What are my FMD obligations as a wholesaler?
Pharmaceutical wholesalers across Europe are required to verify medicines bearing safety features that pass through their warehouses in specific circumstances as set out in the Commission Delegated Regulation (EU) 2016/161. This is done by scanning the 2D barcode on the pack and verifying the pack via an Internet connection to the Irish Medicines Verification System. Wholesalers are also required to decommission packs in certain circumstances, including when they are being supplied to specific customers as per Article 23 of the Delegated Regulation.
There are a number of steps to be completed in order to be able to scan barcodes and check them against the data held in the IMVS:
- Identify what SKUs are in-scope and all locations within your warehouse(s) where scanning will need to take place;
- Put in place procedures to flag when stock must be verified and/or decommissioned and to deal with any alerts from the IMVS;
- Identify what customers you will have to decommission products for under Article 23;
- Identify what software solution you will use to connect to the IMVS. A list of the IT software providers, whose FMD solutions have been certified by IMVO, is available on the FMD Software Providers section of our website;
- Source scanner(s) to read barcodes. If you are using externally sourced software, your IT software provider will be able to advise you on models that will work correctly with their solution;
- Consider what changes are needed to work practices, SOPs, facilities and personnel to support scanning operations and management of alerts;
- Inform your team about what’s happening and training relevant staff;
- Get connected to the IMVS – click here for more details.
Getting connected to the IMVS
You can find more information about getting connected to the IMVS here.
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 email@example.com or phone us on +353-1-5715320.
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.
Article 23 of the Commission Delegated Regulation (EU) 2016/161 gives Member States flexibility to mandate wholesalers to verify and decommission the unique identifier of all medicines bearing the safety features for certain categories of customers. For Ireland, Medicinal Products (Safety Features on Packaging) Regulations 2019 (S.I. No. 36 of 2019) have defined the relevant customer groups as follows:
- persons authorised to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;
- a veterinary practitioner, as defined in section 2(1) of the Veterinary Practice Act 2005 (No. 22 of 2005);
- retailers of veterinary medicinal products;
- a registered dentist, as defined in section 2 of the Dentists Act 1985 (No. 9 of 1985);
- persons registered with the Optical Registration Board under the Health and Social Care Professionals Act 2005 (No. 27 of 2005);
- paramedics and emergency medical practitioners;
- the Defence Forces, An Garda Síochána and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;
- universities and other higher education establishments using medicinal products for the purposes of research and education, with the exception of healthcare institutions;
- nursing homes.
The Delegated Regulation defines a healthcare institution as ‘a hospital, in- or outpatient clinic or health centre.’ S.I. 36 of 2019 further defines ‘in- or outpatient clinics’ and ‘health centres’ as follows:
- ‘In or out-patient clinic’ means an in or out-patient/day patient clinic under the management or control of a hospital;
- ‘health centre’ means a health centre under the management or control of a hospital.
As per Article 20(b) of the Commission Delegated Regulation (EU) 2016/161, wholesalers are not required to verify packs received from the relevant 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 from EMVO.
Wholesalers who wish to know if they have been assigned ‘designated wholesaler’ status for a given product, can use their FMD software to pull this information from the IMVS in one of two ways, depending on how the software has been programmed:
- By way of a request for a report relating to that product, specifically, the ‘Contracted Wholesalers Stakeholder Report’ – this will return a report with the relevant details.
- By way of a query for Product Data for a particular pack (technically a ‘call to ProductDataDownload()’ or a ‘JSON query’) – this generates a response that includes all the information about the product, including the designated wholesaler.
If the wholesaler’s FMD software does not have either type of functionality, then the wholesaler will need to ask the MAH for details of the designated wholesaler for the product in question. If the wholesaler is seeking information about designated wholesalers for a pack that has not been released for Ireland, e.g. an unlicensed pack from the UK, the IMVS cannot return any information on designated wholesalers as this data will not exist in the Irish system.
How to scan correctly – This short video demonstrates how to scan FMD packs and provides useful tips for scanning.
Check your scanner – Use the ‘IMVO Check your scanner’ guidance to test if your scanner is set up correctly. As part of checking your scanner you will need to determine which mode your scanner is in. The ‘Check your scanner’ guidance will tell you how to do this.
If you identify problems with your scanner after carrying out those tests, then proceed to the relevant ‘IMVO Fix your scanner’ guidance for your scanner make and mode. These documents should help you fix any problems with your scanner and set it up correctly.
Fix your scanner – If you identify problems with your scanner after checking it, then you need to ‘fix’ them. This is done by scanning a series of barcodes that will set your scanner to the correct configuration:
- The instructions for fixing the scanner depend on what make it is and the mode it is set up in (keyboard wedge or serial mode. Look at the scanner to see what make it is. See IMVO ‘Check Your Scanner’ for details of how to find out what mode it is in.
- IMVO has drawn up guidance on how to fix Datalogic and Honeywell scanners as these are the most commonly used FMD scanners in Ireland.
- If you have a Datalogic or Honeywell scanner, follow the instructions in the relevant ‘Fix Your Scanner’ guidance below. There are 4 different versions so use the one that corresponds to your scanner’s make and mode.
- If you are using any other make of scanner, your FMD software provider may be able to advise you on how to reconfigure it. Please also inform IMVO (Contact us) so that we can update our scanner guidance.
- If you’re unsure what to do next, please contact us at firstname.lastname@example.org, including the make of your scanner in your email.
Guide to IMVS alerts and next steps
Information to follow
IMVO webinars for wholesalers
For information on upcoming webinars visit the News and Events page.