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
Function as pharmaceutical company
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.