Join industry executives in staying informed on the market access and HTA process in Portugal.  1. What is the definition of an orphan drug in your country? A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (i) that it is intended for the diagnosis, prevention or treatment of…

Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What is the definition of an orphan drug in your country? According to Art. 4 para. 1 lit. adecies TPA, an orphan drug is a medical product for human use for which it has been proven either (1) that…

Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What is the definition of an orphan drug in your country? The term “orphan drug” usually refers to medicins used for rare diseases – i.e. diseases where the prevalence of the condition in the EU is not more…

Join industry executives in staying informed on the market access and HTA process in Romania.  1. What is the definition of an orphan drug in your country? The Romanian legislation defines “orphan drug” by referring to the criteria provided for by Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly…

Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare diseases. As per ANVISA Resolution…

1. What is the definition of an orphan drug in your country? In Spain there is no particularity in relation to the definition of “orphan drug” derived from the Regulation (EC) No 141/2000. Under Regulation (EC) No 141/2000 a medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (i)…