Important information about payment for maintenance of the marketing authorisation

The25/B. § (1) of the Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products contains the following direction:”

(1) Authorization and modification procedures and other proceedings - shown in the Annex 1 - relating to the manufacturing, placing on the market and distribution of medicinal products for human use, the continuation of the marketing authorization, the wholesale distribution of medicinal products, the reclassification of therapeutic substances and preparations which are not classified as medicinal products, parallel imports, clinical trial of investigational medicinal products, the application of principles of good laboratory practice shall be subject - with the exception set out in Subsection (2) - to an administrative service fee (hereinafter referred to as “fee”) as specified in the Annex payable by the person requesting the opening of the proceedings or by the applicant of the authorization, or an annual renewal fee for the continuation of the marketing authorization as specified in the Annex.”

According to this legislation the national Institute of Pharmacy informs cliens about the following:

In line with actual legislation for maintenance of the marketing authorisation the Marketing Authorisation Holder should pay an annual fee depending on the nature of the product according to Annexes I.A.5., I.B.5., and II.D of the Act.

From the January 1, 2011 the Marketing Authorisation Holders bear the charges for the products having valid marketing authorisation by. January 1, 2011.

National Institute of Pharmacy will preapar the invoices for Marketing Authorisation Holders and officially sent it accordingly.

We ask you for cooperation.