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January 4, 2026
Approximately 5 minutes
AEMPS Circular 1/2011 on Mandatory Information in Medicine Package Leaflets in Spain
AEMPS Circular 1/2011 on Mandatory Information in Medicine Package Leaflets in Spain
1. Background and Purpose
The Spanish Agency for Medicines and Medical Devices (AEMPS) issued Circular No. 1/2011 to standardize certain information in the package leaflets (prospectos) of medicines authorized through national procedures in Spain. The circular aims to ensure users have access to the most up-to-date information and are informed about proper medicine disposal.
Date of error correction: April 8, 2011.
2. Scope of Application
The requirements apply to medicines authorized via purely national procedures or European decentralized/mutual recognition procedures where Spain is involved. They do not apply to centrally authorized medicines.
3. Required Statement on Updated Information
All package leaflets must include the following phrase as the last sentence:
“La información detallada y actualizada de este medicamento está disponible en la página Web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.es/”.
This informs users that a more recent version of the leaflet may be available online via the CIMA database.
4. Required Statement on Medicine Disposal
In compliance with Article 62 of Real Decreto 1345/2007, leaflets must include an updated disposal warning:
“Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en [SIGRE point reference].”
This promotes environmentally responsible disposal through SIGRE collection points.
5. Additional Information for Antibiotics
The circular mentions specific generic information to be included for antibiotics regarding indications, use, and disposal, though detailed content is regulated separately.
6. Rationale and User Access
Package leaflets provide essential information on use, indications, adverse effects, and contraindications. As this information may change, directing users to the AEMPS website ensures access to the latest authorized version.
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