5. DHPC detailed processing
5.1. A national implementation of the EMA guidance: the Dutch example
The national authority in the Netherlands responsible for the processing of DHPCs is the College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB). Under a dedicated section on their website [3], the CBG-MEB gives access to the DHPCs that have been issued in the Netherlands since 1998. Several sections refer to what is written in the EMA guideline, the possible reasons for sending a DHPC and the procedure for DHPCs according to the three different routes of MA. The procedures that the MAH should follow when getting in touch with the CBG-MEB are also carefully described; in particular for a DHPC, when it is exclusively a national initiative. The website also provides details about specificities of the Dutch system. For example, the use of an ‘orange envelope’ – rather than a standard white envelope – is discussed for situations that require urgent action to be taken towards the patient. Routine methods of communication should not be used, according to the CBG-MEB, but special wording should be used to focus extra attention on the letter, such as ‘important restriction of indication’ or ‘very important warning that must be implemented immediately’.