Approval procedure
Support with the application and communication with the responsible authorities.
Knowledge · §52a AMG
Wholesale authorisation under §52a AMG.
The central prerequisite for the lawful distribution of medicinal products. We support you from preparation through to the successful granting or amendment of your authorisation.
Requirements
What the authority wants to see.
The authorisation procedure examines your operation thoroughly – typical hurdles are:
- Complete application documents and clean communication with the responsible authority.
- QM documentation as a prerequisite for the granting – from SOPs to the responsibility matrix.
- A nominated Responsible Person with clearly defined and lived duties.
- Completed qualification documentation – rooms, facilities and equipment qualified and fully documented.
Support
How we accompany your procedure.
Documentation & QM
Creation and review of the required quality management documentation.
Advising the RP
Definition of responsibilities, training and coaching of the Responsible Person.
Qualification of premises
Qualification of rooms, storage and cold-storage areas – including temperature mappings and documented evidence.
Outsourced-activity contracts
Review of contracts for outsourced activities for GDP compliance – including quality assurance agreements with service providers.
Inspection preparation
Simulation of inspections, support on the day and structured follow-up.
Process
To the authorisation in four steps.
- Initial talk & analysisClarify the starting situation, company structure and timeline.
- Documentation & QMCreate and review all required documents.
- Authority procedureSubmit the application, answer queries, coordinate appointments.
- Inspection & startWell prepared into the inspection – and safely into operation.
Consultation
Applying for, extending or amending an authorisation?
We know the procedure from numerous authorisation projects – from the single operation to the nationwide distributor.