The Dutch Medicines Evaluation Board (MEB) recently published the “Assessment criteria for combination packages” policy document (MEB 47). The MEB 47 sets out the conditions that the MEB applies for assessing and authorising combination packages, i.e. packages with more than one medicinal product that are marketed under a single trade name and marketing authorisation.
The requirements include:
- A clear pharmaco-therapeutic rationale for the combination of the components of the package.
- At least one of the following special conditions: (i) the package includes instructions for use that are more difficult to be carried out reliably when the medicinal products are marketed individually; (ii) at least one of the components has not been authorised for marketing individually or indicated for the condition that the combination package has been indicated for; and (iii) the combination package provides a full course of treatment for a specific indication.
The MEB 47 also sets out the following general conditions that are not required to be fulfilled though failure to do so may negatively impact the assessment of the combination package:
- It is not possible to replace the combination with a fixed dose combination.
- The patient can independently use all the components of the package.
- It must be reasonable to assume that the components of the combination package are the only medicinal products used by a significant proportion of patients for the indication or condition in question.
- The dosage regime for the components in the combination package must be clear.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, June 2017 Issue (Thomson Reuters).