Will you need help to update SmPCs and PILs?
If any of your products are covered by the MHRA exercise to update product information following European paediatric work-sharing procedures you can expect to receive a request from the MHRA to submit a variation for those products to incorporate paediatric information in the SmPC and package leaflet. You will be given a deadline of one to two months to respond.
- Would you be able to comply?
- Would such a request jeopardise other regulatory deadlines?
Akos is ideally placed to help resolve these conflicts. We can supplement your Regulatory Affairs department when the regulators introduce a sudden increase in your workload. In this instance we would:
- Prepare, submit and monitor your variations in compliance with the MHRA timelines
- Incorporate the approved new wording into the package leaflet
- Arrange any necessary user testing
- Submit the final version via a BROMI application
Alternatively, if you do not agree that the paediatric indication should apply to your product, we can write an expert overview providing a justification for this position.
Akos provides a comprehensive Regulatory Affairs Service helping you develop your research into revenue. A team of highly experienced Regulatory specialists will assess your needs before proposing a cost-effective solution. We work closely with our customers ensuring clear communication on progress of a project at all times and working to the very highest professional standards.
To discuss these projects, or any other aspect of Regulatory development and compliance, please e-mail: regulatory@akos.co.uk or call Business Development on: +44 (0)1582 766339