The proposal adopted by the Commission revises and replaces the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively).
The revision aims to achieve the following main objectives:
- Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines
- Enhance the security of supply and ensure medicines are available to patients, regardless of where they live in the EU
- Continue to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe
- Make medicines more environmentally sustainable
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach.
Consultations activities related to the revision of the general pharmaceuticals legislation
On 30 March 2021, the Commission published its Roadmap for revising the general pharmaceutical legislation.
Since the publication of the strategy roadmap in June 2020, the Commission has conducted a series of consultations and meetings to inform the designing of the strategy.
The Commission has considered the positions and priorities raised by interested parties and the public and has been working closely with Member State authorities in the context of its consultative committees.
As part of the consultation process experts from the European Medicines Agency and from national competent authorities (under the umbrella of the Heads of Medicines Network) drafted at the request of the Commission a series of ‘concept papers’* on technical aspects, based on their experience with operating under the current pharmaceutical legislation to inform the Commission services during the preparation of the legal proposals. The 13 concept papers* can be downloaded in this compendium.
*The views expressed in these concept papers are the product of experts’ reflection process on different possibilities, they do not necessarily represent positions of the organisations to which these experts are affiliated and may not be quoted as such. For the preparation of its legal proposals, the Commission took into account the options presented in the concept papers as part of the total available evidence.
For more on other activities please see below:
- Consultation strategy
- Online public consultation
- Thematic Workshops 2021
- Stakeholders’ dialogue on the pharmaceutical revision (10th May 2023)
Consultation activities related to the revision of the orphan and paediatric legislation
In November 2016, the Commission launched an online public consultation on the experience acquired from applying the paediatric regulation.
On 11 December 2017, the Commission launched an online public consultation for the roadmap evaluating orphan and paediatric legislation.
Excerpt from the official page. The original is authoritative. Continue reading at EC Pharmaceutical Strategy ↗