Examples of Medicines in a sentence
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
An updated RMP should be submitted:• At the request of the European Medicines Agency;• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
In respect of all Pharmaceutical products supplied, shall comply Pharmacopoeia Standards that are indicated in the item specifications, other Pharmacopoeia Standards accepted in the product registration by the National Medicines Regulatory Authority.
The measures and timelines of the agreed paediatric investigation plan and the subset(s) of the paediatric population and condition(s) covered by the waiver are set out in the Annex I.This opinion is forwarded to the applicant and the Executive Director of the European Medicines Agency, together with its annex and appendix.
The Paediatric Committee of the European Medicines Agency has given an opinion on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver.