The Early Access to Medicines Scheme (EAMS) launched in 2014 and allows patients with unmet clinical needs to gain early access to unlicensed medicines and medicines to be used outside of their licence.
Medical device apps are becoming increasingly more common as healthcare management tools used in hospitals and community settings.
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.
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?
Is your scope of Wholesale Distribution Authorisation (WDA) out of date? – Are you aware that the Wholesale Distribution Authorisation (WDA) categories have changed?
