Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Variation applications within the European Community for a) innovative medicinal products authorised by centralised procedure, b) new medicinal products authorised by mutual recognition procedure ***

Sandra Strobl (Abschlußjahr: 2002)

Language: English

This master thesis is to describe variations to the terms of Marketing Authorizations granted via national (mutual recognition) and community (centralised) procedures.

Taking into account the different needs of changes to a Marketing Authorization the Marketing Authorization Holder has to demonstrate compliance with the regulatory conditions to be fulfilled.
Administrative and/or more substantial changes and procedures, which require an approval, are set out in the two Commission Variation Regulations (541/95/EC and 542/95/EC as amended respectively).

Two types of variations are defined and described in this document. Type I Variation (minor variation, notification procedure) and Type II Variation (major variation, approval procedure).
Changes, which fundamentally alter the MA, can not be considered as a variation. A new application has to be applied for. In Annex II of both regulations the respective changes are set out. This master thesis does not give further details on such changes.

After an authorization has been issued in accordance with the respective regulation, based on new experiences the person responsible for placing a medicinal product on the market has to ensure and to adopt continuously quality, safety and efficacy of the product. With respect to the methods of production and control provided for as set out in Article 8 of Directive 2001/83/EC, the MAH has to consider any technical and scientific progress and shall make any amendments that may be required to enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods.
As an authorization does not affect the civil and criminal liability (2001/83/EC, Art. 25) the MAH has forthwith to inform all relevant competent authorities of any safety relevant information which might entail an amendment of the respective documents, for instance the approved summary of product characteristics. Any prohibition or restriction imposed by the competent authorities of any country has to be communicated which might influence the evaluation of the benefits and risks of the medicinal product concerned. The aforementioned person has to apply for approval for these amendments in accordance with the respective Regulation. A lot of recommendations are released for easier understanding and guidance. The procedures to the respective variations and dossier requirements are pointed out by giving reference to the respective legal requirements and guidelines.

Special requirements have to be considered for both procedures in both types of a variation.
The existing variation regulations are very complex and allow low flexibility. The time frames are set legally and changes to a Marketing Authorization are defined. Currently the European Commission has started the initiative to improve the existing variation regulations. The amended regulations shall offer benefit to the health authorities and the industries.

By achieving a common understanding the variation procedures shall be simplified to reduce time, costs and manpower.

Consequently and in view of public health, efficient variation procedures to continuously updating a MA shall be the basis to speed up development and approval of new and innovative medicinal products without sacrificing critical quality, efficacy or safety concerns.

Pages: 43