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:
Specific rules apply to the product type, packaging size, labelling and saleability.
Some products are excluded from sampling. For example, narcotics and psychotropics are forbidden.
The sample you offer must be the smallest pack available for sale in Belgium or the smallest authorised size.
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!
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.
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.
In order to receive free samples, prescribers must issue a written, dated and signed request. No document? No delivery!
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.
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.
“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:
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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