Keeping up-to-date with changes to veterinary medicines
The catalogue of veterinary medicines that have been authorised or registered by the HPRA is regularly updated, because of a number of regulatory developments, for example:
- Newly authorised products are uploaded on a frequent basis (often weekly),
- Existing products that are no longer marketed are withdrawn by the marketing authorisation holder,
- The marketing authorisation is transferred from one company to another, requiring a change in the marketing authorisation number (the VPA number).
Moreover, significant changes to the approved Summary of Product Characteristics (SPC) may also arise when we approve an application to vary the authorisation, for example:
- To add a new target species to an existing authorised product,
- To increase the withdrawal period of an existing authorised product.
Each month we publish a tabulated list of the names of the veterinary medicines that have been newly authorised, withdrawn or subject of significant changes. This list is uploaded to the website at the beginning of each month and contains information in respect of decisions taken during the previous month. To identify those veterinary medicines that have been subject to significant regulatory changes in the recent past, click the link below: Update to the list of authorised veterinary medicinal products - 2019 Update to the list of authorised veterinary medicinal products - 2020 Update to the list of authorised veterinary medicinal products - 2021 Update to the list of authorised veterinary medicinal products - 2022 Update to the list of authorised veterinary medicinal products - 2023
The SPCs for new products may take up to 14 days from the date of authorisation before they are available on the website. There is not a requirement for SPCs for registered homeopathic veterinary medicinal products and they are not published. The SPCs for the centrally authorised veterinary medicines that may also be legally supplied in Ireland are available from the EMA or from the Union Product Database website.
Other important changes to the SPC, that are not captured in our monthly update listings, may also take place, for example:
- The addition of a new clinical indication for a product (but the target species remains the same),
- A reduction in the length of the withdrawal period of a product,
- Minor changes to the instructions for using the product,
- Changes to the shelf life or storage conditions,
- Changes to the advice on the disposal of a product,
- Changes to precautions, warnings, conditions of use or other particulars.
Note that this is not an exhaustive list.
Although we update the SPCs in respect of changes to products daily, the labelling and package leaflet for the products concerned may take several months to be updated, depending on:
• The level of usage of the product concerned,
• The quantities of a particular batch on the market in this country,
• The next scheduled manufacture of the product for Ireland.
For information on the HPRA’s policy on the updating of product labels for veterinary medicinal products, click Guide to the implementation of packaging changes to authorised veterinary medicines.