What do you want to do?
What do you want to do? Provide Information. When do you want to give it to us? Ummmm… OK, you might have been more definite in your final answer. But was it what the MHRA Inspector wanted to hear? Or see in your SOP’s? Particularly with regards to information on...The “Buy Medicines online” debate. How would you evaluate the risks?
Whilst the healthcare agencies criticise the online purveyors of medicines with their pharmacist prescribers to avoid CQC registration. The CQC registered pharmacies which employ European prescribers some of whom lack the controls in place to ensure effective and safe...
Health Service Products (Provision and Disclosure of Information) Regulations 2018
I am sure plenty has been written and said about what I am sure many will see as an additional burden on wholesalers, this simple post is to help provide clarity about the scope of the regulations…
The ‘Making’ of a Good Responsible Person
Despite the MHRA’s guidance note 6 there is a lack of a clearly defined and standardised route into becoming a trained, experienced, and effective Responsible Person (RP), and consequently the MHRA are now placing a greater emphasis on the suitability of a licence holder’s RP, perhaps in an attempt to ensure that all roads eventually lead to the same destination or to gradually develop and define the necessary route, or maybe both…
Standards for Everyone…
For the last 3 years, when delivering GDP Training, and when it comes to the subject of Transportation – and the related GDP requirements – there has always been stock comments and specific observations…
Will the regulators be able to handle all this extra regulatory work ?
The EMA( European Medicines Agency) set up a task force to prepare for the possible eventualities of the UK referendum. They had several areas of concern the main one being the potential disruption to the supply chain of medicines and the impact in public health. The...The last Mile – Main Road or Dirt Track?
The last mile is hard enough to deliver GDP within Europe, but is impossible in countries such as Africa, especially land locked countries in the rainy season…