Brussels, 11 June 2024 – The Association of the European Self-Care Industry (AESGP) is proud to announce the relaunch of its extensively updated and upgraded OTC Ingredients Directory. This free-access database now features the legal status of 269 active pharmaceutical ingredients (APIs) across 30 EU markets, including the addition of Cyprus, Latvia, Luxembourg, and Malta.

The AESGP OTC Ingredients Directory was launched for the first time in October 1999, as part of the ‘OTC in Europe – Facts and Figures’ report. This latest update marks a significant enhancement in the directory’s scope and accuracy, reflecting recent regulatory changes while ensuring it is technologically up to speed.

Varying levels of access to non-prescription medicines in Europe

Self-care is key for public health and the sustainability of healthcare systems. A clear distinction between prescription and non-prescription medicines (legal status) is essential for promoting responsible self-care. In the European Union, medicinal products are not subject to mandatory medical prescriptions unless they meet specific legal criteria.

The legal status of a medicine is typically a national decision, influenced by factors such as reclassification procedures, medical history, and authorities’ stance on self-care. This leads to significant variations in the legal status of medicines across countries, even for those with well-established active ingredients. Consequently, patients’ access to self-care options is fragmented and varies depending on their country of residence.

The AESGP OTC Ingredients Directory is a unique tool offered by the AESGP and a widely consulted reference, not only by Industry but also by stakeholders, which allows users to compare the classification status (prescription vs. non-prescription) of over 200 active pharmaceutical ingredients (APIs) in Europe.

269 APIs, 30 EU markets centralised in one databank

To ensure the highest quality and current data, AESGP partnered with Clarivate™ to review the status of the APIs listed in the Directory as well as to consider the most recent prescription-to-non-prescription medicine (NPM) switches that have taken place. The database was also enhanced with new, essential information such as indications for NPM use, posology, strengths, and any limitations to NPM status. For this update, Clarivate™ employed advanced technology and manual curation to harmonise data from various Competent Authorities’ websites.

The updated directory provides:

• Legal Status of 269 APIs: Highlighting recent switches and back switches across 30 EU markets.
• Expanded Market Coverage: Including new additions from Cyprus, Latvia, Luxembourg, and Malta.
• Detailed Product Analysis: Covering 2,520 products with non-prescription status across 48 ATC therapeutic areas.
• Recent Regulatory Changes: Identifying 26 switches by national procedure in the last 4 years (2020-2024); and 2 by centralized procedure (desloratadine and lidocaine/prilocaine) in 2020.
• New Functionalities: Increased search capabilities; Possibility to provide direct input via the webpage.

Disclaimer

AESGP remains committed to supporting the self-care industry by providing reliable and up-to-date information through the OTC Ingredients Directory. The content of this database is for informational purposes only. The database will continue to be monitored and updated to ensure data accuracy. Official classification is determined by national competent authorities. As regulatory information tends to evolve quickly, AESGP recommends consulting original documents and national competent authorities in case of doubt. For further details, please visit https://otc.aesgp.eu/ or contact info@aesgp.eu.

Further information about the legal and regulatory framework for non-prescription medicines across Europe, including national reclassification procedures, is available in the AESGP Med Data Bank.