No More Paper Leaflets in Medicine Boxes From 2027
You may no longer find the usual folded leaflet in the box of the medicine you purchased from the pharmacy. With a new regulation implemented by the Turkish Medicines and Medical Devices Agency (TMMDA), information about drug usage is transitioning from paper to digital. So, when does this change begin and how will it impact the citizens?
A new era is beginning for medication boxes. It will be completed by January 1, 2027.
The Turkish Medicines and Medical Devices Agency (TİTCK) is making a radical change in the practice of printed leaflets in medicine boxes, according to a regulation it published on December 6, 2024. Apart from a few product groups that are exempted, the transition to Electronic Instructions for Use (eIFU) in medicines is gradually continuing, and the process will be completed on January 1, 2027.
From this date onward, the use of eIFU will become mandatory. Citizens will be able to access the usage information of the medicine they purchase by scanning the QR code on the outer packaging of the box with the camera of their smartphone or tablet. The application will bring all information, from the dosage of the medicine to its side effects, from storage conditions to interaction warnings, onto the screen within seconds.
The regulation does not completely eliminate the printed leaflet. Printed Instructions for Use can still be provided for patients who request it; however, the standard practice will now be digital.
Don't be taken aback by the leaflet in the box. It doesn't imply that it's counterfeit or has been opened.
Experts, alerting the public on the subject, underline that the absence of a leaflet in the box does not necessarily mean that the medicine has been previously opened or is counterfeit. The Manisa Pharmacists' Association continues its awareness-raising efforts regarding the new system; their aim is to minimize potential confusion on pharmacy shelves. During this transition, consumers often mistake the absence of instructions in the box for a deficiency or error; however, according to the statement by the Turkish Medicines and Medical Devices Agency (TİTCK), this is a planned, normal part of the system.
So, what happens if the e-PIL cannot be accessed by scanning the QR code?
According to TİTCK's statement, if there is neither a printed Patient Information Leaflet in the box nor access to the electronic instructions via the QR code, those who obtain the medicine should directly contact the relevant pharmaceutical company. In this case, the responsibility will fall on the manufacturer.
As the transition period will continue until January 1, 2027, in the coming period, boxes with both printed and digital instructions can be seen together on the shelves.
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