Urgent EU action needed to unlock prescription-to-non-prescription Switch
Brussels, 13 OCT 2026 – AESGP today launches its recommendations for prescription-to-non-prescription Switch in Europe, setting out 8 recommendations and 2 key policy actions to unlock wider benefits for people, healthcare systems and society. AESGP calls for clearer Switch pathways and stronger incentives for self-care innovation.
The recommendations were discussed in a soft launch at AESGP Switch Day on 7 October 2026, in Brussels, where regulators and patient representatives joined a highly engaged industry audience to discuss how Switch can expand access to self-care.
By making appropriate prevention and treatment solutions available as non-prescription medicines, Switch enables more people to manage their health responsibly while helping healthcare professionals and health systems focus resources where they are most needed. Realising these benefits requires procedures that applicants can navigate with confidence and assessments that consider the wider contribution of Switch to public health.
Europe’s Switch potential remains, however, underused. Since 2004, only 6 active substances have gained non-prescription status through the EU centralised procedure. Fragmented national pathways and a high-risk process continue to deter investment and limit self-care innovation.
AESGP proposes action at national and EU levels across 8 priorities
- Simplify and increase transparency of switch pathways
EU Rx-to-NPM pathways require further simplification with clear, transparent procedural steps and applicant requirements - Consider wider switch benefits in decision-making
Assessments must weigh risks against public health benefits like improved access, patient empowerment, and reduced healthcare system pressure. - Improve transparency and predictability for MAHs
Switch procedures should offer clear requirements, predictable timelines, and structured dialogue opportunities with regulatory authorities. - Publish clear national guidance in English
National medicines agencies should publish detailed guidance on switch procedures, fees, timelines, and data requirements, including English versions. - Strengthen dedicated switch expertise within agencies
Authorities need specialised non prescription departments or assessors to support consistent evaluation and best practice sharing. - Provide pre-submission advice and meetings
Agencies should offer early scientific/regulatory advice, exploring Simultaneous National Scientific Advice across Member States for MRP DCP switches. - Maintain public registers of switch decisions
Authorities should publish databases of Rx to-NPM switch outcomes and assessment reports to increase transparency and guide future filings. - Clarify the role of expert committees
Advisory committee roles must be clearly defined to deliver expert support while preserving predictable, evidence-based decisions
2 Key Policy Actions to support Switch innovation
- AESGP calls for extending Switch data exclusivity from 1 to 3 years to reward investment, support complex applications and align Europe with Japan and the USA.
- AESGP also urges stronger protection for Switch evidence, including real-world, behavioural and actual–use studies that demonstrate safe and effective non-prescription use.
Europe must now turn these recommendations into wider access to responsible self-care.