The Commission has proposed to amend the variation legislation for medicines, to make the lifecycle management of medicines more efficient and better adapted to the modern context. The Regulation, which is part of the EU’s Pharmaceutical Strategy for Europe, adapts the current system for variations to marketing authorisations, to make it more efficient, reduce administrative burdens and better respond to scientific and technological advances.
The pharmaceutical sector operates under stringent regulations to ensure public health and patient safety. Medicines are only granted marketing authorisation after their quality, safety, and efficacy have been positively assessed. Marketing authorisation holders are responsible for ensuring that the medicine remains compliant throughout its lifecycle and are obliged to report any changes – “variations” – to the initial authorisation, as they arise. These variations can range from administrative details, such as change in company address, to substantial changes, such as changes to the patient and healthcare information, the active substance or strength of the medicine. These variations must be assessed by the authorities based on their impact on public health and the medicine’s characteristics.
Since it was last revised, the Variations Regulation has made a marked contribution in harmonising and aligning the life-cycle management of medicines, post-authorisation, across the EU. However, the rules need to be updated in line with recent scientific and technological advancements and a rise in the number of variation requests.
The proposed revisions will facilitate quicker processing of variations, benefiting both marketing authorisation holders and regulatory authorities. They will facilitate more efficient lifecycle management of medicines while awaiting the broader proposed reform of the EU’s pharmaceutical legislation.
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