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Flukicides containing oxyclozanide. Changes to the withdrawal periods

Notice type: Advisory

Date: 19/01/2018

 Following a European regulatory procedure to harmonise the withdrawal periods of certain veterinary medicinal products containing oxyclozanide, which is used mainly as a flukicide worm drench but is also indicated against certain tapeworms in ruminant animals, the withdrawal periods of the products concerned have been changed.

The following oxyclozanide containing veterinary medicines that have been authorised by the HPRA are concerned:

Zanil Fluke Drench (VPA 10996/262/001)

Rumenil 34 mg/ml oral suspension for cattle (VPA 10987/113/001)

Chanil 34 mg/ml oral suspension for cattle (VPA 10987/114/001)

Distocur 34 mg/ml oral suspension for cattle (VPA 10857/085/001)

Product name or type:
Zanil Fluke Drench (VPA 10996/262/001) Rumenil 34 mg/ml oral suspension for cattle (VPA 10987/113/001) Chanil 34 mg/ml oral suspension for cattle (VPA 10987/114/001) Distocur 34 mg/ml oral suspension for cattle (VPA 10857/085/001)

Active Substance:
Oxyclosanide

Product Classification:
The products concerned are supplied in Ireland under the 'Licensed merchant' (LM) category. This means that they are available, without the need for a veterinary prescription, for veterinary practitioners, pharmacies and from outlets that are licensed by the Department of Agriculture, Food and the Marine (e.g. co-operative stores) to supply certain classes of veterinary medicines to the farming community). 

Authorisation Holder:

A number of companies supply the products in  question, including MSD (formerly Intervet Ireland Limited), as well as

Chanelle Pharmaceuticals Manufacturing Limited, and

Merial Animal Health Limited

Recall Classification:
A recall of the products concerned is not required, as the change to the withdrawal periods have arisen as a result of a European harmonisation procedure, and not an issue to do with consumer safety. 

Target Audience:
Veterinary practitioners, pharmacists, licensed merchants and farmers.

Problem Or Issue:
The European Medicines Agency (EMA) completed a review of the withdrawal periods (meat, milk and offal) of the above products containing oxyclozanide during 2017. Some of the products that were authorised by the HPRA had a withdrawal period for milk of 72 hours, during which time no problems associated with residues were reported. Following the EMA review the European Commission issued a binding decision on 28 September 2017 directing that the withdrawal periods of the products be changed. The new withdrawal periods are as follows:
Cattle meat withdrawal period: 13 days
Milk withdrawal period in cows producing milk for human consumption: 108 hours (4.5 days)
Sheep meat withdrawal period: 14 days
Milk withdrawal period in ewes producing milk for human consumption: 7 days.
The companies concerned have updated the product labelling of the products concerned, which will be implemented on future production batches of the products concerned. However, there are likely to be existing stocks of the products concerned with the old withdrawal periods indicated. 
 

Background Information Or Related Documents:

The change to the withdrawal periods for the products concerned has arisen as a result of the outcome of a European Procedure, undertaken by the European Medicines Agency.
Withdrawal periods are established by the competent authorities for veterinary medicines in each Member State, based on the maximum residue limit established by the EMA for the relevant drug residues in meat and milk.

Such withdrawal periods are established in line with EU guidelines, which are updated periodically in line with scientific advances. Following the submission of a new product containing oxyclozanide to France, the competent authority there noted that there were different approved withdrawal periods for similar products across Member States and referred the matter to the EMA for harmonisation.  

Actions To Be Taken:

In accordance with the applicable legislation, in order to change the withdrawal periods for the products concerned to be in line with the outcome of the EU referral procedure, the marketing authorisation holders for the products involved have submitted variations to the terms of the marketing authorisations to the HPRA and these have been approved. Where cattle and/or sheep have been authorised as target species, the following revised withdrawal periods have been established for the products concerned:

Cattle:

Meat and offal: 13 days.

Milk: 108 hours (4.5 days).

Sheep:

Meat and offal: 14 days.

Milk: 7 days.

Veterinary practitioners, pharmacists, licensed merchants and farmers should follow the amended withdrawal periods, in particular the increase in the milk withdrawal period to 108 hours (4.5 days), and apply them forthwith (even where the product labelling indicates otherwise). While this is NOT a consumer safety issue (but rather a harmonisation of withdrawal periods), the HPRA considers that users of veterinary medicinal products should follow the conditions of the marketing authorisation as set out for the products concerned on the HPRA website (www.hpra.ie ), pending the availability of new stock with updated labelling reflecting the revised withdrawal periods for the products concerned.

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:
The changes outlined above do not apply to products which contain oxyclozanide in combination with another active substance, but apply only to those veterinary medicines containing oxyclozanide as the sole active substance. 

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