HOW MIGHT 'FRAME FORMULATIONS' WORK?

• As proposed in the draft Technical Guidance Document on data requirements (Finland):
  • one formulation (the 'mother product') would be authorised by passage through the full procedure;
  • subsequent formulae, from applicants with rights to the 'mother product', that fit the frame, would only require a simplified dossier;
  • this would lead to 'registration' within 60 days.

• Ownership of 'frame' groups could rest with individual companies, groups of companies or associations

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Last modified: 5/3/06