Europe – Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country

1. What are the obligations of the Qualified Person (QP) regarding testing of batches for ATMPs imported into EU?

In the case of an authorised ATMP imported from a third country, the QP has to ensure that each batch has been manufactured in accordance with Good Manuafacturing Practice and that the quality is in accordance with the terms of the marketing authorisation. Imported ATMP batches have to be retested upon importation into the EU, as required by Article 51(1)(b) of Directive 2001/83/EC.
Article 51(2) of Directive 2001/83/EC, makes provision for the Qualified Person certifying the imported batch to rely on controls conducted in a third country (batch release testing in accordance with the terms of the marketing authorisation) where the product has been manufactured and tested in a country having a relevant mutual recognition agreement (or equivalent arrangements) (MRA) with the EU.
The possibility to rely on controls conducted outside of the EU (where no relevant MRA on GMP is in place) is exceptional and cannot be applied beyond the specific scenarios described in the GMP Guideline for ATMPs…