Combination products are human medicinal products comprising a medicinal product (MP) and a medical device (MD), in which the MP component has the primary effect and the MD has a supporting function. As human medicinal products, combination products are subject to MP legislation.
Combinations can be subdivided into the following three categories based on whether or not the combination of MP and MD is a non-separable UNIT:
Non-separable combinations, integral
The MP and MD form a non-separable UNIT and the combination product may not be reused, i.e. it is intended for single use. The MP has the primary effect. Examples include prefilled syringes, autoinjectors, preloaded powder inhalers and prefilled infusion pumps.
Non-separable combinations, co-packaged
The MP and MD are in the same packaging and are to be used exclusively in this combination (use-specific non-separability). The MP has the primary effect. The MD is used e.g. for dosing and/or administration. Examples include cough syrup with a measuring cup provided.
Separable combinations, referenced
The MD is not enclosed in the packaging with the MP. It is available separately. The medicinal product information refers to a specific MD for combined use. The MP has the primary effect.