Bioequivalence and Bioavailability Forum

Hi Everyone

I have a question regarding the labeling requirement for IMPs (Manufactured in the UK and EU region) and to be used for bioequivalence studies in other countries.

QPs/QA quote Annex 13 for labeling test and reference products as IMPs. And they want to have all the information crammed in the label.

According to my understanding, Annexure 13 is intended for clinical trials. The IMP label should contain certain information that is necessary for the patient's safety and adverse event reporting during clinical trials.


Does the same information need to be provided for bioequivalence studies as well?

Test product: It is reasonable to add certain information to the product label (such as name, strength, batch number, CLinical trial use only, pack size, and expiration date etc) so that it can be identified once it reaches CRO. These products will be further divided into individual packs or units before dosing, and each pack/unit will contain information specific to that bioequivalence study and those labels will be generated by CRO.

Reference product: Are we really required to over-label the blisters or even the secondary packaging? These products will be further divided into individual packs or units before dosing, and each pack/unit will contain information specific to that bioequivalence study and those labels will be generated by CRO.

Putting the required information as per Annexure 13 on small comparator packs is extremely difficult. It could also lead to confusion if the over label comes off during shipment or before it reaches the CRO?

I would like to understand

What is the actual (and practical) labeling practice for IMPs (test and comparator) manufactured and released from UK/EU countries for BE/BA studies?

Is there a separate rule/article for the guidance of labeling of test and comparator for Bioequivalence studies?

Can we put required comparator packs in a box and then add all the information on that tertiary packing?

TIA