The shipment of blood products has to be notified to BASG at least 3 weeks in advance (Art 14 AWEG). This has repeatedly resulted in problems when using the electronic notification portal for investigational medicinal products (IMPs) (e.g., when the future date of shipment is not yet known, the exact amount of IMP is still unknown 3 weeks in advance, additional IMP is urgently needed but the 3-week waiting period applies, trial sites wish to hold IMP in stock, etc.).
Therefore, BASG suggests a new, 2-step, procedure.

A. Preliminary notification of estimated IMP requirements
Step-by-step procedure:

• The initial notification of the estimated amount of IMP that will be needed is submitted 3 weeks before the planned shipment date.
• The shipment date specified can be a preliminary date.
• The amount specified can be the best estimate possible at the time, but has to be covered by one or more hospital pharmacy orders.
• The initial notification also includes the Investigator‘s Brochure, the release certificate by the EU QP, the hospital pharmacy order, the certificate of analysis of the manufacturer, and the batch release certificate of an OMCL or the notification of the Austrian OMCL.
• The notification should also specify all relevant trial sites.

B. Follow-up notification of IMP amounts actually imported, to be submitted every 2 months
The time of the first IMP shipment starts the clock for follow-up notifications. Every 2 months, the IMP amounts actually imported are reported retroactively.
Step-by-step procedure:

• The first group notification covering the entire amount of IMP that has already been shipped by then should be submitted not later than 2 months after the first shipment. (Note: The first shipment should take place within 2 weeks after the planned shipment date specified in the initial notification.)
• The follow-up notification will refer to the reference number (Geschäftszahl, GZ) of the initial notification.
• The hospital pharmacy order(s) should be uploaded again, and the amounts of IMP already imported up to the date of notification should be stated. (It has to be made clear to BASG how much IMP has already been shipped and how much IMP still requires shipment.)
• All of the other documents mentioned above have to be uploaded only if needed, e.g., if there have been changes to the Investigator‘s Brochure or if a new release certificate by the QP, a new certificate of analysis by the manufacturer, a new batch release certificate of an OMCL, or a new notification of an Austrian OMCL has become available. If these documents are not uploaded, this has to be justified.
• All trial sites supplied with IMP in the follow-up reporting interval have to be specified.

The 2-monthly follow-up notifications have to be repeated until all shipments of the entire amount of IMP have been reported.

In addition, please note:
The amounts of IMP stated in the hospital pharmacy order have to match those given in the notifications. However, the date of the hospital pharmacy order is not relevant. Once the entire amount of IMP specified in the hospital pharmacy order has been shipped, a new initial notification has to be submitted. This marks the start of a new notification cycle. If the distribution between active substance and placebo IMP is not known, the randomisation code should be included in the notification. Initial and follow-up notifications always refer to a particular strength of IMP and the corresponding placebo. If a different strength of IMP is required, another initial notification (including any follow-up notifications) for this strength has to be submitted.