WEU: well-established use
Well-established use (WEU) is an application route that shows efficacy and safety through published literature instead of the applicant's own studies.
Under Article 10a of Directive 2001/83/EC, the active substance must have been in well-established medicinal use in the EU for at least ten years, with recognised efficacy and an acceptable level of safety. Annex I, Part II sets the criteria, including the extent of use, the consistency of the literature and how long use has been documented.
Common problems: counting the ten years from the wrong date or from use outside the EU, relying on literature for a different indication, dose or population, and missing bridging data where the product differs from those studied.
Under the new pharma package (not yet in force), WEU is only open where no reference product has been authorised in the EU, or one is authorised but not on the EU market; see WEU changes.
Used in
You can research the literature basis and eligibility for a WEU application in Workbench, with every answer cited.
Related terms
- 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.
- 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.
- Generic application: abridged application under Article 10(1)A generic application under Article 10(1) of Directive 2001/83/EC authorises a copy of a reference product by relying on that product's data.
- Hybrid application: abridged application under Article 10(3)A hybrid application under Article 10(3) of Directive 2001/83/EC relies partly on a reference product's data and partly on new bridging studies.
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