Some veterinary products will never justify a full development programme. The species is too small a market, the disease is rare or geographically confined, or the commercial return cannot carry the cost of a complete safety and efficacy package. Regulation (EU) 2019/6 anticipates this with two derogations, Articles 23 and 25, which reduce the data burden in defined circumstances. Used well, they open markets that would otherwise stay closed.
Article 23: limited markets
Under Article 23, an applicant is not required to provide certain safety and efficacy information and documentation, provided two conditions are met: the benefit of having the product available on the market, to animal or public health, outweighs the risk arising from the missing documentation; and the applicant provides evidence that the product is intended for a limited market.
Authorisations under Article 23 are granted in particular for products intended for animal species of lesser economic importance, or for the treatment or prevention of diseases that are rare or geographically limited. The trade-off is transparency: the summary of product characteristics must state clearly that only a limited assessment of safety or efficacy has been conducted because comprehensive data was lacking, and must carry the statement that the marketing authorisation was granted for a limited market with assessment based on customised documentation requirements.
Article 25: exceptional circumstances
Article 25 addresses a different situation. In exceptional circumstances relating to animal or public health, an applicant may submit an application that does not meet all the requirements on quality, safety and efficacy data. The applicant has to show that, for objective and verifiable reasons, certain documentation normally required cannot be provided, and that the benefit of immediate availability to animal or public health outweighs the risk of the missing data.
Choosing the right route
The two articles are not interchangeable. Article 23 is about the economics and epidemiology of a market that cannot sustain a full package. Article 25 is about data that objectively cannot be generated. An application built on the wrong justification invites a validation problem before any science is assessed.
The European Medicines Agency has published guidance on classifying a product as intended for a limited market and on eligibility for authorisation under Article 23, together with data requirement guidelines that differ for immunological and non-immunological products. Reading those before committing to a route saves considerable rework.
Practical considerations
- Build the limited-market evidence deliberately: species population, disease prevalence, geographic distribution and commercial scale.
- Plan for the product information statements from the outset, because they affect positioning and prescriber communication.
- Expect post-authorisation data expectations, and budget for them.
- Consider whether scientific advice before submission would resolve the classification question cheaply.
How PQRA helps
PQRA assesses whether a veterinary product qualifies for a reduced data route, builds the justification for limited market classification, designs the corresponding data package, and manages the application through to authorisation. We also advise on how the resulting product information affects market access and prescriber uptake in Greece and across the EU.
To explore a reduced data route for your veterinary product, contact PQRA.
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