France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Ery.
Suvaxyn Ery is indicated for the active immunisation of pigs (gilts and sows) to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
The Committee for Medicinal Products for Veterinary Use (CVMP) started the referral procedure on 19 July 2006.
The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product. However, it was important to ensure that the pass limits of the potency test do not drift from the original. In addition, a more robust test for potency should be applied to the product in the future.
The CVMP, therefore, recommended a variation of the Marketing Authorisation. The Marketing Authorisation(s) should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 19 April 2007.
Articles 39 and 40
European Commission final decision
|EC decision date||
Opinion following an Article 40 referral for Suvaxyn Ery: Background information (PDF/28.82 KB)Adopted
First published: 02/06/2008
Last updated: 02/06/2008
Suvaxyn Ery - Article 40 Referral - Annex I, II (PDF/53.35 KB)Adopted
First published: 16/11/2007
Last updated: 16/11/2007
- Opinion - contains the CVMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents may not always be available:
- Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies