In the context of preparedness for the United Kingdom’s (UK) withdrawal from the European Union (EU), we would like to inform you that the deadlines to apply for scientific advice and protocol assistance as a UK-based SME company in order to be eligible for financial fee incentives for scientific advice are as shown in the tables.
For applications starting after 29 March 2019, financial fee incentives for scientific advice will only be accessible through a SME legal entity in the Union (EEA) or indirectly through a SME regulatory consultancy established in the Union (EEA); see question 9 of 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 published on the European Commission and Agency websites.
In addition, to be eligible for orphan fee incentives for protocol assistance, an SME needs to meet the following conditions at the start of the procedure:
- A decision of the European Commission on the orphan designation must be in place (product included in the Community Register).
- The applicant for protocol assistance and the sponsor of the designation must be the same entity and qualified as an SME (companies are reminded that the transfer of orphan designation must be fully completed before 30 March 2019).
- The indication for which advice is sought must fall within the orphan designation indication.
For more information, see Brexit-related guidance for companies. We also encourage you to follow any future updates to the published guidance.
The above advice is provided in view of the planned UK’s withdrawal from the EU as of 30 March 2019. Until ratification of the withdrawal agreement and the transitional arrangements contained therein, preparations should continue under the consideration that the EU rules in the field of medicinal products no longer apply to the United Kingdom from 30 March 2019.
Read further about EMA via this link.