FOI2026/00315 – Legal category changes for VMPs
Published 22 May 2026
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Your request
On behalf of Knoell Animal Health Ltd., I wish to make this Freedom of Information (FoI) request in regard to change of legal distribution category applications for authorised veterinary medicinal products (VMPs).
The information we wish to know in relation to such changes of legal category is the following:
1). How many legal category change requests have been submitted to the VMD in the past 5 years (per year)?
2). Of these legal category change requests, how many have been
• Approved
• Refused
• Withdrawn by the MAH again, disaggregated by year
3). For what therapeutic areas have the legal change category requests been submitted, e.g. gastrointestinal, ectoparasiticidal, etc., and how many were first in class or otherwise
4). For what kinds of animals - by species, or by companion vs. food producing.
Our reply
1). How many legal category change requests have been submitted to the VMD in the past 5 years (per year)?
A total of 34 legal category change applications have been received and completed within the period requested. See table for details.
We are unable to provide information relating to ongoing legal category change applications. Details about applications that have not yet been completed are considered commercially sensitive, as disclosure could reveal information about a company’s regulatory strategy, product development pipeline, or prospective market activity before this is publicly known.
Releasing such information could unfairly disadvantage the companies involved, for example by:
- revealing potential future marketing intentions ahead of competitors
- disclosing confidential business decisions about product positioning or planned regulatory changes
- enabling other market participants to infer commercially valuable insights about a product’s status or timing
For these reasons, information about ongoing applications is withheld to protect the legitimate commercial interests of the Marketing Authorisation Holders, in line with Section 43 FOIA exemptions relating to commercially sensitive information.
2). Of these legal category change requests, how many have been
• Approved • Refused • Withdrawn by the MAH again, disaggregated by year
Of the completed legal category change applications within this period:
29 were approved
2 were refused
3 were withdrawn by the Marketing Authorisation Holder (all in 2025)
| Year | Completed applications | Outcome |
|---|---|---|
| 2021 | 0 | N/A |
| 2022 | 5 | 5 x Approved, 0 x Refused, 0 x Withdrawn |
| 2023 | 13 | 11 x Approved, 2 x Refused, 0 x Withdrawn |
| 2024 | 11 | 11 x Approved, 0 x Refused, 0 x Withdrawn |
| 2025 | 5 | 2 x Approved, 0 x Refused, 3 x Withdrawn |
3). For what therapeutic areas have the legal change category
requests been submitted, e.g. gastrointestinal, ectoparasiticidal, etc., and how many were first in class or otherwise
The completed applications related to the following therapeutic areas:
- Anthelmintics: 21 applications
- Ectoparasiticides: 13 applications
With regard to whether any of these applications were “first in class,” we are unable to provide this information. The term “first in class” is not a classification captured in our systems, and the VMD does not routinely assess or record applications using this terminology.
4). For what kinds of animals - by species, or by companion vs. food producing.
All completed applications during this period related to companion animal veterinary medicines for cats, dogs, and rabbits.