Blog
Upcoming Public Consultation
Another Medical Device update. The MHRA will shortly be opening a public consultation on the future direction of Medical Device regulation, it is vital that all relevant voices are heard so please monitor the MHRA notices and respond when appropriate.
Deadline Approaching – Medical Device Registration
Deadline approaching – Medical Device Registration for registering Class IIa and Class IIb (other than implants) products with the MHRA is the end of August 2021.
Children, Covid 19 and Safeguarding
In all the noise over the past year regarding Covid 19, children have been affected the most, they may have been the least affected by the virus itself but they have suffered disproportionately from lockdown.
Tamiflu in 2009 and Remdesivir in 2019 and what will be the next wonder drug?
What have we learned in ten years? I was a pharmacist in retail practice in 2009 and was a site that collected all the unused Tamiflu which ended up being destroyed having cost billions across the world.
Digital Consultations, Que busting and Inequality
The number of digital consultations has exploded during the pandemic and for some it has been fantastic, but for other is in not a suitable mode of to name a few; elderly who are not silver surfers and autistic children.
Remote Auditing versus On Site Auditing
Remote Auditing versus On Site Auditing: For the last 16 months the pharmaceutical world has had to get used to remote auditing as opposed to auditing in person.
Risk Assessments – Evaluating hazards
Risk Assessments: The aim of writing one is to evaluate hazards, then remove that hazard or minimise the level of its risk by adding control measures, as necessary.
WDA(H) & Import – New Guidelines:
Following Brexit and GB leaving the EU the MHRA have advised that GB wholesale dealers now need to appoint an RPi
API registration
API registration is an MHRA requirement if you manufacture, import or distribute active substances and you are based in the UK.
New Contract RP introduction
New Contract RP says hello! Please allow me to introduce myself as the newest member of PCL’s Contract RP Team.
Export & WDA(H) – Updated Guidelines:
As Great Britain (GB) are no longer part of the European Union (EU) since the 1st of January 2021 exit date. It is essential to ensure all the necessary changes have been made to remain MHRA compliant.
Refrigerated Medicinal Products – what to consider…
How do you manage YOUR refrigerated medicinal products? Check out 10 key points to ensure you are shipping your products effectively