Product Information (PI)

E-mail addresses for draft PL submission

Please send draft Product Information in Hungarian or in English to the following e-mail addresses, depending upon the type of procedure:

MRP/DCP

National

Type of procedure

Hungary/HU

CMS

RMS

New application

mrp-dcp-new-cms@ogyi.hu

mrp-dcp-new-rms@ogyi.hu*

CD only**

Renewal

mrp-dcp-renew-cms@ogyi.hu

mrp-dcp-renew-rms@ogyi.hu

CD only**

Variation

mrp-dcp-var-cms@ogyi.hu

mrp-dcp-var-rms@ogyi.hu***

nat-var@ogyi.hu

Version 1

* Draft Product Information in English for the Assessment Report
** Being part of the submitted documentation
*** Draft Product Information in English for the Preliminary Variation Assessment Report

Please define the relevant procedure number and the name of the product in the e-mail subject line.

Last updated: 2008.08.06 14:44
National Institute of Pharmacy | H-1051 Budapest, Zrínyi u. 3. | Mail: 1372 P.O. Box: 450.
Tel: +36 1 88 69 -300 | Fax: +36 1 88 69-460 | Impressum | Copyright

Opening hours for docketing: Monday to Thursday: 8.30-12.00, Friday: 8.30-11.00