GMP requirements for importation of medicinal products from an MRA country for use in clinical trials

GMP requirements for importation of medicinal products from an MRA country for use in clinical trials

When medicinal products for clinical trials are imported from a third country, the release must be performed by the Qualified Person at the importer. This appears from section 35 of the Danish GMP Executive Order (executive order no. 1358 of 18 December 2012).

When medicinal products are imported directly from an MRA country* (the exporting country) and covered by a marketing authorisation in that country, the Qualified Person may release the products based on the following documentation:

• Evidence that the supplier in the exporting country holds a valid wholesale distribution authorisation in accordance with that country’s regulatory requirements.
• Evidence (e.g. delivery note or bill of lading) confirming that the medicinal product was supplied by the supplier authorised by the importer.
• A declaration from the supplier stating that the medicinal product has a marketing authorisation in the exporting country, that the batch was released by the manufacturer for sale in the exporting country, and that the batch was stored and handled in compliance with the approved storage conditions.
• Evidence that the approved storage temperature was maintained during transportation from the exporting country to the importer.
• Evidence that the clinical trial for which the medicinal product is intended has been authorised.

Upon release of the batch, the Qualified Person must state that the batch is released for use in the specific clinical trial. 

* The countries having entered a Mutual Recognition Agreement (MRA) with Europe are: Australia, New Zealand, Canada, USA, Switzerland, Israel, Japan