The Process of National Marketing Authorisation Renewal
Applications for renewals of marketing authorisation if they have not been submitted so far – should be presented according to §5 (7) of the XCV Medicines Act of 2005 and the §31of Decree No. 52 of 18 November, 2005 of the Minister of Health and submitted 6 months before the expiry of MA.
The following documentation should be attached to the application:
- 4 copies of signed, completed Application Form for Renewal of a Marketing Authorisation
These have to be submitted only correctly filled, without invalid form or content. Otherwise the status of the submitted documentation and procedure will be invalid and suspended.
- One copy of all the annexes listed in the Application Form
These should also be submitted in electronic format (CD) in two copies.
The name of the files have to be in accordance with the content of the paper documentation (Cover letter, Application Form, Proof of payment, supporting documentation in CTD format, SmPC, Labelling, PIL).If the medicinal product has two or more strengths, please indicate them in the name of the files. Floppy is not accepted.
- Valid quality specification concerning the preparation(s) accompanied by requirements.
- If the product information is changed, please submit in electronic format with corrected signs (corrected Word format)
For national requirements see Notice to Applicants Chapter 7.
Application for renewal concerning preparations which have already had renewed marketing authorisation should be submitted according to the deadline stated in the licence.
Since it is already the 2nd renewal you have to submit only a letter in which you declare that all variations were submitted after the first renewal and to pay the fee for renewal.
Please note that all variations should be applied for separately, in compliance with directions.
Please use the following e-mail addresses for the perfect connection:
mailto:mrp-dcp-renew-cms@ogyi.hu – MRP (CMS Hungary) Renewal,
mailto:mrp-dcp-renew-rms@ogyi.hu – MRP (RMS Hungary) Renewal
mailto:elo@ogyi.hu – National Renewal
