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European regulators mull use of… QR codes

EMA’s Heads of Medicines Agencies committee outlines packaging proposals

EMA QR codes pharma packaging

European regulators are considering allowing the use of QR codes as a convenient shortcut for patients and healthcare professionals to access online information about pharmaceutical products.

The EMA’s Heads of Medicines Agencies (CMDh) committee said using two-dimensional quick response (QR) codes was being discussed by the region’s National Competent Authorities.

The CMDh added that pharmaceutical companies too were considering the technology, which is being proposed for inclusion on medicine packaging.

The codes would then point to online information about the medicine - webpages maintained by either firms themselves or National Competent Authorities, the CMDh said.

The CMDh has already agreed on the elements that could be provided through a QR code for products that go through Europe’s Mutual Recognition or Decentralised procedures, namely:

* Product information: statutory information (as approved by competent authorities)

* Additional risk minimisation material for the patient which has been approved by the NCAs (ie educational material as outlined in a risk management plan)

But, in a recent CMDh position paper on the topic, the committee noted that the inclusion of the QR code on the packaging for all member states would not be mandatory.

It added that it would be for individual pharma companies to decide in which Member States packs with the code are marketed. The CMDh said discussions about pointing to extra information, such as videos, should be managed on a national basis.

The CMDh has also agreed on the possibility of including only a URL without including its correspondent QR code. The information to be linked via this URL should comply exactly with the same conditions established for QR codes.

However, using QR codes would not allow firms to forgo the inclusion of statutory information like printed package leaflets.

8th June 2017

From: Regulatory

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