ANSM publishes recommendations on the labelling and packaging of oral medicinal products

On 22 February 2018, the French National Agency for Medicines and Health Products Safety (ANSM) published recommendations for applicants and holders of marketing authorisations, or variations, on the labelling and packaging of human medicinal products dispensed in solid oral form. These recommendations follow a public consultation, as well as unanimous positive opinions of the ANSM consultative commissions in November 2017.

The recommendations aim to improve readability, visibility and understanding of the labelling and packaging of oral medicines to promote their safe use and eliminate medication errors resulting, for example, in over dosage. To date, approximately 12% of packaging errors that are reported to the ANSM pertain to the labelling of oral medicines.

To achieve this aim, the recommendations provide guidance on the type of information to be included on the outer and primary (blister, pack, vial, bottle, tube) packaging. This includes the mandatory particulars, as well as recommendations on additional particulars (e.g. space reserved for the pharmacist), font, colours, materials, and recommended pictograms or logos. Packaging and labelling examples are included for illustration purposes.

Manufacturers must include the non-proprietary name of the active substances in the outer (or, in its absence, primary) packaging if the product contains up to three substances. The ANSM encourages them to include this information, accompanied by any branded name or the name of the company, on the front, lateral and back of the packaging, as well as the dosage.

The ANSM has issued the recommendations in collaboration with stakeholders (patient and consumer associations, healthcare professionals, pharmaceutical companies). The recommendations complement the ANSM recommendations on names on the choice of medicinal product names (see our update,  ANSM publishes recommendations prohibiting use of umbrella brands in health products) in an effort to strengthen patient safety in France, and are aligned with the WHO objective to halve medication errors globally in five years.

This post was originally co-authored by Patricia Carmona Botana.