![]() quality defect, pharmacovigilance reporting, etc.), in parallel, as appropriate: ![]() MAHs are advised that when cessation/suspension/withdrawal is due to efficacy, safety and/or quality related issues for which already particular procedures are established, reporting of such cessation in IRIS is without prejudice to applying the other specific related procedures (e.g. In case of a temporary marketing cessation, the anticipated reintroduction date needs to be provided. due to the presence of nitrosamine impurities), MAHs should also notify the EMA of actions undertaken in third countries. When the marketing cessation or withdrawal is due to reasons listed in Articles 116 and 117 (e.g. The MAH should specify the reasons for such action and particularly if this is solely based on a commercial decision or related to any of the reasons listed in Articles 116 and 117 of Directive 2001/83/EC (e.g. This also includes the withdrawal of a medicinal product from the EU market, or any decision to withdraw or suspend the marketing authorisation or not to apply for the renewal of a marketing authorisation.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |