Isotretinoin - referral

Current status

European Commission final decision

Overview

Isotretinoin (13-cis-retinoic acid) is a retinoid compound and a derivative of vitamin A. Isotretinoin is used for the systemic treatment of acne. Like all retinoids, isotretinoin is teratogen and is contraindicated during pregnancy to avoid congenital defects.

A marketing authorisation for Isotretinoin was granted to Schering Health Care Ltd in UK, on 16 August 2001. The dossier was submitted as a so called “generic application”, as essentially similar to Roaccutane first authorised in EU in 1983. Applications for mutual recognition of Isotretinoin were submitted to Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal and Spain. The Mutual Recognition Procedure started on 4 February 2002.

On 3 May 2002, France presented to the EMEA a referral under Article 29 of Directive 2001/83/EC. The referral by France mainly related to the pregnancy prevention measures proposed for this generic product as reflected in the summary of product characteristics of the mutual recognition procedure.

The referral procedure started on 30 May 2002.

During its April 2003 meeting, the CPMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that a marketing authorisation should be granted provided amendment to the summary of product characteristics. In particular, isotretinoin (oral) should only be prescribed to women of childbearing potential under strict pregnancy prevention measures supported by a Pregnancy Prevention Programme (see annex III, amended summary of product characteristics). A positive opinion was therefore adopted on 25 April 2003.

The scientific conclusions and the grounds for the amendment of the Summary of Product Characteristics are set out in Annex II, together with the amended Summary of Product Characteristics in the Annex III.

The final opinion was converted into a Decision by the European Commission on 17 October 2003.

Summary information on a referral opinion following an arbitration pursant to Article 29 of Directive 2001/83/EC, for Isotretinoin, Lurantal, Trivane, Rexidal, Rcheritonin (See Annex I) International Non-Proprietary Name...

Adopted Reference Number: CPMP/2811/03

Key facts

About this medicine

• Approved name:
  Isotretinoin
• International non-proprietary name (INN) or common name:
  isotretinoin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/2811/03
• 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:
  25/04/2003
• EC decision date:
  17/10/2003

All documents

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

Adopted

Summary information on a referral opinion following an arbitration pursant to Article 29 of Directive 2001/83/EC, for Isotretinoin, Lurantal, Trivane, Rexidal, Rcheritonin (See Annex I) International Non-Proprietary Name...

Adopted Reference Number: CPMP/2811/03

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.