France: Details of hybrid groups register published
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In accordance with Article 66 of the 2019 Social Security Financing Bill (PLFSS), the details of the hybrid medicines register have been published through a decree on 20 November 2019 (see our previous blog post: French 2019 Social Security Financing Act introduces new healthcare measures).
Decree No 20169-1192 specifies the registration procedure and removal of hybrid medicines and reference medicinal products from the hybrid groups register, the content of that register and the procedures for publishing the decisions of the National Agency for Medicines and Health Products Safety (ANSM) taken in this area. It also clarifies that the register of hybrid groups indicates all the medicines included in each hybrid group. Hybrid groups are classified by an active ingredient designated by the International Nonproprietary Name and preceded by the words "International Nonproprietary Name". The hybrid group register indicates for each medicine: its name, its strength, its pharmaceutical form or route of administration, the marketing authorisation holder (MAH) name (and if different from the latter, the name of the medicine operator) and, where applicable, the nature of any differences found between a hybrid medicine and the reference medicinal product of the hybrid group concerned, in particular with regard to dosage.
A hybrid medicine does not meet the definition of a generic medicine, but it can be listed on both the generic and hybrid registers if the medicinal product meets the criteria. It differs from the reference medicinal product in terms of therapeutic indication, strength, pharmaceutical form and route of administration, or when bioequivalence to that reference medicinal product has not been demonstrated by bioavailability studies. These medicines will also be subject to a pharmacist's substitution once they are listed in the register.
The registration procedure is similar to that for generics. However, the Director General of the ANSM is required to register the hybrid medicine in the hybrid group register 30 days after the MAH of the reference medicinal product is notified (instead of 60 days after for a generic).
Except in the case of risk to a patient's health, medicines fulfilling the conditions to be a reference medicinal product in an already existing hybrid group may be registered by the Director General in the register of hybrid groups in the same group, until a marketing authorisation is granted for a hybrid medicine.
The aforementioned provisions will enter into force on 1 January 2020. However, the medicine classes that can be listed on the register have yet to be published.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2019 Issue (Thomson Reuters).