Please login to the form below

Not currently logged in
Email:
Password:

EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

European Medicines Agency (EMA) - logoThe European Medicines Agency (EMA) expects its marketing application fees will this year rise at a slower pace than last year.

The regulator says it anticipates fee rates, which are adjusted each year in line with the EU's inflation rate for the previous year, will increase by around 2.6 per cent, compared to 3.1 per cent in 2012.

The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line with its 2012 inflation rate.

The final adjustment is not yet known, but full details of the revised fees should be published at the end of March.

The EMA said that applications received by March 31 would be charged at the current fee and reduction rates, but later applications would be charged the adjusted fees.

The full fee for a marketing authorisation application of a single strength and form of a pharmaceutical product is €267,400, with reductions offered to, for example, micro, small and medium sized enterprises.

Meanwhile, for scientific advice and protocol assistance, the cut-off date will be the date of validation of the request for advice.

26th February 2013

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Healthcare Media Europe – HME Ltd

HME are an innovative and technology enabled agency offering our clients over 35+ years of knowledge and expertise in delivering...

Latest intelligence

GDPR and events. What does the pharma industry need to know?
...
Digital trends in B2B sales - how far behind is Pharma?
The modern approach to B2B sales is data-driven, and enabled by digital tools....
The rise of vertical integration in the US payer landscape
Is it a solution to addressing the challenges of the value-based marketplace?...

Infographics