Bioequivalence and Bioavailability Forum

Dear Hallagulla,

❝ 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.

I can't say about the UK, they're no longer part of the EU and I don't know what rules they are following now, sorry.

❝ 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.

They should no longer do, it is not applicable any more, since Regulation 536/2014 came into force and introduced new requirements. But that's not your question.

❝ 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?

BE trials are considered to be clinical trials. Regulations applicable in the EU do not make any difference between BE trials and other clinical trials.

❝ I would like to understand

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

The question is not where the products are manufactured, but where they will be used. The products should be labelled following whatever regulatory requirements apply in the country where you run your trial. If it is done in the EU, then the labelling requirements in Articles 66 and 67 of Regulation 536/2014 apply.

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

In the EU, no. But check what is applicable where you run your study.

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

If you run your study in an EU Member State, and the comparator product is authorised in that Member State: according to the provisions of Article 67 (1)(b) of Regulation 536/2014, you may not need to re-label the reference product. In other countries: again, check the local requirements.