Medical Device Regulatory Updates
Those companies manufacturing and handling medical devices should be aware that there are changes to the UK regulatory environment coming.
Do you know the GPhC Standards you must adhere to when operating a pharmacy? Part 2, Principle 2 Staffing.
When operating a pharmacy, the General Pharmaceutical Council (GPhC) will come and inspect you against the pharmacy standards, do you know what evidence you will need to present to demonstrate how your pharmacy adheres to the standards?
RegulatoryConnect The MHRA’s new ‘Front Door’
The MHRA have made the first release of their RegulatoryConnect service available which allows tracking of the submission status of product licence applications but will soon offer much more.
New Valproate safety measures
The Medicines and Healthcare products Regulatory Agency (MHRA) announced that from the 31st of January 2024 new regulatory measures have been implemented to ensure that the known harms associated with valproate use are reduced.
Codeine linctus to be reclassified to a prescription-only medicine
A press release from the MHRA today, 20th February 2024, has announced that Codeine linctus will be reclassified as a prescription only medicine because of the risk of abuse and addiction.
Pharmacy First
Pharmacy First officially launched on 1st February 2024 and 95% of pharmacies in England have signed up for the service. Pharmacists will soon have referrals from surgeries and from other sources for patients with sinusitis, sore throat, impetigo, UTIs, earache in Children, shingles and infected insect bites; and will be able to supply antibiotics where indicated.
Casgevy
The MHRA is the first Regulatory body in the world to authorise a Crispr-based gene therapy.
GPhC Standards do you know what you must adhere to when operating a pharmacy? Part 1, Principle 1 Governance arrangements
When operating a pharmacy, the General Pharmaceutical Council (GPhC) will come and inspect you against the pharmacy standards, do you know what evidence you will need to present to demonstrate how your pharmacy adheres to the standards?
Common Trends from 2023 GPhC Inspections
Now we have started 2024, this blog highlights the common trends identified from inspections carried out in 2023.
MHRA Extension of GMP and GDP certificates validity period
The UK regulator for medicines, medical devices and blood components for transfusion in the UK, The Medicines and Healthcare products Regulatory Agency (MHRA) have further extended the validity period of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Certificates.
