Blog
How will the reclassification of pregabalin affect the supply chain
From the 1st of April 2019 pregabalin and gabapentin will be re-classified as class C controlled substances in the UK. The change has been prompted due to a sharp increase in deaths which toxicology has proved an association with the medicines. In addition the...
What is the “10 day rule and when would I apply it?
“10 day rule" What is the ten day rule? All stakeholders in the medicines supply chain such as, wholesalers, pharmacies, hospitals will have to verify and decommission medicinal products when they are supplied to the patient or a healthcare provider who is exempt...
What is an “Aggregated Code” and how can it help save medicine wastage?
“Aggregated Codes” how can they help wastage? Community pharmacies, at the time of dispensing , must verify the safety features and decommission the "UI" of the medicinal products they dispense and decommission the medicinal products as they hand them to the patient....
What are Anti-Tampering Devices “ATDs”?
What is an Anti-Tampering device "ATD"? An anti-tampering device "ATD" is designed to be attached to all medicinal products placed on the market after the 9th of February to aid the different stakeholders in the supply chain to check it is...
What is a Unique Identifier “UI”?
Unique Identifiers “UIs” are to be printed on all new packs, of mainly prescription medicines for human use, put on the market from the 9th February 2019 . The UI is in the form of a 2D data matrix, and (space permitting) in human readable form (printed in text adjacent to the barcode)…
After a ‘Hard Brexit’ would you like to be an RPi?
The role of the RPi is described in regulations 45AA & 45AB of the Human Medicines Regulations 2012 (as amended). The draft legislation is live but not yet approved by the Houses of Parliament…
Keeping up with Brexit
Keeping up with Brexit This is a big “family” affair as well. As we are all aware Brexit is on our doorstep. We are all waiting for the latest news on the way we exit from the EU. There are different scenarios already on how to act and take steps as a wholesaler. But...
Keeping up with the Brexit
This is a big “family” affair as well. As we are all aware Brexit is on our doorstep. We are all waiting for the latest news on the way we exit from the EU. There are different scenarios already on how to act and take steps as a wholesaler. But what will be the end...
Keeping up with the Brexit
This is a big “family” affair as well. As we are all aware Brexit is on our doorstep. We are all waiting for the latest news on the way we exit from the EU. There are different scenarios already on how to act and take steps as a wholesaler. But what will be the end...
Keeping up with Brexit
brexit fmd WDA(H) Responsible Person
Parallel Imports – Lorna Welbourn
The UK Parallel Importing scheme allows for a medicinal product authorised in another EU member state to be marketed in the UK providing there is no therapeutic difference. In order to parallel import (PI) and repackage medicinal products, relevant licences would be...
MHRA GDP SYMPOSIUM 2018
The MHRA GDP Symposium heralds the end of the year and the opportunity to mull over any advice on Regulatory changes and Inspectorate trends. The chance for clarity and what will be expected for (very) near future changes to trading laws and status - especially...