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RegisterBibliographic application [Regulatives / Guidelines]
Dear all,
Request the team members to suggest a list of molecules (other than the OTC molecules) accepted for bibliographic application in the EU.
Most generics are out in the market after completion of 8-10 years of marketing of the innovator product. Would not the timeline of 10 years qualify for a generic version (especially of the prototypes) to be classed as 'well-established use'. Which molecules are specifically granted MAA without any clinical study as 'well-established use'?
Thank the team in advance for the kind help.
Request the team members to suggest a list of molecules (other than the OTC molecules) accepted for bibliographic application in the EU.
Most generics are out in the market after completion of 8-10 years of marketing of the innovator product. Would not the timeline of 10 years qualify for a generic version (especially of the prototypes) to be classed as 'well-established use'. Which molecules are specifically granted MAA without any clinical study as 'well-established use'?
Thank the team in advance for the kind help.
Complete thread:
- Bibliographic applicationTina 2013-05-14 11:53
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Ing. Helmut Schütz