Taking Responsibility: Acting as Marketing Authorization Holder
As an external Marketing Authorization Holder, Diapharm enables manufacturers to leverage a comprehensive, EU-GMP-certified quality management system, as well as an established pharmacovigilance system. This not only ensures the continuous monitoring and assessment of drug safety, but also streamlines regulatory compliance within the market.
Diapharm manages the planning and execution of marketing authorization procedures, particularly in the context of Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP), acting as the central point of contact for regulatory authorities. In this way, companies from non-EU countries can bring their medicinal products and investigational medicinal products to market in Europäischen Union in full compliance with the law. EU batch certification and import release can also be reliably handled by Diapharm’s Qualified Persons.
In addition, manufacturers and marketing authorization holders benefit from attractive submission time slots with regulatory authorities, as well as strategic advice to optimize all procedural workflows. Portfolio changes – such as the acquisition or sale of authorizations, regulatory dossiers, or co-marketing partnerships—can be managed flexibly and always in adherence to applicable regulatory requirements.
As a Marketing Authorization Holder, Diapharm oversees all relevant regulatory processes: this includes variation management, preparation of Periodic Safety Update Reports (PSURs), direct communication with authorities, and the implementation of market surveillance measures – ensuring that your products remain fully compliant and ready for the market at all times.
