Sentence examples for time of authorisation from inspiring English sources
Alignment of data requests between the stakeholders, both around the time of authorisation and during a product's life cycle, would markedly simplify the process of data generation to answer important questions concerning a given drug.
At the time of authorisation, information was known about the psychiatric side effects of rimonabant 10 and liver toxicity associated with sitaxentan 11 and the benefit-risk balance deemed to be favourable.
Risk management plans form part of these programmes and aim to: specify what is and is not known about safety at the time of authorisation; make a plan with milestones indicating how safety knowledge will be extended postauthorisation; where necessary, define the necessary measures to minimise known risks and monitor the success of these measures.
At the time of marketing authorisation, the available information relating to a medicine may not yet be sufficient to fully assess the benefit/risk profile to the desired degree of certainty or may lack aspects of interests to the Committee for Medicinal Products for Human Use CHMPP) that are requested to be provided after marketing authorisation is granted.
For many treatments in common use there is no evidence to inform choice between available options, and, for most new medicines, evidence based assessment of any added therapeutic value is not published at the time of market authorisation.
REACH introduced the first time an authorisation requirement for common chemicals into the chemicals legislation of the EU.
Although not significant, it shows that the odds of authorisation for products based on existing synthetic entities may be about four times higher compared to biotechnological products.
The Lithuanian border guards would accept our letter of authorisation.
The latter required a greater degree of authorisation than a shotgun licence, he said.
Independent watchdog Monitor has ruled James Paget University Hospitals NHS Foundation Trust at Gorleston now meets its terms of authorisation.
The process of authorisation in a company as monolithic as Woolworths is immense.
