BassieNL schreef op 28 juni 2018 16:56:
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Je moet je mening bijstellen.
www.ema.europa.eu/ema/index.jsp?curl=...Conditional marketing authorisations may be granted if the CHMP finds that all the following requirements are met:
- the benefit-risk balance of the product is positive;
- it is likely that the applicant will be able to provide comprehensive data;
- unmet medical needs will be fulfilled;
- the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data.
Allemaal van toepassing. Anders was die hele aanvraag niet in behandeling genomen.