Assessment criteria for combination packages policy established
The Medicines Evaluation Board (MEB) has described the terms and conditions which are to be used to assess applications for combination packages of medicinal products. These terms and conditions can be found in the Assessment criteria for combination packages policy document (MEB 47).
Combination packages are packages which contain more than one medicinal product and are brought to the market under a single trade name and a single marketing authorisation. The individual products are different as regards qualitative or quantitative composition and are administered simultaneously or sequentially.
Terms and conditions
In the Assessment criteria for combination packages policy document (MEB 47) the MEB interprets the terms and conditions which have been established at European level. This relates to:
- a necessary condition
- a number of special conditions
- a number of general conditions
Combination packages are only accepted if they comply with the necessary condition as described and at least 1 special condition.
Failure to comply with all the general conditions may prevent acceptance of a combination package because it can cast doubt on the safety and relevance of the new combination package.
Public consultation responses
In November 2016 the MEB held a public consultation with regard to drawing up the terms and conditions for accepting combination packages of medicinal products. The responses referred primarily to:
- Devices - the combination of a medicinal product with a device must comply with the necessary condition referred to in the policy document. The MEB assesses, for each application, whether there is a pharmacotherapeutic reason for the combination of a medicinal product and a device.
- Fixed-dose combination - this policy document only relates to combination packages, for example 2 individual tablets in 1 package (instead of 2 individual tablets in 2 packages).
This policy document does not relate to fixed-dose combinations (FDCs), whereby the active ingredients from 2 or more individual tablets are combined into 1 tablet.
- User-friendliness - the MEB regards user-friendliness not to be an argument for accepting a combination package. User-friendliness can therefore only be used as a supplementary argument when applying for a combination package.