and security, Veterinary medicines and the environment and Animals & society.
You can download the early programme overview for more details.
Programme_overview_-_EMA_3rd_International_Awareness_Session_on_science_and_regulation_for_animal_health_and_welfare_public_health_and_the_environment.pdf (110.5 KiB, 10 hits)
Expressions of interest should be sent to EMA at EMAinternational@ema.europa.eu by 9 March 2020. The session will also be broadcast and selected information published on the EMA website after the event.
Please note that there is no registration fee but the EMA will not fund participation, nor reimburse travel, visas, or accommodation.
The European Medicines Agency has published the “Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use”.
This guideline has been revised and provides new text to be included in the package leaflet of medicines containing ethanol as excipient. It contains more detailed information on the effects of ethanol when used as excipient, in particular on babies and children.
This document is the Annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use. It contains the information which should appear in the package leaflet for the excipients known to have a recognised action or effect. The annex is effective from 22 November 2019.
For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex.
For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation within 3 years after the publication of the revised annex
Please find a link to additional information on the Annex. The rational for revising information on ethanol, which went through public consultation, has also been published: Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use.
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 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).
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.
