REGULATORY ANALYSIS OF THE VARIATION PROCEDURES OF MEDICINAL PRODUCTS AFTER THE EU ACCESSION OF BULGARIA FOR THE PERIOD 2007 - 2010

摘要

The marketing authorisation regime resulted in a requirement for regulatory procedures of variations in quality, efficacy and safety of the medicinal products which are being placed on the EU market. The number of submitted variation applications according to the Community procedures of medicines in Bulgaria for the period 2007-2010 was researched and analysed for the purposes of a comparison analysis. Some advantages and challenges of Commission Regulation (EC) No 1234/2008 are outlined and, for comparison, former documents in the field on both national and EU level are reviewed. In addition, a number of challenges in the national procedures after the introduction of Regulation (EC) No 1234/2008 have been addressed by the marketing authorisation holders (MAHs). Analysis, conclusions and proposals were made aiming to facilitate the activities between the MAHs and the regulatory authority. The new variation legislation shows several advantages, such as type IA “do and tell”procedures, reporting onan annual basis and variations grouping possibility. Considerable flexibility and convenience for tracking variations by the regulatory authority and the MAH have been achieved.