Information to include on leaflets of medicinal products authorised by AEMPS


The Circular information Nº 1/2011 of AEMPS, the Spanish Medicinal and Health Products Agency, published on 24 March 2011 (corrected on 8 April 2011), states the information that must be included on the leaflets of medicinal products. The Patient Information Leaflets (PIL) must indicate where an updated version of them can be obtained and how to eliminate used medicinal products. In addition, antibiotics’ leaflets must include general information regarding their indication, utilization and elimination.

This circular applies to all medicinal products possessing a national Marketing Authorization (MA), obtained through a national, a decentralised or a Mutual Recognition Procedure (MRP).

MA holders must include this information at the time of their next leaflet print; this can be made without waiting for the authorisation of the variation.

Nevertheless, the included information must be indicated in the next variation or renewal affecting the PIL. The inclusion of this particular information has no charges and only the fee of the concomitant variation is to be paid.

Actualised leaflets are available at the «Information Center of authorised medicinal products» (CIMA) at the AEMPS Web site.