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


On 20 June 1995, Hoechst Roussel B.V. (The Netherlands) submitted an application for Mutual Recognition of the Marketing Authorisation, on the basis of the Marketing Authorisation granted by the Dutch Competent Authorities for Amaryl 1 mg, 2 mg, 3 mg, 4 mg and 6 mg tablets. The Mutual Recognition procedure started on 29 September 1995. The Reference Member State was The Netherlands and the Concerned Member States were Austria, Greece, Italy, Portugal and Spain. Sweden and Denmark had previously granted Marketing Authorisations for Amaryl 1 mg, 2 mg and 3 mg tablets under national procedures. The Concerned Member States, Austria and Portugal, not being able to agree with the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State referred the reasons for disagreement to the EMEA on 21 December 1995 and 28 December 1995, respectively.

The major reasons concerned the possible carcinogenic potential and the less possible glycaemic control with Amaryl.

The Reference Member State sent its report to the EMEA on 28 December 1996. The matter was referred to the CPMP on 18 January 1996. Written explanations were provided by the Marketing Authorisation Holder on 29 February 1996.

The CPMP adopted a positive opinion on 17 April 1996 recommending the granting of the Marketing Authorisation for Amaryl with amendments to the Summary of Product Characteristics of the Reference Member State.

A copy of the final opinion for Amaryl 1 mg as a relevant example is provided on the Internet, together with Annex I and Annex II, which contains an example of the amended Summary of Product Characteristics. Annex III provides an overall summary of the CPMP scientific evaluation.

The final opinion was converted into a Decision by the European Commission on 29 August 1996.

Key facts

About this medicine
Approved name
International non-proprietary name (INN) or common name
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

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.

How useful was this page?

Add your rating
1 rating
1 rating
1 rating