Netherlands regulator 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 authorization. The individual products are different as regards qualitative or quantitative composition and are administered simultaneously or sequentially.
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:
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