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Veterinary medicinal products containing tylosin base (as a single active substance) presented as solutions for injection for intramuscular use in pigs – change in the withdrawal period for animal slaughter

Notice type: Advisory

Date: 02/10/2020

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.

Product name or type:
See authorisation holder section below.

Authorisation Number:
See authorisation holder section below.

Active Substance:
Tylosin

Authorisation Holder:
Corresponding to the above lists:

Name of VMP

VPA number

MAH

Bilosin 200 mg/ml, Solution for Injection

22033/036/001

Bimeda Chemicals

Bilovet 200 mg/ml Solution for Injection for Cattle and Pigs

22033/055/001

Cross Vetpharm Group Ltd.

Pharmasin 200 mg/ml Solution for Injection for Cattle and Pigs

10782/015/001

Huvepharma N.V.

Tylan 200, 200 mg/ml Solution for Injection

22020/033/001

Elanco GmbH

Tyljet 200 mg/ml solution for injection for cattle, sheep, goats and pigs

10815/055/001

Ceva Santé Animale

Tylosin Biovet JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs

10464/001/001

Biovet JSC

Tylucyl 200 mg/ml Solution for Injection for Cattle and Pigs

10983/060/001

Vetoquinol Ireland Limited


Prescription Required:
Yes

Target Audience:
Veterinary practitioners, pharmacists, farmers.

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.

Background Information Or Related Documents:

Withdrawal periods are established by the competent authorities for veterinary medicines in the individual Member States where the products are marketed, based on the maximum residue limit established by the EMA for the relevant drug residues in meat.

Such withdrawal periods are established in line with EU guidelines, which may be updated periodically in line with scientific advances.

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.

Further Information:

Commission decision (2020)2560 of 17 Apr 2020

https://ec.europa.eu/health/documents/community-register/2020/20200417146957/anx_146957_en.pdf



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