Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 5

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 final Part 5 of the questions and answers. All responses reflect the speaker’s personal views based on his professional experience. Part 1 (returns/Swissmedic, USA, HPRA), Part 2 (temperature control), Part 3 (transport validation and Annex 15) and Part 4 (computer system validation / artificial intelligence) can be found in our news archive.

MKT

1. Is the approach of not using MKT limited to the US, or is it also valid in the EU, given that the rationale applies to all pharmaceuticals?
Answer: Principally, MKT may be applied everywhere, but only if product properties allow its application. Being not mentioned in EU GDP at all, MKT could be a risk-based approach but scientifically derived stability data of pharmaceutical products weigh more than this approach.

EMA

1. In the EMA three-year plan, it was mentioned that the EMA intends to establish standards for remote/hybrid inspections. If not yet established, when can this be expected?
Answer: No explicit date has been mentioned here. An earliest expectation would be in 2027/2028.

Miscellaneous

For updates to guidelines issued by individual countries that were presented during the webinar, do they apply only within that territory, or are they implemented EU-wide?
Answer: These are country-specific regulations which apply in respective countries. EU-wide the GDP guideline applies.

2. Active substances for veterinary medicines: inspection passed but no certificate issued (only mentioned in the report) – is a timeline known for when GDP certificates will be issued?
Answer: At the current point of time no timeline is known.

3. Have any EU authorities issued guidelines regarding subcontracting transportation to freight forwarders (i.e. entities without their own warehouse or fleet that organise transport via third parties)?
Answer: A current guideline on European basis currently does not exist, but GDP guidelines apply generally (chapter 7 - outsourced activities). Supplier qualification can be performed on a risk-based approach, containing a set of actions such as audit, contractual agreement, self-questionnaire, certificates, business report. Necessity of availability may be based on risk matrix defined by company.

4. To which level should a mock recall be performed if the company distributes only to other wholesalers?
Answer: The simulation should cover own access of distribution records, demonstrating readiness for supporting a MAH in his recall activities. GDP applies to wholesaling companies which take over a segment of total transport chain and for this activity recall competence must be proven (here until product ownership ends).

5. What is the experience in relation to the following: On application for a WDA in the Netherlands (or other EU competent authorities) the site has no employees i.e. everything is either subcontracted from another subsidiary in the group or from an external service provider. Answer: WDAs can be issued to "virtual wholesalers" provided that chapter 1 and 7 of GDP guideline are fulfilled including (shared but applicable) QMS and assignment of responsible person with full oversight.

6. In Germany, many pharmacy licences are very old (e.g. issued in 1997). How can validity be ensured during customer qualification?
Answer: German pharmacy licenses do not expire unless removed by competent supervisory authority. If a pharmacy appears in "Notdienstverzeichnis" or in the list of "Landesapothekenkammer", this can be seen as proof that institution still holds valid license.

7. We use an ingredient that is also a medicinal product. When we receive it, it is labeled with "for processing use only", packed in a multibox, the label differs and is not serialized. Do we need a GDP license for the warehouse where this arrives? This is the only medicinal product that they receive.
Answer: This ingredient you mentioned is labelled "for processing use only" and does not possess an official release certification by a Qualified Person, meaning it is not a finished pharmaceutical product and its storage does not require a WDA but the warehouse should comply with GMP requirements.