Reference medicinal product

The reference medicinal product is the medicinal product authorised on the basis of a full dossier, including its own pre-clinical and clinical trials, to which an application for authorisation of a generic or hybrid medicinal product refers. Article L. 5121-1 of the French Public Health Code defines the generic medicinal product by reference to it, and Directive 2001/83/EC requires that it is or has been authorised in the Union. In practice it is often called the originator product (princeps).

Conditions for qualifying as a reference product

Only a medicinal product authorised on the basis of a full dossier can serve as a reference, so a generic cannot itself become the reference for another generic. The reference medicinal product need not still be marketed, nor even still be authorised when the application is filed, provided that it has been authorised in a Member State or through the centralised procedure. Where the application is filed in a State in which the reference has never been authorised, the applicant designates the Member State in which it is or was authorised, and the authority of that State confirms the authorisation and provides the composition of the product. This is known as a European reference medicinal product.

Starting point of regulatory protection

The date of the first authorisation of the reference medicinal product in the Union triggers data exclusivity and market protection. Later strengths, pharmaceutical forms, routes of administration and extensions obtained by the same holder fall within the same global marketing authorisation, so that a new presentation does not start a new period. The generic manufacturer’s choice of reference and the date adopted by the authority are therefore key checkpoints for the holder.

The reference, the generics register and patents

In France, each group in the generics register (répertoire des groupes génériques) brings together a reference medicinal product and its generics, which opens the way to pharmacist substitution and in principle leads to a reduction in the price of the reference. The health authority does not examine the patents protecting the reference medicinal product. Bioequivalence studies carried out for the generic application are covered by the Bolar exemption, but marketing before the expiry of the patent or the supplementary protection certificate constitutes infringement.

Key points

Identifying the reference medicinal product amounts to setting the timetable for generic competition. The date of first authorisation in the Union, the scope of the global marketing authorisation and any European reference product designated in another Member State should be checked. For the holder, monitoring the marketing authorisation applications and register entries that target its reference is the first step in defending its patents.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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