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 §31 of Decree No. 52 of 18 November, 2005 of the Minister of Health and submitted 9 months before the expiry of MA.
The following documentation should be attached to the application:
all of the documents listed in the annexes of the Application Form
o Module 1
o Module 2
Valid quality specification concerning the product
If the product information is changed, please submit it in tracked Word format
These should be submitted in electronic (CD/DVD), eCTD or NEES (Non eCTD Electronic Submission) format in 1 copy.
If the medicinal product has two or more strengths, please indicate them in the name of the files.
Please note that variations should be applied for independently, in frame of variation procedure.
Administrative renewal application should be submitted according to the relevant guideline of EMA. http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Renewal/CMDh_004_2005_Rev12_2015_07_clean.pdf
In the international procedures please contact us via the following e-mail addresses: