Stakeholder Workshop from 26 February 2016

Recommendation

Tuesday, 8 June 2027 13.00 - 16.00 h

Drug Shortage Policy in the EU: How to deal with Regulatory Requirements? - Live Online Training
The EMA Guidance on Medicine Shortages and Availability Issues and the European Shortages Monitoring Platform (ESMP)

In our News entitled "Important Publication of the Delegated Regulation complementing the Anti-Counterfeiting Regulation" we informed you about the publication of the Delegated Regulation. Now, the European Commission has published the summary of a workshop to inform all stakeholders of the recent publication of the EU Delegated Regulation for the implementation of safety features for medicinal products.

The regulation has set the deadline for the implementation of the safety features which will be binding as of 9th February 2019.
Belgium, Italy and Greece have the possibility to postpone this date for up to 6 years.

Another point discussed was the request for a pragmatic approach regarding the regulatory requirements, for example regarding variations for the implementation of safety features in view of the around 250,000 products potentially needing variations.

The commission explained that the plans for the implementation - for both centrally and nationally authorised products - would contain much pragmatism. Regulatory procedures should be used which would have been needed anyway.

Another point of discussion was the fact that some Member States may have a low awareness of the new Regulation. The Commission was asked to do more to inform all stakeholders.

You can find more details in the summary of the European Union: "Stakeholders Workshop on the Delegated Act on Safety Features for Medicinal Products for Human Use" dated 26th February 2016. The document is available in the Members Area of the ECA Website.