Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System
Ireland has extended the “use and learn” phase of the implementation of the Falsified Medicines Directive (FMD) for a second time. The implementation phase will now end in a staggered manner starting sometime after the end of September.
When the FMD safety feature requirements came into effect on 9 February, the Irish Health Products Regulatory Authority (HPRA) opted against fully enforcing the rules from day one. Rather, the agency saw the months following the go-live date as a chance to “use and learn” the system, thereby freeing organizations from the risk of being punished over teething problems. After three months, HPRA extended the implementation phase out to 9 September because of problems with the system.
Now, HPRA has again extended the use and learn period. HPRA is yet to say how long the period will run, stating only that it will end in a phased manner. The industry is expected to learn more at the end of September when HPRA is due to publish a detailed plan for how it will wind up the use and learn phase and over what timeframe.
HPRA, in collaboration with other Irish organizations, took the action despite progress made over the past few months. Manufacturers have uploaded barcode data on 180 million packs to a national system, as compared to 100 million when HPRA previously provided an update in May.
However, in other areas there is still progress to make. While the rate of alerts per scan has fallen from a high of 20%, it still stands at 3.5%. Given Irish pharmacies, hospitals and wholesalers have scanned 11.3 million packs since February, the rate of alerts still translates into a significant number of alarms. At the May level of 60,000 scans a day, the rate translates into 2,100 alerts a day. HPRA said the number of daily scans is still rising but did not disclose a figure in the recent update.
There are also still some pharmacies, hospitals and wholesalers that are yet to register with the Irish Medicines Verification Organisation (IMVO) and connect to the national system. As in May, HPRA said the “vast majority” of these organizations are registered with the IMVO.
The situation for the registered organizations and other groups will remain unchanged until HPRA shares more details of its staggered end to the learn and use phase later this month. HPRA used the update to remind pharmacies, hospitals and wholesalers of what that means.
“Pharmacies, hospitals and wholesalers must scan packs where obliged to do so. The data generated from these scans is critical for identifying root causes of alerts and other issues that need to be resolved in order to ensure an orderly ending of the use and learn period with minimal disruption to end-user workflow and patient supply. FMD is an important patient safety initiative and end users’ support at this stage by way of scanning is vital for its successful implementation,” HPRA wrote.
MHRA Chastises Company Over Promotion of Generic Viagra
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has upheld an advertising complaint against a provider of generic Viagra. MHRA concluded that Cornerstone Brands breached the rules on the sale of samples by offering products at “an unreasonably low sum.”
Under the Human Medicines Regulations, companies are prohibited from selling or supplying drug samples. In the view of the complainant and MHRA, a promotional offer run by Cornerstone violated that rule. That conclusion rests on MHRA’s interpretation of the prohibition on selling samples.
“Offers to potential consumers to enable them to obtain the pack for free or for an unreasonably low sum so as to be almost free is considered to fall within this prohibition,” MHRA wrote. Cornerstone removed the promotional materials.
The company also agreed to remove references to product being “MHRA approved” from its website. At MHRA’s request, Cornerstone agreed to take down the references and not to refer to the agency on its website or marketing materials in the future.
HPRA Asks Companies to Mitigate Risk of No-Deal Brexit Supply Disruptions
HPRA has asked companies to mitigate the risk that a no-deal Brexit will disrupt supplies of human and veterinary medicines in Ireland. The statement lacks a prescriptive request, such as the six-week stockpile demanded by the UK government, but calls for companies to consider multiple actions.
Ireland is more exposed to the impact of a no-deal Brexit than the other 27 member states that will remain in the European Union after the UK leaves. The close trade ties between Ireland and the UK, which share a land border, mean any disruption to the flow of goods could have major effects on the availability of medicines and other products in both territories.
In light of those risks, HPRA has asked companies to consider how they can maintain supplies, both in the run up to the UK’s current departure date of 31 October and beyond.
“Companies are requested to take the necessary steps to ensure sufficient stock levels and continuity of supply. This includes consideration of stocks at wholesale level and ensuring arrangements are in place to allow for timely replenishment of such stocks including custom requirements where applicable and allowing for potential delays during transportation,” HPRA wrote.
HPRA issued the request in two near-identical statements covering human and veterinary medicines. The statements discussed HPRA’s efforts to identify potentially vulnerable medicines and get their suppliers to act to cut the risk of disruptions.
The publication of the request preceded an effort in the UK Parliament to stop the government from taking the UK out of the EU without a deal. Concerns about the likelihood of a no-deal Brexit peaked early on Tuesday, only for a majority of parliamentarians to vote against the government and seize control of the legislative agenda. On Wednesday, Parliament passed legislation intended to prevent the UK leaving without a deal.
Finland to Revise Drug Shortage Reporting Process in Light of EU Guidance
The Finnish Medicines Agency (Fimea) is set to revise its process for reporting drug shortages. Fimea based the new process on guidance released by the European Medicines Agency (EMA) earlier this year.
Currently, companies can use either the existing notification or the revised document to send details of a supply disruption to Fimea. Whichever form is used, Fimea is recommending companies submit additional information describing the supply disruption in more detail. The submission of the extra information is optional for now. Fimea plans to make it mandatory at the start of next year.
To facilitate the reporting of the extra information, Fimea plans to release a template companies can use to share all the details requested in the standard form and appendix document. The use of the new standard form will become mandatory on 1 October.
Fimea framed the changes as being in line with EU-level policies on reporting shortages. EMA posted documents on the reporting of drug shortages and dissemination of that information to the public in July.
has issued a notice about a global public meeting on draft ICH clinical trial guidelines. The agency is encouraging people to register for the meeting, which will be held in the United States at the end of next month. EMA Notice