Reporting of adverse events ONLY

Patients should always seek the advice of a doctor or pharmacist in case of adverse events.

If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:

00420 224 910 672

(from 09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.

Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

00420 224 910 672

(09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

The MNAT initiative – what’s new?

Back in 2013, the European Medicines Agency (EMA) established a pilot scheme called the Multinational Assessment Team (MNAT) Initiative. For the assessment of new marketing authorisation applications, the MNAT provides the option for the EMA scientific committees to rely on an assessment team formed from national competent authorities (NCAs) of different European Union (EU) Member States in return for payment by the EMA to the individual NCAs.

In practice, every new marketing authorisation for human medicinal products submitted under the centralised procedure is assessed by a rapporteur and a co-rapporteur from the EMA Committee for Medicinal Products for Human Use (CHMP), or the EMA Committee for Advanced Therapies (CAT). These scientific committees are composed of individual experts from different NCAs who must choose teams of assessors and experts to support them. Traditionally, the scientific committees choose teams of assessors and experts from their respective NCAs. The MNAT Initiative is intended to encourage the scientific committees to form multinational co-rapporteur teams with the best expertise available from a broader number of EU Member States.

The overarching objective of the MNAT Initiative is to allow a broader involvement of NCAs from different EU Member States in the work of the EMA scientific committees. The logic behind this is to spread the workload and to broaden the expertise across the EU. With the MNAT Initiative, the EMA is seeking to optimise the use of national resources, whilst maintaining the high quality scientific work of the EMA scientific committees.

In December 2016 the EMA endorsed the EMA document “Multinational assessment team concept: the next phase – Broadening the concept to the post-authorisation phase”. This document stipulates that, from April 2017, assessment teams consisting of different EU Member States NCAs will also be able to evaluate applications for extensions of marketing authorisations of existing medicinal products.

The expansion of the MNAT Initiative has been initially limited to assessments of applications for extensions of indications and line extension applications, relating to products in relation to which an MNAT was involved in evaluating the original marketing authorisation application. In July 2017, the EMA released further guidance to rapporteurs and coordinators managing MNAT procedures.

Importantly, the EMA has also seen that the MNAT initiative is one possible way of finding a solution to the issue of Brexit and its reliance on United Kingdom experts and, once the UK leaves, to compensate for the loss of UK expertise.

Here at ELC Group we have a team of experts available and on-hand to help plan and manage your future EMA submissions, taking into consideration the rapidly changing regulatory environment and potential pitfalls in regulatory submission strategy.