Medical Device Apps – Stand-alone software and apps
Medical device apps are becoming increasingly more common as healthcare management tools used in hospitals and community settings.
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.
Conditional marketing authorisations
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.
Advertising rules for unlicensed medicines, do you knows
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Is your scope of Wholesale Distribution Authorisation (WDA) out of date?
Is your scope of Wholesale Distribution Authorisation (WDA) out of date? – Are you aware that the Wholesale Distribution Authorisation (WDA) categories have changed?
Separation of the Licence Holder and Responsible Person
Separation of the Licence Holder and Responsible Person – The last paragraph on page 128 of the 2017 Green Guide contained the following sentence:
In the case of small companies, the licensing authority may accept the licence holder as the nominated RP.