What are my FMD obligations as an MAH?
Marketing authorisation holders (MAHs) who market in-scope products in Ireland must ensure that all packs released for the Irish market carry safety features (unique identifiers and anti-tamper devices).
The key steps to be undertaken to comply with FMD requirements include:
- Identify what products require safety features (as defined in Article 2 of the Commission Delegated Regulation (EU) 2016/161.)
- Prepare packaging artwork with the relevant safety features and submit it for regulatory approval.
- Upgrade production lines to apply the 2D barcode containing the unique identifiers and also the anti-tamper device.
- Connect to the EU Hub which is managed by EMVO. One legal entity per pharmaceutical corporation, known as the ‘Onboarding Partner’ or ‘OBP’, onboards with EMVO and they look after data upload on behalf of all MAHs within the corporation. MAHs are legally responsible for ensuring that the data has been uploaded correctly. Visit the EMVO website for details of EMVO’s onboarding process for OBPs.
- Upload unique identifier data that has been placed on packs to the EU Hub. The data will then transfer from the EU Hub to the national repository for the market where the packs are intended to be sold.
- Register as an MAH with IMVO and pay the relevant fees (one-off registration fee and annual fee).
- Notify IMVO of your ‘Alerts Single Point of Contact’ (SPOC) and back-up SPOC for communications relating to alerts. Click here to download the form to notify this information.
- Ensure that the necessary communication processes are in place to ensure that all alerts notified to OBPs via the EU Hub are transmitted to the relevant parties internally for analysis and follow-up.
How do we register with IMVO?
There are three steps in IMVO’s registration/onboarding process for MAHs:
- Complete the IMVO MAH registration form so we have all your details, including invoicing requirements. One form will be required per MAH, but this may be completed by the local affiliate.
- Sign the IMVO MAH Agreement. A separate agreement must be signed for each MAH.
- Pay the IMVO MAH registration fee (this may be paid before the MAH Agreement is signed).
What fees are payable to IMVO by MAHs?
Registration fee – A one-off registration fee of €16,000 (ex VAT) is payable by all MAHs on initial registration with IMVO.
Annual MAH user fee – All MAHs are required to pay an annual user MAH fee. It is payable on 9th February each year and invoices are issued to registered MAHs in early January.
All MAH fees are reviewed each year as part of IMVO’s annual budgeting process. The amount of the annual MAH user fee will be notified by IMVO to MAHs in writing no later than 30th September in the previous calendar year.
IMVO’s payment terms are 30 days.
Are there any variations to the above fee structure?
Rebates for MAHs with low turnover – Like most other national medicines verification organisations, IMVO bases its financial projections on a flat fee per MAH model. In recognition of the challenges that this may pose for MAHs with a low turnover, a rebate of 60% will be provided on the registration fee and annual MAH user fee for MAHs with a turnover of less than €100,000 in Ireland (based on previous year’s data). The turnover figure will be self-certified, but IMVO reserves the right to request supporting evidence and/or audit the declared turnover. Fee rebate decisions will be valid for one financial year only. Separate application must be made in subsequent year(s) if a MAH considers that it continues to be eligible for a rebate and such application(s) will be considered by IMVO independently of previous decision(s). If you are a MAH that might be eligible for this rebate, please email us at firstname.lastname@example.org and we will provide details of how to apply.
MA transfers – If all the marketing authorisations (MAs) belonging to one MAH are transferred to a different MAH within the same pharmaceutical corporation or to an unrelated company that is not already registered with IMVO, please contact us by email (email@example.com) for guidance on the fee arrangements in this situation.
When you scan the 2D barcode, an alert will be generated if the data in the barcode or the pack status (‘active’/’decommissioned’) doesn’t match what’s in the IMVS. During the use and learn period, you may continue to supply the pack if an alert has been generated unless you have an overriding concern that the pack may be falsified or has been tampered with.
IMVO may contact you from time to time for additional information on alerts generated in your pharmacy. If you have any queries about alerts for IMVO, please email firstname.lastname@example.org or phone us on +351-1-5715320.
Use and learn
The Safety Features Oversight Group comprising the IMVO, the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the Health Service Executive (HSE) and the Private Hospitals Association (PHA) has been closely monitoring progress with the implementation of the IMVS since it went live on 9th February 2019. In order to allow time for it to stabilise, the system has been in a use and learn phase since then and this will be ended on a phased basis over the coming months.
During the use and learn period:
- All medicinal products released for the Irish market since 9th February 2019 must bear the safety features as required i.e. a tamper proof seal (anti-tamper device) and 2D barcode.
- During the use and learn period, pharmacies, hospitals and wholesalers must scan packs where obliged to do so 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 in pharmacies, wholesalers and hospitals, upon scanning a pack during the use and learn phase, are forwarded by the system to IMVO, the HPRA and the manufacturers/MAHs 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 to support the implementation of the Delegated Regulation was introduced in February 2019. However, offences for breaches of the legislation will not be commenced until a later date, after use and learn ends.
For more information on Use and Learn visit the News and Events page.
Coding / serialisation requirements
There are no Ireland-specific coding or serialisation requirements. GTINs from GS1 are widely used in the pharmaceutical sector in Ireland. Reimbursement codes do not have to be included in unique identifiers on packs placed on the Irish market.
Connecting to the EU Hub
EMVO has published a wide range of guidance documents to assist OBPs in connecting to the EU Hub and uploading data to the national systems. See the EMVO website for details.
Article 20(b) of the Commission Delegated Regulation (EU) 2016/161 relieves wholesalers from the requirement to verify packs if received from the manufacturer or MAH or a wholesaler designated by the MAH, by means of a written contract, to store and distribute products covered by his MA on his behalf (i.e. ‘Designated Wholesaler’). MAHs (including parallel importers / parallel distributors) are obliged to upload to the EU Hub a list of ‘Designated Wholesalers’ for each product placed on the market. For detailed guidance on Designated Wholesalers, please see Appendix 5 to the EMVO Master Data Guide which is available on the EMVO website.
Regulatory guidance for MAHs
Guidance on the regulatory aspects of FMD has been published by the:
- Health Products Regulatory Authority (HPRA)
- Heads of Medicines Agencies Co-ordination Group for Mutual Recognition & Centralised Procedures – Human (CMDh)
- European Medicines Agency
The European Commission also published information on falsified medicines, including a detailed Q&A on Safety Features which is regularly updated.
IMVO webinars for Marketing Authorisation Holders
For information on any upcoming webinars visit the News and Events page.