On Tuesday, 28 September, the European Commission entered the final phase of the work to accomplish in preparation for revising legislation on medicines for rare diseases (141/2000) and on medicines for paediatric use (1901/2006).
This revision was specifically promised by the European Commission in the context of its pharmaceutical strategy (see EUROPE 12609/10).
After presenting its roadmap on this initiative and launching an initial request for comment last March (see EUROPE 12690/10), it opened a public consultation on the subject on Tuesday.
This consultation will last for 12 weeks, until this coming 21 December. It will be used to “collect views of stakeholders and the general public in order to support the evaluation [...] and the impact assessment” that were previously conducted.
“I call on all interested citizens and stakeholders to help us shape EU rules for the future, responding to patients’ needs and keeping our industry innovative and globally competitive,” indicated European Commissioner for Health Stella Kyriakides in a statement on Tuesday.
By the end of its initial consultation phase, the European Commission had received around 100 comments that were primarily written by businesses, NGOs, and professional associations.
To access the consultation: https://bit.ly/3ulY7BK (Original version in French by Agathe Cherki)