BassieNL schreef op 1 februari 2018 13:18:
[...]
Klopt, de term voorlopige vergunning is niet de officiële term, maar dekt wel degelijk de lading. Het gaat om:
Conditional marketing authorisation
... is valid for one year and can be renewed annually
Aan alle onderstaande voorwaarden moet worden voldaan:
1. the benefit-risk balance of the product is positive;
2. it is likely that the applicant will be able to provide comprehensive data;
3. unmet medical needs will be fulfilled;
4. the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data.
meer info:
www.ema.europa.eu/ema/index.jsp?curl=...