Requirements for Importing Medical Products and Substances of Human Origin
Most medical products and substances of human origin are subject to the same requirements as other standard goods.
As of 1 January 2022, suppliers will need to make full customs declarations on medical products and substances of human origin.
- Suppliers must have the relevant regulatory licences in place before importing medicines from the EU into GB
- Regulatory checks will continue to be made at individual elements of the supply chain rather than at the border
- There are no changes to controlled goods (e.g. controlled drugs) are imported from January 2022, as:
- a controlled drug import licence which must be physically presented at the border
- a full customs declaration is still required.
Further guidance from the MHRA is available to download.
Substances of Human Origin
- Hospitals, tissue or blood establishments, clinics or their representatives importing or exporting human organs, blood, blood products, tissues and cells will need to make an import or export declaration
- A ‘declaration by conduct’ can be made if importing or exporting substances into or from the UK and:
- it is for an emergency medical procedure that is time critical
- the journey cannot be planned to include time to make a full import or full export declaration
- An import or export declaration must be made if the substances are not needed for an emergency situation
- May be able to claim relief from Customs Duty and VAT when importing organs and other substances of human origin into the UK for emergency transplant or transfusion.
Guidance on Importing Medicines
Guidance on how to import human medicines including unlicensed medicines.
New guidance and information for industry from the MHRA.
Import Duties on Substances of Human Origin for Transplant
Claim relief from Customs Duty and VAT when importing organs and other substances of human origin into the UK for emergency transplant or transfusion.