The European Medicines Agency (EMA) yesterday released a questions and answers (Q&A) document specifically in relation to Advanced Therapy Medicinal Products (ATMPs), clarifying the circumstances in which an exemption from the normal requirement to re-test batches of medicinal products imported from third countries into the EU may be granted. According to the Q&A document, an exemption may be granted if the product has been manufactured and tested in a country that has a relevant mutual recognition agreement (or equivalent arrangements) on Good Manufacturing Practice (GMP) with the EU; and if the conditions laid down in paragraph 11.17 of the EU GMP Guidelines for ATMPs (Guidelines) are met. The Q&A document emphasises that the exemption is ‘exceptional’ and ‘primarily foreseen for imported patient-specific ATMPs (e.g. autologous product)’ and strongly advises applicants intending to request an exemption to proactively consult with EMA early in product development.