GMA: global marketing authorisation
The global marketing authorisation (GMA) groups an initial authorisation with its later strengths, forms and extensions, so exclusivity runs once for all.
Article 6(1), second subparagraph, of Directive 2001/83/EC provides that once an initial marketing authorisation has been granted, any additional strengths, pharmaceutical forms, administration routes and presentations, as well as any variations and extensions, are either granted in accordance with the Directive or included in the initial authorisation, and that all of them are considered as belonging to the same global marketing authorisation, in particular for the purpose of applying the rules on data exclusivity in Article 10(1). The same principle is in Article 6(1) of Regulation (EC) No 726/2004 for centrally authorised products.
The consequence is that the eight years of data exclusivity and the ten years of market protection start with the first authorisation in the Union of a product containing the active substance by that holder, and later developments do not restart the clock. A new strength, a prolonged-release form or a new route filed years later shares the original dates. A new active substance, by contrast, begins a new global marketing authorisation, and a fixed combination of known substances also starts its own. The Court of Justice confirmed the scope of the concept in Novartis Europharm in 2017, holding that a second authorisation for the same substance under a different brand and with a different indication belonged to the same global marketing authorisation as the first.
Generic applicants use the concept when they identify the reference product: they can rely on the data of any product within the originator's global marketing authorisation, including strengths and forms authorised later than the one they copy, provided the first authorisation is at least eight years old. Originators use it when they plan lifecycle developments, because the protection they can expect for a reformulation is usually none.
What goes wrong: lifecycle plans that budget for a fresh protection period on a new form; generic entry calculations that count from the authorisation of the specific strength copied rather than from the first authorisation of the substance; and confusion about products of the same group held by different legal entities, which the authorities treat as one holder for this purpose. Transfers of the authorisation to another company do not break the global marketing authorisation either.
Used in
Planning teams map every strength and form to the first authorisation date that governs exclusivity in the loss-of-exclusivity workflow.
Related terms
- Data exclusivity: regulatory data protectionData exclusivity is the eight years after a reference product's first EU authorisation in which generics cannot rely on its preclinical and clinical data.
- Market protection: period in which generics cannot be marketedMarket protection is the period after data exclusivity ends during which a generic or biosimilar can be authorised but not placed on the market.
- Line extension: extension application to an existing authorisationA line extension (in EU terms, an extension application) adds a new strength, pharmaceutical form or route of administration to an authorised product.
- NAS: new active substanceA new active substance (NAS) is a substance not previously authorised in an EU medicine, whose first product starts a new protection period.
- Reference product: reference medicinal productThe reference medicinal product is the product, authorised in the EU on a full dossier, whose data a generic or hybrid application relies on.
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