The European Medicines Agency (EMA) and the European Commission have released further guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK’s) withdrawal from the European Union (EU).
This guidance is an updated version of the initial questions-and-answers (Q&As) document that was published at the end of May 2017. Updates are marked with ‘NEW’ and provide additional information on how the UK leaving the EU will affect marketing applications and authorisations for different types of medicinal products, such as generic, hybrid and biosimilar medicines.
The guidance notes that “Generic/hybrid applications for which marketing authorisations will be granted after 29 March 2019 should refer to a reference medicinal product (RefMP) that is or has been authorised in an EU-27 Member State or a contracting state of the European Economic Area (EEA).”
Information regarding whether medicinal products used in bioequivalence studies can be sourced in the UK is noted in the guidance. Bioequivalence studies that have been conducted with a medicinal product sourced in the UK can be used in generic/hybrid marketing authorisation applications only if the marketing authorisation for that application will be granted before 30 March 2019.
The new guidance also provides information on data sourced from the UK while it was an EU member state. The data “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 EMA and European Commission also added that for orphan designation applications submitted after 29th 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)”.
Furthermore, after 29th March 2019, the mentioning of a UK local representative in product information will no longer be used.
The EMA recommends that, in order to avoid any impact on the continuous supply of medicines, companies should plan in advance for the situation that the UK will leave the EU on 29th March 2019.
To read the updated Q&As, please click here.