Porcilis M Hyo - referral

Current status

European Commission final decision

Overview

Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae. The product is indicated for finishing pigs from 1 week of age. Pigs should be vaccinated twice with a 3 week interval.

The marketing authorisation holder Intervet International B.V. submitted an application for a Type II variation subject to Mutual Recognition Procedure for Porcilis M Hyo concerning simultaneous administration with Porcilis PRRS. The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the Reference Member State was France2 and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Germany, Denmark, Estonia, Greece, Spain, Finland, Hungary, Ireland, Italy, Malta, Luxembourg, Lithuania, Latvia, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovakia and the United Kingdom. The Mutual Recognition procedure (FR/V/0158/001/II/002) started on 30 January 2009.

On 2 October 2009 the United Kingdom on behalf of France, referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns raised by Spain relating to the quality, safety and efficacy of the simultaneous administration of Porcilis M Hyo with Porcilis PRRS.

The referral procedure started on 14 October 2009. The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr A.M. Brady as co-rapporteur. During the procedure Dr C. Muñoz Madero replaced Dr C. Rubio Montejano as rapporteur. Written explanations were provided by the marketing authorisation holder on 15 January 2010 and supplementary information was submitted on 20 April 2010.

Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 19 May 2010, an opinion recommending that the variation application applied for the veterinary medicinal product Porcilis M Hyo satisfies the criteria for approval.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended Summary of Product Characteristics and package leaflet in the Annex III.

The final opinion was converted into a Decision by the European Commission on 16 August 2010.

Opinion following an Article 6(12)1 referral for Porcilis M Hyo: Background information

Adopted Reference Number: EMA/345914/2010

Key facts

About this medicine

• Approved name:
  Porcilis M Hyo
• International non-proprietary name (INN) or common name:
  inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/345914/2010
• Type:
  Articles 39 and 40 referrals (prior to January 2010)

  Article 39 referrals are initiated because of disagreement between Member States on a variation for medicines authorised by mutual recognition or via the decentralised procedure. This referral has been replaced by Article 13 referrals

  Article 40 referrals are initiated when a Member State is seeking action (variation, suspension or withdrawal) to protect public or animal health or the environment. This referral applied to medicines with a marketing authorisation granted via the mutual-recognition or decentralised procedure.

Key dates and outcomes

• Opinion date:
  19/05/2010
• EC decision date:
  16/08/2010

All documents

Porcilis M Hyo - Article 6(12) referral - Annexes I, II, III

Adopted Reference Number: EMA/345914/2010

Opinion following an Article 6(12)1 referral for Porcilis M Hyo: Background information

Adopted Reference Number: EMA/345914/2010

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)