Swissmedic publishes Technical Interpretation on Shipment under Quarantine

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Swissmedic, the Swiss national authorisation and supervisory authority for drugs and medical products, has published a new document (so-called Technical Interpretation) on "Shipment under Quarantine". It clarifies some situations in which a shipment under quarantine of active substances, intermediate drug products and finished drug products would be acceptable to inspectors.

The nine-page PDF document with the document number I-SMI.TI.26e, valid from 14 February 2024, is publicly available for download on the authority's website.

The first section (Purpose and scope) states that inspections have repeatedly found that "active substances, intermediates or even finished products are shipped from a manufacturing site to another or even to distribution partners abroad, under quarantine whilst quality control tests and batch record review are ongoing and batch certification by the manufacturer have not yet been performed, although in principle products should not be sold or supplied before a Qualified Person has certified the batch." The document is intended to clarify in which cases a shipment under quarantine is acceptable from Swissmedic's point of view.

In the second chapter (Basics), the main legal framework is cited, in particular those from Eudralex Vol. 4 Parts 1 and 2.

The core of the new document is the fourth chapter (Interpretation). It outlines various situations that could in principle lead to the decision to consider a shipment under quarantine (e.g. limited storage capacity, long transportation times). It is also emphasized that shipment under quarantine is generally not in line with GMP requirements and should therefore not be standard practice, and that appropriate safety measures must be implemented in all cases.

For five specific cases, a table indicates whether shipping under quarantine is acceptable or not. Within the five scenarios, a distinction is made between active substance, intermediate product and finished products. In the fourth example case (transfer of manufactured goods to a central distribution hub under third party control), the document stated that shipment under quarantine is acceptable, if, among others, "this central distribution hub is located in a country that applies EU GDP rules as an EU country or in a formalised manner through a bilateral agreement with the EU."