The new administration of process of the modification applications

In the course of the official procedures started after January 1, 2010, directed to the modification of the marketing authorization of the pharmaceutical preparations registered in national, decentralized and mutual recognition procedure, one must act in accordance with the Commission Regulation 1234/2008/EU Committee Decree (hereunder: Regulation) concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, and not according to the previous Commission Regulation 1084/2003/EU Committee Regulation. The Regulation tries to make efforts at many points to simplify and hasten the previous system of the modification procedures.

The aim of this information is to make the course of the official processes understandable, unambiguous and followable in relation to the modifications. Hereunder we try to summarize shortly the most important information related to procedures to be used in the course of the different modification types.

Modifications affecting the marketing authorization of the pharmaceutical preparations can be basically classified into four groups:

- Type I. A, minor modifications, requiring immediate reporting;

- Type I. A, minor modifications, not requiring immediate reporting;

- Type I.B., minor modifications;

- Type II, significant modifications

* If the modification has not been implemented yet by the Applicant, therefore the correct date of the execution of the modification(s) are not indicated on the application form, then the 31st day of the procedure is indicated on the SmPC and PIL.

It must be noted that the procedures in relation to

- extension of the marketing authorization – i.e. by changing the active ingredient, strength, pharmaceutical form or mode of application of the pharmaceutical product („line extension”); and

- the transfer of the marketing authorization (“MAH transfer”)

do not fall within the Decree.