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The Veterinary Medicines Regulations (VMR) set out the controls on the authorisation, manufacture, supply, possession, and administration of veterinary medicines and medicated feed. These controls are required to ensure the protection of animal health, public health, and the environment. The VMR also sets out the statutory fees associated with various regulatory services provided by the Veterinary Medicines Directorate (VMD). The statutory fees and fee structure are changing from 17 May 2024.

The changes to the fees and fee structure are not arbitrary. They are part of our commitment to operating on a cost recovery basis. This means that the fees we charge for regulatory services under the VMR are intended to cover the costs we incur in providing these services to stakeholders, without seeking to generate a surplus.

Fee changes to the GB VMR

The change to fees brings several benefits, which includes the introduction of new fees, updating existing fees and simplifying fee structures. The fees are set out inthe Veterinary Medicines Regulations 2013 (as amended) and will be listed on gov.uk by 17 May 2024.

The changes are summarised under the relevant headings below:

Supply (wholesalers and retailers) of veterinary medicines, including veterinary surgeons

• Reduction of fees for the inspection of wholesalers and variation fees for wholesalers, reflecting efficiency savings made in processes

• All wholesale dealer authorisation holders will now pay the same fixed annual fee. The annual fee will be paid for the year ahead rather than retrospectively for the previous year

• A range of fees has been introduced for Veterinary Practice Premises (VPPs) to ensure that those inspections that are more complex, such as a mixed practice, pay more than an inspection of a single species practice

• All VPP inspection fees have increased to reflect the level of work involved

• A new fee is introduced to witness the disposal of controlled drugs at a VPP, whether as part of an inspection or as a specific visit

• SQP retailers will now pay separate annual and inspection fees. Previously, SQP retailers only paid an annual fee, which included part of the cost of an inspection

• SQP retailers will now pay a reduced annual fee and a separate inspection fee

• There are four new categories of SQP retailer, those that supply:

* livestock medicines category L

* avian medicines category A

* companion animal medicines category C

* equine medicines category E

The inspection fee for a category L retailer is slightly higher than the inspection fee for any other, which reflects the additional checks that must be conducted at these premises.

• Where an SQP retailer is authorised for more than one category, only one annual fee and one inspection fee (the highest) will apply.

Manufacturers of veterinary medicines

• Fees have been standardised for manufacturers.

• The same application fee will apply to applications to manufacture an authorised veterinary medicine or Schedule 6 product or for a specific manufacturing authorisation; other than to manufacture an autogenous vaccine, will pay the same application fee.

• An application to manufacture an autogenous vaccine will have a higher fee as it includes the scientific assessment of the vaccine.

• All authorisation holders will pay the same fixed annual fee in advance.

• All authorisation holders, other than manufacturers of autogenous vaccines, will pay the same fees to vary their authorisation. There are two types of variation; administration only and scientific/pharmaceutical, which requires an inspectors assessment.

• A specific variation fee applies to authorisation holders to manufacture autogenous vaccines due to the scientific assessment of the vaccine.

• Inspection fees are generally based on the size of the manufacturing operation and whether the manufacturing site is in the UK or overseas. Non-UK sites will continue to incur direct travel and subsistence costs.

Feed business operators

• Increased fees for applications for authorisation as manufacturer or distributor of medicated feed and other Schedule 5 products; and increased annual fees.

• The current categories of manufacturer and distributors have changed:

* Category 1 specified feed additive manufacturers become Category S

* Category 2 Premixture manufacturers become Category I

* Categories 3, 4 and 5 commercial feed manufacturers are consolidated into a new Category C

* Categories 6 and 7 home-mixers are combined to make a new Category F

* Category 8 distributors become Category D

Inspection fees have been updated for those new categories.

Authorisation of veterinary medicines

• The fee structure has been updated with the utmost transparency and simplicity, ensuring stakeholders can easily understand and plan for the changes.

• Grouped MA Variations: We note grouped variations submitted to the VMD usually include less than 5 changes. Therefore, we have reduced the number of changes permitted within the grouped increment to 5, as well as the respective 50% reduction to the fee; this will avoid you incurring the full 100% fee when you havent reached the 10 change maximum previously included.

• Renewal of MA and Homeopathic remedies: Fees for renewals will be removed because it is no longer necessary to carry out a renewal assessment after 5 years of a product being on the market.

• Autogenous Vaccine Authorisation (AVA) assessment and variations: New fees were introduced to ensure the total cost of assessing the authorisation and manufacture of these products is recovered.

• Animal test certificate (ATC) related applications: The fee for applications for ATCs will increase. However, reduced fees apply where a study is for a small-scale non-commercial trial. The reduced fee will be charged at less than the full cost to encourage UK based animal field trials.

• Pharmacovigilance inspections: New fees were introduced for the inspections of MA holders to ensure they have the correct systems and processes to fulfil their pharmacovigilance obligations under the VMR.

• Scientific advice: A new fee is introduced for written scientific advice to companies prior to an MA application to ensure the VMD recovers the cost of assessing the evidence and providing feedback.

Impact on stakeholders

Marketing Authorisation Applications

The current fees set out under Schedule 7 of the VMR 2013 apply to all marketing authorisation applications received and validated before 17 May 2024. For all other applications, the fees set out under Schedule 7 of the VMR 2013 (as amended) will apply from 17 May 2024.

Wholesalers and manufacturers

The current fees set out under Schedule 7 of the VMR 2013 are applicable for all inspections carried out before 17 May 2024. Otherwise, the fees set out under Schedule 7 of the VMR 2013 (as amended) will apply from 17 May 2024.

For wholesalers and manufacturers, the fee under the current VMR 2013 applies to any applications received and validated by 16 May 2024. Any applications received or validated from 17 May 2024 will be charged under the VMR 2013 (as amended). If a variation is received that we later assess requires an inspection, that inspection will be charged under the VMR 2013 (as amended).

SQP retailers and Feed Business Operators

For SQP retailers and Feed Business Operators (FeBOs), the fee under the current VMR 2013 applies to any applications received by 16 May 2024. Any applications received after this date will be charged under the VMR 2013 (as amended).

Fees applicable to the VMRs in Northern Ireland

These remain under Schedule 7 of the Veterinary Medicines Regulation 2013.

The NI-related fees will be listed on gov.uk by 17 May 2024.

Changes to the fee applicable in Northern Ireland

The fees set out in Schedule 7 of the VMR 2013 (as amended) for GB introduce new inspection-related fees for manufacturers and wholesale dealers in GB, while the fees currently charged in Northern Ireland remain the same, other than outlined below.

Manufacturers and wholesale dealers

• Where a manufacturer or WDA fee is lower in the VMR 2013 (as amended) for GB compared to the fees applicable in NI, then the lower of the fees will apply.

• To align with the payment procedure in GB, NI manufacturers and WDA holders that currently pay annual fees in arrears will

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