Masterarbeit
National dossier requirements in the European countries – Last step in obtaining the marketing authorisation or rather a burden for the applicant? ***
Dr. Alina Frantescu (2015)
Summary
Language: English
Harmonisation of dossier requirements between Competent Authorities of the European Member States during the mutual recognition / decentralized procedures (MRP/DCP) is an important regulatory topic for all pharmaceutical companies that want to timely bring their medicinal products on the market. The preparation of the dossier for submission in such a way that invalidation is minimized, potential concerns of the Member States can be anticipated and the efficiency of the regulatory process is enhanced, can be performed only if the specific requirements of each Member States are known and taken into consideration.
Experience with the actual implementation of the guidelines of the coordination group for mutual recognition and decentralised procedures, human (CMDh) regarding the national requirements for New Applications, Variations and Renewals during the MRP/DCP have been gathered based on a survey within the experienced professionals belonging to the company where the author of this master thesis is employed. This experience is balanced with the requirements that can be found by screening the NCAs homepages, the CESP Contact website and Cortellis Regulatory database.
A critical evaluation of the Additional Data (Letter of Authorisations, Application Forms, Cover Letters and specific statements) requested during the above mentioned regulatory activities is provided including guidance information also for practical use. Other important aspects of regulatory activities for dossier preparations such as manufacturing and import licenses, product information, samples requirements are presented.
Electronic submission of the applications via Common European Submission Platform (CESP) is another topic that is discussed within this thesis. Even if this Platform was created in order to support submission of applications in all EU countries, some Member States indicate specific national use of other submission portals and/or paper submission of specific documents.
The correct amount of fees that are to be paid to the respective National Competent Authorities for new applications, renewals and variations is of utmost importance for validation of the application. Practical experience with timelines for granting national approvals within an initial application and type II variations was balanced with available information from other publications.
Finally, a comparison of all collected information as well as an evaluation indicating potential synergies for the applicant and possible solutions for obtaining the harmonized single market in the European Union are presented.
Pages. 57
Annexes: 10, Pages: 46
Pages total: 104