I have just started a NVQ 3 in Pharmaceutical sciences and at the end will qualify as a pharmacy technician.
Just working my way through my Law and Ethics modules and one of my questions is to do with te MHRA and the roles they play with advertising/promoting medicines in the UK.
How would the MHRA know if a medicine being advertised/ promoted without a license? I have looked through the MHRA website and also in the MEP but cant seem to find anything.
Hi Kitty89
It is not unusual for competitors to report each other to the MHRA - this is probably one of the ways in which the regulator finds out about unlicensed promotion.
JM342
Hi Kitty89. Try the link above. It should have the information you need. I could be wrong but I think the MHRA have relaxed the rules on advertising unlicensed medicines to healthcare professionals but I'm sure they are still not allowed to be advertisied to the general public by name. As JM342 says, often it is competitors that report adverts which breach the regulations.
Hi Kitty, Doctors and Pharmacists receive journals which are out every week or month? - But these often contain advertisements of new products well in advance before they get released that’s one way of finding out a new product is coming out, so if a product comes out which hasn’t been advertised or what not, there should be some suspicion as to where it came from and check it out to find out if its licensed etc..
Licenses are granted through the MHRA anyway I believe, so they should be actively seeking out any products which licenses have expired etc – But the usual way is that other companies grass them up as mentioned above..
One of the sneaky and illegal ways that someone could get a product out there that wasn’t authorized would be to produce a counterfeit medicine, which is another conversation..
So to even risk marketing a medicine that hasn’t been marketed before and without a license and the chance of it going unnoticed is extremely low, thankfully
Most ethical companies will restrict pre-authorisation literautre to clinical data and scientific updates (i.e. not immediately obvious as marketing). Marketing literature should, at the very least, have abbreviated prescribing information along with PL and date of preparation.
There is also legislation against the promotion of unlicensed indications and the promotion of specific unlicensed medicines (specials) - although it is possible to advertise a specials service.
found your post interesting what module are you on? is it your first or second year?can i request you as a soundung board?i could help you if i can .lilly