Techspec schreef op 2 november 2018 15:25:
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Het betreft gaan wijziging in de aanvraag voor goedkeuring!
De adaption slaat op;
The PDCO committee's roles include:
* assessing data generated in accordance with agreed PIPs;
* adopting opinions on the quality, safety or efficacy of a medicine for use in the paediatric population, at the request of the Committee for Medicinal Products for Human Use (CHMP) or a medicines regulatory authority in a European Union (EU) Member State. The PDCO can give an opinion if the data have been generated in accordance with an agreed PIP