What do you want to do?

Provide Information.

When do you want to give it to us?


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 Suspected Falsified products, or if some are missing or damaged. It’s common practice, or at least it has been, to contact the supplier to obtain your own information and make a judgement from there on whether to inform the MHRA directly. However, you, as a Licence Holder/Responsible Person, are required to inform the MHRA (or MIA Holder) of possible irregularities with products’ supply in the first instance.

Obviously, there are always informed, internal steps to take –  your own procedures will reflect a decision-making process and how the chain of information will be handled. But bear in mind that your experience of delivery discrepancies (especially if regularly repeated) may appear easily rectifiable – or as an isolated incident – but it could, COULD, be a pattern that the MHRA are keen to collect data and information on.

Without a doubt, Inspectors are looking that you and your staff can recognise the obligations on Product and delivery checks, but also that you appreciate the promptness to inform them if they produce negative results.