marketing authorization

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

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

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

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

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

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

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

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.

It has successfully secured more than 700 marketing authorizations globally.

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