• 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

Approved name
International non-proprietary name (INN) or common name


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.

European Commission final decision
Opinion date
EC decision date

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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