MHRA Guidance Note 6
MHRA Guidance Note 6 – Notes for applicants and holders of a Wholesale Dealer’s Licence (WDA(H)) or Broker Registration was updated in November 2022 with some significant changes regarding Brexit.
Unlicensed Cannabis-Based Products for Medicinal (CBPM) Use
On the 16th of November 2022 the Medicines and Healthcare products Regulatory Agency (MHRA) released a blog with guidance on the process for approving Manufacturing Authorisations/ API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal (CBPM) use.
MHRA Response to contaminated paediatric medicines
On the 7th of October The Medicines and Healthcare products Regulatory Agency (MHRA) released a response to contaminated paediatric medicines identified by the WHO region of Africa.
Early Access to Medicines Scheme (EAMS): Sickle Cell Disease
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 – 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.