Solacyl 100 % powder for oral solution for calves and pigs is indicated in calves for supportive treatment for reduction of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary and in pigs for the supportive treatment for relief of pain in musculoskeletal disorders in combination with appropriate (e.g. anti-infective) therapy if necessary.
In August 2006 a Decentralised Procedure started with The Netherlands as Reference Member State and thirteen Concerned Member States.
Ireland considered that, due to the absence of efficacy documentation it could not be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health. The Netherlands notified the EMEA in November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution and the matter was referred to the CVMP.
Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands).
CVMP started the referral procedure on 11 December 2007 and agreed on a 37 day time frame. A List of Questions was adopted by CVMP and sent to the applicant on 12 December 2007. The applicant submitted written responses to the List of Questions on 10 January 2008 and the clock was re-started.
On the basis of the grounds for referral, CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products
The aim of the assessment is to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
Solacyl 100% powder for oral solution proved to be essentially similar to the reference product, Natrium salicylaat 100%. Consequently, the same conclusions on efficacy and safety apply to both products. The objections raised by Ireland should not prevent the granting of a marketing authorisation for Solacyl 100% powder for oral solution for calves and pigs.
It is recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
The CVMP Opinion was adopted on 13 February 2008 and the subsequent Commission Decision adopted on 17 April 2008.
European Commission final decision
Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.
|EC decision date||
Opinion following an Article 33 (4) referral as amended for Solacyl: Background information (PDF/30.12 KB)Adopted
First published: 02/05/2008
Last updated: 02/05/2008
Solacyl - Article 33 Referral - Annex I, II, III (PDF/21 KB)Adopted
First published: 24/05/2008
Last updated: 24/05/2008
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of CVMP
- Divergent positions – divergent positions of the CVMP members (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)