Module 6

03/10/2024

Clause 20 Samples

• Only provided to HCP qualified to prescribe the product

• No more than 4 samples / product / HCP / year

• Only up to two years after the HCP first requests the sample

The Organisation for Professionals in Regulatory Affairs

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39

Clause 20 Non-interventional studies

• Non-interventional studies are prospective in nature and involve the collection of patient data for a scientific purpose, not to induce prescribing:

• written study plan/protocol, submitted to EC

• written contracts with the HCP / organisation study protocol

• any remuneration must be reasonable and reflect the fair market value

• the company’s scientific service must certify the protocol and supervise the conduct of the study

The Organisation for Professionals in Regulatory Affairs

40

40

20