Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

A critical review of the current marketing authorisation transfer procedure in Europe ***

Gilda Gordon (Abschlußjahr: 2013)

Summary
Language: English

The procedure for marketing authorisation transfers is outside the scope of the current Variation Regulation and is therefore processed by the competent authority which granted the marketing authorisation, regardless of the authorisation route. In this thesis the main significant aspects of the procedure from the applicant’s perspective, such as required documentation, timelines and implementation are reviewed for the 30 EEA member countries.
Marketing authorisation transfers are processed nationally and any subsequent variations must be submitted separately according to the Variation Regulation. The implications for the applicant of the current situation are discussed, taking into consideration various changes which are often consequent from a marketing authorisation transfer, followed by possible proposals for change of the current transfer procedure.

Pages: 55, Annexes: 27 pages