EU Pharma Revision Proposals Still Awaiting Start Of Legislative Debate
The texts of the proposals cannot be formally presented to the European Parliament until they have been translated into all of the EU’s official languages.
You may also be interested in...
The late delivery of the “pharmaceutical package” leaves little time for the legislative process to take shape before European Parliament elections are held in June next year.
The European Commission may well be flexible over its proposals on data protection periods, but it is unlikely to give ground on plans to restructure the European Medicines Agency and to introduce a new temporary emergency marketing authorization, says lawyer Vincenzo Salvatore.
Pricing and reimbursement processes as well as health technology assessments should be explicitly included in the procedures that can be conducted for generic and biosimilar products without infringing patent rights, according to the European Commission’s legislative revision proposals.