H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, Fax: (1) 8869-460

Mail: 1372 P.O. Box: 450.

MAGYAR

Information on medicinal products' annual maintenance fee payment obligation

Dear Partners,

We would like to inform our Partners that according to Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products, Section 25 / B. § (6) „The fee shall be paid at the time the application is submitted, whereas the annual renewal (maintenance) fee shall be paid by 31 January of the given year to the government body for pharmaceuticals in the manner decreed by the minister in charge of the healthcare system “

Our Institute issues the invoice of maintenance fee to the medicinal product marketing authorization holder (MAH) in every case.

The mailing of the invoices finished on the 23st of January 2017.

However please note that the maintenance fee should be considered as an administrative service fee, for which payment obligation applies regardless of sending an invoice.

According to the above mentioned the maintenance fee must be paid until the 31st of January regardless of receiving the invoice.

Furthermore we would like to call our Partners attention that according to the modification of the law, applicable from 01/01/2017. 25 / B. § (6a) The government body for pharmaceuticals shall suspend further distribution of a medicinal product, if the marketing authorization holder failed to fulfill the obligation to pay maintenance fee as detailed under Subsection (2) within the time limit specified in Subsection (3).

Furthermore we would like to call your attention that in case the annual maintanance fee will be paid by a legal person other than the medicinal product marketing authorization holder, it should be reported to the National Institure of Pharmacy and Nutrition.

In order to ensure the timely arrival of the maintenance fees the National Institute of Pharmacy and Nutrition will send the copy of the invoice electronically (in PDF) upon request to its Patners.

In case of any questions arising in connection to the maintenance fees we would like to kindly ask you to send us a letter to the annualfee@ogyei.gov.hu email address.

Thank you for your cooperation in advance.

Last updated: 2017.01.23 17:21