H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, General information: 1812

E-mail: info@egeszsegvonal.gov.hu

Mail: 1372 P.O. Box: 450.


Mellékhatás bejelentő
NOR keresőfelület Minőségi kifogás
magisztrális gyógyszerek

Authorization of indiviual medicine import

Medicinal products which have no marketing authorisation in Hungary (but in the EEA or outside the EEA) may be imported within the frame of outpatient and bedpatient service.

Application for a requested medicinal product may be handed in only by the medical attendant or the specialist by submitting the appropriate forms for this purpose. The stamped data sheet being filled in correctly and the detailed anamnesis (not older than 6 months) have to be submitted to the Department of Indiviual medicine import(address: 1372, Pf. 450; fax: +36 1 88 69 470).

All applications are examined thoroughly within 8 days - if necessary in cooperation with a medical expert advisory panel – and a declaration or a decision is issued by the National Institute of Pharmacy dependently whether the medicine is being imported from the EEA or outside the EEA:

• if the product would be imported from the EEA the National Institute of Pharmacy will issue a declaration whether the request is reasonable;

• if the product would be imported from outside the EEA the National Institute of Pharmacy will issue an authorisation after the examination of the necessity of the medicine.

The physician takes the responsibility for the application of the medicine, it is confirmed by their signature. Please note that the medicinal product is to be applied only in the indication stated in the Summary of Product Characteristics. Off-label use is to be considered as a medical investigation carried out without any licence and will be punished with 5 years' imprisonment.

Last updated: 2018.09.30 12:19