Pharmaceutical wholesale is an intermediary between the pharmaceutical industry and their customers by purchasing and distributing medicines to their customers.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.
According to the EU Good Distribution Practice Guide the wholesale distributor must designate a person as responsible person (RP/FFA). The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP. Norwegian Medicines Agency demand a pharmaceutical degree.
The Norwegian regulatory authorities focus heavily on quality and safety, and demands to fulfil these requirements are continuously increasing. We can provide pharmaceutical wholesale support:
- Guidance according to Good Distribution Practice (GDP)
- Guidance according to Norwegian and European requirements
- Applications for wholesale distribution authorisation for medicinal products
- Act as your Responsible Person (RP)