CSC: EVMPD-Lobbying Efforts Worthy, but Industry Needs to Be Prepared – By Andrew Marr, Managing Director, Marr Consultancy Ltd

In the hopes that the EMA will delay, defer, or ease the transition to the EVMPD mandate, industry trade associations have been lobbying the agency and the European Commission. Efforts in particular have been focused on the impact of the provision required around structured substance information (SSI). Lobby groups argue that the requirements are excessive and the demands on companies far outweigh any possible pharmacovigilance benefit.

In addition the European Generic Association (EGA) has challenged the validity of the Legal Notice issued by EMA in July 2011, saying it believes this exceeds what is actually defined in the legislation. Further, the association believes the concept of a ‘Legal Notice’ does not fit any definition of terms used in the pharmaceutical legislation and hence should only be considered as guidance, which therefore didn’t follow an appropriate process for consultation.

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