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Behind the scenes of Free Medicinal Samples: who is behind that little box?

What Exactly Are Free Medicinal Samples?

The conditions for which products can become free medicinal samples are described in the Royal Decree of 11 January 1993. Free medicinal samples are small quantities of prescription medicines that pharmaceutical companies provide to healthcare professionals (doctors) at no cost. Important to know is that some products are excluded to be free medicinal samples (e.g. narcotics and psychotropics). The idea of free medicinal samples is simple:

• Help patients begin treatment immediately.
• Assess how they respond to a new medication.
• Support those who might struggle to afford the medication.

Sounds helpful, right?  Yes, but there are rules. Especially in Belgium, where the distribution of free samples is strictly regulated. Therefore, different roles are involved in the process of providing patients with free medicinal samples. Let’s take a closer look.

 The RIP: Responsible Person for Information and publicity

In Belgium, one of the most critical figures in the sample distribution chain is the Responsible Person for Information and Publicity (RIP).

The RIP is the gatekeeper of compliance when it comes to anything promotional, including free medicinal samples. Appointed by the pharmaceutical company, the RIP makes sure everything follows the Royal Decree of 7 April 1995, which governs how medicines are advertised and promoted.

When it comes to free medicinal samples, the RIP must ensure:

• They are only given to authorized healthcare professionals.
• Only the smallest pack available for sale in Belgium or the smallest authorised size can be used.
• In order to receive the free medicinal sample, the prescriber must issue a written, dated and signed request.
• No more than 8 samples per doctor per year.
• Detailed records are kept for 10 years, ensuring traceability.

In short, the RIP makes sure that those free medicinal samples don’t cross the line into illegal promotion. The free medicinal samples are there to help, not to push product.

The Qualified Person

Next up: the Qualified Person (QP). Although the QP plays a less visible role than the RIP in the free medical samples process, their responsibilities are just as important. Free medical samples must display the phrase “free sample – not for sale” in all three official Belgian languages. This often requires relabelling of commercially available products. Because relabelling is a manufacturing step, it falls under the QP’s strict oversight. Their job is to:

• Ensure that any physical changes to the packaging (like labelling samples differently from retail products) are compliant with Good Manufacturing Practice (GMP).
• Make sure the packs are decommissioned during this process. This means they can’t be sold or accidentally make it into the commercial supply chain.

Without the QP, that “sample” could legally and logistically be mistaken for a for-sale product, and that’s a big no.

The responsible person (RP)

Last but not least: the Responsible Person (RP).

The RIP is focused on promotion, the QP is focused on manufacturing and the RP ensures that distribution follows the rules. Here’s what the RP takes care of:

• Ensures Good Distribution Practices (GDP) are followed at every stage of the sample’s journey, just like for regular commercial medicines.
• Oversees storage conditions, making sure samples are kept at the right temperature.
• Maintains the traceability and documentation for each sample, from warehouse to healthcare provider.
• Guarantees that samples are not mixed with saleable stock, avoiding difficult situations.
• Handles recall or returns if needed, ensuring there is a clear pathway to act quickly and safely if an issue arises.

In other words, the RP is the logistics expert!

Final Thoughts

The next time your doctor hands you a free sample, remember: it is not just a kind gesture or a convenience. It is the result of meticulous compliance, thoughtful oversight, and several professionals working hard behind the scenes.

From the promotional safeguards set by the RIP to the quality checks by the QP, and the distribution controls from the RP, that little pack represents a huge amount of care and coordination. And ultimately, it exists to help patients! So yes, it is just a sample, but it is one with a serious support system.

By Kelsey Frederikx