HMA highlights deficiencies of the proposal for the new VMPs legislation

The HMA has published a statement on the review of the VMPs legislation (Link), highlighting "unintended and unacceptable consequences" and missed opportunities. Their most important concerns are summarised as follows:

• The requirement for an Applicant to send an application dossier to only the RMS and not make it available to the CMS
• Changing the CMDv voting system to one of a simple majority
• Harmonisation of existing MAs, particularly the intention to adopt a "Highest common denominator" approach (e.g. maximum number of target species, shortest withdrawal period etc)
• Lack of provisions proposed for conditional approval of VMPs, as exists in the legislation for human medicines
• The shift of responsibility for monitoring VMPs through pharmacovigilance from the MAH to the regulators
• Inadequate provisions proposed to stimulate innovation, with the retention of the concept of the global marketing authorisation and the changes to the cascade system
• Lack of provisions for the regulation of new, advanced therapies
• The absence of reference to autogenous vaccines in the proposal
• Continued requirement for generic MA applications to include an ERA even when one is already available for the originator
• Lack of reference to GMP as a requirement for VMPs