Glimepirida Parke-Davis - referral

Current status

European Commission final decision

Overview

On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Glimepirida Parke-Davis (glimepiride, tablets 2, 3 and 4 mg). The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Glimepirida Parke-Davis outweigh its risks, and that the marketing authorisation can be granted in Portugal and in the following Member States of the EU: Cyprus, France, Germany, Italy, Sweden and the United Kingdom.

What is Glimepirida Parke-Davis?

Glimepirida Parke-Davis is a medicine used to treat type-2 diabetes (a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively).

The active substance, glimepiride, stimulates the pancreas to produce more insulin. As a result, blood glucose is reduced and this helps to control type-2 diabetes.

Glimepirida Parke-Davis is a 'generic medicine', which means that it is similar to a 'reference medicine', already authorised in the EU, called Amaryl.

Why was Glimepirida Parke-Davis reviewed?

Parke-Davis submitted an application for Glimepirida Parke-Davis (1, 2, 3 and 4 mg tablets) to the Portuguese medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance Portugal) 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', in this instance Cyprus, France, Germany, Italy, Sweden and the United Kingdom). However, the Member States were not able to reach an agreement and the Portuguese medicines agency referred the matter to the CHMP for arbitration on 31 May 2012.

The grounds for the referral were concerns over the approach used to demonstrate that Glimepirida Parke-Davis 2, 3 and 4 mg are 'bioequivalent' to Amaryl at the corresponding doses. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. The bioequivalence study submitted by the company was carried out using 1 mg of Glimepirida Parke-Davis, and the results were applied to the higher strengths. Although the Member States agreed that 1 mg Glimepirida Parke-Davis was bioequivalent to 1 mg Amaryl, concerns remained over whether a bioequivalence study should have been carried out with the highest strength, 4 mg, to show bioequivalence for Glimepirida Parke-Davis 2, 3 and 4 mg with Amaryl at the corresponding doses.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the bioequivalence study conducted with the 1 mg tablet is adequate to show that the higher strengths of Glimepirida Parke-Davis and Amaryl are also bioequivalent. The CHMP therefore concluded that, as Glimepirida Parke-Davis 2, 3 and 4 mg strengths are bioequivalent to the reference medicine, marketing authorisation should be granted in the concerned Member States.

The European Commission issued a decision on 19 November 2012.

Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg)

Reference Number: EMA/480596/2012, Rev. 1 Summary:

On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Glimepirida Parke-Davis (glimepiride, tablets 2, 3 and 4 mg)

Key facts

About this medicine

• Approved name:
  Glimepirida Parke-Davis
• International non-proprietary name (INN) or common name:
  glimepiride
• Associated names:
  • Glimepiride Pfizer
  • Glimepirid Pfizer
  • Glimepiride tablets 2 mg
  • Glimepiride tablets 3 mg
  • Glimepiride tablets 4 mg
• Class:
  Sulfonamides, urea derivatives

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1338
• 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:
  19/07/2012
• EC decision date:
  19/11/2012

All documents

European Commission final decision

Glimepirida Parke Davis - Article 29(4) referral - Assessment report

Glimepirida Parke Davis - Article 29(4) referral - Annex I

Glimepirida Parke Davis - Article 29(4) referral - Annex II

Glimepirida Parke Davis - Article 29(4) referral - Annex III

Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg)

Reference Number: EMA/480596/2012, Rev. 1 Summary:

On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Glimepirida Parke-Davis (glimepiride, tablets 2, 3 and 4 mg)

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.