Wholesale Distribution Authorization
To obtain a Wholesale Distribution Authorization under Articles 76 ff. of EU Directive 2001/83/EC — in Germany: § 52a AMG — the following requirements must be met:
- a pharmaceutical quality management system in accordance with the EU GDP Guideline,
- appropriate facilities and premises for proper storage and distribution,
- a Responsible Person (RP) with the required expertise for wholesale activities.
Diapharm checks whether all prerequisites for obtaining the Wholesale Distribution Authorization are met and ensures compliance with Good Distribution Practice. We prepare everything required: compiling and updating necessary documentation, creating the quality assurance system and SOPs, qualifying the supply chain, and auditing storage facilities and logistics providers. Diapharm can also establish contact with the competent authorities and provide support during (pre-approval) inspections.
Responsible Person for Wholesale Distribution
For many pharmaceutical companies, providing one or more full-time Responsible Persons who are available 24/7 is neither economical nor necessary. Diapharm assumes the role of Responsible Person for Wholesale Distribution on your behalf — providing both expertise and capacity.
Manufacturing and Import Authorization
In order to manufacture medicinal products, companies require a manufacturing authorization in accordance with §13 of the German Medicines Act (AMG). The basis for this is a GMP-compliant quality management system and the necessary personnel qualifications. Diapharm handles the implementation of the quality management system, communication with the regulatory authority, inspection support, and assumes the following functions:
- Qualified Person (QP) acc. §14 AMG
- Head of Manufacturing acc. §12 AMWHV
- Head of Quality Control acc. §12 AMWHV
Whoever intends to import medicinal products into the EU must obtain an import authorization in accordance with §72 AMG. Once products are imported into the European Economic Area, batch release must be carried out by an EU-based Qualified Person (QP). Diapharm handles all necessary steps to obtain this authorization for clients — or performs the import batch release under Diapharm’s own manufacturing and import license.
Marketing Authorization Holder
Submitting a notification in accordance with §67 AMG is a prerequisite for acting as a Marketing Authorization Holder (MAH) in Germany. This requires a GMP-compliant quality management system, a pharmacovigilance system, and responsible persons for
- Quality assurance
- Pharmacovigilance (Qualified Person for Pharmacovigilance acc. to §63a AMG)
- Advertising and labeling compliance (Information Officer under §74a AMG)
Diapharm sets up the required quality management system for clients, handles the notification process with the local authority, and provides the necessary role-holders. Alternatively, Diapharm can act as the Marketing Authorization Holder itself.
