Information concerning RMS-requests in Hungary
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!
Slot requests have to be submitted from 1st January to 1st May every year and can only contain requests for the next year.
We do not give slots for more than one year in advance.
The planning period is from 1st January to 30th June. All the applicants will be informed about our decision on their requests until 30th June.
If the Hungarian National Institute of Pharmacy accepts the RMS-request the applicant is asked to submit the Module 1 on a CD/DVD one month before the proposed day-14.
Neither the slot-time nor the product can be changed once the slot has been accepted.
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
- the files have to be created according to CTD structure
- originally signed cover letter in paper format
E-mail: mrp-dcp-new-rms@ogyi.hu
