EMA to Review Product Combination Packages on Case-By-Case Basis

September 1, 2017

The European Medicines Agency updated its advice on navigating its centralized pre-authorization procedures to include a section on combination packs of medications.

In contrast to fixed-dose combination treatments, the EMA defines combination packs as separate active substances and pharmaceutical forms included in the same package, such as multiple tablets, which are covered by a single marketing authorization.

The agency said approvals of these products would be very exceptional and based strictly on public health considerations — telling sponsors they should not be designed for convenience or commercial purposes.

On a case-by-case basis, applicants will have to justify that the marketing is needed for “indispensable public health reasons,” the agency said, and advised companies to consult the EMA early during development.

The agency said it will work to notify sponsors on the acceptability of the combination pack within 60 days.

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