The MHRA took the opportunity in the recent Symposiums to clarify their definitions of Export, Importation and Introduction within WDA (H). With so many companies now looking to start, or extend, their licenced activities to beyond the European Economic Area (EEA), this was very welcome information.
For Export, let’s be clear on what it is not. The term “export” in the context of MHRA activities, does not apply to medicines procured, held and then supplied within the EEA. Export applies to medicines procured or received from within the EEA (with an EEA marketing authority) and then supplied to a 3rd country outside the EEA.
Importation is applied when a product that has been manufactured outside of the EEA but is intended for the EEA market. In these cases, a Manufacturing Licence is required and is therefore a GMP activity, requiring a Qualified Person (QP) to release the product into the EEA market.
Introduction refers to a medicinal product that does not have an EEA marketing authorisation, is supplied to a country outside the EEA, but is “introduced” to the EEA either physically or financially (that being, if the procurement and/or supply has been facilitated at any stage from within the EEA). Furthermore, this is defined as a GDP activity and must be compliant within those guidelines.
The reason for the clarification of these terms is to assist and ensure the intent of wholesale activities, and for any necessary export documentation to be completed appropriately.
Written by Brian Lindsay