The Health Products Regulatory Authority (HPRA) wishes to advise that the withdrawal period for meat and offal derived from pigs treated with the products identified below has been amended to 16 days (representing a longer withdrawal period for most products). In addition, the injection volume has been restricted to 5 mls per injection site.
This change has been made following an EU review of the residue data, in order to implement a harmonised withdrawal period for the products concerned throughout the EU.
Problem Or Issue:
Following the outcome of a referral procedure to the European Medicines Agency on 05/12/2019 and the subsequent implementing decision by the European Commission on 17/04/2020, the withdrawal period for porcine meat and offal for products containing tylosin base (as a single active substance) presented as solutions for intramuscular injection in pigs have been harmonised throughout the European Union to 16 days. The injection volume for pigs has also been restricted to 5 mls.
Note that the scope of the referral was restricted to the withdrawal period for pigs. Where a product is also authorised for use in species other than pigs, no change to the withdrawal period for those other species is necessary.
Actions To Be Taken:
Prescribers and users should note that the withdrawal period for pig meat and offal has changed to 16 days and that the injection volume in pigs is restricted to 5 mls per injection site. The marketing authorisations have been updated in line with the outcome of this binding EU-wide decision.
The HPRA advises veterinary practitioners and users of these veterinary medicinal products to adhere to the conditions of the marketing authorisations as set out on the HPRA website (www.hpra.ie); this includes the latest updates to withdrawal periods. The labelling and package leaflets of current market packs of the products concerned might not reflect the revised withdrawal period, until new stock with updated labelling is available.
Any adverse events occurring following use of veterinary medicinal products should be reported to the HPRA via the online reporting form available at https://www.hpra.ie/homepage/about-us/report-an-issue/veterinary-medicines-adverse-reaction or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.
Commission decision (2020)2560 of 17 Apr 2020