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Is your scope of Wholesale Distribution Authorisation (WDA) out of date?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?
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.
The main concerns with regard to possible defects of medicinal products and the substances used in their manufacture or packaging.
Medicinal products seized within the week running from the 23rd-30th June, the Medicines and Healthcare products Regulatory Agency (MHRA) seized 285,000 medicines and medical devices which were valued at almost £1,000,000.
