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.
What makes a good RP/FFA:
- Knowledge of GDP and the relevant regulations
- Industry experience – relevant GDP experience
- Induction/primary training – role familiarity
- Role definition and place within the organisation – sufficient seniority and influence
- Delegation and training others – The RP is responsible for all GDP activities, even those delegated
- Training records – RP, Licence Holder and staff
- Continuing development for the RP – the supply chain continually presents new challenges
- Implement a quality system tailored to the Licence Holder
Mericon AS can offer support to every aspect of your distribution and supply chain, including Contract Responsible Person (RP/FFA).
Benefits of a Contract Responsible Person (RP/FFA):
- Lack of experienced or qualified people in your company
- Valuable support for on-site staff in your company and assist in their development.
- Free up time in your company to focus on business developmental activities instead of managing GDP activities
- Financial prohibitive, especially for low turnover companies or new start-up companies
- Cost-effective solution, takes away the need of hiring a permanent employee, resulting in substantial savings
Qualifications of our Contract Responsible Person (RP/FFA):
- Pharmaceutical degree
- Over 30 years expericence from the pharmaceutical industry
- Experienced within:
- Establishing GDP routines/reviewing existing routines
- Mapping of transport
- Qualifying suppliers of warehouse/transport services
- Setting up quality agreements
- Approval/release of received medical products/Active Pharmaceutical Ingredient (API)
For further information on the possibility of using Contract Responsible Person (RP/FFA) or about how Mericon can help your company optimise the quality aspects of the distribution and supply chain, please contact
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)
For further information, please contact Mette Hassan or Már Steinsen