Masterarbeit

Regulatory Requirements of Marketing Authorization Holder Transfers in International Markets

Astrid Zimmermann (2016)

Summary
Language: English
A marketing authorization holder transfer is the process of transferring a current approved marketing authorization to a new holder.
The comparison of marketing authorization holder transfers in international markets show a huge variety between the different markets.
The range goes from an approval time line of 45 days, with no grace period up to approval time lines of 180 days with a grace period of 6 months. In some countries of international markets the transfer of the marketing authorization holder is an administrative change, whereas in other countries also the CMC part of the dossier is reviewed.
Due to these facts, the required documentation and time lines have to be evaluated separately for each country when a transfer of the marketing authorization holder is planned in international markets.
The reviewed regulations and guidelines do not show a difference in the procedures of the marketing authorization holder transfer for prescription or Over the counter (OTC) products.
In addition, the process of the transfer of the marketing authorization holder can not be grouped with other variations. Therefore, a separate regulatory strategy has to be developed for each country in international markets to avoid regulatory incompliance.
Another way to reduce the risk of incompliance is the implementation of the marketing authorization holder transfer on a country by country basis by product supply. Therefore, marketing authorization holder transfers in international markets have to be balanced in close cooperation with regulatory affairs and product supply.
Pages: 27
Annexes: Pages: 4