Target groups›Pharmaceutical wholesale distributors›Wholesale authorisation for medicinal products

Service area · Wholesale distribution of medicinal products

Apply for a wholesale authorisation in Germany

tiger.PHARMA supports preparation for German wholesale distribution authorisation: the activity scope, Responsible Person, GDP QMS, premises, qualification evidence and authority dossier.

Prepare the wholesale authorisation →

Wholesale authorisation · GDP · application · inspection readiness

Wholesale distribution authorisation in Germany

tiger.PHARMA supports preparation for German wholesale distribution authorisation: the activity scope, Responsible Person, GDP QMS, premises, qualification evidence and authority dossier.

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 Expertise

Topics we master

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

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.