Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Denmark Outlines Process for Handling Alarms Triggered by Anti-Counterfeiting System
The Danish Medicines Agency (DKMA) has posted guidance on the handling of alarms triggered by anti-counterfeiting systems. DKMA’s document details what it will expect of manufacturers and other organizations when the Falsified Medicines Directive comes into force next month.
The incoming requirements mandate the use of 2D barcodes and anti-tampering devices to stop counterfeits from entering the legal supply chain. If the system suspects a drug is fake, it will trigger an alarm. DKMA’s guidance discusses what pharmacies, wholesalers and marketing authorization holders must do when that happens.
DKMA has created a chart to guide organizations through the steps they must take. Drugs that trigger alarms cannot be given to patients and must be investigated, starting with a probe by the pharmacy or hospital into whether the alarm was caused by a technical fault or a genuine problem with the authenticity of the drug package.
When a probe eliminates technical fault as the possible cause of the alarm, the pharmacy or hospital must quarantine the suspect package and contact the marketing authorization holder. If suspicions about the authenticity of the product remain after talks with the marketing authorization holder, the package should be returned to the wholesaler.
The receipt of the package by the wholesaler starts the process again. Specifically, the wholesaler looks into whether a technical error could explain the alarm and, in the event that it cannot, sends the package to the marketing authorization holder for further testing. DKMA wants to be informed immediately if the marketing authorization holder deems a package to be a counterfeit.
In this process, the ultimate responsibility for determining the authenticity falls on the marketing authorization holder or manufacturer. DKMA thinks these organizations are best placed to confirm whether a drug is a counterfeit or not.
MHRA Finalizes Position on Falsified Medicine Safety Features After Consultation
The Medicines and Healthcare products Regulatory Agency (MHRA) has finalized its position on the implementation of safety features under the Falsified Medicines Directive. MHRA’s final stance hews closely to the position it laid out at the start of last year’s consultation, although the feedback has led it to offer certain other exemptions from the requirements of the directive.
The European Union directive is set to standardize many aspects of the management of counterfeit medicines across the region. However, the directive also features flexibilities that allow member states to tailor the requirements to their national supply chains. The United Kingdom’s MHRA set out its views on the appropriateness of these flexibilities for its jurisdiction in July and closed out 2018 with the publication of its response to the feedback on its plans.
With MHRA receiving broad support for its planned use of the flexibilities provided by the directive, the agency is set to push ahead with most of the proposals detailed in the consultation. That means the UK will take advantage of the option to allow wholesalers to decommission medicines on behalf of other people or organizations. MHRA said a minority of wholesalers objected to the proposal but overall the responses supported its view that the option is the least burdensome way forward.
MHRA also received support for three of its other proposals. The positive feedback means the UK will not extend the unique identifier to medicines that “are otherwise out of scope for the purposes of reimbursement or pharmacovigilance.” MHRA will also allow companies to add extra information to 2D barcodes and spare them from the need to use a national reimbursement number.
For each of those proposals, MHRA maintained the position set out its consultation on the grounds that it was broadly supported by respondents. MHRA received pushback against its other proposal, though, and has changed its position in response to the feedback.
The EU directive permits member states to exempt people employed at healthcare institutions from decommissioning under certain circumstances. MHRA saw no use for this exemption before hearing feedback from hospital pharmacy departments, which told the agency that they hold warehouse and distribution agreements. In light of that information, MHRA will take advantage of the flexibility that exempts people at healthcare sites from verification and decommissioning obligations.
MHRA’s finalization of its position comes weeks before the safety feature regulation is set to come into force. As the 9 February implementation date comes before the UK is due to leave the EU, the requirements will automatically become part of UK law. However, a no-deal Brexit would cut the UK off from the central data hub, leaving companies unable to upload, verify and decommission unique identifiers.
Dutch Regulator Warns Patients About Dosing Risks of UCB’s Xyrem
The Dutch Medicines Evaluation Board (MEB) has issued a warning about UCB’s narcolepsy treatment Xyrem. MEB posted the notice after learning that the markings on the dosing syringe can fade over time, raising the risk of over or underdosing.
UCB supplies Xyrem with a graduated measuring syringe that patients use to dispense the medicine into a dosing cup prior to ingestion. The syringe features markings to show how much of the drug a user needs to dispense into the dosing cup, but after repeated use these lines can fade and become unreadable.
MEB is yet to hear of a patient taking too much or too little Xyrem as a result of unclear markings but it thinks that remains a risk. As such, MEB is advising pharmacists and other healthcare professionals to tell patients about the risk that the markings on their syringes may fade.
UCB plans to make a revised dosing syringe available in the Netherlands in June. MEB wants patients to contact their pharmacist or healthcare professional if they have a problem with a syringe to obtain a new device with clear, unfaded markings.
MHRA Publishes Letter About EU-UK Approval Conversions in the Event of a No-Deal Brexit
MHRA has published a letter about the handling of marketing authorizations if the UK leaves the EU without a deal in March. The agency plans to automatically convert the authorizations for centrally authorized products (CAPs) to UK approvals within weeks of a no-deal Brexit.
Under its no-deal contingency planning, MHRA wants manufacturers of CAPs to tell it if they plan to opt out of the automatic conversion by the end of the month. The ultimate deadline for informing MHRA of opt out plans in writing is 22 April. After that, MHRA will convert all CAPs not covered by opt-out requests into UK marketing authorizations at no charge to the companies involved.
In converting the CAPs, which do not need to currently be on the market in the UK, MHRA will issue one or more product license numbers based on existing UK licensing practices. As the UK practice is to issue a single marketing authorization number for multiple pack sizes, the conversion may result in a company having fewer authorization numbers in the UK than in the EU.
Ahead of the potential conversion, MHRA wants manufacturers to confirm its records of their CAPs are correct and let it know if they want to exercise any opt outs. MHRA sent that request to companies in late November and shared the letter publicly shortly before the end of 2018.