Is GDP mandatory? Activity and jurisdiction

GDP obligations depend on activity and jurisdiction

EEA medicinal-product wholesale distribution requires the relevant national authority’s authorisation and GDP compliance. A manufacturing-authorisation holder distributing products covered by that authorisation has an exception from separate authorisation; active-substance registration is a different route. These rules are not one universal “GDP certificate required” statement for every product or country. Confirm current Turkish warehouse requirements separately.

A food warehouse does not automatically become authorised for medicines

Suppose a logistics business adds medicine transport to food storage. Its existing food file does not establish authorisation or storage suitability for the new pharmaceutical activity. Identify the product category, actual service and jurisdiction; separate regulatory duties from a customer’s private assessment requirement. Neither the carrier’s name nor an ISO certificate establishes medicine-distribution authority by itself.

Distinguish private assessment and public authorisation

For a requested private assessment, state its basis, scope and decision maker. Its document cannot replace the competent authority’s authorisation or inspection. Kayra helps organise gaps and evidence links; it does not issue a regulatory GDP certificate or licence. Without checking the applicable jurisdiction and products, do not prescribe one mandatory temperature range, fee or completion time for all businesses.

Official references and limits

References checked on 3 October 2026. European and Turkish routes are distinguished; the worked examples explain preparation only.

• EMA — GDP, competent authority and EudraGMDP
• European Commission — medicinal-product distribution framework
• European Commission — human medicinal-product GDP guideline 2013/C 343/01
• Uşak İl Sağlık Müdürlüğü — published public-service procedures, 2025 context