Glucomed - referral

Current status

European Commission final decision

Overview

Glucomed and associated names, 625 mg, tablet, contains glucosamine which is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans. Glucosamine was mainly introduced on the world-wide market as a foodsupplement but with the aim to improve symptoms in patients with osteoarthritis or joint pain or function.

Navamedic ASA submitted applications for mutual recognition of Glucomed and associated names, 625 mg, tablet on the basis of the marketing authorisation granted by Sweden on 4 August 2005. The Mutual Recognition Procedure started on 18 October 2005

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

These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. Sweden referred the reasons for disagreement to the EMEA on 31 March 2006.

The applicant was asked to demonstrate efficacy of glucosamine in the intended indication “relief of symptoms in mild to moderate osteoarthritis of the knee”. In addition the applicant was asked to justify the proposed dose and posology, to characterise the safety profile, including a discussion of reported adverse drug reactions, to justify the relevance of literature considering that the formulations of glucosamine sulphate (as the sodium chloride complex) used in the cited literature differ from the concerned application formulation and whether the differences in formulation will alter the efficacy and safety of the product, to elucidate the possibility of interactions with other medicinal products, and finally to show a positive risk/benefit profile of glucosamine hydrochloride in the intended indication.

The arbitration procedure started on 27 April 2006 with the adoption of a list of questions. The Rapporteur was Dr. Salmonson and the Co-Rapporteur was Dr Abadie. The Marketing Authorisation Holder provided written explanations on 21 July 2006.

During their September 2006 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 Glucomed and associated names for the relief of symptoms in mild to moderate osteoarthritis of the knee, that there was no objection for 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 y a majority of 19 out of 27 votes on 21 September 2006.

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, labelling and package leaflet in Annex III.

The final opinion was converted into a Decision by the European Commission on 13 December 2006.

Opinion following an Article 29(4) referral for Glucomed and associated names International Non-Proprietary Name (INN): glucosamine hydrochloride: Background information

AdoptedReference Number: EMEA/405628/2006

Key facts

About this medicine

• Approved name:
  Glucomed
• International non-proprietary name (INN) or common name:
  glucosamine hydrochloride

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/405628/06
• Type:
  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:
  21/09/2006
• EC decision date:
  13/12/2006

All documents

Glucomed - Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(4) referral for Glucomed and associated names International Non-Proprietary Name (INN): glucosamine hydrochloride: Background information

AdoptedReference Number: EMEA/405628/2006

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.