The FAMHP would like to remind the pharmaceutical industry regarding the following topics:
Pictograms related to the environment and recycling (e.g. green dot pictogram) do not comply with art.56§1 of the Royal Decree on medicines. The current guideline ‘Labelling of medicinal products’ clearly states that only logos of the MAH and local representative are acceptable, and that pictograms must have an added value, must be in line with the SmPC, and in principle with a text (in the three national languages). Therefore, pictograms related to the environment and recycling may not be added to the packaging.
Negative formulations on the packaging of medicinal products for human use are refused since 2019 (e.g. “without sugar – Sugar-free “ / “Without Lactose” / …). All MAHs should adapt their existing and future packaging to this point of view via an editorial change included in a variation with impact on the product information.