- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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.
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
European Commission final decision
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.
Key dates and outcomes
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|EC decision date||
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.