Named Responsible Person · GDP
Responsible Person for GDP (RP), Belgium and the Benelux.
The Responsible Person named on your authorisation is the person you actually work with. Not an RP on paper who hands you to someone else in practice.
The role of the Responsible Person
You need a Responsible Person if you hold, or are applying for, a wholesale distribution authorisation in Belgium, Luxembourg or the Netherlands. Companies engage MEDCOR to act as their named RP, to prepare for a licence application or renewal, or to get a distribution quality system inspection-ready.
What this covers
- —Acting as the named Responsible Person for wholesale distribution authorisations, covering import, purchase, warehousing and export, including customs warehouses.
- —Building and maintaining Good Distribution Practice quality systems to EU GDP standards.
- —Preparing and managing wholesale distribution licence applications and renewals, with supporting quality documentation and the authority contacts and inspections that go with them.
- —Reviewing your GDP quality system before an inspection and setting out a prioritised plan to close any gaps.
- —Standard operating procedures written for your operation, not taken off a shelf.
How it works
The Responsible Person named on your authorisation is the person you actually work with. You are not assigned an RP on paper and handed to someone else in practice. You get senior pharmacist judgement, direct authority liaison, and one point of accountability for your distribution compliance.
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Need a Responsible Person for GDP?
Whether you are applying, renewing or preparing for inspection, let us talk it through.
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