Do you want to be a Responsible Person (Import) “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…
Pregabalin and Gabapentin
With everything going on at the moment it is easy to forget that there are things other than Brexit happening. An important one for the pharma supply chain is the scheduling of Pregabalin and Gabapentin as Class C, schedule 3 controlled drugs from 1st April 2019….
Who is responsible when the “Serious Shortage Protocol” is put into action and will you be insured?
If a pharmacy allows the pharmacist to supply different strengths, quality or pharmaceutical form or indeed a different medicine to the prescription only medicine prescribed, using the newly agreed “Serious Shortage Protocol” who is liable if the patient...Travel insurance after Brexit have you considered buying?
The Government is advising people that they must obtain their own travel insurance after Brexit. This is because the European Health Insurance Card the EHIC will disappear over night. This will also affect all the UK citizens who currently live abroad and take up...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...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...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...
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…