Sentence examples for dossier was submitted from inspiring English sources

A regulatory dossier was submitted to the Indian authorities in April 2009 and WHO in September 2009.

A registration dossier was submitted to the FDA in late 2008 for the treatment of refractory ovarian cancer and a decision of approval is expected to take place in 2009.

The vaccine was licensed by the Drug Controller General of India in January 2010 and prequalified by the World Health Organization (WHO) in June 2010, and a common regulatory dossier was submitted to the first 3 countries (Burkina Faso, Mali, and Niger) by SIIL prior to introducing the vaccine, in accordance with regulatory requirements.

The first part of the 13 000-page dossier was submitted in April 2009 and included nonclinical data; a second part was submitted in July 2009 and contained data from phase 1, phase 2, and phase 2/3 clinical studies conducted in India and Africa.

By contrast, the dossier is submitted at market entry in Germany.

When a registration dossier is submitted to ECHA, it generally passes only an IT-supported accordance check which might not reveal incorrect information.

Besides a rating based on self-assessment by the manufacturer when the dossier is submitted, an assessment from the IQWiG and/or the GBA is vital for the final benefit rating [2].

The dossiers were submitted in August 2010.

In total 145 dossiers were submitted, seven were withdrawn by the submitting authorities before voting in the Member State Committee.

Excluding the registrations for on-site intermediates, 19,772 dossiers were submitted to ECHA by the first registration deadline [18].

In the Substance Exchange Fora (SIEFs c, a disproportionately large number of German companies are 'Lead Registrants', and in the first registration phase 40% of the lead dossiers were submitted by German companies [2]. Figure 1 Share of the member states in registrations.