Free sampling – your easy checklist!

Does your company (plan to) give away free samples of medicines? Then be sure to do it correctly, as particular rules apply. We’ve given you a helping hand with our Q-support checklist.

When manufacturing medicinal products, you probably expect to follow the same procedures for samples as you do for commercial products. Quite right! Regardless of whether the product is free or charged for, the quality for patients must naturally be identical. Therefore, the GDP (Good Distribution Practice) guidelines established in 2013 apply in both cases. However, are you also aware of the Royal Decree of 11 January 1993 relating to the distribution of free samples? This establishes some specific conditions for the delivery of drugs for human use. To make your life easier, we’ve highlighted the most important points for you:

Products for sampling

Specific rules apply to the product type, packaging size, labelling and saleability.

  • Not all products

Some products are excluded from sampling. For example, narcotics and psychotropics are forbidden.

  • Smallest pack size

The sample you offer must be the smallest pack available for sale in Belgium or the smallest authorised size.

  • Labelled as a sample

To allow proper identification and prevent resale, samples must be labelled according to the requirements of Article 96 of Directive 2001/83/EC and marked with the words ‘free medical sample – not for sale’ (or similar) in the three official Belgian languages: Dutch, French and German. The label must be clearly visible, easy to read, indelible and permanent. Plus, watch out when applying the label not to cover any important information on the pack!

  • Decommissioning

Extra rules apply to prescription medicines. As well as applying the usual anti-tamper device, prescription products must also be decommissioned as a free sample in the European Medicines Verification System. This prevents them from being resold.


Free samples must be handed to specific persons according to a documented procedure and in restricted quantities.

  • Prescribers only

Free samples may only be handed to prescribers. However, if those prescribers work in a hospital, they (generally) must be given to the hospital pharmacist. It sounds so simple! Yet, the reality can be a little more complicated! Busy doctors are notoriously hard to track down, and leaving goods with a pharmacist who is not expecting them can often cause confusion. Not to mention the logistical challenges of delivering a small quantity. Q-support can help you if you’d like a hand.

  • Documented request

In order to receive free samples, prescribers must issue a written, dated and signed request. No document? No delivery!

  • Restricted quantity

Free samples may only be given on an exceptional basis. The law limits the number of samples per prescriber, per year and per product. The permitted total is 8.

  • 10-year record

All details of the sample, the recipients, the quantities and formats must be documented and monitored. So you will need an effective procedure. Something else to remember: your records must be kept safe for longer than usual: 10 years rather than 5.

  • Accompanying information

“Every sample shall be accompanied by a copy of the approved Summary of Product Characteristics.” That’s the rule! Our tip for an easy way to provide the last approved version upon delivery? Provide a digital link! It may not be physical, but in our experience it is both effective and accepted.


Free samples are treated differently to standard commercial products when it comes to the system and surveillance. Here’s a recap of who needs to do what:

  • The Responsible Person for Distribution takes care of storage and transport according to GDP. In that respect, there’s no difference compared with commercial medicines.
  • As a manufacturing activity, the labelling of samples is the responsibility of the Qualified Person (QP), in accordance with Good Manufacturing Practices (GMP).
  • The main difference between commercial and sample medicines lies in documentation and control. Since free samples are considered as promotional, the Responsible Person for Information & Publicity (RIP) is charged with controlling the documentation and putting the procedure in place, rather than the RP in the case of commercial sales. This task includes:
  • establishing the legitimacy of the requesting prescriber
  • validating the coherence of the prescriber’s written request and the sample delivery
  • guaranteeing that the number of samples does not exceed the permitted annual quantity
  • submitting an annual declaration of the provided free samples in the past year to the Federal Agency of Medicinal and Health Products by 1 March.

Would you like some help in setting up all or parts of your sample distribution procedure? Or need extra hands for a short period or longer? At Q-support we’re experienced in GDP, information and publicity, and our QPs/RPs/RIPs are here to help you with your QMS, auditing and many other medicine manufacturing /distribution/promotion matters.

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