Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 1

Around 120 participants attended the ECA Webinar “GDP Update 2026” on 12 March 2026. The aim of this two-and-a-half-hour session was to provide participants with a comprehensive overview of current developments and key updates in the field of Good Distribution Practice (GDP).

The webinar was divided into a regulatory and an operational part. The following topics were addressed:

• ZLG (Germany) – GDP for active substances in Germany
• MHRA (UK) –  Requirements for sea and air transport
• Swissmedic (Switzerland) – When to report changes to authorities?; Guideline on the return of medicinal products; Requirements for supply chain traceability
• HPRA (Ireland) – Update GDP Guidance
• FDA/USP (USA) – Implementation of DSCSA; Temperature mapping & transport validation; Use of Mean Kinetic Temperature
• EMA/ECA – GDPA: Practical implementation of GDP; When is a wholesale license necessary?
• GDP Non-compliance reports – GDP deviations and observations 2025; Potential preventive measures
• Vehicle qualification – Best practice from ECA training
• Storage at -40 °C – GDP for biopharmaceutical API
• Excursus – AI applications in the GDP environment

During the final Q&A session, numerous interesting aspects were raised and discussed. Following the webinar, the speaker, Dr Christian Grote-Westrick, provided written answers to all submitted questions.

Below you will find the first part of the questions and answers. All responses reflect the speaker’s personal views based on his professional experience. Further parts will be published in the coming months.

Returns/Swissmedic

1. What is the definition of a return? Are we considering only final customers? We can have a company buying our product under a trade agreement – does this fall under a “return” as per GDP regulation?
Answer: Basically, a return covers an "out and back-in process" independent of the customer or receiver including pharmacies or any other business-to-business customers. In order to consider a potential rebooking into saleable stock, criteria must be met such as known reason for return, known sender, product age, no visible damage or openings and, where applicable, temperature records of transport and intermediate storage at the customer. Evaluation must be performed by the responsible person or delegated personnel.

2. Can you please clarify how returns between 10 and 30 days are handled (related to the Swissmedic Technical Interpretation)?
Answer: A return occurs in any case (in less than 10 days, between 10 and 30 days and more than 30 days). Only individual handling and intensity of risk assessment differs between these scenarios.

3. On the update slide for Swissmedic regarding returns, it states “NO resale” at 30 days. Does this mean that returned product cannot be returned to saleable stock?
Answer: Rebooking into saleable stock remains possible in any of these cases, but for periods of more than 30 days not recommended and only realizable via deviation and comprehensive risk analysis.

4. Talking about returns: I am the RP for GDP of a Swiss company. Imagine that a customer based in Turkey wants to return an API to the manufacturer in India. Should I comply with Swissmedic requirements (even though the companies involved are outside Switzerland)?
Answer: Returns of APIs from Turkey to India do not fall under Swiss regulations. Only if wholesaling of finished pharmaceuticals is performed by a Swiss company outside of Switzerland (or contains an import/export process) specific license by Swissmedic is required.

5. The sales department establishes special commercial contracts with customers that allow them to return unsold products after a long period. How should these returns be considered? If a declaration of proper storage is provided by pharmacies or distributors, can the product be released again?
Answer: If wholesaling activity is registered in Germany, the answer is yes, but only if GDP relevant criteria for rebooking into saleable stock are fulfilled (see question 1). There is no quantitative restriction except for Switzerland.

USA

1. If you are an API manufacturing site based in Switzerland and you send your API to a finished dosage form manufacturer in the US (within the same company), do you have to comply with USP <1079.5>?
Answer: API manufacturers are excluded, same as excipient and medical device manufacturers (please compare slide). Thus, USP <1079.5> does not apply to API importers to the US, solely finished pharmaceuticals are affected.

HPRA

1. It was stated that, for HPRA supplier qualification, the EudraGMDP database alone is no longer sufficient without additional HPRA confirmation. How will this work if inspectorates such as IGJ (NL) or ANSM (FR) only upload the MIA/WDA to the EudraGMDP database without providing an original certificate?
Answer: In general, available WDA/MIA downloaded from EudraGMDP database is sufficient for European authorities, HPRA in turn currently expects stronger due diligence.