Module 3 2019

Other Products in Clinical Trials

As well as the innovator IMP there may be several different products, for example: - Other innovator’s IMP (in combination)… Letter of cross reference / Letter of access

Is Commercial Product within Label Claim? Submissions

- Commercial Comparator – IMP… sIMPD

- Non-IMPs (Annex 13) / Auxiliary Medicinal Products (CTR)… sIMPD or NIMP Dossier - Rescue Medications; Background Medications; Challenge Agents; Medical Product to assess endpoint

vary by market

The Organisation for Professionals in Regulatory Affairs