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MHRA picks medicines for anti-counterfeiting controls

The medicines regulator is calling for views on which drugs should be placed on a ‘white’ list of exempted prescription medicines and a ‘black’ list of over-the-counter medicines that must be scanned

The government is consulting on which over-the-counter medicines should be included in EU anti-counterfeiting plans.


Pharmacists will be able to give their views on which prescription medicines should be exempt from the upcoming EU directive, which will require all prescription medicines to be scanned before dispensing (unless specified otherwise) from 2017. They can also voice their opinions on which OTC medicines should be scanned due to risk of falsification in the MHRA consultation, which opened on Friday (August 1).

Prescription medicines can be added to the ‘white' list exemptions if they are not used to treat a life-threatening disease, have not been counterfeited in the past and would not pose a "significant risk" to public health if they were counterfeited.


An over-the-counter medicine could be included on the ‘black' list of those that should be scanned if there were documented cases of it being counterfeited, the medicines watchdog added.


Pharmacists have until September 15 to submit their consultation responses to [email protected]. The UK will then submit its proposals to the EU by October 3.


In June, generics manufacturers warned that it could take up to two years to amend the ‘white' and ‘black' lists once they had been agreed by the EU. This delay could cause safety issues, as it meant pharmacists would be unable to verify the authenticity of certain medicines even if they knew there was a risk they were counterfeits, the European Generic Medicines Association said.


Click here to access the MHRA's consultation


What are most at risk of counterfeiting?

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