Diclofenac Sodium Spray Gel 4% - referral

Current status

European Commission final decision

Overview

On 15 November 2018, the European Medicines Agency completed a review of Diclofenac Sodium Spray Gel 4% following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of the medicine outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.

What is Diclofenac Sodium Spray Gel 4%?

Diclofenac Sodium Spray Gel 4% contains the active substance diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). The spray gel is applied on the skin of affected areas to relieve pain and swelling due to trauma in small and medium joints and surrounding tissues.

Why was the medicine reviewed?

MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK (the ‘reference Member State’) in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain (the ‘concerned Member States’).

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 4 April 2018.

The grounds for the referral were concerns raised by Germany and Spain that the data provided by the company were not sufficient to show that the product was effective at treating joint pain and swelling. In addition, the use of data from the published literature obtained with other diclofenac medicines to demonstrate the benefits of Diclofenac Sodium Spray Gel 4% needed to be further justified.

What is the outcome of the review?

The Agency considered that the data provided by the company show that, when applied to the skin, Diclofenac Sodium Spray Gel 4% produces similar levels of diclofenac in the body to another diclofenac gel already authorised for the same use. The company also provided the results of a study indicating that Diclofenac Sodium Spray Gel 4% is effective at reducing joint swelling and relieving pain.

Since Diclofenac Sodium Spray Gel 4% is absorbed in a similar way to other diclofenac medicines applied to the skin and the supporting study demonstrated an effect similar to that of other diclofenac medicines in the published literature, the Agency considered that it was acceptable to use published data on the effectiveness and safety of other diclofenac medicines to support the use of Diclofenac Sodium Spray Gel 4%. The Agency also considered that, although the effectiveness of diclofenac and other NSAIDs applied to the skin is somewhat modest, these medicines have been authorised and used for decades and their safety is not in question.

Overall, the totality of the data provided by the company was considered sufficient to demonstrate that Diclofenac Sodium Spray Gel 4% is effective at treating joint swelling and pain due to trauma. The Agency therefore concluded that the benefits of the medicine outweigh its risks, and therefore the marketing authorisation should be granted in the concerned Member States.

More about the procedure

The review of Diclofenac Sodium Spray Gel 4% was initiated at the request of the United Kingdom under Article 29(4) 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 the marketing authorisation of Diclofenac Sodium Spray Gel 4% on 18/01/2019.

Diclofenac Article 29(4) referral - EMA recommends authorisation of Diclofenac Sodium Spray Gel 4% (diclofenac) in the EU

Reference Number: EMA/631720/2018 Rev.1

Key facts

About this medicine

• Approved name:
  Diclofenac Sodium Spray Gel 4%
• International non-proprietary name (INN) or common name:
  diclofenac sodium

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29(4)/1467
• 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:
  15/11/2018
• EC decision date:
  18/01/2019

All documents

Opinion provided by Committee for Medicinal Products for human Use

Diclofenac Article 29(4) referral - CHMP assessment report

AdoptedReference Number: EMA/33272/2019

Diclofenac Article-29(4) referral - Annex III

Diclofenac Article 29(4) referral - EMA recommends authorisation of Diclofenac Sodium Spray Gel 4% (diclofenac) in the EU

Reference Number: EMA/631720/2018 Rev.1

European Commission final decision

Diclofenac Article-29(4) referral - Notification

Diclofenac Article-29(4) referral - Annex II

Adopted

Diclofenac Article-29(4) referral - Annex I

Adopted

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.