Global marketing authorisation

The global marketing authorisation is the concept that attaches to the initial authorisation of a medicinal product all its subsequent developments, whether new strengths, new pharmaceutical forms, new routes of administration, new presentations or variations and extensions. It is laid down by Directive 2001/83/EC, which specifies that these successive authorisations belong to the same global marketing authorisation, in particular for the purposes of data protection. It prevents a mere development of the product from reviving full regulatory protection.

Content of the concept

Once a medicinal product has received an initial authorisation, any development must either be included in that authorisation or be the subject of a separate authorisation that remains attached to it. The form chosen is irrelevant. A new indication obtained by variation, a new strength obtained by extension or even a separate authorisation under another name all belong to the same global authorisation, provided they concern the same active substance and the same holder. The EU courts take a broad view of the concept, focused on substance rather than on the formal presentation of the authorisations.

Effects on data protection

The period of data protection and market protection runs from the initial authorisation and is not restarted by subsequent authorisations falling within the global authorisation. The holder may only claim an additional year for a new indication bringing a significant clinical benefit, under the conditions of the « 8+2+1 » rule. Only a medicinal product containing a new active substance opens an independent protection period. A generic may therefore target the various strengths and forms of the reference medicinal product as soon as the protection attached to the initial authorisation expires, subject to the patents in force.

Interaction with the supplementary protection certificate

The global authorisation belongs to regulatory law, but it has a counterpart in the law of supplementary protection certificates. The Court of Justice of the European Union now holds that a new therapeutic application of an active ingredient that has already been authorised does not make it possible to obtain a new certificate, the first authorisation of the active ingredient alone being decisive. Lifecycle strategies therefore rely on secondary patents rather than on regulatory protection, and they are closely scrutinised from the standpoint of evergreening and competition law.

Key points

The global authorisation groups together the initial authorisation of a medicinal product and all its developments, whatever their form. It prevents data protection from being restarted by a new strength, a new form or a new indication, subject to the additional year provided for a new indication. The supplementary protection certificate follows a similar logic. Protection should be dated from the very first authorisation of the active substance granted to the holder, not from the authorisation of the product concerned.

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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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