Policy rule on classification of individual veterinary medicinal products
The Policy rule on classification of individual veterinary medicinal products contains criteria relating to classification/legal status of supply. The current Policy rule on classification needs to be amended to bring it into line with Articles 34 and 106 of the Veterinary Medicinal Products Regulation.
Update: 15 December 2023
As of 15 December 2023, all injection preparations for farm animals will become subject to prescription.
In the list 'Overview of change in legal status of supply of injection preparations from VRIJ to URA as of 15 December 2023' you can find an overview of the veterinary medicinal products that have been given the legal status of supply URA as of 15 December 2023.
The process of amending the Policy rule on classification is currently underway. It is not yet known when exactly the amended policy rule will be published. Below, we provide an update on what has already emerged with regard to the classification of injectable preparations.
European POM classification for all injectable preparations
One of the objectives of the current Veterinary Medicinal Products Regulation is to harmonise the legal status of supply (POM/NON POM) of identical veterinary medicinal products within Europe. The legal framework for this harmonisation is set out in Article 34 of the Veterinary Medicinal Products Regulation. The ‘Guideline on the application of Article 34 of Regulation (EU) 2019/6’ provides further details.
These classification criteria make it clear that, according to the European rules, injectable preparations must be classified as POMs (Prescription-Only Medicines).
All injectable preparations that can currently be sold in the Netherlands without a veterinary prescription are intended for food-producing animals. These will all become prescription-only medicines. This decision has been made at the national level, based on the European POM classification of these injectable preparations. In the Netherlands, they will be given the classification status of 'URA' (prescription-only medicines).
This decision will have consequences for:
- vitamin preparations and corrective preparations (such as iron injections) administered by injection;
- intravenous calcium/magnesium infusions.
There is no need to wait for publication of the Policy rule on classification before implementing this change, since it follows directly from the criteria in Article 34 of the Veterinary Medicinal Products Regulation. The change to the new URA classification status will therefore take effect for all injectable preparations intended for food-producing animals that can currently be sold without a prescription.
The change in classification status for these veterinary medicinal products is a consequence of rules resulting from the Veterinary Medicinal Products Regulation. It is not a consequence of a change to the risk profile of these veterinary medicinal products.
All injectable preparations will become prescription-only medicines on 15 December
We are responsible for implementing the change in status from 'VRIJ' (unrestricted) to 'URA'1. As a marketing authorisation holder, you will automatically receive a decision letter setting out the amended product information for the veterinary medicinal product concerned. These decisions will come into effect on 15 December. It is possible that amended decisions may appear in our Veterinary Medicinal Product Database before that date. This is because the change in status is a major process, which cannot be carried out for all veterinary medicinal products on the same day. However, all decisions will come into effect together on 15 December, regardless of the date on which they appear in our Veterinary Medicinal Product Database. Once the decisions come into effect, the transition periods set out below will apply to the veterinary medicinal products concerned.
1When the veterinary medicinal product is authorised via the MRP or DCP procedure, we will inform the RMS that the classification in the Netherlands has changed to POM.
Period: first 12 months after the decision comes into effect
(i.e. from 15 December 2023 to 15 December 2024)
- As a manufacturer, you will be given time to adjust your operational processes. This means that you may still produce and release batches of veterinary medicinal products with unaltered product information. The product information may still include the 'VRIJ' classification/status of supply.
Period: from 12 months after the decision comes into effect (i.e. after 15 December 2024)
- For veterinary medicinal products for which the classification status has changed to URA, producing and releasing veterinary medicinal products with unaltered product information ('VRIJ' classification/status of supply) is no longer permitted.
Period: until the end of the shelf life period, or shortly before
- As a wholesaler, you may still supply stock with unaltered product information ('VRIJ' classification/status of supply) to retailers until the end of the shelf life period for the veterinary medicinal product, or shortly before.
Period: until the end of the shelf life period, or shortly before
- As a retailer, you may still supply stock with unaltered product information ('VRIJ' classification/status of supply) to animal keepers until the end of the shelf life period for the veterinary medicinal product, or shortly before.
Period: until the end of the shelf life period
- As an animal keeper/end user, you may use a veterinary medicinal product with unaltered product information ('VRIJ' classification/status of supply) until the end of the shelf life period.
We will inform you
We will inform you by email when this change affects one or more marketing authorisations, if you are the marketing authorisation holder.
We will also let you know when the Policy rule on classification is published and what changes will occur as a result.
We will inform you shortly of the procedure that will apply for changing the classification status from UDD (only to be applied by veterinarians) to UDAV (only to be supplied subject to additional requirements). This will be a new classification category for products subject to additional requirements. It will apply to antibiotics as well as certain pig vaccines that can be administered by animal owners.
Further information on this topic can be found on the status of supply page.
If you have a question regarding this topic, please send it to the Veterinary Medicinal Products Unit using our contact form. Select ‘Other’ for the subject and specify that your question relates to the change in classification status. If your question relates to a particular marketing authorisation, state the associated REG NL number.