Brexit – Unforeseen consequences 2

I might be an old cynic but I fear that both the challenges and the opportunities presented by Brexit will lead more people to consider what I am going to call ‘more creative business practices’. To misquote a colleague’s favourite saying, “there are two things...

Brexit – Unforeseen consequences 1

With the Pound in freefall, I am sure we have all done a quick calculation to try to second guess how it will affect us. The most obvious is the cost of holidaying abroad; next summer’s trip to France will cost considerably more in terms of travel and accommodation...

What boundaries?

To what extent now, do we – when exporting – need to be aware of the local guidelines of those countries outside of the EEA we are shipping Pharmaceutical products to?  It seemed to be a little more clear-cut before. We could find out if the recipient company was...

FAKEMEDs Campaign, Do you sell medicines online?

The Medicines and Healthcare products Regulatory Agency (MHRA) have created a campaign to combat the selling of fake medicines online. More than half of the medicines sold online are fake or unlicensed. Common examples are erectile dysfunction medication, ‘smart...

Requirements of Herbal Registration

According to the Human Medicines Regulation (2012), a product is a herbal medicine if the active ingredients are herbal substances and or herbal preparations only. A herbal preparation is when herbal substances are put through specific processes, which include:...

SOPs: what do these mean?

As a consultancy firm, we are regularly contacted by companies after they have been inspected by the regulators and been told they need help in compliance, or when there is a looming threat of an inspector turning up soon.  Having now visited a few companies (WDA...

Recall – drug

Important to have a robust procedure for handling recalls. Have you tested your “recall” system? What will you do with the recalled product?  Here are a few points to consider about your process: Set out responsibilities: recall, traceability and approval...