Reference product: reference medicinal product
The reference medicinal product is the product, authorised in the EU on a full dossier, whose data a generic or hybrid application relies on.
Defined in Article 10(2)(a) of Directive 2001/83/EC, it must be or have been authorised in the EU under Article 6 with a complete dossier. A generic can be filed in a Member State where the reference was never authorised by naming the Member State where it is or was authorised, known as a European reference product.
Data exclusivity runs from the first authorisation of the reference product anywhere in the EU, which covers later strengths and forms under its global marketing authorisation. Problems come from naming a reference that was itself authorised on a bibliographic or generic basis, and from comparator batches whose origin cannot be justified.
Used in
Generic developers research reference products, their holders and where they are marketed in the competitive intelligence workflow.
Related terms
- Bioequivalence: equivalent rate and extent of absorptionBioequivalence means two products with the same active substance deliver it at the same rate and to the same extent, within accepted statistical limits.
- 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.
- 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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