You no longer need to re-test certain pharmaceutical products imported from the USA to the EEA. This is due to a Mutual Recognition Agreement (MRA) that was reached between the United States and the European Union on 11th July 2019, after the original Brexit deadline in March 2019.
We have been able to reassure a number of our US-based manufacturers who have been anxiously awaiting the effect of Brexit. These clients were re-testing imported product in the UK, but they can now rely on their US testing.
Regarding import into the UK; we await the outcome of the negotiations between the UK and the EU, to see if an MRA can be agreed between those two parties. However, the Brexit transition period means that the UK is following EU regulations until 31st December 2020 and so will accept US-based testing for now.”
What are MRAs?
MRAs are trade agreements that aim to facilitate market access and encourage greater international harmonisation of compliance standards while protecting consumer safety. They also facilitate trade in pharmaceuticals because they reduce costs for manufacturers by reducing the number of inspections taking place at facilities and waiving re-testing of their products upon importation.
MRAs allow EU authorities and their counterparts (i.e. FDA) to:
• rely on each other’s GMP inspection system;
• share information on inspections and quality defects;
• waive batch testing of products on import into their territories;
The MRA between the United States and the European Union became fully operational for human medicines as of 11 July 2019. As a consequence, qualified persons within EU pharmaceutical companies will no longer need to carry out quality controls and batch test human medicines covered by the MRA, provided that they have verified the product was manufactured in and imported from the US when these controls have been carried out in the US. Each batch will need to be accompanied by a batch certificate (in alignment with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch.
Products covered by this MRA
Human medicines only, including:
- marketed finished pharmaceuticals for human use in various pharmaceutical dosage forms such as tablets, capsules, ointments and injectables, including:
- medical gases
- radiopharmaceuticals or radioactive biological products
- herbal (botanical) products if classified as medicinal products
- homeopathic products
- marketed biological products:
- therapeutic biotechnology-derived biological products
- allergenic products
- active pharmaceutical ingredients or bulk drug substance
Products excluded from the MRA
- human blood and plasma
- human tissues and organs
- veterinary immunologicals
- advanced therapy medicinal products
Chronological order of the MRA agreement
The EU and the US signed a broad MRA, which was never fully implemented. The MRA included an Annex providing for a limited reliance on each other’s GMP inspections.
Following EU/FDA talks the Annex was revised in 2017.
1 November 2017 marked the entry into operation of the agreement between the EU and the US to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. The transition phase ended on 11 July 2019 when:
- the US FDA completed its assessment of all 28 EU GMP inspectorates for human medicines, confirming that they have the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the US
- the European Commission confirmed in June 2017 that the US FDA has the capability, capacity and procedures in place to carry out GMP inspections for human medicines at a level equivalent to the EU
As of 11 July 2019, qualified persons in EU Member States do not need to batch test human medicines covered but the MRA, provided that they have verified that these controls have been carried out in the US for products manufactured in and imported from the US.
For more information about Brexit and USA-based Pharma Importation Testing and other regulatory affairs services, contact us.