Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Updates Guidance in Light of Lack of 2D Barcodes in Greece and Italy
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has updated its falsified medicine guidance in light of the situation in Greece and Italy, neither of which has set up a 2D barcode unique identifier system.
MHRA’s revised guidance states that organizations have a responsibility to identify falsified, stolen or recalled stock received by their systems, even if the products lack 2D barcodes. That responsibility extends to decommissioned systems.
To help companies meet their responsibilities, MHRA has detailed the security measures that are in place in Greece and Italy and what they mean for organizations that handle products originating from the countries.
In Italy, products carry a security label known as the “bollino.” The system features a two-layered label that carries a series number. When a product is dispensed, the top layer of the label is removed. If a product lacks a label or has a fake bollino, the product should be considered falsified and reported via the required channels, MHRA said.
The bollino on products exported from Italy should carry a nullification stamp. However, MHRA is advising organizations against treating products that lack the stamp as noncompliant. Rather, MHRA wants organizations in this situation to question the supplier about the traceability of the product.
Increased scrutiny of the labels of drugs exported from Italy has led to the identification of packs that lack the two-layered sticker required within the country. MHRA is working with Italian authorities to check these products on a case-by-case basis and wants people to continue reporting them.
Greece uses similar two-layered stickers, but MHRA has offered little advice on what organizations should do when they encounter these labels.
MHRA updated its guidance around the time that Tracy Moore, a member the agency’s inspectorate, published a blog post about the implementation of the falsified medicines directive. Moore said MHRA has seen “some excellent examples of robust systems” but revealed that not all organizations have met such high standards.
“We have also seen some systems that required improvement and examples of systems that failed to identify falsified stock as part of the pharmaceutical quality system requirements,” Moore wrote.
Moore’s comments come weeks after the Safety Features Oversight Group extended the “use and learn” phase of the falsified medicine directive implementation agenda. MHRA’s Irish counterpart attributed the extension to the number of bugs and other problems seen in the months after the system went live.
, Blog Post
Danish Regulator Bans Staff From Owning Shares in Pharma, Device Companies
The Danish Medicines Agency (DKMA) has banned its staff from owning shares of pharmaceutical and medical device companies.
Under the new conflict of interest rules, existing employees who own such shares have two years to divest the assets. DKMA will require new employees to disclose and divest any shares before joining the organization. Employees who inherit shares will also need to divest them.
DKMA thinks the new rules further its aspirations to be a leading European regulatory agency, both by dispelling suspicions about links to industry and moving it closer to the policy of the key body in the region.
“With this tightening, we wish to send a clear signal to the world that the Danish Medicines Agency is disconnected from economic interests of pharmaceutical and medical device companies. At the same time, we are bringing our conflicts of interest rules closer to those of the European Medicines Agency (EMA),” Thomas Senderovitz, director general of DKMA, said.
The change in policy will affect a small proportion of senior DKMA employees. Of the more than 60 executives and inspectors who previously needed to disclose their holdings of drug and device stocks, seven have shares in companies subject to DKMA oversight. Most of the disclosures relate to holdings in Denmark’s Novo Nordisk.
DKMA brought the new policy into force on 4 July.
Finland Seeks to ‘Actively Influence’ Pharma Meeting Agendas During EU Presidency
The Finnish Medicines Agency (Fimea) has outlined its intent to “actively influence” the agendas of pharmaceutical meetings held during Finland’s presidency of the Council of the EU.
Finland’s presidency began at the start of July and will run until the end of the year. Prior to taking up the responsibility, Finland sketched out its ambition to make the European Union more competitive and ratchet up its response to climate change. Now that the presidency has begun, Fimea has fleshed out its industry-specific objectives for the coming six months.
During its presidency, Finland will host eight pharmaceutical meetings, including two gatherings of the Heads of Medicines Agencies (HMA) and multiple events involving EMA committees and working groups.
Fimea expects around 800 pharmaceutical experts to attend the meetings. Presented with such an opportunity to reach the European pharma community, Fimea plans to work with other parts of the Finnish state to “actively influence” the agendas of the meetings. Fimea’s goal is to promote certain themes that are important to it.
“The themes raised will include innovations and new medicines, rational pharmacotherapy and the availability of medicines, and making EU’s joint processes more effective,” Fimea wrote.
The series of meetings will start later this month, when organizations including the Scientific Advice Working Party arrive in Helsinki, and run through to a gathering of HMA members in late November.
Dutch MEB Starts Campaign to Educate Public About Drug-Herbal Product Interactions
The Dutch Medicines Evaluation Board (MEB) has begun a campaign to educate the public about how herbal products can interact with medicines. MEB wants to ensure people always tell their doctor or pharmacist about their use of herbal products.
More than 10% of people in the Netherlands use herbal products, such as ginseng. MEB assesses the quality, efficacy and safety of herbal medicines, but they can interact with those of drugs.
To raise awareness of these interactions, MEB has published a notice and created a video. The MEB materials discuss interactions, including the potential for St. John's wort to diminish the effectiveness of cancer drugs and for ginseng to raise the risk of thrombosis when used with a blood-thinning drug.
The French National Agency for Medicines and Health Products Safety
(ANSM) has ordered makers of paracetamol to add an overdose warning to their product labels. ANSM decided on a message that translates as “OVERDOSE = DANGER” after 85% of the 2,300 people it polled expressed a preference for warnings that began with that statement. Almost every respondent was in favor of adding a warning about liver damage to the front of packages. ANSM has given companies nine months to comply. ANSM Statement
The Swiss Agency for Therapeutic Products
(Swissmedic) has held off on making a recommendation about the safety of paclitaxel-coated balloons and paclitaxel-eluting stents. Since Swissmedic said it would gather and analyze data on the devices, other regulators including MHRA have revised their recommendations. Swissmedic referred to these developments in an update but did not make any new recommendations of its own. Swissmedic Notice
has updated its clinical trial guidance in response to an EU-level push to get sponsors to comply with reporting requirements. The new text refers to the letter published by EU bodies and states that sponsors must tell MHRA about the premature ending of a clinical trial within 15 days. MHRA Guidance