Basiron AC and associated names - referral

Current status

European Commission final decision

Overview

Change not granted to the marketing authorisation for Basiron AC (benzoyl peroxide 5% and 10% gel) in the EU

On 28 March 2019, the European Medicines Agency completed a review of Basiron AC (benzoyl peroxide) following a disagreement among EU Member States regarding a change in the marketing authorisation of this medicine. In particular, the Agency was requested to make a recommendation on a change in the medicine’s formulation that would allow for greater stability in warmer countries. As the Agency could not conclude whether the change would impact on the effectiveness and safety of the medicinal product, the change in formulation cannot be granted.

What is Basiron AC?

Basiron AC is a medicine used to treat acne. It is available as a gel to be applied on the affected skin.

The medicine contains the active substance benzoyl peroxide, which kills certain bacteria that are associated with acne and has skin-peeling effects.

Basiron AC is authorised in Austria, Belgium, Denmark, Ireland, Italy, Finland, France, Germany, Luxemburg, the Netherlands, Norway, Portugal, Spain and Sweden. The company that markets the medicine is Galderma Nordic AB.

Why was Basiron AC reviewed?

Basiron AC has been authorised in the EU via national procedures.

In December 2017, Galderma Nordic AB submitted an application to the Swedish medicines agency, MPA, to change the formulation of the medicine by replacing the gelling agent Carbomer 940 with Simulgel 600 PHA. The change aimed to improve the stability of the gel to allow for a longer shelf-life in warmer countries.

The company wanted this change to be recognised in all the other Member States where the medicine is authorised.

However, the Member States were not able to reach an agreement and the Dutch medicines agency referred the matter to EMA for arbitration on 26 October 2018.

The grounds for the referral were concerns that the data provided by the company were insufficient to conclude that the change in formulation would not impact the effectiveness and safety of the medicine.

The company had provided data from laboratory studies that compared the skin absorption and penetration with the old and new formulation. In addition, the company provided data from clinical studies with another medicine, Epiduo (benzoyl peroxide and adapalene), containing the gelling agent Simulgel 600 PHA. However, no clinical studies were performed with the new formulation of Basiron AC.

What is the outcome of the review?

The Agency evaluated the currently available data but could not conclude whether the change in formulation would impact the effectiveness and safety of the medicine on the basis of the data provided. As a result, the change in formulation cannot be approved in all concerned Member States.

More about the procedure

The review of Basiron AC was initiated on 15 November 2018 at the request of the Netherlands, under Article 13 of Regulation (EC) No 1234/2008.

The review was carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.

A European Commission decision valid throughout the EU was issued on 4 July 2019.

Basiron AC Article-13 referral - Questions and answers on Basiron AC and associated names

Reference Number: EMA/400057/2019

Key facts

About this medicine

• Approved name:
  Basiron AC and associated names
• International non-proprietary name (INN) or common name:
  benzoyl peroxide

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/H/A-13/1475
• Type:
  Article 13 referrals

  This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• CHMP opinion date:
  28/03/2019
• EC decision date:
  04/07/2019

All documents

Opinion provided by Committee for Medicinal Products for human Use

Basiron AC - Article 13 referral - Assessment Report

Reference Number: EMA/304143/2019

Basiron AC - Article 13 referral - Annex II

Basiron AC - Article 13 referral - Annex I

Basiron AC Article-13 referral - Questions and answers on Basiron AC and associated names

Reference Number: EMA/400057/2019

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.