• Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision


Rapinyl and associated names, 50ug, 100ug, 200ug, 300ug, 400ug, 600ug, 800ug, sublingual tablets is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.

ProStrakan Ltd submitted applications for Rapinyl and associated names, 50ug, 100ug, 200ug, 300ug, 400ug, 600ug, 800ug, sublingual tablets. The Decentralised Procedure, SE/H/575/07/DC, started on 1 September 2006.

The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain and
United Kingdom.

These Member States were not able to reach an agreement and Sweden referred the reasons for disagreement to the EMEA on 27 September 2007.

Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/risk and the lack of PK data under normal conditions of use of the product. This refers to the bridging strategy of the Applicant and was considered to be a serious public health concern.

The arbitration procedure started on 18 October 2007 with the adoption of a list of questions. The Rapporteur was Dr Tomas Salmonson (SE) and Dr Pierre Demolis (FR) was Co-Rapporteur. The Applicant provided written explanations on 7 April 2008.

During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended. A positive opinion was adopted by consensus on 26 June 2008

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

The final opinion was converted into a Decision by the European Commission on 11 September 2008.

Key facts

About this medicine
Approved name
International non-proprietary name (INN) or common name
fentanyl citrate
About this procedure
Current status
European Commission final decision
Reference number
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes
CHMP opinion date
EC decision date

All documents

  • List item

    Opinion following an Article 29(4) referral for Rapinyl and associated names International Non-proprietary Name (INN): fentanyl citrate: Background information (PDF/28.37 KB)


    First published: 12/09/2008
    Last updated: 12/09/2008

  • List item

    Rapinyl - Article 29 referral - Annex I, II, III (PDF/260.71 KB)


    First published: 25/09/2009
    Last updated: 25/09/2009

  • 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
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • 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. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (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)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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