FAQ 2. Companies Concerned

Companies which in Belgium

• manufacture, import, deliver and/or distribute medicinal products and/or
• have a marketing authorisation for a medicinal product and/or
• have a CE marking for a medical device and/or
• manufacture, import, deliver, distribute and/or rent-out medical devices,
• and invite or sponsor one or more healthcare professionals who practise in their capacity in Belgium to participate in an event of a scientific nature.

In other words, are concerned:

• both pharmaceutical companies and companies of the medical devices sector
• both Belgian companies and those from other countries
• both manufacturers and distributors, wholesalers or importers.

As soon as there is a connection with the prescribing, dispensing, administering, or using of medicinal products or medical devices, Article 10 applies—regardless of the company’s other activities. A mixed portfolio within a company does not affect the applicability of Article 10. Example: a company that distributes both medicines and dietary supplements falls under Article 10, even if the majority of its activities fall outside the scope of the Act.