Food effect on bioequivalence

Is it possible to use Art. 10(3) legal basis?

The CMDh has recently discussed the following situation during a RUP:

The bioequivalence of the medicinal product was proven only under fed conditions and NOT for fasting conditions. The legal basis of Article 10(3) has been applied for the dossier submission. SPC changes considering the difference in bioavailability were proposed as a risk minimization measure.

RMS position: The approach is in line with the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms.

CMS position: NOT acceptable. Their interpretation of the Guideline is as follows: Products with a lesser food effect compared to the reference product should be authorised under Art. 10(3) to promote the availability of products with the superior formulation.

Conclusion: The CMDh will send a question to Pharmacokinetics Working Party for the correct interpretation of the Guideline.