Module 3 Presentations

07/05/2024

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 - 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

Is Commercial Product within Label Claim? Submissions

vary by market

The Organisation for Professionals in Regulatory Affairs

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IMPs should remain under the control of the sponsor until after completion

Shipping

of a 2-step procedure: • Certification by a QP • Release by the sponsor in accordance with ethics

approval and competent authority approval

Shipping should be under the correct conditions for the product

The Organisation for Professionals in Regulatory Affairs

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