PRODUCT INFORMATION OF CENTRALIZED PRODUCTS

The AEMPS has enabled the possibility to break up the Product Information (SmPC and PIL) of medicines authorized by procedure centralized.

The Spanish Medicines Agency (hereinafter AEMPS) and the Pharmaceutical Industry have made an important effort to transform documents that support the information to patients and health care professionals, SmPC and Patient Leaflet. This transformation had two objectives: on the one hand to facilitate document management national regulatory processes, and on the other, an improvement in the information provided from the AEMPS. These documents can be found now in formats easier to adapt to reading mobile devices and enabling indexing of text in our databases in function of its sections, which facilitates access to information of medications; In addition, in the future functionalities will be developed that help to perform text searches on these documents.

So far medicines authorized by a centralized procedure have been out of the scope of these initiatives.

It is very important that these medicines that are the most important therapeutic innovations are also adapted to this system. Given that the marketing authorisation is granted by the European Commission the conversion is not required but all the support will be given to facilitate it.

Fractionated from texts and format conversion will take place through the application ‘Edición telemática de fraccionamiento’. Once the information has been inserted it will be posted in the online information centre.

It is the responsibility of the Marketing Authorization Holder to keep updated all the product information through this electronic application in Spain.