As of 2006 the new Central Review Decree (Besluit Centrale Beoordeling medisch-wetenschappelijk onderzoek met mensen, BCB) (in Dutch) came into force. This states that the CCMO is the assigned reviewing committee for for ‘scientific research aimed at the development of a vaccine’. Since 2009 this description is given for research with one or more non-authorised vaccines. An authorised vaccine has an RVG (national authorised medicinal product) or EU (European authorised medicinal product) number.
There are two exceptions to this rule:
- Non-therapeutic intervention research with vaccines in minors and/or incapacitated adult research subjects. In this case it does not matter if the vaccine has not been authorised: research with an authorised vaccine that you wish to carry out in this target group must also be submitted to the CCMO. An example is research into an authorised travelers vaccine in children in the Netherlands.
- Mock-up flu vaccines. If a new influenza stem is introduced in an authorised mock-up vaccine, the CCMO does not view this mock-up vaccine to be registered until it has been re-authorised. Until that has been realised the study must be submitted for review to the CCMO. If the mock-up vaccine is used with the influenza stem for which it is already authorised, then the vaccine is of course registered. In this case the research can be submitted to an accredited MREC for review.
Is the research into an increase in the indication or a different dosage within the present registration file? In other words, is there no new RVG or EU number? Then the vaccine is determined to be registered and the research van be reviewed by an accredited MREC. Unless, once again, it concerns a mock-up vaccine with a new stem.