H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, Fax: (1) 8869-460

Mail: 1372 P.O. Box: 450.



2017.02.10 - Marketing authorisation holders are informed on the publication of updated requirements on the national implementation of additional risk minimisation measures

2017.01.23 - Information on medicinal products' annual maintenance fee payment obligation

2016.06.07 - Periodic Safety Update Reports (PSURs)

2016.06.01 - Please note that the account number of National Institute of Pharmacy and Nutrition (OGYEI) has changed on 1 March 2015.

2015.08.12 - Updated guideline on the right choice of names for medicinal products for human use

2015.08.04 - EMA started to publish the outcomes of PSUSA procedures from July 6, 2015. MAHs are requested to continuously monitor and implement obligations originating from such procedures. For further details please click here.

2015.06.23 - Change of e-mail correspondence in association with PSUR submissions and queries

2015.06.02 - Questions and answers regarding safety reporting in clinical trials

2015.03.09 - Information concerning the change of „details of the national reporting system” in Product Information

2015.02.26 - Organizational change - 01 March 2015

2015.02.17 - Information concerning the implementation date of variations

2015.01.06 - Updated guidance documents are available for marketing authorization holders on adverse drug reaction reporting requirements

2014.09.30 - Information concerning RMS-requests in Hungary

2014.08.28 - Information on sample requirements

2012.10.27 - Information on the rules in the matter of representatives and agents for service of process

Last updated: 2008.08.25 09:37