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.
Article 10(1) of Directive 2001/83/EC, mirrored in Article 14(11) of Regulation (EC) No 726/2004, allows an applicant to omit its own pre-clinical and clinical studies when the product is a generic of a reference medicinal product that has been authorised for at least eight years in a Member State or in the Union. Article 10(2)(b) defines a generic: the same qualitative and quantitative composition in active substances, the same pharmaceutical form and bioequivalence shown by appropriate bioavailability studies. Different salts, esters, isomers and complexes count as the same active substance unless they differ significantly in safety or efficacy, and the immediate-release oral forms are treated as one pharmaceutical form.
The dossier still needs a full Module 3 on quality, a bioequivalence study or a justified biowaiver, and non-clinical and clinical overviews in Module 2 that summarise the known profile of the substance. The product information must match the reference product, except that Article 11 lets the applicant leave out indications or dosage forms still covered by patent law at launch, which is the so-called carve-out. The route is open through the national, decentralised and mutual recognition procedures, and generics of centrally authorised products may also use the centralised procedure under Article 3(3) of Regulation (EC) No 726/2004.
A generic can be submitted once data exclusivity ends, but it cannot be marketed until the market protection period has run, ten years after the reference product's first authorisation, or eleven if a new indication with significant clinical benefit was added in the first eight years. Patents and supplementary protection certificates are separate and can run beyond that date.
What goes wrong: a reference product that was itself authorised on a generic or bibliographic basis and so cannot serve as the reference; comparator batches sourced outside the EEA without a bridge; starting the procedure too early so that the application is invalidated for exclusivity reasons; SmPC text that drifts from the reference and triggers questions; and launch plans built on the eight-year date rather than the ten-year date.
Under the new pharma package (not yet in force), the data protection period stays at eight years but baseline market protection falls to one year, with conditional extensions for the reference product that generic planners will have to check case by case; see exclusivity changes.
Timing
The application can be validated once eight years have passed since the first authorisation of the reference product in the Union. Assessment follows the chosen route: 210 active days in the centralised and decentralised procedures, 90 days in mutual recognition, plus clock-stops. Marketing can begin only after ten or eleven years from the reference product's first authorisation, and after any patent or SPC expiry the applicant chooses to respect.
Used in
Generic developers work out the earliest submission and launch dates for a generic in the loss-of-exclusivity workflow.
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.
- 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.
- 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.
- 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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