- 27 августа 2019
- 11.17, applicant, ATMP, authorised, autologous, batch, control, country, EEA, EMA, EU, exemption, GMP, guidelines, import, MA, MAH, paragraph, patient, product, Q&A, QP, quality, re-testing, section, specific, third,
On 21 August 2019 EMA has published document entitled Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country.
The exemption from re-testing batches upon import into the EU for authorised ATMPs may only be granted where the conditions laid down in paragraph 11.17 of the EU GMP guideline for ATMPs are met, specifically:
limited amount of
the testing in the third country should be conducted
in GMP-certified facilities
(a GMP pre-approval inspection is expected to be triggered unless a valid GMP certificate is available from an inspection carried out by an EEA competent authority, on the same or similar category of testing).
This exceptional exemption is primarily foreseen for imported patient-specific ATMPs (e.g. autologous product). In addition, applicants intending to rely on paragraph 11.17 of the GMP for ATMPs Guidelines to request for such an exemption are strongly advised to proactively consult with EMA early in product development.
To substantiate the request, the applicant/MAH should provide at least the following data in the initial marketing authorisation application:
- total batch size and number of units required for batch release testing;
- available stability data and proposed shelf life;
- analytical sampling plan;
- a GMP certificate issued by an EEA Competent Authority relevant to the particular category of testing at the facility located in the third country.
It should be noted, however, that only in case of a granted exemption, the EU QP certifying the imported batch may rely on quality control testing in accordance with the terms of the marketing authorisation performed in a third country.