Instructions for Using the AESGP Ingredients Directory

Self-care is vital 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 (Article 72 of Directive 2001/83/EC, as amended).

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 varies depending on their country of residence.

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

The AESGP Ingredients Directory

The AESGP Ingredients Directory presents a non-exhaustive list of active substances that are available as non-prescription medicines and compares their classification status in 30 European countries. A major update was completed in May 2024 and it is now reviewed yearly.

Please note that only a limited number of combinations is available in the database. Should you wish to have additional ingredients or combination included please indicate as such in the “Submit a change form”.

How to Use the Directory

• Status: “OTC” indicates that at least one dosage or form of the ingredient has non-prescription status in the specified country. This status is independent of the reimbursement or advertising status of products containing the ingredient.
• For ingredients available as OTC, details are provided regarding indication, dosage, posology, and any limitations to the non-prescription status.
• Disclaimer: The classification of ingredients is for informational purposes only. AESGP is not liable for the content or its use by third parties. Official classification is determined by national competent authorities.

Search Instructions

• Basic Search: Start typing an ingredient name and select it from the list. Once satisfied with your terms, click the search button.
• Advanced Search: Allows searching by parameters such as country, ATC level, year of switch, or legal status.

Tips&tricks

• Sort: You may sort alphabetically each column by simply clicking on it.
• Search adjustments: Any changes made after the initial search take place immediately, you do not need to click ‘search’ every time something is changes
• Print: The results of a search can be easily exported via the ‘Print’ button for future reference

Submitting Changes

• Year of switch
• Pharmaceutical form
• Indication(s) for non-prescription use
• Recommended dosage for non-prescription status
• Any limitations to OTC status (e.g., sub-classification, advertising restrictions)

Source of information to confirm validity.