MARKET ENTRY LOGISTICS
Prepare the logistics behind your German market launch. The Cheb warehouse combines a 20,000-pallet-position capacity base with project-defined GDP onboarding, launch inventory and distribution processes. Authorisations, product status, quality responsibilities and the intended recipients are assessed before go-live.
AT A GLANCE
Pharmaceutical market entry logistics turns a launch plan into an operational supply model with suitable stock, warehouse processes, data and distribution handovers. Explore pharmaceutical warehousing for Germany →
The logistics workstream translates product status, the distribution model, permitted recipients, temperature limits, release procedures, packaging and master data into an executable warehouse and delivery process. Regulatory approval, benefit assessment, pricing and reimbursement remain separate responsibilities. Operational market entry focuses on stock that is controlled, available and ready for authorised distribution.
Review the legal entities, sites, activity scope, product and marketing-authorisation status, quality requirements and outsourced processes. Record outstanding items with owners and due dates. A general warehouse commitment is not a substitute for checking the specific project.
Agree initial quantities, receipt dates, batch and expiry records, release status and minimum remaining shelf life. Launch stock and safety stock can be distinguished by status, client or purpose where the process supports it. The 20,000-pallet-position capacity supports scaling; temperature-zone suitability is confirmed separately.
Larger projects can typically be onboarded within 2–3 weeks when documents, quality agreement, scope, master data and interfaces are complete. Additional audits, qualification or unresolved authorisation questions require a project-specific schedule. Go-live requires the agreed prerequisites to be completed, not merely a planned calendar date.
Wholesale, pharmacy, hospital or other professional recipients may have different data, packaging and delivery requirements. Orders, stock allocation, picking, dispatch and carrier handover form one agreed chain. Customs treatment for Union goods within the EU does not remove pharmaceutical authorisation and recipient obligations.
Track stock, remaining shelf life, open orders, replenishment, returns and deviations through agreed reports. Recall and shortage risks receive defined escalation routes. Product and market decisions beyond the agreed GDP activity scope remain with the responsible legal functions.
Send product status, target launch date, approved storage requirements, initial inventory, expected orders and intended customers. The offer identifies work packages, required documents, responsibilities and go-live conditions so the manufacturer and logistics partners can review the same plan.
RESPONSIBILITIES
| Workstream | Operational scope | Boundary |
|---|---|---|
| Readiness review | Turn product, authorisation, warehouse and distribution requirements into a go-live plan | Does not grant or assume a marketing authorisation |
| Launch logistics | Plan initial and safety stock, master data, receipt and dispatch readiness | Does not determine benefit assessment or reimbursement |
| GDP and quality | Agree quality responsibilities, SOPs, deviations, returns and recall processes | Manufacturing-related activities require the appropriate confirmed authorisation |
| German distribution | Define recipients, service levels, picking, dispatch and carrier handover | No universal delivery commitment without product and recipient checks |
| Supply review | Monitor inventory, shelf life, batches, performance and shortage risks | Pricing and AMNOG negotiations remain outside the warehouse scope |
PROJECT STEPS
Record the product, authorisation status, legal entities, sites, target market and recipients.
Agree the quality model, oversight, roles and escalation routes.
Define launch stock, safety stock, temperature, batch, expiry and replenishment.
Set up master data, order exchange, reporting, picking and transport handover.
Receive stock, confirm status and start the agreed distribution operation.
Review performance, stock coverage, deviations, returns, recalls and supply readiness.
FREQUENTLY ASKED QUESTIONS
It establishes the warehousing, stock, data, quality and distribution processes needed to supply suitable products to authorised recipients at and after launch.
No. Marketing authorisation and the marketing authorisation holder's responsibilities remain with the appropriate legal entities.
No. Those are separate market-access workstreams. The warehouse offer focuses on operational supply readiness and distribution.
Larger projects can typically be onboarded within 2–3 weeks once scope, documentation, authorisations, data and interfaces are complete. Additional prerequisites can extend that schedule.
A multi-market model can be assessed where product status, authorised activities, permitted recipients and transport arrangements are suitable.
Only after an individual activity review and confirmation of the necessary site and authorisation scope.
REGULATORY BASIS
The process descriptions refer to the EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01). Site, legal entity and authorised activity scope must be verified before project start through the competent authority and relevant EudraGMDP records. SÚKL is the national medicines authority for Czech sites.
English content updated: 11 October 2026 · Pharmaceutical contact: Martin Didunyk, licensed pharmacist.
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