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New European laws have been introduced that will fundamentally affect the registration of human and veterinary pharmaceutical and biotechnology products in the near future. Amongst the changes introduced are:
- Changes to the scope of the European centralized procedure and incorporation of new features
- New data protection rules affecting the period of marketing exclusivity and when generic applications can be submitted
- Introduction of a “Bolar” provision for the development of generics and changes to what constitutes a reference product
- The introduction of a new European decentralized procedure. The centralized procedure and mutual recognition procedure, will continue to operate
- New rules in relation to packaging and patient information leaflets
- Changes to the renewals procedure
This can be considered as the most important recent change in European regulatory affairs and our Regulatory Affairs group can provide you with advice and guidance on how the changes will affect your business  |
