Recent updates to the list of authorised Veterinary Medicines

The list of veterinary medicinal products authorised or registered* by the HPRA is subject to regular updating, consequent to a number of regulatory developments, e.g. 

• New products are authorised or registered by us on a frequent basis (often weekly), 
• Existing products are no longer marketed and are notified to us as having been withdrawn by the marketing authorisation holder,
• The ownership of, and responsibility for, the marketing authorisation is transferred from one company to another, requiring a change in the marketing authorisation number (the VPA number),
• Product names are changed, upon the request of the marketing authorisation holder,
• The approved method of supply of the product changes, either upon the request of the marketing authorisation holder or in accordance with a direction from us on the basis of a change to the benefit/risk balance. 

Moreover, significant changes to the approved Summary of Product Characteristics (SPC) may also arise when we approve e.g.

• An application for a variation to add a new target species to an existing authorised product,
• An application for a variation to increase the withdrawal period of an existing authorised product.

In order to raise awareness amongst veterinarians, prescribers, dispensers and users, as well as those carrying out on-farm checks of animal treatment records, each month we provide tabulated lists of the names of the products that have been newly authorised, withdrawn or subject of significant changes.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 - February 2015
Update to the list of authorised veterinary medicinal products - March 2015
Update to the list of authorised veterinary medicinal products - April 2015
Update to the list of authorised veterinary medicinal products - May 2015
Update to the list of authorised veterinary medicinal products - June 2015
Update to the list of authorised veterinary medicinal products - July 2015
Update to the list of authorised veterinary medicinal products - August 2015
Update to the list of authorised veterinary medicinal products - September 2015
Update to the list of authorised veterinary medicinal products - October 2015
Update to the list of authorised veterinary medicinal products - November 2015
Update to the list of authorised veterinary medicinal products - December 2015
Update to the list of authorised veterinary medicinal products - January 2016
Update to the list of authorised veterinary medicinal products - February 2016
Update of the list of authorised veterinary medicinal products - March 2016
Update to the list of authorised veterinary medicinal products - April 2016
Update to the list of authorised veterinary medicinal products - May 2016
Update to the list of authorised veterinary medicinal products - June 2016
Update to the list of authorised veterinary medicinal products - July 2016 
Update to the list of authorised veterinary medicinal products - August 2016
Update to the list of authorised veterinary medicinal products - September 2016
Update to the list of authorised veterinary medicinal products - October 2016
Update to the list of authorised veterinary medicinal products - November 2016
Update to the list of authorised veterinary medicinal products - December 2016
Update to the list of authorised veterinary medicinal products - January 2017
Update to the list of authorised veterinary medicinal products - February 2017
Update to the list of authorised veterinary medicinal products - March 2017
Update to the list of authorised veterinary medicinal products - April 2017 
Update to the list of authorised veterinary medicinal products - May 2017 
Update to the list of authorised veterinary medicinal products - June 2017 
Update to the list of authorised veterinary medicinal products - July 2017
Update to the list of authorised veterinary medicinal products - August 2017
 
This service to the animal health sector does not replace the legal obligation on stakeholders to use veterinary medicinal products in accordance with the authorised conditions of use as specified in the product SPC. Readers are therefore directed to access the full details of each authorised product, which is available in the SPC of each product. The SPC may be found in the Veterinary Medicines Information page of this website.  

The SPCs for new products may take up to 14 days from the date of authorisation before it is uploaded to the website.  There is not a requirement for SPCs for registered homeopathic veterinary medicinal products and they are therefore not published.  The SPCs for the centrally authorised veterinary medicines that may also be legally supplied in Ireland are available from the EMA website (www.ema.europa.eu).

Other important changes to SPC, that are NOT captured in our monthly update listings, may also take place e.g. 

• The addition of a new clinical indication for a product (but the target species remains the same), 
• Changes to reduce 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. Such changes may arise as a result of a European harmonisation procedure which results in updating of the existing particulars to achieve a common SPC with those of other Member States where the product concerned is marketed.

Note the above is not an exhaustive list but serves to provide examples of the types of changes which may take place without them being highlighted in our monthly update. 

We update our database of product information in the SPCs in respect of existing products on a daily basis; 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.

*Note that while, following HPRA evaluation, conventional veterinary medicinal products are 'authorised', certain homeopathic veterinary medicinal product can be approved under applicable EU and national legislation using a simplified registration system.  Details of this system are available on the Homeopathic Medicines section of this site.