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"We would seek to take advantage of this to mitigate any losses in the event that no authorisation is granted.
Even if an authorisation is granted, it can be withdrawn at any time after having been reviewed.
Clinical Trials Authorisation is granted from the Medicines and Healthcare Products Regulatory Agency (MHRA, 07/01/2013) and University of Oxford Genetic Modification Safety Committee GSMCC reference GM462.11.64, 21/01/2013).
Where a marketing authorisation is granted or varied, any waiver or deferral which has been granted pursuant to this Regulation shall be recorded in the SmPC and, if appropriate, in the PL of the medicinal product concerned.
After expiration of the transitional period for each Annex XIV-SVHC, articles, such as most products of daily use, produced in the European Economic Area (EEA) may not contain such substances unless an authorisation was granted for the specific use or this use falls within the scope of an exemption from the authorisation requirement.
"In one case the Igis was notified 10 days after the authorisation was granted.
What is called "interim authorisation" was granted to 5,247 brokers, and only since 1 October has the authority begun assessing applications in detail.
Authorisation was granted by the National Ethics Committee for Health Research and agreement delivered by the Ministry of Health of the Kingdom of Cambodia in October 2002 (Document signed under No 1296/02 OGH).
Clinical Trial Authorisation was granted by Medicines & Healthcare Products Regulatory Agency, Eudract number 2008-001620 and the study was approved by the North of Scotland Research Ethics Committee, study number 06/S0901/39.
This study was an in-depth analysis of data from a previous study on the availability of comparative information on new medicines at the time European market authorisation was granted [ 8].
7. The holder of the authorisation shall notify the customs authorities of all factors arising after the authorisation was granted which may influence its continuation or content.
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CEO of Professional Science Editing for Scientists @ prosciediting.com