Hybrid products and registration in the register of generics (“directory of generic groups”) | Hogan Lovells



[co-author: Hugo Petit]

The French Supreme Administrative Court (“Board of state“) confirms that only the marketing authorization can define a pharmaceutical product as generic.

In two recent decisions of July 7, 2021 (Johnson & johnson, req. no. 437803 and GlaxoSmithKline, req. no. 440747), the French Supreme Administrative Court (“Board of state“) confirmed national and European law, as well as long-standing Supreme Court jurisprudence: the identification of a pharmaceutical product as a generic with a view to its inclusion in the register of generics (“generic groups directory“) falls within the competence of the authority in charge of the MA.

In the first case, the French Supreme Administrative Court (“Board of state“) recalls that health regulations do not grant the Director General of the French National Agency for health products (“National Agency for Medicines and Health Products Safety“) the power to identify a product as a generic by registering it in the register of generics (“generic groups directory“) since this assessment is the sole responsibility of the authority responsible for granting the marketing authorization.

The second decision, the importance of which is underlined by its publication by the Court, concerns a specific case, “respiratory” pharmaceutical products. The Tribunal de Grande Instance canceled the registration of a hybrid product distributed by Mylan France in the generic register (“generic groups directory“) and the associated price.

The former decisions of the National Agency to register hybrid products in the register of substitute generics (“generic groups directory“), was therefore against the law.

The next step will be the establishment of the hybrid registry (“hybrid directory“) for an effective substitution of hybrid products by pharmacists and associated discussions with the competent French authorities!

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