Function as marketing authorisation holder

Through our Hälsa Pharma service, we  take on all the duties and responsibilities of a marketing authorisation holder for manufacturers and distributors, either for a specific period of time or permanently, depending on your needs.

This service is ideal for all manufacturers and distributors that:

• need a comprehensive Good Manufacturing Practice (GMP) compliant quality management system and pharmacovigilance system without delay
• want to apply for marketing authorisation procedures, particularly mutual recognition procedures (MRP) and decentralised procedures (DCP) easily using an external marketing authorisation holder
• would require attractive submission periods (time slots) from regulatory authorities in the European Union
• want to market medicinal products and/or distribute investigational medicinal products in the European Union as manufacturers from non-EU member states (Switzerland, United States, etc)
• want to change their portfolio by buying or selling marketing authorisations and dossiers or co-distribution agreements confidentially through a third party

As defined by EU legislation, Hälsa Pharma GmbH is fully equipped to handle these responsibilities. For example, it is certified according to GMP (good manufacturing practice) as a pharmaceutical company and importer.
Depending on a company’s individual needs, Diapharm can also coordinate the assumption of additional duties and responsibilities – such as the Qualified Person for Pharmacovigilance (QPPV), Qualified Person (QP) or information officer – through its marketing authorisation holder service.