Referrals to the EMA and CHMP? Keep calm and carry on.
What is a Referral all about?
A Referral to the EMA and CHMP is a procedure used to resolve issues such as concerns over the safety or the benefit-risk balance of a medicine or a class of medicines. The matter is ‘referred’ to the European Medicines Agency, so that its expert committees can make a recommendation for a harmonised position across the European Union.
There are a number of reasons why a Referral may be started, ranging from concerns over the safety of a class of medicine to disagreements among Member States on the use of the medicine.
Whatever the reason, your product going to a Referral is a challenging and most probably an unknown (and unwanted) procedure and unfortunately it would seem in recent years Referral procedures have increased, especially Article 29 and Article 30 Referrals.
Recent success with a complicated fixed combination referral
Ivowen recently guided a company through a successful Article 29(4) Referral. This type of Referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.
With all the “big players” involved in the concerned decentralised procedure; United Kingdom, Germany, France, Spain, Portugal, Austria, Belgium, Croatia, Ireland, Luxembourg, the Netherlands, this Referral was challenging in more ways than one.
However, on 18 May 2017, the EMA completed the arbitration procedure. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the product outweigh its risks, and the marketing authorisation can be granted. Information regarding this Referral procedure can be found on the EMA website.
Need help with a Referral?
If your products are heading into any Referral, be it an Article 29, 30, 31, 35 or 36, and you need support; from talking you through the complicated timetable, supplying quality and clinical support to the provision of translations why not contact Ivowen to help you through this daunting task?
