Time savings due to parallel submissions in batch release

messages in brief | 18/07/2019

The concept of parallel submission in official control authority batch release means that the applicant sends samples to the BASG-OMCL (Official Medicines Control Laboratory) while he is still testing them himself. Complete documentation is not necessary at that point of time. By that means, a lot of time can be saved. When all necessary documents are submitted by the manufacturer and the application is complete the time starts to run. Usually the testing is already completed by the OMCL at that point of time. In 2018, the OMCL has released coagulation factors, human albumins and immunoglobulins in an average time of two days very time-saving, whilst the statutory period would be 60 days.