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.
The mention of negative formulations is not part of the mandatory information that must be present on the packaging of medicinal products according to the Royal Decree of 14 December 2006. Negative formulations include formulations such as no sugars, sugar-free, gluten-free, lactose-free, ethanol-free or no colourings.
Moreover, 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. Nor do these negative formulations refer to any particular target audience or application.
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.
An adaptation of the packaging text and designs (mock-ups) to remove negative formulations, can be done through an editorial change and can be included in the subject of a variation with impact on the packaging texts along with a planned IB or Type II variation under Chapter C of the Commission Classification Guideline. The proposed changes must be clearly described in the scope section of the electronic variation application form (eAF) as well as in the "present and proposed" section.
If within the three-year period such a variation is not scheduled then this change must be submitted separately through a national notification according to Article 34(4) of the Royal Decree of 14 December 2006.
Formulations such as "sugar-free" or "no preservatives" may be accepted as a suffix in the name of a medicinal product if it is necessary to distinguish it from a second form of the same medicinal product (same active substance, same pharmaceutical form ...) and where the distinction was not yet indicated in any other way. "Sugar-free" may be accepted on the packaging of medicinal products specifically intended for diabetics in accordance with the indications in the Summary of Product Characteristics (SPC).
Additional information on substances not present in the medicinal product may be important for certain target groups in some cases and may be added in the SPC and Patient Information Leaflet (PIL). This will be assessed by the FAMHP on a case-by-case basis.
The adaptation of the SPC and PIL can be done together with a planned IB or Type II variation under Chapter C of the Commission Classification Guideline. This is only possible with a variation that also adapts product information. The proposed changes must be clearly described in the scope section of the electronic variation application form (eAF) as well as in the "present and proposed" section. The changes can also be submitted separately via a variation type IB C.I.z.
Guideline: labelling of medicinal products