Perlinring and associated names - referral

Current status

European Commission final decision

Overview

EMA recommends authorisation of Perlinring (etonogestrel / ethinylestradiol vaginal ring) in the EU

EMA completes review following disagreement among EU Member States

On 18 October 2018, the European Medicines Agency completed a review of Perlinring following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Perlinring outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Spain, Finland, France, Germany, Hungary, Ireland, Italy, Lithuania, Latvia, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia and Sweden, plus Iceland and Norway.

What is Perlinring?

Perlinring is a contraceptive vaginal ring used to prevent pregnancy. Each ring contains two hormones, etonogestrel and ethinylestradiol, which are slowly released into the blood circulation and prevent the release of eggs from the ovaries. Perlinring is used for 21 days (3 weeks) in a row, followed by a 7-day break, after which a new ring should be used.

Perlinring was developed as a generic medicine. This means that Perlinring was developed to contain the same active substance and work in the same way as a ‘reference medicine’ already authorised in the EU called Nuvaring.

Why was Perlinring reviewed?

Actavis Group PTC EHF submitted Perlinring to the UK medicines agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned’ Member States, see list above) where the company has applied for a marketing authorisation.

However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 7 August 2018.

In its application, the company for Perlinring provided data demonstrating that Perlinring is ‘bioequivalent’ to Nuvaring over a period of 3 weeks, which is the authorised length of treatment. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

The grounds for the referral relate to concerns raised by Germany, France and the Netherlands, that the Nuvaring product information for doctors and patients states that the product continues to be effective if it is used for an additional 4^th week. Although the bioequivalence data submitted were sufficient to show that Perlinring is bioequivalent to Nuvaring over a period of 3 weeks, they did not cover the additional 4^th week during which the contraceptive ring may still be used, even though this use is not recommended.

Bioequivalence data for week 4 were considered necessary by Germany, France and the Netherlands as Perlinring is expected to be used in the same way as Nuvaring.

What is the outcome of the review?

Based on evaluation of the currently available data, the Agency considered that bioequivalence to the reference medicinal product has been shown for the authorised duration of treatment (3 weeks). In addition, there is enough evidence to expect that Perlinring continues to be effective for an additional 4^th week, as is the case for Nuvaring. The Agency therefore concluded that the benefits of Perlinring outweigh its risks and recommended that the marketing authorisation be granted in all concerned Member States.

More about the procedure

The review of Perlinring was initiated at the request of the United Kingdom, under Article 29 of Directive 2001/83/EC.

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

The European Commission issued an EU-wide legally binding decision on 18 December 2018.

Perlinring Article-29(4) referral - EMA recommends authorisation of Perlinring (etonogestrel / ethinylestradiol vaginal ring) in the EU

Reference Number: EMA/720896/2018 Rev 1

Key facts

About this medicine

• Approved name:
  Perlinring and associated names
• International non-proprietary name (INN) or common name:
  • etonogestrel
  • ethinylestradiol

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29(4)/1473
• 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.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• CHMP opinion date:
  18/10/2018
• EC decision date:
  18/12/2018

All documents

European Commission final decision

Perlinring Article-29(4) referral - Annex III

Adopted

Perlinring Article-29(4) referral - Annex II

Adopted

Perlinring Article-29(4) referral - Annex I

Adopted

Perlinring Article-29(4) referral - Assessment report

AdoptedReference Number: EMA/897708/2018

Perlinring Article-29(4) referral - EMA recommends authorisation of Perlinring (etonogestrel / ethinylestradiol vaginal ring) in the EU

Reference Number: EMA/720896/2018 Rev 1

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.