Third Briefing Note from the VMD (February 2012)
As an update to the earlier briefing notes (see below), the VMD is pleased to confirm that the maximum residue limit (MRL) for altrenogest has been revised. The revised MRL is higher than the previous MRL and as a consequence it is necessary to re-examine the existing residue studies and to modify the withdrawal periods of relevant products across the EU. This is likely to culminate in shorter withdrawal periods being set which are expected to be within the limit of 15 days set by Council Directive 96/22/EC for hormonal products. The process to establish the revised withdrawal periods has started and is being co-ordinated across the EU. It is anticipated that before the end of 2012 all new batches of altrenogest containing products destined for the UK market will specify the shorter withdrawal periods. In the meantime product can remain on the market.
Second Briefing Note from the VMD - 10 June 2011
The Availability of Veterinary Medicines containing Altrenogest
As an update to the earlier briefing note (see below), the VMD is pleased to confirm that investigations have established that there is scope to modify the maximum residue limit (MRL) for altrenogest which in turn will modify the withdrawal period of altrenogest containing products. A Member State submitted a request to the European Medicines Agency (EMA) asking it to re-examine the MRL for altrenogest (in accordance with article 11 of MRL Regulation 470/2009). This request was considered and accepted by The Committee for Medicinal Products for Veterinary Use (CVMP) at their June 2011 meeting. Once a revised MRL has been agreed a co-ordinated approach to re-examine the existing residue studies in light of the revised MRL and to modify the withdrawal periods of relevant products across the EU is planned. At this stage it is not possible to rule out the possible need for new residue studies. In the meantime product can remain on the market.
Whilst there is still some way to go to resolve the situation the VMD is cautiously optimistic that this further work will achieve the desired outcome. Having identified a mechanism to resolve the situation the focus of activity will now be considering the scientific data. A further briefing note will be issued once the review of the MRL for altrenogest has been concluded by the CVMP.
First Briefing Note
On the basis of current rules Member States were asked to withdraw Marketing Authorisations for products containing altrenogest where the withdrawal period exceeds 15 days, as such authorisations are in contravention of Directive 96/22/EC. In addition such products were also expected to be recalled from the market. However, the Heads of Medicines Agencies (HMA) are considering whether it is possible to take any steps to remove the need for such action.
The HMA are currently working together to establish if there is a technical solution to this problem as they recognise the importance of these products for the commercial breeding of pigs and horses. The available safety information is being collated and will be scientifically reviewed to establish whether it would be possible to assign withdrawal periods of 15 days or less to altrenogest products. Once the outcome of this review is available a further briefing note will be issued (within 4-6 weeks from now) to keep relevant stakeholders informed of the situation as it develops. Product remains on the market in the interim
(Source: Veterinary Medicines Directorate - VMD)
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