marketing authorization AmE , auch: marketing authorisation BrE

In most countries, a marketing authorization is valid for a period of 5 years.

The companies are expected also to file for marketing authorization in Europe and around the world.

I therefore ask the Commission to consider this fact when they give marketing authorizations.

The company was tasked with seeking individual marketing authorizations in each of the seven countries.

It has successfully secured more than 700 marketing authorizations globally.

Guerbet withdrew the marketing authorization application for this product in 2007.

In several countries Krka also obtained 612 new marketing authorizations for various products.

On consumer safety, we note that the Commission consulted three expert committees before giving marketing authorization to this product.

The company has maintains 3,800 marketing authorization licenses for 630 different pharmaceutical products, classified in over 10 therapeutic categories.

The Commission is only able to intervene directly for medicinal products that have received a Community marketing authorization through the centralized procedure.

This, along with the potential for abuse, led to the suspension of the French marketing authorization for Survector in 1999.

It was once an approved drug in Brazil, but its marketing authorization was suspended in 2003, effectively prohibiting its sale.

However, in the European Union, after one renewal, the marketing authorization shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise.

A marketing authorization application was filed to EMA 21 June 2012, where a decision could come as soon as early 2013.

Consequentially, the marketing authorization of Tolcapone was suspended from December, 1998 to August, 2004 when it was lifted.

The article establishes that the holder of a marketing authorization for a drug for human use must have a QPPV.

European Commission has granted Marketing Authorization in Europe to Lixisenatide on February 2013.

The types of information covered by the arrangements include legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorization procedures, and post-marketing surveillance.

A conditional marketing authorization was licensed in December 2007 by the European Commission which was valid throughout the European Union.

Finland switched to a Danish strain BCG vaccine which did not have marketing authorization in Finland.

Phase III results of human trials were submitted to the Drug authorities of Government of India and obtained marketing authorization.

For these same indications brentuximab vedotin received a conditional Marketing authorization from the European Medicines Agency in october 2012.

Ulipristal acetate was granted marketing authorization by the European Medicines Agency (EMA) in March 2009.

It was approved in the 27 European Union member states plus Iceland, Liechtenstein and Norway via a centralized marketing authorization in March 2009.

Biocon has received marketing authorization for the drug from the Drugs Controller General of India (DCGI).