The Commission published its proposal for the revision of the Variation regulation for medicines, as a part of the EU’s Pharmaceutical Strategy for Europe. The final objective is to adapt the current system for variations to the evolving reference framework, to make it more efficient, reduce administrative burdens and better respond to scientific and technological advances.

MAHs are responsible for ensuring that each medicine remains compliant throughout its lifecycle.  Variations to the initial authorisation can refer to administrative details, such as a change in company address, or to substantial changes, such as changes to the patient and healthcare information, the active substance or strength of the medicine. 

The Commission’s proposals simplify the notification of minor, type IA variations, and introduce  among others the possibility of super-grouping certain types of variations.

Source: European Commission

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