Referral Archives | European Regulatory Affairs Specialists

Ivowen attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November.

We all saw Brexit come and go, Twice !! We wait to see what lies in store for the next deadline in January 2020.

The FMD came into effect across Europe in February in most member states.

Bulgaria joined CESP, eCTD became mandatory for all human procedures, lots of new guidance was published (to keep us all on our toes) and Nitrosamines in medicinal products moved to the top of everyone’s agenda.

With the festive season now upon us and 2020 on the horizon, Ivowen are setting our sights on the year ahead.

We will be attending the Medicines for Europe conference in January 2020 (Regulatory and Pharmacovigilance) and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’. This is a great opportunity to ask those difficult questions that you just could not get a straight answer to in 2019, on the ever present grey areas of Regulatory procedures.

To help you to plan ahead here are some helpful updates, in brief, as full articles will be posted in 2020:

Falsified Medicines Directive – Where we are now:

Implemented on 9^th Feb 2019 in all MS except Greece, Italy and Belgium
The European Commission has produced a video to explain more about the safety features.
The HPRA have extended the use and learn period, initially to Sep 2019 and extended it again to end on a phased basis starting from 31st January 2020.
The MHRA is also taking a pragmatic, flexible approach to how they enforce the new legal requirements.

Nitrosamines

Step 1: MAHs should conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome by 26 March 2020 at the latest.
EMA guidance can be found at https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities-overview
CMDh guidance can be found at https://www.hma.eu/226.html#c6548

Ivowen are here to assist you in 2020 and will continue to provide the top quality service you have come to expect from us.

For more information on Ivowen’s services and how we can help you, contact us.

Written by Alice D’Alton.

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.

2019 – What a year

Referrals to the EMA and CHMP? Keep calm and carry on.

What is a Referral all about?

Recent success with a complicated fixed combination referral

Need help with a Referral?

Need help with all the regulatory jargon?

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