Applicants are obliged to present to Swissmedic for inspection all data that are relevant for reviewing an application (e.g. cost-benefit considerations). By signing the Swissmedic form Application for Authorisation / Variation, Human / veterinary medicinal products, applicants confirm that they meet this requirement.
Swissmedic has, however, found that applicants have not actually been fully meeting this criterion: they have not been submitting all the data required for reviewing the application even though these were available to the applicant at the time of submission. As a result, Swissmedic has had to request the missing data through the List of Questions.
By adapting the Guidance document on time limits for authorisation, Swissmedic is now spelling out the procedure to adopt in such cases: Swissmedic will continue to request the missing documentation through the LoQ. Depending on the case, the review status will be reset to the "Doc OK" milestone and Evaluation phase I will be repeated; a second List of Questions is possible. Any additional costs incurred will be invoiced to the applicant.
The changes to the Guidance document take immediate effect.