Licence for the handling of controlled substances

A company must already be in possession of a licence for the handling of controlled substances at the time of submission of the application for authorisation of a medicinal product with a controlled substance (“narcotic”). From receipt of the complete application, the maximum processing time until receipt of the licence is approximately 10 weeks, not including any possible inspections. There is no possibility to shorten the processing period. However, by submitting a correctly completed application containing all of the required documents, it is possible to avoid additional time being added for queries or for additional requests for missing documents arising during the review of the documentation.