The Windsor Framework Part 2
After the implementation of the Windsor Framework, the Medicines and Healthcare products Regulatory Agency (MHRA) will license all medicines across the whole of the UK’.
The Windsor Framework Part 1 (recap)
From the 1st of January 2025 the supply of medicines to Northern Ireland will be governed by the Windsor Framework, which will replace the Northern Ireland Protocol.
Management of Change in your business
Management of change in your business should be a main cornerstone of any robust and functioning Quality Management System (QMS). The main advantages of having a strong change control process within your business include:
Be Careful What You Advertise
Most of us will know that it is illegal to promote prescription only medicines (POMs) to members of the public, however, it is always worth a reminder that you must be careful what you advertise.
Medical Device Update
In good news for the UK Health economy, the Government last week published a draft policy to allow medical devices and IVDs that have been approved in certain other countries quicker access to the UK market.
Self-Inspections
Self-Inspections are an important part of GDP and ensuring you keep your activities and licence compliant.
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.