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


A referral under article 12 of Council Directive 75/319/EEC, as amended, was invoked by Finland on 12 October 1998, requesting the Committee for Proprietary Medicinal Products (CPMP) to “give an opinion on whether there is an unfavourable benefit/risk ratio for vigabatrin, especially in relation to its potential to induce serious visual field defects”.

The Marketing Authorisation Holders provided written explanations on 27 November 1998, 15 March 1999 and 22 April 1999 and oral explanations at the April 1999 CPMP meeting.

On 20 May 1999 the CPMP adopted an Opinion recommending the maintenance of the Marketing Authorisations for all vigabatrin containing medicinal products according to the amended Summary of Product Characteristics (SPC) and under specific conditions.

A copy of the Opinion on vigabatrin containing medicinal products is available on the Internet together with the scientific conclusions and grounds for amendment of the SPC in Annex I, the list of the concerned Marketing Authorisation Holders and Marketing Authorisations in Annex II, the amended SPC in Annex III and the conditions of the Marketing Authorisations (CPMP requirements in relation to pre-clinical studies, clinical studies and patient follow-up) in Annex IV. Translations of such Opinion and its Annexes are available on the Internet in French, German and Spanish.

On the basis of the Opinion adopted by the CPMP the European Commission issued a Decision on 5 October 1999 which was addressed to the concerned Member States for compliance within 30 days.

Key facts

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


Reference number
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

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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