Orphan medicines
Orphan medicines are medicinal products that are intended to treat diseases which are so uncommon that it would be difficult to secure funding for drug development under usual marketing conditions.
Orphan medicines are medicinal products that are intended to treat diseases which are so uncommon that it would be difficult to secure funding for drug development under usual marketing conditions.
Conditional Marketing Authorisations (CMAs) were introduced in Great Britain as a scheme by the MHRA in January 2021. The CMAs can be granted for new medicinal products in GB whose benefits outweigh the potential risks of the new medicinal product.
Do you supply to customers in Northern Ireland – If you do, then you will be aware of a range of issues following Brexit and that we are still some way away from a long term agreement. However, we wanted to highlight a specific issue.
Robust Quality Management Systems (QMS) are the heart of our Quality Management. With the right process in place for your business model and the right people managing it, the Quality System will be robust, compliant, easy to navigate and a fantastic tool for trending.
In an unprecedented move NHS bosses appeal to the Government to address rising costs before the winter causes a public health emergency.
Following the MHRA and Commitees of Advertising Practice (CAP) releasing a joint enforcement notice regarding advertising Kenalog injections for an unlicenced use, are you as a wholesaler or end user such as clinic aware of the rules around advertising medicines?