FDA Warning Letters
The MHRA has reviewed its current approach to contacting UK Licence Holders who may be implicated by USFDA Warning Letters
Emerging issues – Communique from the GPhC
As part of maintaining professional vigilance and regulatory compliance across pharmacy services, PCL would like to draw attention to several critical issues recently highlighted by the General Pharmaceutical Council (GPhC).
New MHRA/NICE Collaboration
The UK is entering a new phase of innovation in how it regulates, assesses, and adopts new medicines—and it’s a development the global pharmaceutical and biopharmaceutical industry cannot afford to overlook.
The Future of Pharmacy first
Pharmacists, remember to direct their virtual patients to the Pharmacy First Survey to leave their feedback on the service.
Pharmaceutical Wholesalers – an eclectic bunch
It is probably true that there are no two pharmaceutical wholesales that are the same, but the variation out there is also probably a little surprising.
What are the main requirements for controlled drugs?
As described in the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations (MDR) 2001, any company wishing to possess, manufacture, produce or supply controlled drugs in England, Wales or Scotland will need to apply for a domestic licence – this includes where you are not physically handling but are directing and / or taking ownership.
FSN for Zoll Powerheart G5 AEDs
FSN (Field Safety Notice) for Zoll Powerheart G5 AEDs was issued by Zoll earlier this year for G5 AEDs that may display Error Code (EC) 501.
Virtual Wholesaling
It is common in today’s rapidly evolving pharmaceutical sector that companies need to outsource key activities. This can be for a number of reasons including specialist expertise, specialist storage facilities, capacity of both facilities and people, cost to your organisation and time.
Pharmacy Regulatory changes
There have been several Pharmacy Regulatory changes which will come into force on the 23rd June 2025. Are you ready for them? Firstly, the market entry for Distance Selling models is closing, if you are contemplating a Distance Selling Pharmacy, the application must...
Distance selling Pharmacy market entry is closing on 23rd June 2025
The market entry process for distance selling pharmacies is closing on 23rd June 2025. Having been laid before parliament on the 2nd of June changes to the community pharmacy sector will come into force in 21 days.