France has broadened the medicine classes that may be managed through hybrid groups, extending a substitution route that sits between conventional generic substitution and prescriber-led brand switching. The measure is an incremental framework extension rather than a new substitution policy, but it adds further product types to a mechanism that can influence dispensing and post-exclusivity competition.
Two 10 April orders, published in the Official Journal on 14 April, amend the hybrid medicines framework introduced in 2022 and 2023. The first order expands the classes of medicines that may be included in the register of hybrid groups. The second order sets the medical situations in which substitution may take place for those added classes.
The added classes include osmotic laxatives, wound and ulcer treatments, antipruritics, topical dermatological antibiotics, dermatological corticosteroids, topical anti-acne preparations, gynaecological anti-infectives and antiseptics, topical products for joint and muscle pain, nasal preparations and otological medicines. The order also replaces the narrower otological anti-infective category with the broader otological class.
For each added class, the second order allows pharmacist substitution in any medical situation. This remains subject to the existing ability of the prescriber to exclude substitution where the legal conditions are met.
The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM) then published a 20 April decision updating the register of hybrid groups. ANSM describes the register as covering medicines in the classes defined by ministerial orders and as recalling the situations in which pharmacists may substitute within a hybrid group.
The change is incremental, but it continues the widening of pharmacy-level substitution beyond the conventional generic model. Its immediate commercial effect is likely to vary by class, given the lower unit value of many affected products. The direction of travel is clear: France is adding more product types to substitution frameworks that can influence dispensing behaviour and competition after reference products lose exclusivity.
Source: Légifrance
Link: Arrêté du 10 avril 2026 modifiant l’arrêté du 12 avril 2022 fixant la liste des classes de médicaments pouvant faire l’objet de groupes inscrits au registre des groupes hybrides (Order of 10 April 2026 amending the order of 12 April 2022 setting the list of medicine classes that may be included in groups entered in the register of hybrid groups)
Date: 14 April 2026
