Tue. Feb 7th, 2023

The Commission has launched the process on the revision of the general pharmaceutical legislation, one of the flagships of the Pharmaceutical Strategy for Europe. For the next four weeks, the public and stakeholders are invited to post their views on the combined evaluation Roadmap and Inception Impact Assessment.

Adopted last November, as a pillar of the European Health Union, the Pharmaceutical Strategy is an ambitious project intended to reinforce the European pharmaceutical system’s patient-centred focus and to make it future-proof and crisis-resistant. The Strategy will also take into account learnings from the COVID-19 pandemic which has clearly demonstrated how critical it is to ensure timely access to safe, high quality and affordable medicines.

Stella Kyriakides, Commissioner for Health and Food Safety, said: 

“The Pharmaceutical Strategy for Europe is a cornerstone of a stronger European Health Union. And to ensure that all patients have access to safe, high quality and affordable medicines, we need a pharmaceutical legislation that is fit for today’s world. This is the chance for everyone, citizens and stakeholders alike, to take part in this ambitious reform and help us reshape and strengthen our legislation.” 

In the coming months, the Commission will be evaluating the current general pharmaceutical legislation and assessing the impacts of any changes intended to address the problems outlined in this Roadmap. One follow-up step will be a public consultation, to be launched in the second semester of 2021. The Commission aims to present a legislative proposal for revision of the general pharmaceutical legislation by the end of 2022. The Roadmap will be accessible for four weeks until 27 April 2021.

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