Masterarbeit
Harmonisation of quality dossier following Union Referral - Challenges and points to consider with focus on sterile finished products ***
Dr. Susan Heller (2018)
Summary
Language: English
In accordance with Directive 2001/83/EC different types of referral may be triggered for medicinal products with the aim to resolve issues in case of safety, efficacy or quality concerns and to harmonise the divergences among the different EU countries.
The concerned marketing authorisations will be mainly harmonised with regard to their Summary of Product Characteristics, Package Leaflet and Labelling as well as with regard to the related Module 4 (non-clinical dossier) and Module 5 (clinical dossier). If the quality dossier is not part of the referral procedure it is recommended to the Marketing Authorisation Holder (MAH) or applicant to also harmonise the Module 3 after the end of the referral procedure.
This master thesis focuses on the different challenges when harmonising the quality dossier following a Union referral and gives a comprehensive overview on the regulatory requirements and relevant items that have to be taken into consideration by the Marketing Authorisation Holders or applicants in this context. The focus is on liquid sterile finished products which are registered nationally in the EU for several years.
Considering the various regulatory requirements and expectations of the Health Authorities the handling of this harmonisation process in a pharmaceutical company is discussed particularly with regard to the required activities at the different procedural stages and the consequences of one approved harmonised dossier in EU.
Pages: 48, Annexes: pages: 2