H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.


Mellékhatás bejelentő

Information concerning RMS-requests in Hungary


The Applicants are herewith kindly informed that accepting RMS slot requests and the planning period are continuous in our Institute from 30 September 2014.

All the applicants will be informed within 14 days about our decision on their requests accordingly. 


A letter of intent has to be submitted according to our template ("letter of intent") to which the completed form of Request for RMS in a decentralised procedure – published by the CMD(h) has to be attached as well (http://www.hma.eu/219.html).

The request will only be assessed after receiving the above mentioned information!

The validation criteria for the submission are the following:

  • electronic documentation (CD/DVD) in editable format (word or pdf)
  • product information and readability test in word format
  • risk-management plan in word format
  • the files have to be created according to CTD structure
  • originally signed cover letter, Letter of Authorisation (Annex 5.4), first page of the Application Form, Data exclusivity/Patent declaration (if relevant) in paper format
  • Samples of the active substance(s) and finished product with their Certificate of Analysis

Last updated: 2014.09.30 16:04