Transitional Regulations for the New Pharmacovigilance Package: Commission's Q&A Document provides Clarity

Several provisions for pharmacovigilance have been newly defined among others with Regulation (EU) No 1235/2010 and Directive 2010/84/EU from 2010. Marketing authorisation holders are now confronted with a complex set of rules which raises quite a number of questions in the current transition period. The EU Commission has now published a Q&A document to clarify certain aspects, like for example:

  • Centralised authorisation procedures and renewals for applications pending at the date when the new provisions will become effective
  • National authorisation procedures
  • Pharmacovigilance system master file
  • Involvement of the European Pharmacovigilance Committee (PRAC) in ongoing procedures

Regarding the entry into force of new regulations, transition deadlines should be defined as the already submitted applications cannot refer to new legislation. For example: when should a renewal application be submitted which ends on a certain date? The Q&A document gives the following answer:

The new requirements for centralised authorisations will apply from 2 July 2012 on. Therefore, the renewal application must be submitted 9 months before the expiry date for a centralised authorisation which ceases after 2 April 2013. If the centralised authorisation expires before 2 April 2013, the deadline for application is only 6 months.

Regarding national authorisations, the new requirements apply from 21 July 2012 on. The deadlines for renewals are 9 months for authorisations ending after 21 April 2013 and 6 months for those ending before 21 April 2013.

Respective deadline rules (2 July 2012 for centralised procedures and 21 July 2012 for national ones) also exist for the obligation to update application documents. However, the update cannot be performed when the authorisation procedure has already started before the respective deadline. The introduction of the pharmacovigilance system master file is also possible on a voluntary basis. Yet, the system master file will be obligatory at the time of the date of the renewal acceptation or by 2 July 2015 (Regulation) /21 July 2015 (Directive), whichever is the earliest.

Please also see the Regulation (EU)No 1235/2010, the Directive 2010/84/EU and the Commission's Question & Answers Document.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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