Question to the Department for Environment, Food and Rural Affairs:

To ask Her Majesty's Government what assessment they have made of progress in implementing the recommendations of the 2003 Competition Commission Report on supply of Veterinary Medicines; and what the implementation outcome is for each of the recommendations, including reasoning for those that have not been implemented.

All recommendations were implemented.

1 & 9

The Veterinary Medicines Regulations (VMR) provide four distribution categories, based on the perceived risk of a veterinary medicine and striking the right balance between appropriate controls and availability.

'Prescription Only Medicines - Veterinarian' (POM-V) require prescribing by a vet for animals under their care, following clinical assessment. POM-V covers those products containing narcotic or psychotropic substances or requiring veterinary diagnosis/clinical assessment. Clients may request a prescription which can be dispensed elsewhere.

'POM - Veterinarian, Pharmacist, Suitably Qualified Person' (POM-VPS) and 'Non-Food Animal-VPS' products can be prescribed and/or supplied by vets, pharmacists or SQPs; without clinical assessment but with point-of-sale advice.

'Authorised Veterinary Medicine - General Sales List' category covers products with safety profiles allowing distribution across a range of retailers.

7

The distribution category is assessed during the veterinary medicine application procedure. Factors considered in deciding the category include the need for clinical diagnosis, point-of-sale advice, administration route, nature of the product/active substance and safety profile. Cost is not considered as the scope is limited to the safety of the product for both the animal and people handling the product.

8 & 3

The EU centralised procedure is compulsory for products containing a new active substance, constituting significant therapeutic/scientific/technical innovation, or where a marketing authorisation (MA) is in the interest of animal health at EU level. These products are classified 'Prescription-Only' as their novelty represents an increased risk. The UK had the flexibility to assign one of its distribution categories, based on increased knowledge of the product's safety profile. Under the Northern Ireland Protocol the EU centralised system will still apply in Northern Ireland.

5

The Veterinary Products Committee (VPC) reviewed products over seven categories, recommending the appropriate distribution category. In some cases, this required removal of indications to support the products being more freely available via a lower distribution classification.

6

MA holders can apply to change the category. This will be considered by the VPC unless they previously advised on category changes for comparable products.

4

The VMD may grant, without requiring a full dossier, an MA for an EU-authorised medicine for import into the UK under Parallel Import provisions, provided the applicant demonstrates it is identical to a UK-authorised medicine for food-producing species, or therapeutically identical to a UK-authorised medicine for companion animals. The VMD requests a detailed description of the product's intended re-labelling.

10

An MA is initially valid for five years, after which it may be renewed upon re-evaluation of the risk-benefit balance. Once renewed, the MA is valid indefinitely unless pharmacovigilance raises concerns.

11

The VMD publishes standards and transparent targets around the assessment processes - something recognised and welcomed by industry. The VMD encourages companies to consult on their proposed MA application, particularly for exceptional MAs, prior to submission or during the process itself. After EU Exit the VMD introduced additional MA options - national-only or in parallel with an EU application to better utilise company resources.

2

The RCVS Code of Professional Conduct contains a chapter on fair trading requirements. This includes provision of information on medicine prices.