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CESP submission (only for new national registrations) Jan 2016

eAF is mandatory Jan 2016


New structure of health administration system: Instead of GYEMSZI --> OGYÉI May 2015

Information for marketing authorization holders on the transitional arrangements of the new pharmacovigilance legislation September 2012

Information for marketing authorization holders on the transitional arrangements of the new pharmacovigilance legislation July 2012

New requirements for national variations December 2011

The new administration of process of the modification applications November 2011

Information necessary for submitting an application for the registration of a new medicine November 2011

Where is NIP, what is GYEMSZI? June 2011

Baseline documentation – Variations – Versions February 2011

Paper, electronic non - eCTD and eCTD acceptance in the EEA February 2011

Paramedicine again January 2011

Paper, electronic non - eCTD and eCTD acceptance in the EEA March 2010

eCTD submissions for generics February 2010

Information related to Braille Labeling January 2010

Conditions of requalification to medicinal product December 2009

Information related to the readability test October 2009

Pro-Pharma ’93 Gyógyszeripari Tanácsadó Intézet Kft.
1144 Budapest, Füredi utca 34.
Tel.: 06-1-231-8060 Fax: 06-1-790-1038
e-mail: company@propharma.hu