Clarify the site and activities
Describe who physically stores medicines and which activities take place. SÚKL distinguishes a distribution warehouse established in Czechia from supply from another EU Member State without a Czech warehouse. Clarify the correct authorisation pathway before beginning a Czech warehouse operation.
Prepare the application and evidence
SÚKL refers to DIS-8 for distribution applications and DIS-15 for temperature control. Align the site file with both the application and the operation: activities, responsibilities, plans, equipment, quality system and qualification records. Check scope and current formal requirements against applicable SÚKL guidance.
Verify authorisation and certificates
A wholesale distribution authorisation and GDP certificate serve different purposes. Verify the legal entity, site address, activity scope and restrictions. EudraGMDP supports checking regulatory records. Documents for another site or different activities do not establish suitability for your intended use.
Consider Cheb and the destination market
A Czech site does not replace destination-market requirements. Assess recipient eligibility, product status, supply-chain arrangements and any additional cross-border obligations. Treat authorisation, fit-out and qualification as separate project milestones; they do not establish a universal start-up timeline.
Prepare for site planning
The planning lists below are practical recommendations for your site project; they do not replace project-specific qualification or a regulatory decision.
- Identify the legal entity, site and activities
- Confirm the competent authority and current application
- Prepare responsible-person and premises documentation
- Compare authorisation scope and certificate details
- Plan start-up after the necessary approvals