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

Notice to the MAH or person/company authorized for communication on behalf of MAH regarding declaration on pack sizes of medicinal products pending under MR or DC procedure

You are kindly requested to make a declaration on pack sizes the MAH is going to register and purposing to launch in Hungary as in CMS.

  • send an electronic format to mrp-dcp-new-cms@ogyi.hu
  • send the hard copy to National Institute of Pharmacy at the same time the national texts of product information submitted.

Take notice, that in case of several types of packaging approved in the documentation, the declaration has to be applied each of them, as the registration number depends on different types of packaging as well.

Last updated: 2008.08.18 21:21