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Changes to the marketing authorisation numbers of certain veterinary medicinal products

Notice type: Advisory

Date: 04/02/2019

  

Product name or type:
Products where the VPA number has changed

Target Audience:
Veterinary practitioners, pharmacists, licensed merchants, farmers, pet owners etc.

Problem Or Issue:
When a marketing authorisation (licence for a veterinary medicinal product) is transferred from one company to another, the legal entity with responsibility for the product changes. In these circumstances the HPRA issues a new marketing authorisation number (VPA number).  The volume of such transfers has increased in recent months as a consequence of Brexit, as marketing authorisations that were held by companies legally based in the UK must be transferred to companies that are legally based in the EU.  The consequence of this is that the VPA numbers for the products concerned are being or have been changed, even if, in some cases the name of the marketing authorisation holder (MAH) remains similar/the same.  The change in VPA number appears on the HPRA website immediately once the marketing authorisation is transferred to the new MAH, however, it takes some time for this change to filter down to product packaging in the marketplace.  The new numbers and MAH’s name will appear on the product labels and package leaflet over time as new batches of the product reach the marketplace. 

Background Information Or Related Documents:
More information on the impact of Brexit on veterinary medicinal products in available elsewhere on the HPRA website.

Actions To Be Taken:

Users should note that there may be a discrepancy between the marketing authorisation number on the product labelling for a period of time, compared to that given in the HPRA database of authorised veterinary medicinal products, pending the introduction of updated labelling and package leaflets for the products concerned.

 

No recall of affected products is needed as this is not a safety issue, per se.



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