In order for the VMD to prioritise its resources and expertise and provide you with a predictable authorisation process; we will be extending the requirement for submission slots to include national marketing authorisations for selected pharmaceutical applications submitted under Article 12(3) (full) or 13a (well-established use/bibliographic).
Applicants should contact us at least six months in advance to discuss your application(s). We may suggest a virtual company meeting for you to outline your proposed application and to discuss the regulatory aspects and timing of the submission.
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