Define the authorisation scope
Business model, activities, sites, products and countries are mapped before the application.
- Activity and scope matrix
- Premises and equipment
- Responsible Person and deputy
- Supplier, customer and partner roles
Service area · Wholesale distribution of medicinal products
Apply for a wholesale authorisation and establish GDP-compliant operations
tiger.PHARMA structures the wholesale authorisation application and aligns scope, Responsible Person, QMS, premises, storage, transport and inspection readiness.
Prepare the wholesale authorisation →Wholesale authorisation · GDP · application · inspection readiness
Wholesale authorisation for medicinal products
tiger.PHARMA structures the wholesale authorisation application and aligns scope, Responsible Person, QMS, premises, storage, transport and inspection readiness.
A wholesale authorisation is not an isolated form. Authority, site, activities, product groups, responsibilities and evidence must match the intended operation; the competent authority and qualified legal advice determine the specific scope.
tiger.PHARMA Kompetenz
Topics we master
Prepare the application and evidence
The dossier is derived from the planned operation so organisation, SOPs and technical evidence remain consistent.
- Authority-specific evidence list
- QMS and document control
- Storage, temperature and security concept
- Contracts and quality agreements
Prepare GDP operations and inspection
A mock audit tests roles, records, deviations, CAPA and practical workflows, not only documents.
- Self-inspection and gap plan
- Training and competence evidence
- Recall, returns and falsification controls
- Go-live release and KPIs
Plan time and cost
Duration and effort depend on authority, site, scope, technology and maturity; work packages and dependencies replace blanket promises.
- Project plan and ownership
- Separate authority, consulting and qualification packages
- Structure investment and operating cost
- Document risks and decision gates
FAQ
Frequently asked questions
Who needs a wholesale authorisation?
This depends on the actual business and goods flow. The intended scope must be clarified with the competent authority and, where appropriate, legal counsel before operations start.
How long does the procedure take?
Timing depends on the authority, completeness, site, scope and inspection readiness. A reliable plan therefore uses work packages and dependencies rather than one blanket deadline.