Line extension: extension application to an existing authorisation
A line extension (in EU terms, an extension application) adds a new strength, pharmaceutical form or route of administration to an authorised product.
Annex I of Commission Regulation (EC) No 1234/2008 lists the changes that count as extensions, including changes to the active substance, strength, pharmaceutical form and route of administration. An extension is assessed like a new application but falls within the same global marketing authorisation, so it does not start a new data exclusivity period.
Mistakes include filing an extension as a Type II variation, overlooking the separate extension fee in each market, and missing the ERA, bioequivalence or paediatric requirements that a new form or strength can trigger.
Used in
Before filing, classify whether a change is an extension or a variation in Workbench, with cited answers from EUR-Lex and EMA.
Related terms
- Type II variation: major change requiring prior approvalA Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.
- 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.
- GMA: global marketing authorisationThe global marketing authorisation (GMA) groups an initial authorisation with its later strengths, forms and extensions, so exclusivity runs once for all.
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