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EU Moves Towards Inclusion of QR Codes on Pharma Packs


Allowing QR codes on medicines packaging is being considered by European regulators, reflecting the shift towards digital communication between drug makers and patients, according to a recent article in Securing Industry. The move shows that EU regulators are in favor of using on-pack codes in a way that extends beyond compliance with the drug authentication principles – based on 2D datamatrix codes – enshrined within the Falsified Medicines Directive.

The huge increase in smartphone use means more and more companies are using QR codes to interact with customers. For pharmaceuticals, this code would be included on the packaging and link to webpages maintained by drug companies or the National Competent Authorities. The European Medicines Agency (EMA) issued guidance on using QR codes on packs in 2015.

According to a recent position paper, Europe’s Heads of Medicines Agencies’ Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) says the 2D codes that can be scanned by a smartphone could be useful as a means to provide product information for both prescription and over-the-counter medicines.

The group says QR codes are not mandatory but any inclusion of a QR code would be automatically accepted by all Member States “without any further assessment”. The intention of including a QR code would have to be declared in marketing authorization applications, the details of which the CMDh outlines in the position paper.

The CMDh has also agreed that elements that can be provided via a QR code include approved product and statutory information, and risk minimization material such as education material.

But it goes on to say: “The inclusion of the QR code cannot replace the inclusion of the statutory information (printed package leaflet).” Rather the QR code would be a way to provide “updated information” on medicinal products, which may not be included on the printed leaflet.

It also notes that some countries allow the QR code to link to additional information such as video content. The inclusion of such extra information should be managed and discussed nationally.

The position paper only considers the use of QR codes for product information, and stresses that only 2D datamatrix codes can be used for manufacturing processing and as a safety feature under the falsified medicines legislation. The position of the QR code is also discussed in the paper.

Aggiornamento fogli illustrativi e schede tecniche: Omega formula – Guna

I fogli illustrativi e schede tecniche per i seguenti prodotti della linea Omega formula di Guna sono ora disponibili in formato eLeaflet:


  1. Omega formula integratore alimentare





Vitamin K2 Impairment by Common Drugs May Cause CVD

Statins and warfarin shown to share mechanism that causes CVD, Diabetes

OSLO, NORGE and METUCHEN, NJ (23 June 2016) A new review paper published in leading journal, Pharmacology, examines the positive associations observed between cardiovascular disease (CVD) and type 2 diabetes mellitus (DM), and the negative effect of medications prescribed to both groups of patients share a common mechanism: to inhibit vitamin K2-dependent processes, which was interpreted to lead to increased onset of CVD, DM, chronic kidney disease, bone fracture, and even mental disorder.

The authors of the review paper1, “Medicines and Vegetable Oils as Hidden Causes of Cardiovascular Disease and Diabetes,” note that impaired vitamin K2-dependent processes by some types of vegetable oils and medicines, but not plasma high low-density lipoprotein cholesterol, were proposed as the cause of CVD, DM and other lifestyle-related diseases.

“Once again the scientific community recognizes that the inhibition of vitamin K2 synthesis by common medications carries serious, newly recognized repurcussions,” says Hogne Vik, chief medical officer with NattoPharma, the world leader in vitamin K2 research and development, adding that while it has been well known for some time that statins inhibit CoQ10, a 2015 review paper2 finally highlighted that statins also inhibit K2 synthesis. ”Recognized Vitamin K2 antagonists significantly inhibit Vitamin K activity outside the liver with serious, unintended consequences.”

The function of K vitamins is unique among other vitamins and important throughout all life stages. Vitamin K2 activates proteins that are made in different organs in the body – clotting factors in the liver, osteocalcin in bones, and Matrix Gla Protein (MGP) in the vasculature. These proteins help coagulate blood, bind calcium to the surface of bones, and keep calcium from depositing in the arteries and soft tissues.

While the function of Vitamin K2 is vital to ensuring that the body properly utilizes calcium, studies have shown that 97 percent of Western populations are Vitamin K2 deficient/insufficient.3

“We are not only finally seeing recognition that Vitamin K2 is woefully insufficient in the diet, but the is a growing body of evidence that pharmaceuticals further exacerbate the problem of our limited Vitamin K2 status, delivering potentially dangerous consequences for human health,” Vik continues.

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About MenaQ7®

MenaQ7® is the best documented, commercially available vitamin K2 as MK-7 with guaranteed actives and stability, clinical substantiation, and international patents granted and pending. MenaQ7® is available in two varieties: natural vitamin K2 as MK-7 Crystals and nature-identical synthetic vitamin K2 as MK-7 PURE. For more information on the health benefits of MenaQ7, visit menaq7.com.

About NattoPharma

NattoPharma ASA, based in Norway, is the world’s leader in vitamin K2 research and development. NattoPharma is the exclusive international supplier of MenaQ7® Vitamin K2 as MK-7, and has a multi-year research and development program to substantiate and discover the health benefits of vitamin K2 for applications in the marketplace for functional food and dietary supplements. With a global presence, the company established its North American subsidiary, NattoPahrma USA, Inc., in Meuchen, NJ. For more information, visit nattopharma.com.


1 Okuyama H et al. Medicines and Vegetable Oils as Hidden Causes of Cardiovascular Disease and Diabetes. Pharmacology 2016;98:134–170. DOI: 10.1159/000446704.

2 Okuyama H et al. Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms. Expert Rev Clin Pharmacol. 2015 Mar;8(2):189-99. doi: 10.1586/17512433.2015.1011125. Epub 2015 Feb 6.

3 Shea MK et al. Circulating uncarboxylated matrix gla protein is associated with vitamin K nutritional status, but not coronary artery calcium, in older adults. J Nutr. 2011 Aug;141(8):152934.