Since 2019, negative formulations are no longer allowed on the packaging of medicinal products for human use in Belgium. This decision came after consultation at European level and in agreement with the other European Member States. The FAMHP will therefore reject such formulations.
Negative formulations include formulations such as no sugars, sugar-free, gluten-free, lactose-free, ethanol-free or no colourings. According to the European guideline, only substances with known effects should be indicated on the packaging. Freely chosen negative formulations are not covered by the guideline. Substances not present in the medicinal product have no direct effect on the patient’s health and are therefore irrelevant to the use of the medicinal product.
Information on packaging should not have a promotional nature. The indication of substances that are not present, is often unnecessary and serves to advertise the medicinal product. The use of negative formulations does not emphasize factual information, but suggests compatibility or harmlessness in order to distinguish a medicinal product from the competition. This is considered promotional. More information on the labelling of medicinal products is available on our website.
Packaging to be adapted
The FAMHP asks all marketing authorisation holders to adapt existing and future packaging for human medicinal products. The deadline for this adaptation is three years after publication of this communication on the FAMHP website.
Guideline: labelling of medicinal products