Medical products

Draft amendments to the Rules for Marketing Authorization and Assessment of Medicinal Products for Human Use

The draft Decision envisages updating the text of the Marketing Authorization and Assessment of Medicinal Products for Human Use, taking into account the experience of their enforcement, improving the classification of changes to the registration dossier of a medicinal product, detailing the requirements and number of documents submitted by the applicant as part of the amendment procedure; optimizing administrative procedures related to this procedure