A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors

10th October 2025

A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors

Summary: The MHRA's blog post delves into the complexities of distributing medicinal products to aviation and marine sectors, highlighting the importance of adhering to GDP standards. Key points include:

• Qualification of Customers: Under Schedule 17 of the Human Medicines Regulations 2012, companies must establish the legitimacy of customers, such as aircraft commanders or ship masters, before supplying medicines. This involves verifying their authority and ensuring proper documentation within the Quality Management System.

• Regulatory Requirements: Specific medicines, as outlined in Schedule 17, are exempt from certain restrictions. However, these exemptions are limited and do not apply universally. Companies must ensure that only authorized individuals place orders and that these orders are traceable to the legitimate source.

• Delivery Challenges: Delivering medicines to remote locations presents logistical hurdles due to restricted access to docks and airports. The MHRA permits deliveries to goods inwards facilities at ports or airports, provided there is clear documentation confirming timely delivery. A "just in time" approach is recommended to minimize storage time in these facilities.

• Regulatory References: Organisations should familiarize themselves with legal requirements for supplying vessels and ports, as detailed in UK Regulation (EU) No. 965/2012 and the Ship Captain's Medical Guide (24th Edition).

The MHRA encourages companies to conduct regular risk assessments to ensure compliance with GDP guidelines when supplying medicines to the aviation and marine sectors.

Link: A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors

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