EU GDP: keep medicines in the right conditions, and prove it
Wholesale distributors must show medicines stayed in the right conditions, came from authorised suppliers and went to authorised customers.
In Short
- A responsible person can delegate duties, not responsibility.
- Map storage temperature before use, then by risk.
- Returns re-enter stock only if every condition is met.
The Regulated Warehousing & Distribution Guide
The right lot leaves, and every hold stays held.
- Which rules apply
- Who decides what
- Hold, pick, trace
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Regulated Warehousing & Distribution Guide
The right lot leaves, and every hold stays held.
The EU GDP guidelines (2013/C 343/01) apply to wholesale distributors of medicinal products for human use. They have eleven chapters, from quality management to brokers. They are Commission guidelines under the Directive 2001/83/EC framework and are enforced through national wholesale authorisations. Sources were checked on 2 Oct 2026.
The Responsible Person
The distributor must designate a responsible person, who meets national qualifications, fulfils duties personally and stays continuously contactable. They may delegate duties but not responsibilities, and their authority to decide is written into the job description.
Storage and Temperature Mapping
Section 3.2.1 asks for an initial temperature mapping of storage areas under representative conditions, with monitoring devices placed at the extremes found. Mapping is repeated after a risk assessment or significant changes.
Worked Example: a Cold Room Excursion
- 02:14Sensor in zone C-2 reads above range; alert sentMonitoring
- 02:40Stock in C-2 placed on holdWarehouse lead
- Day 1Excursion data shared with manufacturers for assessmentQuality
- Day 3Responsible person records the decision on affected stockResponsible person
More on storage and Temperature Mapping
Monitoring equipment is calibrated at defined intervals.
Qualified Suppliers and Customers
Chapter 5 expects you to check that suppliers hold the right authorisation and that customers are authorised to receive medicines, and to keep those checks current.
Returns
Returned products go back to saleable stock only if all conditions are confirmed: unopened and undamaged packaging, not expired or recalled, storage conditions demonstrated, and assessment by a trained, authorised person. Returns from customers without a wholesale authorisation have a time limit; the guideline gives 10 days as an example.
Can this return go back to saleable stock?
All must be confirmed (Chapter 6).
Where V5 fits
V5 supports storage zones with temperature classes, temperature sensors with alerting, calibration schedules, supplier qualification, holds, recalls and lot trace. V5's product reference does not cover wholesale authorisation checks or EU FMD verification.
More on where V5 fits
The responsible person decides on returns and suspect product.
Questions
Who must follow EU GDP?
Wholesale distributors of medicinal products for human use in the EU, under their national wholesale distribution authorisation. Brokers have specific provisions in Chapter 10.
How often must storage areas be temperature mapped?
An initial mapping before use, then repeated according to a risk assessment or whenever significant modifications are made.
Can returned medicines go back to saleable stock?
Only if every condition in Chapter 6 is confirmed, including demonstrated storage conditions and assessment by a trained, authorised person.
Does V5 verify medicine packs against the EU repository system?
V5's product reference does not list EU FMD verification. Use your verification provider; V5 can keep the related holds, investigations and lot trace.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
EU Acrylamide Regulation 2017/2158: Mitigation, Sampling and Benchmark Levels
Digital Labels for Supplements: SmartLabel and EU QR Codes
EU 10/2011 Plastics Food Contact: Union List, Migration Limits and the Declaration of Compliance
EU AI Act (Regulation 2024/1689) for Regulated Manufacturers
EU Cosmetics Regulation 1223/2009: Responsible Person, Safety Report, PIF and CPNP
EU Falsified Medicines Directive: Safety Features for Manufacturers