News Category: Regulatory news
(Update originally published: 05/02/2019)
The European Commission’s Delegated Regulation on safety features for medicinal products for human use comes into operation across Europe from 9 February 2019.
Delegated Regulation (EU) 2016/161 supplements the Falsified Medicines Directive 2011/62/EU by setting out detailed rules for the safety features appearing on the packaging of medicinal products for human use.
These new requirements will help to enhance patient safety by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and introducing new rules to more rigorously regulate the supply chain.
The Irish Medicines Verification Organisation (IMVO) has been established to manage the medicines verification system for Ireland and the vast majority of pharmacies, wholesalers, MAH’s and manufacturers have registered with the IMVO.
The Department of Health has been working closely with the IMVO, the HPRA, the Pharmaceutical Society of Ireland (PSI), the HSE and Private Hospitals Association (PHA) for the last year to monitor progress in the implementation of the new safety feature requirements across all sectors.
This new medicines’ verification system is a significant undertaking involving the collaboration of almost 2,000 pharmacies and hospitals, along with pharmaceutical manufacturers and wholesalers, stakeholder representatives and regulators, which sees over 95 million prescription medicines dispensed to patients every year.
Notwithstanding the significant work undertaken to date and given the complexities associated with setting up the medicines verification system impacting all stakeholders in the medicines supply chain across Europe, it is anticipated that the initial period of operation will identify issues as the new system comes into effect Europe-wide.
Following discussions at a national and European level with stakeholder representatives, it has been decided to adopt a pragmatic approach to the implementation of the Delegated Regulation (and the associated statutory instrument) after the go live date, to ensure the continuity of safe supply of medicines to patients while all parties gain a better understanding of the new system. This means that:
- All medicinal products released by MAH’s for the Irish Market after 9 February should bear the safety features as required i.e. a tamper proof seal and 2D barcode
- During the initial period of operation, the system will be considered to be in ‘use and learn’ phase. Therefore wholesalers, pharmacies and hospitals should scan medicines bearing the safety features and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
- All alerts generated by the FMD system upon scanning a pack during this ‘use and learn’ phase will be forwarded by the system to the IMVO, the HPRA and the pharmaceutical companies so that they can be investigated and monitored.
- Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.
National legislation including the provisions of Article 23 of the Delegated Regulation will be introduced, however, the offences provided for in the Regulations will not be commenced for a period of time to let the new system bed in.
During this period, the alerts generated will be analysed by the Department of Health, IMVO, HPRA, PSI, HSE and private hospitals pharmacies to determine why they are occurring and develop appropriate protocols for their resolution. Manufacturers (and marketing authorisation holders) will also be involved in the investigation of alerts generated against their products. The system will be reviewed again in three months’ time.
This approach will ensure that medicines continue to be provided to patients without delay and also ensure that all stakeholders, manufacturers, wholesalers, pharmacists and other healthcare professionals work to build confidence in operating the new safety system.
Specific Information for Marketing Authorisation Holders in relation to reporting Suspected Quality Defects
MAHs will receive details of the alerts generated by the IMVO system and will need to ensure that the necessary resources are in place to deal with them as a matter of priority. In certain cases, reports of suspected quality defects will need to be submitted by the MAHs (or their manufacturers) to the HPRA. These cases are where there is reason to believe that the packaging of a medicinal product has been tampered with or when the investigation of an alert by the MAH or its manufacturer results in an indication that the pack may not be authentic.
Such reports of suspected quality defects should be made to the HPRA in the usual manner by completing the Quality Defect Report form.
The form needs to be downloaded, completed and emailed to the following email address: firstname.lastname@example.org. The subject line of the email should start with the words “Safety Features” followed by the name of the product.
Such suspected quality defects should be reported to the HPRA as soon as possible.
Our guidance document provides further information on the reporting of suspected quality defects.
Further Information on Safety Features for Medicinal Products for Human Use
View the European Commission's Delegated Regulation for Safety Features. In addition, the Commission has published a related Questions and Answers document.
Further background details are also available from the Falsified Medicines sections of the Commission and HPRA websites.