Various products – Labelling requirements for veterinary medicines

16/10/2023
Medicines for animal use Product information update (PIU)

The labelling of all veterinary medicines in Ireland is changing, primarily as a result of requirements of EU legislation for simplification of label text. The legislation was applied in 2022 and requires that all veterinary medicines meet new requirements before January 2027. Simultaneously, national requirements for designation of certain routes of supply of veterinary medicines are also changing. Accordingly, we are in a period of transition, and some products will undergo more than one labelling change. During this transition period, there is a risk that products might not be used correctly and that medicines imported by the public might not comply with legal requirements. 

Problem or issue

The labelling of veterinary medicines is changing currently and the process will continue until 2027. While the objective of the legislation is to simplify labelling requirements to improve the economics of manufacture, allowing for multi-lingual labelling in the EU, there is still a legal requirement that:

Each veterinary medicine is authorised for sale or supply in Ireland. The marketing authorisation number (VPA number or EU authorisation number) must appear on the package leaflet of the product. However, it will generally no longer appear on the product label itself.

The label of the product supplied in Ireland must be in English. Products labelled exclusively in a foreign language do not comply with the legislation.

A package leaflet must be provided in paper copy with the product. The package leaflet must contain all relevant information in English, but can also contain the same information in other EU languages.

Veterinary medicines that do not comply with the labelling requirements pose a risk to animal and public health. Illegally imported veterinary medicines also threaten availability of legitimate veterinary medicines in the State, posing additional challenges in securing availability of needed medicines in Ireland. You can check the licensing status of a veterinary medicine on the HPRA website.

Other relevant changes include:

The introduction of pictograms in place of text to list the target species.
The change of location of the approved route of supply from the labelling to the package leaflet. This means that the POM designation will migrate from the label to the leaflet.
A change in the designation of certain national categories of supply. This means that Licensed Merchant (LM) category becomes Licensed Retailer (LR) category, while other categories (such a pharmacy sale) have been abolished.
 

The market for veterinary medicines in Ireland is relatively small compared to other countries. Medicines that are produced for Ireland might only be manufactured once during the year or once every couple of years, meaning that products in old livery could remain on the market until the date of expiry of the medicine. It is important that veterinary medicines be used properly and responsibly. For up-to-date information on veterinary medicines visit HPRA.ie.


Product information

Manufacturer or supplier
Various
Authorisation number
Various
Serial or batch number and expiry date
Various
Human or veterinary medicine
Veterinary medicine 
Target audience
Veterinary practitioners, Pharmacists, Licensed retailers, wholesalers and the public

Actions to be taken

Always check the label of the medicine. By law it should always be in English. If this is not the case, report the matter to the Department of Agriculture, Food and Marine.

Buy veterinary medicines from approved sources. Accessing veterinary medicines that are advertised on the internet carries risk that the products might not be authorised for use in Ireland, or might be counterfeit. Use of veterinary medicines in Ireland that are intended for supply and use in other countries risks the long-term availability of veterinary medicines in this country.

Reference

Background Information Or Related Documents:

EU legislation on veterinary medicinal products