March 2019: EMA Updates Guidance on Brexit
Posted 01 December 2017 | By
The European Medicines Agency (EMA) and the European Commission on Friday updated guidance for pharmaceutical companies on the UK’s departure from the EU, much of which hinges on March 2019 deadlines.
For instance, the guidance notes, “Generic/hybrid applications for which marketing authorisations will be granted after 29 March 2019 should refer to a RefMP [reference product] that is or has been authorised in a EU-27 Member State or a contracting state of the EEA [European Economic Area].”
In addition, the guidance notes that bioequivalence studies conducted with a medicinal product sourced in the UK can be used in generic/hybrid marketing authorisation applications (MAAs) only if the marketing authorization is granted before 30 March 2019.
“Batches of the RefMP released by the UK after 29 March 2019 will not be considered as a Union (EEA) authorised comparator,” the guidance says.
Data sourced from the UK while it was an EU member state “can be taken into account to demonstrate that the active substances of a medicinal product in the claimed therapeutic indication and (for veterinary products) target species have been in well-established use within the Union (EEA) for at least ten years, with recognised efficacy and an acceptable level of safety,” the guidance says.
For orphan designation applications submitted after 29 March 2019, “patients in the UK should no longer be taken into account in the calculation of the prevalence of the disease in order to meet the requirements for orphan drug designation as set out in Regulation (EC) No 141/2000 i.e. a condition affecting no more than 5 in 10 thousand persons in the Union (EEA),” EMA and EC add.
And after 29 March 2019, the guidance says the mentioning of a UK local representative in product information will also become obsolete.
Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure