Generic products are equivalent to a brand name product in strength, performance and intended use and are usually marketed once the patent protection and data protection afforded to the brand name product has lapsed.
Having worked with many leading generic companies in the successful management of New Product Introduction (NPI) programmes for European registration over the years, Kerona Scientific provides specialist advice to clients on the full range of strategies available for entry into the EU, ranging from the minimalist ‘me-too’ approach to the generation of full Annex III (product) data packages. We advise clients on the advantages and risks associated with each different approach, and guide them through the regulatory maze at Member State level.
We provide the following services to our clients for registration of generic products in the EU:
- Advice on selection of new candidates for development, management of background research into regulatory status at EU and Member State level, and management of market research
- Preparation and submission of applications to seek confirmation of formulation comparability versus a chosen reference product
- Preparation and submission of ‘me-too’ submissions at Member State level, including ‘preparation bis’ applications to France
- Preliminary ‘data gap analysis’ to determine which studies are required for registration
- Management of study commissioning programmes to generate full zonal dRR dossiers for generic applicants
- Preparation and submission of full zonal dRR dossiers for generic products and liaison
with the authorities until successful authorisation