8. Question: Will the file be reassessed during the transmission of the MAH? Answer: In the event of a transfer of a ma to one or more Member States, the new summary of the pharmacovigilance system (Human) of the new MAH must be presented to all the Member States concerned with regard to the variation of the provision (if any, in the form of a notification of type IAIN, C.I.8.a or under category C.II.7). The same applies to the use of the Section 57 database (only humanly) as a classification directive (C.I.8) also requires “evidence that the applicant has a qualified person responsible for pharmacovigilance and a statement signed by the applicant indicating that the applicant has the means to perform the tasks and responsibilities covered under Title IX of Directive 2001/83/CE.” Therefore, a variant has yet to be introduced for the introduction of a new summary of the pharmacovigilance system after the MAH modification, and subsequent changes to the QPPV coordinates or the location of the PSMF no longer require derogations when introduced through the Article 57 database. There is no need to change the summary of the pharmacovigilance system if the authorization is given to companies owned by the same parent company and if the same PSMF is still in use. Transfers of orphan names and ma transfers are different procedures and should be treated as such. It is preferable that applications for the transfer of names and transfer of marketing authorization be filed simultaneously with the Agency. The accompanying fact sheet accompanying each application should refer to both applications, as the two procedures are conducted in parallel by the Agency. 10. Question: Should the MA/LA PSMF transfer request be filed by the current or new MAH? Answer: Lots of product submissions from the previous PMI must be depleted within six months of the transfer coming into effect. If you have any e-mail issues, please contact the Medicines Agency`s Marketing Authorization Directorate.
The transmission of a marketing authorisation holder (MAH) is usually carried out following a merger or acquisition and is always presented in the form of national procedures, including the transfer of products authorised under European procedures (mutual recognition and decentralised procedures).