Aemps is starting an IPT of drugs approved by the EMA CHMP, which will take place in June.

The Spanish Agency for Medicines and Health Products (Aemps) is about to start working on therapeutic positioning reports (IPT) for medicinal products that have received a positive opinion through a centralized procedure at the meeting of the Committee for Medicinal Products for Human Use (CHMP). , abbreviation in English) European Medicines Agency (EMA)carried out in June 2024. These IPTs correspond to both new drugs and new indications or modifications to them that have received committee approval and are described below.

In the case of new medicines, the IPT preparation process will begin the moment Aemps receives from the marketing authorization holder (TAC) a communication of intent to market these medicines in Spain and an application for national registration. code. To do this, the Agency requests TAC to contact ipt@aemps.es indicating the following:

Their intention or not to sell new drugs in Spain that have received a positive conclusion as a result of a centralized procedure. In this case, they need to request the national code through the Raefar II app as mentioned in this guide.

If Aemps does not receive marketing confirmation and therefore the TAC does not request a national code for new drugs, preparation of the corresponding IPT will not begin.