Frequently asked questions

About the Irish Medicines Verification System (IMVS)

Q1. What is the role of IMVO?

IMVO is responsible for setting up and managing the Irish Medicines Verification System (IMVS) which is part of the European Medicines Verification System (EMVS). We support pharmacies, hospitals and wholesalers (‘end-users’) to connect to the IMVS, assist with any problems that arise, and work with end-users and marketing authorisation holders (MAHs) to minimise avoidable alerts. IMVO is not a regulatory or enforcement body.

Q2. Who is responsible for enforcement of FMD?

The HPRA is responsible for supervising compliance with the Delegated Regulation by IMVO, wholesalers, MAHs and manufacturers. The PSI is responsible for supervising compliance with the Delegated Regulation by pharmacies.

Q3. Who are the members of IMVO?

As required by the Commission Delegated Regulation on Safety Features (EU) 2016/161, the cost of developing and running the IMVS (including IMVO’s running costs), is borne by marketing authorisation holders (originator companies, generic companies and parallel distributors). This includes everything up to the interface with the wholesalers, pharmacies and hospitals but not the cost of scanners and FMD software used by pharmacies, hospitals and wholesalers. Each group is required to cover their own implementation costs.

Q4. Why isn’t the IMVS used for reimbursement?

The Commission Delegated Regulation (EU) 2016/161 on Safety Features gives Member States discretion to require barcodes to include national reimbursement numbers to facilitate barcode scanning for reimbursement purposes. The Department of Health (DoH) and Health Service Executive (HSE) were consulted and decided not to use the IMVS for reimbursement purposes as there is already a functioning electronic reimbursement system in place.

Q5. Do reimbursement numbers have to be included in the unique identifier of medicinal products place on the market in Ireland?

No. The Department of Health (DoH) and Health Service Executive (HSE) decided not to use the IMVS for reimbursement purposes and reimbursement numbers are not required in the unique identifier of medicinal products place on the market in Ireland.

About FMD

Q6. What is ‘FMD’?

FMD stands for Falsified Medicines Directive and is a general term used to refer to EU and Irish legislation relating to falsified medicines and safety features – Directive 2011/62/EU, Commission Delegated Regulation on Safety Features (EU) 2016/161 (as amended) and the Medicinal Products (Safety Features on Packaging) Regulations 2019 (S.I. No. 36 of 2019). This legislation aims to reduce the risk of falsified medicines reaching patients.

Q7. What are the benefits of FMD apart from identifying falsified medicines?

The objective of FMD is to protect European patients from falsified medicines in Europe. Barcode scanning has significant potential to be used for other purposes to add value. IMVO ran a webinar to explore some of the possibilities (you can watch this webinar here).

Q8. Has it ever been considered if the chance of identifying counterfeits in the supply chain is proportionate to the extra burden and manpower of scanning? Do you know if this will or could ever be considered at European level?

FMD legislation was passed at EU level in 2011 and it is highly unlikely that the requirement to serialise packs and scan them prior to supply to patients will ever be reversed. Most other major markets in the world have introduced similar requirements as they are deemed to be a highly effective deterrent to counterfeiters becoming active in the legitimate supply chain.

Q9. Have any counterfeit medicines been identified in Ireland via FMD scanning?

No counterfeits have been identified to date in Ireland in the legitimate supply chain. The EMVS is primarily intended to be a deterrent, and the 12 billion transactions that take place in the EMVS each year appear to be making Europe a less attractive region for counterfeiters. That said, the EMVS plays an important role in identifying falsified medicines that fall through the net of the various measures introduced by the Falsified Medicines Directive (2016/63/EU) and falsified medicines have been identified in the Czech Republic, Slovakia, Bulgaria and most recently, in Germany and Austria (Ozempic falsifications).

Safety features

Q10. What are safety features?

Most prescription medicines placed on the market since February 2019 are required to carry the following ‘safety features’:

  • An anti-tampering device (ATD) so the person supplying it can be sure it hasn’t been interfered with.
  • A special 2D barcode (data matrix) containing information about the medicine, known as unique identifiers, i.e. product code, batch/lot identifier, expiry date and serial number (unique to each pack). In some countries, national reimbursement codes have to be included in the barcode, but this is not the case in Ireland. 

Q11. What is a ‘unique identifier’?

A ‘unique identifier‘ is the combination of information encoded in a 2D barcode on the packaging of medicinal products that enables the verification of the authenticity and the identification of the individual pack. The information to be included in the barcode is the product code, serial number, batch number and expiry date. These details must also be printed on the pack in a human-readable format in case the barcode is unreadable by the scanner.

Q12. What information is included in the 2D barcode?

The following information must be encoded in the 2D barcode:

  • Product code
  • Serial number
  • Batch/lot number
  • Expiry date
  • National reimbursement number or other national number (not required in Ireland)

Q13. Do reimbursement codes have to be included in unique identifiers in Ireland?

The Department of Health has confirmed that reimbursement codes do not have to be included in unique identifiers on packs placed on the Irish market.

Q14. What is the product coding scheme used in Ireland?

GS1 GTINs (Global Trade Item Number) is the product coding scheme used in Ireland. In some countries, GS1 has allocated a range of GTINs specifically for use with that country, which are collectively referred to as NTINs (National Trade Item Numbers). There are no NTINs for Ireland. Germany uses a different coding scheme called PPNs. The EMVS supports GTIN/NTIN and PPN coding schemes.

Scope of FMD requirements

Q15. Do all medicines require safety features?

The requirement for unique identifiers and anti-tampering devices applies mainly to prescription-only medicines, with some limited exceptions as set out in Annex I of the Commission Delegated Regulation (EU) 2016/161 which has a list of relevant products. Non-prescription medicines (also known as over-the-counter or ‘OTC’ medicines) only require safety features where there has been a known incident of falsification and the product concerned is listed in Annex II to the Delegated Regulation. The only OTC products listed in Annex II to date are omeprazole 20mg and 40mg gastro-resistant hard capsules and these products are not available in Ireland. Annex I and II may be reviewed and updated from time to time.

Q16. Can anti-tampering devices be included on OTCs and other products out of scope of FMD?

The HPRA has confirmed that anti-tampering devices may be placed on OTC (over-the-counter) and other out-of-scope medicinal products if the relevant manufacturer considers, on foot of a risk assessment, that it is necessary to do so in the interests of patient safety.

Q17. Do veterinary medicines have to be decommissioned by pharmacies or wholesalers?

No. FMD only applies to medicinal products for human use and veterinary medicines do not carry FMD safety features. However, human medicines supplied for animal use to an animal owner on foot of a veterinary prescription or to a vet on foot of a requisition, must be decommissioned as supplied at the time of supply.

Q18. Do ‘fridge lines’/cold chain products have to be decommissioned?

Yes, if they are prescription-only medicines and FMD compliant (i.e. have a 2D barcode and an anti-tampering device).

Q19. Do medical devices have to be decommissioned using FMD software?

No. If you scan the 2D barcode on medical devices using your FMD software, you will get a ‘product code unknown’ message. The IMVS only contains data for medicinal products, not medical devices.

Q20. Do vaccines have to be decommissioned?

Yes. All unopened vaccines, including those supplied through the HSE National Cold Chain Service , e.g. flu vaccines, must be decommissioned by pharmacies and hospitals. Wholesalers should decommission vaccines supplied to Article 23 customers.

Q21. Are unlicensed medicines (ULMs) in scope of FMD and should they be scanned?

Sometimes ULMs (also known as exempt medicinal products or EMPs) originating from other countries will have 2D barcodes on them.

If you know the pack is a ULM, don’t scan the 2D barcode as the IMVS may not recognise the pack.

If you inadvertently scan a ULM and get an alert, you may supply the pack unless:

  • you have overriding concerns that a falsified medicine is involved or believe the pack has been interfered with, or
  • the pack is flagged as expired, recalled, withdrawn, stolen or destroyed

Always check the anti-tampering device on a ULM Pack (if there is one). If you have any reason to believe the pack has been interfered with, please report this to the HPRA as a product quality defect to qualitydefects@hpra.ie and do not supply the pack.

Q22. Are fluids/IV fluids within scope of FMD?

Although IV fluids that are medicinal products are classified as prescription-only medicines, not all fluids are in scope of FMD, depending on their anatomical therapeutical chemical (‘ATC’) classification. Fluids that are out of scope of FMD are listed in Annex I to the Commission Delegated Regulation on Safety Features (EU) 2016/161 and do not have to carry safety features. The relevant entries from Annex I are included in the table below:

Product category Pharmaceutical form Strength
Solutions for parenteral nutrition having an anatomical therapeutical
chemical (‘ATC’) code beginning with B05BA		Solution for infusionAny
Solutions affecting the electrolyte balance having an ATC code
beginning with B05BB		Solution for infusionAny
Solutions producing osmotic diuresis having an ATC code beginning
with B05BC		Solution for infusionAny
Intravenous solution additives having an ATC code beginning with
B05X		AnyAny
Solvents and diluting agents, including irrigating solutions, having an
ATC code beginning with V07AB		AnyAny

The ATC code for a medicinal product can be found in section 5.1 (Pharmacodynamic properties) of the product’s summary of product characteristics.  

Connecting to the IMVS

Q23. How do I get connected to the IMVS?

There are a number of steps involved in connecting your organisation to the IMVS.

  • Decide what FMD software you will use to scan barcodes – click here for a list of software providers whose FMD software has been certified by IMVO.
  • Apply for registration as an ‘end-user’ with IMVO – for details of how to do this, click here.
  • Once the application is received and if all is in order, it will be processed, and you will be sent details of your IMVO account, and the steps involved in getting connected to the IMVS.
  • Your FMD software provider will assist you with the final step of connecting to the IMVS using the information provided by IMVO.

Q24. I have been locked out of my account in the IMVS Can you unlock my account?

You have been locked out of your account in the IMVS because six attempts were made at logging in with an incorrect password. Please wait one hour for your account to reset and before logging in again. If you have forgotten your password, click the ‘password reset’ link on the login page.

Managing your IMVS/IMVO account

Q25. Where do I access my account in the IMVS?

Click here for instructions on how to access your account in the IMVS. If you are having issues accessing this account please phone us on (01) 5715320 or email registration@imvo.ie.

Q26. How do I add a new location to my account in the IMVS?

All new locations being added to an existing account in the IMVS must first go through IMVO’s legitimacy check process. If you need to add a new location to your account please phone us on (01) 5715320 or email registration@imvo.ie.

Q27. I have added a new location to my IMVS account, but the status of the location says ‘pending’ what does this mean?

New locations being added to an end-user organisation’s account in the IMVS are initially in a ‘pending’ status, and need to be approved by IMVO before they are connected to the system. Super Users will receive email notifications when the approval process has been completed. If we have queries about a new location, we will contact your organisation’s Super User directly. 

Q28. How do I delete a location from my account in the IMVS?

  1. Access and sign into your account in the IMVS, with your super user log in details.
  2. Navigate to the ‘Locations’ page.
  3. Find the location and click the bin icon under the ‘Actions’ column, beside the location that needs to be deleted.
  4. Enter the name of the location into the modal window to confirm that the location should be deleted.
  5. This will delete the location and any client equipment connected to that location (NOTE: These steps are permanent and cannot be reversed).

If you need assistance with this please phone us on (01) 5715320 or email registration@imvo.ie.

Q29. I’ve installed a new computer in the pharmacy and need to reinstall the FMD software. How do I do this?           

In order to set up your FMD software on a new device, you will need to contact your FMD software provider who will do it for you. As part of this you will need to access your account in the IMVS – click here.

Q30. My FMD software provider has asked me for my client ID and client secret / client credentials – where can I get these?

The client ID and client secret are two codes that are generated when a new piece of equipment is being added to a location in your account in the IMVS. They are collectively known as ‘client credentials’. If you would like to receive a copy of the guide on how to generate client credentials please email info@imvo.ie or call (01) 5715320.

Q31. I want to update the details of my organisation’s Super User. How can I do that?

To update these details, please email registration@imvo.ie with the name, email address and phone number of the new Super User. Please use a business email address and phone number. We will update these details in your organisation’s IMVO account and also in the IMVS. The IMVS will then send an automated email (from notification@nmvo.eu) to the new Super User email address asking them to register. The email contains a temporary password and will request that the new Super User sets up a new password for logging in.

Q32. I have been locked out of my account in the IMVS. Can IMVO unlock my account?

You have been locked out of your account in the IMVS because six attempts were made at logging in with an incorrect password. Please wait one hour for your account to reset and before logging in again. If you have forgotten your password, click the ‘password reset’ link on the login page.

FMD software

Q33. Does IMVO have a list of FMD software providers?

A list of providers of FMD software systems providers is available on our website here.

Q34. I want to change to a different FMD software provider – what is involved?

You will need to provide your new FMD software provider with ‘client credentials (client ID and client secret for each piece of equipment)’ to be able to connect their software on your computer to the IMVS. If you would like to receive a copy of the guide on how to generate client credentials please email info@imvo.ie or call (01) 5715320.

Q35. How do I avoid issues with my FMD software?

Keep all of your IT equipment and applications (not just your FMD software) up to date and on the latest versions – this will help avoid any IT issues that could affect FMD software performance. If upgrades to other software applications (including antivirus) seem to be affecting your FMD software as seen by an increase in the number of alerts, contact your FMD software provider for support.

Q36. What is the impact of IT changes on my FMD software?

If you make any IT/internet/electrical wiring changes in your pharmacy, make sure your FMD software is still connected and working after the changes. Contact your FMD software provider or IMVO if you need help with this.

Q37. How can I be sure that my FMD software is connected and that my scans are being transmitted to the IMVS?

You will need to contact us to check this for you.

Scanners

Q38. Is there a scanner that doesn’t require a trigger (you just present the product like in a supermarket) that can be linked to a tablet?

We recommend contacting your FMD software provider about this. They will be able to give you guidance on scanners that work best with your FMD software.

Q39. Can I use more than one scanner in my pharmacy?

Yes, you can have multiple scanners.

Q40. Can IMVO see all the items that have been scanned in my pharmacy?

IMVO can see if scans are being transmitted to the IMVS but we have do not visibility in relation to exactly what you have scanned. The only time we are aware of the outcome of an individual scan, i.e., details of what product is scanned, is when an alert/exception is generated. In order to carry out its role in monitoring compliance with the legislation, the PSI periodically requests reports on the number of scans and decommissioning for dispense actions carried out in individual pharmacies. IMVO is obliged to request the relevant reports from the IMVS provider (Solidsoft Reply) for the PSI and carry out analysis on those reports on their behalf.

Q41. Can I see all the items that have been scanned in my pharmacy?

Your FMD software should offer reports to allow you to see this. If you need assistance to run these reports, please contact your FMD software provider.

Q42. How do I buy a new FMD scanner?

If you require a new FMD scanner please ask your FMD software supplier which scanner they recommend and which scanners are supported by their software. When setting up a new scanner you will be required to generate new client credentials for the piece of equipment the scanner will be connected to. If you would like to receive a copy of the guide on how to generate client credentials please email info@imvo.ie or call (01) 5715320.

Scanning packs

Q43. What happens when I scan a medicine?

When the 2D barcode is scanned, the number is checked in the IMVS to see if it is a valid serial number, or if it is marked as previously decommissioned. If there is a mismatch between the data returned from the scan and the data in the IMVS, your FMD software displays a response which contains text and is colour coded (green/amber/red) depending on the outcome of the scan. If the response is green, the scan has been successful. If the response is amber or red, follow the link in the exception message to ‘alert help’ pages in the IMVO website for further advice on what to do next.

Q44. If there is more than one barcode on a pack, which one do I scan?

The 2D barcode required by the Falsified Medicines Directive is part of the labelling requirements for medicinal products and applies to whatever is the outer packaging (e.g. box containing a vial, box containing blister packs), or the immediate packaging if there is no outer packaging (e.g. bottle supplied without a box). No other 2D barcodes may be placed on the relevant packaging. Some packs carry a linear barcode as well as a 2D barcode, which is allowed. It is important to ensure the linear barcode is not scanned using FMD software as doing so may generate an alert.

Q45. How can I be sure that my FMD software is connected and that my scans are being transmitted to the IMVS?

Contact us we can check this for you in the IMVS.

Q46. What is ‘manual entry’?

Manual entry means that instead of scanning a pack, you type the barcode data into an online portal – Emergency Verification Application (EVA) – which then returns a response to your request to verify or decommission a pack. The website address for the EVA is https://eva-ie.nmvo.eu. This may be accessed from any computer that has an attached keyboard, a web browser and Internet connectivity and not just the computer where your FMD software has been installed. You will require your IMVS account login details to access this site. You then type in the unique identifier data that is printed on the pack – it is important to do this slowly as any mismatch between what you type in and what appears on the pack will lead to an alert. Options presented with the EVA will depend on the type of user

  • Pharmacies (including hospitals) can verify packs and decommission packs as: Destroyed, Sample and Supplied
  • Wholesalers may verify packs and decommission packs as: Destroyed, Sample, Supplied, Locked, Exported and Stolen

Note: pack reactivation (recommissioning) via manual entry using the EVA is not permitted nor is the ability to decommission packs as free samples.

If you would like more details on how to use the EVA, please email info@imvo.ie and we will send you the NMVS Portal User Guide for Local Organisations.

Q47. Will the IMVS identify if the wrong medicine has been selected from the dispensary shelf compared to the prescription?

For products that are authorised for supply in Ireland, your FMD software may display the name of the product in the IMVS (or in some cases, the IPU product file) on screen, allowing you to check if the correct product has been selected. If the name, form or strength does not match, please inform IMVO so we can follow up to identify what caused the mismatch.

Q48. Can the IMVS verify what goes into the bag and then decommission the bag label when handing the prescription to the patient?

No. The IMVS is designed to decommission medicines individually. However, some FMD software is designed to enable you to do this two-step decommissioning. Check with your FMD provider if you are unsure whether this functionality is part of your FMD software.

Decommissioning/verifying medicines

Q49. How long will it take to decommission a medicine?

The maximum response time of the IMVS for a single scan is 300 milliseconds and in practice it is much faster than this. If the system has to check repositories in other EU Member States, for example, for exempt medicinal products, the process will take slightly longer as there are 4 steps involved, each taking a maximum of 300 milliseconds.

Q50. What is the difference between verification and decommissioning?

Verification: A medicine may be scanned to verify it is in the IMVS and its status, i.e. is it ‘active’ or marked as expired or decommissioned as dispensed, recalled, locked, exported, stolen etc. A verification may be done at any point the medicine is in stock and does not change the status of the medicine in the IMVS. You can verify a pack as many times as you wish.

Decommissioning: When supplying a medicine to a member of the public, the medicine must be scanned to verify it is in the IMVS and that is not marked as already decommissioned. Decommissioning the pack causes the status of the medicine in the IMVS to be changed to ‘supplied’, meaning if the same number is scanned again, it will be flagged to the person scanning it. Community pharmacies must do this for all relevant medicines dispensed or supplied. Be aware that trying to decommission a pack more than once may lead to alerts.

Q51. When you do you have to decommission a pack?

The rules regarding decommission as set out in the Commission Delegated Regulation on Safety Features (EU) 2016/161 as summarised below:

  1. When pack is being dispensed, it must be decommissioned as supplied/dispensed.
    – In community pharmacies, the pack must be decommissioned at the ‘time of supplying it to the public’.
    – In hospitals, decommissioning may take place any time after pack arrives in hospital, although anti-tampering device check must be done at time of supplying the pack).
    In case of a bulk pack, the pack should only be decommissioned once, when opened for the first time.
  2. When the pack is being sent for destruction, it should be decommissioned as ‘destroyed’. If the pack has expired, it doesn’t need to be decommissioned as ‘destroyed’ as the IMVS automatically changes its status to ‘expired’ when the expiry date is reached.
  3. When the pack is being supplied as a sample to a competent authority, e.g. PSI, HPRA, decommission it as a ‘sample’.
  4. When an authorised medicine is being supplied for use in a clinical trial, decommission it as ‘supplied’/’dispensed’.

Q52. Do I have to decommission a bulk/split pack every time I dispense from it?

No. If you are dispensing from a bulk pack or partially dispensing a pack, the pack must only be decommissioned once – when opened for the first time. If it is scanned on subsequent dispensings, this may lead to alerts. Many pharmacies have implemented creative solutions to identify which packs have been scanned, e.g. marking scanned packs with an X to remind them to not scan that pack again.

Q53. Can packs which were scanned and only partially dispensed be dispensed at any time up to expiry date?

Packs which have been partially dispensed and are already decommissioned may be dispensed at any time up to their expiry date. They should not be decommissioned again as this may lead to alerts.

Q54. Does ‘decommission’ mean the same as ‘supply’ or ‘dispense’ in FMD software?

The term ‘decommission’ under the FMD means changing the status of a pack from active in the IMVS to another state such as ‘supplied’, ‘destroyed’, ‘sample’ etc. If you are unclear about how your FMD software works or how to switch decommissioning modes, please consult the training materials provided by your software provider or contact their helpdesk for support.

Be aware that FMD software may use different terminology for decommissioning packs as supplied. The table below shows the names of the scanning modes used by the most common FMD software systems in community pharmacy:

FMD Software Name of scanning mode to decommission pack as supplied Other scanning modes
EasyFMD (QuickpharmDispense Verify, Decommission (as ‘sample’, ‘Intended for destruction’), Reactivate
ezFMD (HE Clissmann)DispenseVerify, Free Sample, Destroyed, Reactivate
MPS (McLernons)Supply Verify, Destroy, Sample NCA, Reintroduce
RxWeb (Clanwilliam)Supply Verify, Decommission (as sample or destroyed), Reintroduce
Touchstore Dispense now Verify, Decommission (as sample or destroyed), Reactivate

Q55. What is meant by Article 23 decommissioning?

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:

  1. persons authorised to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy
  2. a veterinary practitioner, as defined in section 2(1) of the Veterinary Practice Act 2005 (No. 22 of 2005)
  3. retailers of veterinary medicinal products
  4. a registered dentist, as defined in section 2 of the Dentists Act 1985 (No. 9 of 1985)
  5. persons registered with the Optical Registration Board under the Health and Social Care Professionals Act 2005 (No. 27 of 2005)
  6. paramedics and emergency medical practitioners
  7. the Defence Forces, An Garda Síochána and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control
  8. universities and other higher education establishments using medicinal products for the purposes of research and education, with the exception of healthcare institutions
  9. prisons
  10. schools
  11. hospices
  12. 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.

Wholesalers who supply any organisations referred to in Article 23 should check if they are doing their own decommissioning before decommissioning packs on their behalf. This avoids the problem of alerts being generated where the organisation decommissions packs that have already been decommissioned by the wholesaler.

Pharmacies and hospitals who supply persons/organisations covered by Article 23 must also decommission medicines supplied to them.

Q56. How many scans are needed to decommission a pack as supplied?

Most FMD software involves a one-step decommissioning process where you scan the pack once to mark it as supplied before giving it to a patient. This one scan combines the two actions of ‘verifying’ that the information in the barcode is correct and ‘decommissioning’ the pack.

Some FMD software enables a two-step process: first you scan each individual pack when the prescription is being assembled. The data from these scans is then captured in a barcode on the bag label. Secondly, you scan the bag label to decommission all the packs in that bag. We understand that many pharmacies opt to complete this final step just before handing the prescription to the patient. If you use this two-step process, make sure you have switched to the correct decommission mode before the second step. If you prefer not to have to scan the bag label separately, set your software to the correct ‘decommission’ mode so the packs are marked as supplied when they are scanned.

Q57. Do I need to verify medicines at the point of receipt from the wholesaler/manufacturer as well as when they are dispensed?

There is no requirement to verify medicines when you receive them from the wholesaler/manufacturer. Doing so will not fulfil the obligation of a pharmacy to decommission packs at the point of supplying them to the patient. It is however recommended that you verify high-tech medicines/critical medicines on receipt, to pre-empt any data related alerts when they are decommissioned at the point of dispensing where a delay in getting the medicine to the patient could be problematic.

Q58. Can I decommission medicines when they arrive in the pharmacy instead of during the dispensing process?

No, decommissioning must be done ‘at the time of supplying it to the public’.

Q59. What is the meant by decommissioning a pack ‘at the time of supplying it to the public’?

Decommissioning packs for patients must be done at some point between when you know that a particular pack is being dispensed for a particular patient and the pack being handed over to that patient. It is entirely a matter for each pharmacy whether they wish to do this when preparing the prescription or when the patient is collecting the prescription (by scanning the FMD barcode on the bag label if your FMD software generates a bag label for decommissioning).

Q60. Can a decommissioning action be reversed?

Certain decommissioning actions may be reversed – supplied/dispensed, locked, exported, free sample. The following decommissioning actions are irreversible – marking packs as destroyed, withdrawn, recalled or stolen. Reversing decommissioning is also known as reactivating the pack, reverting the pack to active in the IMVS, recommissioning and undoing a decommissioning action.

Certain conditions apply to this step:

  • The reactivating step must be completed within 10 days of the original decommissioning step and in same location;

Reactivating is not allowed if the pack:

  • was supplied to patient or
  • has expired
  • has been marked in the IMVS as destroyed, recalled, withdrawn or stolen

Q61. Does the 10-day window for reactivating packs run from the time the medicine was decommissioned or up until midnight on the tenth day?

The 10-day window runs until midnight on the tenth day.

Q62. Why aren’t packs decommissioned at wholesaler level?

Under the Commission Delegated Regulation (EU) 2016/161(Art 25(1)), pharmacists are required to “verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public”, the rational being that packs should be decommissioned at the final point in the supply chain to reduce the risk of counterfeits. This obligation cannot be delegated to wholesalers. It should also be noted that wholesalers are not required to scan all packs under the DR (see Art 20-24) and it should not be assumed that every pack you receive in the pharmacy has been scanned by your wholesaler

Q63. Does the barcode on the patient’s bag label have to be scanned when dispensing and again when handing to patient?

The assumption is that this question relates to those FMD software systems which generate a bag label with 2D barcode containing information when barcodes on individual packs are scanned during the dispensing process with the software in ‘verification’ mode. In this situation, the bag barcode is scanned once (either when the script is being dispensed or when given to the patient) – with the software in ‘decommission’ mode, marking the packs in the bag as decommissioned in the IMVS. The only information transmitted from the bag barcode to the IMVS is the data collected from the pack barcodes (product code, serial number, expiry date, batch number). NO patient data is sent to the IMVS.

Q64. What happens if an alert is generated on a high-tech medicine?

It is strongly recommended that you take steps to prevent last minute problems with these products, such as:

  • Reducing the risk of alerts when you scan these packs by ensuring your scanner is properly configured, that your FMD software is up to date and that your team is aware of the need to avoid repeated scanning
  • Where possible, encourage your patients to order their medicine in advance
  • Verify these medicines immediately on receipt from the wholesaler and contact IMVO for help if any alerts/warnings are generated

The IPU has worked with the HSE to have the High Tech Hub adapted to enable a replacement High Tech pack to be ordered by the community pharmacy if an alert is generated that cannot be quickly resolved, for example, you cannot find a procedural or scanner or software issue in the pharmacy and there has been no feedback yet from the marketing authorisation holder on their investigation. The dropdown reasons to record a ‘bad’ delivery on the High Tech Hub now includes: ‘FMD faulty product alert’.

Q65. What happens if an alert is generated on a critical medicine, and I don’t have an alternative pack available to supply?

If an alert is generated on a pack where there is an urgent patient need for the medicine and it is not possible to immediately identify a root cause, the pharmacy or hospital must establish if an alternative pack can be quickly sourced or if a different product could be given instead. IMVO has no authority to direct that the pack may be supplied in circumstances where an alert remains unresolved. It is a matter for the pharmacy or hospital to determine what is the most appropriate action to take having regard to all the circumstances and in the case of pharmacists, their obligations under the Code of Conduct for Pharmacists.

Q66. What do I do about phased dispensing?

Dispensing medicines on a phased basis should not be any different to normal dispensing, i.e. decommission the pack at the point of supplying it to the patient.

Q67. What do I do about monitored dose system (MDS) dispensing?

When you are removing medicines from their original pack to put into a monitored dosage system (MDS), you must decommission the pack at that time. If you only use part of the pack, treat in the same way as for broken bulk, i.e. decommission the pack when it is first opened. The next time you dispense from this part-pack, do not decommission it again as this may lead to alerts.

Q68. What do I do with unlicensed medicines (ULMs)/ exempt medicinal products (EMPs)?

Many ULMs carry 2D barcodes, which gives rise to the question of whether to scan them and what to do if an alert is generated. The following guidance on scanning of ULMs with 2D barcodes has been agreed with the HPRA:

  • If you know the pack is a ULM, don’t scan it as the IMVS may not recognise the pack;
  • If you inadvertently scan a ULM and get an alert, you may supply the pack unless:
    • you have overriding concerns that a falsified medicine is involved or believe the pack has been interfered with; or
    • the pack is flagged as expired, recalled, withdrawn, stolen or destroyed;
  • Always check the anti-tampering device (if there is one) – if you have any reason to believe the pack has been interfered with, please report this to the HPRA as a product quality defect to qualitydefects@hpra.ie and do not supply the pack.

This guidance is also available to download here.

Q69. What do I do about medicines supplied on foot of a requisition?

If you supply medicines on foot of a requisition, e.g. to a dispensing doctor, dentist, optician, vet, ship or other organisation, you must decommission each medicine before it leaves your pharmacy.

Q70. What do I do about medicines supplied to nursing homes?

You should treat medicines supplied to patients in nursing homes the same way as you treat medicines supplied to other patients, i.e. you decommission each medicine before it leaves your pharmacy. If the nursing home requisitions medicines on a stock order, you decommission each medicine before supply.

Alerts

Q71. I’ve scanned a pack and got an alert – do I quarantine the pack?

Please withhold this pack from saleable stock and follow the link in the exception message to ‘alert help’ pages in the IMVO website for further advice on what to do next.

Q72. I scanned the pack and got a red or amber exception. How will I know what the problem is?

When you verify or decommission a pack, your FMD software displays a response which contains text and is colour coded (green/amber/red) depending on the outcome of the scan. The exception/alert message will give you a high-level summary of what has happened, e.g. ‘serial number unknown’, ‘pack already decommissioned in another location’, and provide you with a link via your FMD software to an ‘alert help’ page on the IMVO website to assist you in a identifying a root cause for the alert and guidance on how to fix it (if is something under your control such as a scanner or software issue).

Q73. When I get an alert, does this mean that the pack is falsified?

When you verify or decommission a pack, your FMD software displays a response which contains text and is colour coded (green/amber/red) depending on the outcome of the scan. Amber and red responses are commonly described as ‘alerts’ and these are typically generated when there is a mismatch between the data sent by your FMD software to the IMVS or there is a mismatch in the pack state. Only so-called ‘Level 5’ exceptions are alerts that represent potential falsifications, but they do not automatically mean that a pack is falsified. These alerts are generally due to a technical procedural or system error or missing data, rather than because the pack is falsified or defective. Level 5 alerts require investigation by the relevant parties to establish its root cause. This involves looking for technical issues (scanner and software), procedural errors, missing data and issues with the European Medicines Verification System (EMVS). If no root cause can be found, the pack is deemed to be a suspected falsification and must be returned to the MAH for examination (keep the pack in the pharmacy/hospital until the MAH or HPRA advises you what to do next with it). If the MAH cannot confirm that a suspected falsified pack is genuine on foot of their examination of the pack, it is deemed to be a confirmed falsification.

Q74. What are Level 5 alerts?

‘Level 5’ exceptions are alerts that represent potential falsifications. An alert can be identified as a Level 5 alert if it has a unique ‘alert ID’ e.g. IE-LJB-AGR-34G-R3A-VG3. This is not the case for other levels of alerts/exceptions. All Level 5 alerts will be flagged as ‘red’ by your FMD software and will include the message ‘An alert has been raised’. Level 5 alerts are automatically sent to IMVO, the MAH and the HPRA and recorded in the NMVS Alerts alert management system.

Q75. What happens if an alert is not due to an issue in the pharmacy such as a scanner or software problem or procedural error?

Withhold pack from saleable stock (i.e. quarantine it) until:

  • The MAH confirms they have identified root cause (e.g. data issue, system issue) & if possible fixed root cause (e.g. by uploading data) or
  • The MAH requests pack to be returned for examination on basis that end-user error, data and system issues have been ruled out and they now need to analyse the pack. The MAH will advise on how pack is to be returned.

The HPRA has confirmed packs with alerts must be retained in the location where they were scanned and not returned to the wholesaler as part of standard business returns.

Recalls

Q76. How will the system deal with recalls?

The recall process will continue to operate as usual, i.e. the pharmacy will receive a ‘Dear Healthcare Professional’ letter with instructions on what to do about the recall i.e. pharmacies will receive recall information from the manufacturer/HPRA in the normal way.

However, if a medicine is recalled to pharmacy level, the manufacturer or parallel distributor will update the IMVS marking the relevant batch numbers as being recalled. If a pharmacy omits to return the recalled medicine, as part of their usual SOP, and tries to dispense it at a later date, when the barcode is scanned, the system will indicate that the product has previously been recalled. If you received recall information from the manufacturer/HPRA, you must not dispense such medicines to patients.

Q77. Do recalled medicines have to be scanned?

No, it is not necessary to scan recalled packs before returning them

Q78. Does the IMVS manage patient-level recalls?

No, as IMVS does not have access to any patient information. If you receive a patient-level recall after having dispensed a medicine to a patient, you should follow the usual process in your SOP for Dealing with the Recall or Withdrawal of Medicinal Products.

Expired/damaged medicines

Q79. How does the IMVS system deal with expired/out-of-date medicines?

The 2D barcode contains the expiry date of the product. If you attempt to dispense the product after the expiry date has passed, the system will alert you to the fact that the medicine has expired. You must not dispense such medicines to patients.

Q80. What do I do when disposing of damaged stock?

The advice depends on whether the packs are expired or not:

  • Stock is in date: Decommission it as destroyed using your FMD software before disposal.
  • Stock is expired: Stock is automatically changed to an expired state in the IMVS when it reaches its expiry date and no further decommissioning step is required before disposal.

Borrowing/lending medicines

Q81. What happens if/when I lend pack(s) to another pharmacy?

We recommend that you scan the pack(s) to verify its status before lending it to another pharmacy. That way you can be assured that the pack(s) has not already been decommissioned. The pack(s) should only be decommissioned by the pharmacy at the point of dispensing to a patient.

  • Lending a complete pack: The lending pharmacy should verify the medicine before it leaves the pharmacy to ensure that it is active and not decommissioned. If it is decommissioned, they should reactivate it. If this is not possible because more than 10 days have elapsed since it was decommissioned, the borrowing pharmacy should be made aware of this and advised not to decommission it again. The borrowing pharmacy should verify the pack on receipt to check that it is active. If not and you are unable to confirm that it was decommissioned by the lending pharmacy, contact IMVO for support in identifying where it was previously decommissioned.
  • Lending part of a pack: The lending pharmacy will ensure the original pack was decommissioned before it leaves the pharmacy (by verifying it) and let the borrowing pharmacy know that it is decommissioned. The pack should not be decommissioned again by the borrowing pharmacy as this will generate an alert.

To view IMVO’s FMD reference card on lending packs, click here.

Q82. If I borrow a pack from another pharmacy, what do I need to do?

If you are unsure whether the pack is an active state when you receive it, verify it on receipt. You will get an alert if you try to decommission a pack that was decommissioned in another pharmacy. If you are unable to confirm that it was decommissioned by the lending pharmacy, contact IMVO for assistance.

To view IMVO’s FMD reference card on borrowings, click here.

Q83. What happens if I, as a hospital, borrow/lend pack(s) from/to another hospital?

If you are a HSE hospital, consult the HSE’s ‘HSE FMD PHARMACY’ SOP for guidance on how to manage this. If you are a private hospital remember that the pack you are lending/borrowing will likely have been decommissioned at goods inwards. As such, you will not need to decommission it again if you have borrowed it. A verification scan will confirm the status of the pack in this situation. If you are lending a pack, please ensure that you inform the borrowing hospital whether the pack has already been decommissioned.

Training and support

Q84. Do I need to make sure that locums are familiar with my procedures?

Please ensure all staff (new/temporary/part-time) are fully trained in your pharmacy’s FMD scanning procedures. IMVO has seen several examples of pharmacies scanning successfully until a locum comes on duty and suddenly a lot of avoidable alerts are generated which suggests that the locum may not be familiar with the pharmacy’s FMD procedures or FMD software.

Q85. Do I need to have a Standard Operating Procedure (SOP) for FMD?

You should adapt SOPs for the Dispensing Process to accommodate FMD activity. The SOPs are available in the IPU members area.

Aggregation

Q86. What is meant by ‘aggregation’ in the context of FMD?

The Commission Delegated Regulation on Safety Features (EU) 2016/161 at recital 20 refers to wholesalers verifying the authenticity of medicinal products by scanning an ‘aggregated code’ allowing the simultaneous verification of multiple unique identifiers. Functionality enabling this to take place has not been implemented to date in the EMVS, although discussions are taking place as to when this might happen.

Q87. Does the EMVS support aggregation?

The EMVS (including the IMVS) has no functionality to support aggregation at this time.

Q88. I understand that wholesalers offer a service to hospitals where packs in an order are scanned by the wholesaler and the data embedded in a 2D barcode on the invoice which is then scanned on receipt in the hospital leading to the packs being decommissioned – why this can’t be extended to pharmacies?

The European Commission has indicated that this type of arrangement is acceptable in hospitals until such time as aggregation of barcodes is part of the European Medicines Verification System. The HSE developed this functionality in its FMD software and pay a fee to wholesalers to scan the packs and provide the invoices with the aggregated barcodes. The European Commission has not approved this functionality in community pharmacy systems.

Q89. I am based in a hospital and our wholesaler supplies invoices with 2D barcodes on them. If I scan the 2D barcode on the invoice, does this mean the whole order is decommissioned?

This appears to be a situation where you are receiving a tote where the scanning of the packs has been undertaken by the wholesaler on your behalf where you complete the actual decommissioning on receipt of the tote in the hospital pharmacy by scanning the barcode on the invoice. This arrangement has been entered into by the HSE with certain wholesalers and is not something that IMVO is involved in or able to help with as aggregation is an extra service offered by wholesalers to hospitals, supported by the hospital’s FMD software, and this functionality is not part of the IMVS. Any queries should be directed to the relevant wholesaler or the HSE’s FMD support (email HSE.Support@ezfmd.com).

Q90. I have a product which was decommissioned when scanned for a patient who never turned up or who doesn’t need it. I presume that I can give it to another patient (as the product never left the premises)?

If more than 10 days have elapsed since the pack was decommissioned when you realise it is not required by the patient, it is not possible to reactivate (or recommission) it in the IMVS. You may however dispense the pack to another patient, but it should not be decommissioned again as doing so may generate an alert. It is recommended that a note be attached to the pack stating that it is already decommissioned. It is also recommended that you put in place procedures to monitor medicines which are not collected and aim to reactivate them within the 10-day window, to avoid this scenario arising and minimise the risk of double-decommissioning alerts.

If you become aware that the product is not required by the patient within 10 days of being dispensed, the pack should be reactivated and put it back into stock, and then decommissioned again whenever it is being dispensed for another patient.

It is also recommended that you put in place procedures to monitor medicines which are not collected and aim to reactivate them within the 10 day window, to avoid this scenario arising and minimise the risk of double-decommissioning alerts.

Returns to wholesalers

Q91. I ordered a medicine in error and now wish to return it to the wholesaler. Do I need to decommission the medicine before returning it to the wholesaler?

Do not decommission it as the medicine still needs to remain ‘active’ in the system as the wholesaler cannot accept back decommissioned packs.

Q92. I ordered a medicine for a particular patient, dispensed and left it aside for the patient to collect. When they came back to the pharmacy, they said they no longer required that medicine. I now wish to return it to the wholesaler. What do I need to do before returning the medicines to the wholesaler?

As you have decommissioned the medicine, you need to ‘recommission’ the medicine before returning it to the wholesaler, as this can only be done by the party that decommissioned it in the first place. Please note that this ‘recommissioning’ step may only be undertaken for up to 10 days after the original decommissioning action. If you are unable to recommission the pack due to the time limit elapsing, it will not be possible to return it to the wholesaler as they cannot accept back decommissioned packs. It is strongly recommended that you review medicines awaiting collection to identify those coming up to the 10-day limit.

Q93. What do I do if medicines are stolen from my pharmacy?

In relation to FMD there is nothing that you can do as you will not know what the 2D barcodes are for such medicines.

Q94. If I need to supply a medicine to a patient in an emergency, do I need to decommission it first?

If you need to administer a medicine in an emergency, e.g. adrenaline, you may not have time to decommission it before administration so you should administer the medicine first and decommission it later. However, it would be good practice to ensure such emergency medicines are verified when received from the wholesaler. If you are simply making an emergency supply of a medicine, the medicine should be decommissioned before being given to the patient in the normal way.

Supplying samples to the HPRA or PSI

Q95. What do I do if the HPRA and/or PSI require stock as a sample during inspection?

Your FMD software includes functionality to decommission/mark a pack as a sample for the HPRA and/or PSI if they request it as a sample during an inspection.

Troubleshooting

Q96. Why won’t my scanner read barcodes on a dark background?

These are ‘inverse’ barcodes and if they don’t scan correctly, this is a sign that your scanner needs to be re-configured.

Q97. If I identify a problem with my scanner, how do I fix it?

Your scanner needs to be fixed or reconfigured. 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’ guidance 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:

Please ensure you use these configuration steps for the appropriate scanner and only if you are experiencing issues with your scanner, for example if you have noticed inverse scanning does not work or using the ‘Check your scanner’ guidance has flagged a problem.

If you are using any other make of scanner, your FMD software provider may be able to advise you on how to reconfigure it. If you’re unsure what to do next, please contact us at info@imvo.ie, including the make of your scanner in your email.

Q98. I have followed all the steps in the IMVO ‘Fix your scanner’ guidance but my scanner is still not scanning all the 5 codes in the IMVO ‘Check your scanner’ guidance. Can you advise on how we should deal with this?

Check if you used the appropriate ‘Fix your scanner’ document for your scanner make and mode. If not, try again with the right document. If this doesn’t work, the next step is to contact IMVO or your scanner supplier for assistance. Have the answers to the following questions ready before you do so as this will help to identify what the issue is:

  1. Are the codes not scanning at all? Or are they scanning but not matching the ‘expected output’ for the codes?
  2. Which codes are you having trouble with?
  3. What make of scanner are you using?

Q99. I went through the ‘Check your scanner’ and it scanned all the codes, except the output from scanning the fifth code (special character test) didn’t match the expected output?

Refer to the relevant ‘Fix Your Scanner’ guidance on the IMVO website here. For the issue that you have encountered, in section 2 you will only need to scan step 1, step 4 and step 5, in that order.

Q100. There is a time delay when scanning in products and eventually it comes up as a ‘time-out’ error message which is delaying the whole process, is there anything that can be done about this?

Please see link to the page on IMVO’s website that contains ‘Check Your Scanner’ and ‘Fix Your Scanner’ guidance.

Q101. My Internet/broadband is slow. Will that affect my ability to use the IMVS?

No. FMD software and the IMVS is designed to function with very low Internet speed.

Q102. What happens if my Internet broadband is down?

The IMVS is designed to function with very low Internet speed. If your broadband is completely down and you are using a desktop FMD software system, continue scanning packs. The scanned codes will be recorded and uploaded when the connection to the IMVS is restored. In the meantime, medicines can be suppled as normal. If an alert message is returned when the connection to the IMVS is restored, you will need to take action.

If your software is web-based and doesn’t allow you to continue scanning, you will need to record the barcode details (e.g., photo) and decommission the pack later by scanning the photo. Alternatively, you can verify or decommission the pack by manually entering the barcode data into the Emergency Verification Application within the IMVS.

To check if your FMD software is a desktop system or web-based, contact your software provider

Q103. What happens if the IMVS is down?

Continue scanning packs with your FMD software and the data will upload automatically when the IMVS is restored. Once scanned, the pack may be supplied. If your connection to the IMVS is lost, either because the IMVS is down or because of a broadband issue, you may continue scanning with your FMD software. If your FMD software is a web-based application, please note that if your broadband is down, it will not be possible to continue scanning with it during the downtime.

Q104. What happens if my FMD software is not working?

If your FMD software is not working, contact your FMD software provider for support as soon as possible. It would also be helpful if you can let IMVO know so that we can liaise with the software provider to ascertain how many pharmacies are impacted.

The Commission Delegated Regulation (EU) 2016/161 states that you may go ahead and supply the pack even though you have been unable to decommission it at the time of dispensing, however, you must record the unique identifier of the pack supplied (i.e. barcode details) and, as soon as the technical problems are solved, verify the authenticity of and decommission the unique identifier. The easiest way to do this is to take a photo of the 2D barcode and scan the barcode in the photo when your FMD software is working again. The other option is to decommission the pack by ‘manual entry’, i.e., typing the barcode data into an online portal – Emergency Verification Application (EVA) – which then returns a response to your request to verify or decommission a pack. IMVO does not recommend using manual entry as the volume of data to be typed in is such there is a high likely of an error which will lead to an alert due to mismatched data.

Q105. What happens if the barcode is damaged or the scanner can’t read the barcode?

The unique identifier data must be printed on the medicinal product in a human-readable format in case the barcode is unreadable by the scanner. You can manually enter the data using the Emergency Verification Application to decommission the medicine. However, if the scanner can’t read the 2D barcode and you can’t read the human-readable code because of damage, it is recommended that the medicine is not supplied to the public.

Q106. I often have to scan an item multiple times before it scans successfully or certain products are not scanning, how can this be avoided?

Please contact us so that we can help you to identify what the problem is.

Q107. Why does my FMD software not display the product name on screen?

If you scan a medical device, OTC pack or an exempt medicinal product/unlicensed medicine originating from outside Ireland, your FMD software will not display the product name as the IMVS only has this information for packs intended for sale in Ireland. If the pack is authorised for sale or supply in Ireland and the product name is not displayed, please inform IMVO so we can follow up to identify what the issue is.

Enforcement

Q108. Who ensures that pharmacies are complying with FMD?

The PSI is responsible for ensuring that pharmacies comply with FMD obligations placed on them by the Commission Delegated Regulation on Safety Features (EU) 2016/161. IMVO has no discretion to grant any leeway. IMVO is obliged under Article 35 (j) of the Delegated Regulation to provide the PSI with reports to enable them to verify pharmacists’ compliance. The PSI has requested reports on a regular basis and been in contact with pharmacies who are not scanning or only doing low levels of scanning.

Q109. What happens if I do not scan and decommission packs?

It is a legal requirement for pharmacists to comply with FMD requirements. Pharmacists registered with the PSI make a statutory declaration upon registration and subsequent continued registration undertaking to comply with all pharmacy and medicines legislation.

Data privacy and data access

Q110. Are there any implications for data protection?

No, because the IMVS does not collect any information from your patient records, bag labels etc.

Q111. What does IMVO do with the data generated from pharmacy scans?

The data in the IMVS is collected and used solely in accordance with the Delegated Regulation. IMVO does not share details of pharmacy transactions in the IMVS with pharmaceutical companies, as doing this would breach data ownership and access provisions in the Delegated Regulation (Article 38). We have no visibility over what products are scanned in a pharmacy and are only permitted to access details of transactions on a particular pack if an alert has been generated. In this situation, the company that owns the product also receives details of the alert (but not the name or address of the pharmacy) so they can carry out their own investigation as to whether the pack is falsified.

Q112. Does IMVO generate income from selling pharmacy data to pharmaceutical companies?

IMVO does not generate any income from selling pharmacy data to pharmaceutical companies. IMVO is primarily funded by fees charged to marketing authorisation holders who have uploaded pack data to the IMVS, with a very small proportion of our income coming from subscriptions paid by our member organisations.

Pharmacy acting as wholesaler

Q113. I have a wholesale account to facilitate medicines being transferred between the pharmacies in my chain. What else do I need to do?

Pharmacies with a wholesale distribution authorisation (WDA) will need to have two separate registrations with the IMVO, one for the pharmacy business and one for the wholesale business. There will be a separate interface to manage the wholesale activities.

Q114. Are there are any fees associated with registering as an end-user with IMVO?

No.

Wholesalers

Q115. What packs are wholesalers required to scan?

The requirements for wholesalers vary depending on where goods have come from and where they are being supplied to:

The following packs must be verified:

  • Medicinal products received from any wholesaler other than the manufacturer, the MAH or a wholesaler who is designated by the MAH by means of a written contract, to store and distribute their products (i.e. ‘designated wholesaler’)
  • All returns

The following packs must be decommissioned:

  • Packs supplied to Article 23 customers (e.g. GPs, dentists, prisons, nursing homes etc.) who have not informed you that they are doing their own decommissioning decommission as ‘supplied’
  • Medicinal products that are placed in quarantine – decommission as ‘locked’
  • Medicinal products intended for destruction – decommission as ‘destroyed’
  • Medicinal products intended for export outside the EEA – decommission as ‘exported’ (see separate question on export to the UK for guidance on requirements applicable to the UK)
  • Medicinal products given to HPRA inspectors as samples – decommission as ‘samples’

Q116. What is a ‘designated wholesaler’?

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 (as part of the ‘product master data’ for each product, a list of ‘Designated Wholesalers’. For detailed guidance on Designated Wholesalers, please see Appendix 5 to the EMVO Master Data Guide which is available from EMVO.

The links below contain further information about designated wholesalers, their role and responsibilities.

EMVO Master Data Guide – Designated Wholesalers

EMVO – Designated Wholesaler Webinar (YouTube)

EMVS Master Data Guide

Q117. Where can I find out if I am a designated wholesaler?

The easiest way to find out is by asking the MAH if they have assigned you ‘designated wholesaler’ status in the EMVS and for what products. This may be described in your technical agreement with them.

You may also be able to use your 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 Product Data Download’ or a ‘JSON query’) – this generates a response that includes all the information about the product, including the designated wholesaler.

If you are looking for information about designated wholesalers for a pack that has not been released for sale or supply in Ireland, e.g. an unlicensed pack from the UK, please note that the IMVS cannot return any information on designated wholesalers as this data does not exist in the IMVS.

Q118. Our wholesaler distribution authorisation only covers ‘procurement’ activities but not storage or distribution activities. Do we need to register with IMVO?

No. If the company does not physically hold any stock, then you will have no requirement to register with IMVO and connect to the IMVS as you will never be scanning barcodes on packs.

Q119. We store and distribute medicinal products but none of them are in scope of FMD. Do we need to register with IMVO?

If the company does not handle FMD packs, then you will have no requirement to register with IMVO and connect to the IMVS. If at any point in the future, you start to distribute products that are in scope of FMD, you will then need to register with IMVO and connect to the IMVS to be able to meet your obligations in relation to those FMD packs.

Windsor Framework

Q120. What is the Windsor Framework (WF)?

The Windsor Framework is a post-Brexit legal agreement between the EU and the UK and will have an impact on several areas including medicines. It is due to come into effect on 1 January 2025, on condition that certain written guarantees being given by the UK Government to the EU are provided before then.

Some of the changes due to be introduced by the Windsor Framework at the end of this year will have an impact from an FMD perspective throughout Europe, particularly in countries like Ireland that have strong traditional links with the UK.

Q121. When does the Windsor Framework come into effect?

It is due to come into effect on 1 January 2025, on condition that certain written guarantees being given by the UK Government to the EU are provided before then.  

Q122. What will change in the UK due to the Windsor Framework?

FMD will no longer apply in Northern Ireland from 1 January 2025, having already been disapplied in the rest of the UK at the time of Brexit. The UKNI medicines verification system will cease to operate and the data in it will be deleted. Pharmacies, hospitals and wholesalers in Northern Ireland will be disconnected from the EU FMD system and will no longer have to scan packs. 

Q123. Will UK packs continue to have 2D barcodes and anti-tampering devices?

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised companies in the UK that 2D barcodes may remain on UK packs after FMD ceases to apply, as well as anti-tampering devices. In addition, all packs placed on the UK market from 1 January 2025 must be labelled as ‘UK Only’, however we expect that it will take some time before packs with this additional text appear in Ireland.

Q124. How will the Windsor Framework have an impact in Ireland?

FMD still applies across the EU post Windsor Framework, and FMD obligations for pharmacies and hospitals in Ireland are unchanged.

The key impact of the Windsor Framework relates to UK packs that move into EU markets. Some of the changes introduced by the Windsor Framework will have an impact from an FMD perspective in Ireland where the UK is a source of exempt medicinal products (EMPs) (also known as unlicensed medicines, or ULMs).

Currently most EMPs/ULMs sourced from the UK do not generate alerts when scanned in Ireland, as the data for these packs in the UK system can be retrieved via the Irish Medicines Verification System (IMVS). After the disconnection of the UK system, all UK packs bearing 2D barcodes that are scanned in Ireland will generate an alert, as the pack data will no longer be available to the IMVS to verify the pack. 

Q125. What actions have been taken to mitigate the effects of the Windsor Framework from an FMD perspective in Ireland?

IMVO has worked closely with the Department of Health, Health Products Regulatory Authority (HPRA), the PSI, the Pharmacy Regulator and colleagues in other national medicines verification organisations and the European Medicines Verification Organisation (EMVO) over the last 18 months to assess and mitigate the impact of the Windsor Framework from an FMD perspective in Ireland. Some of the issues identified have been resolved by way of changes to the system, however, it is not technically possible to prevent UK packs from generating alerts when scanned from 1 January 2025 onwards. 

Q126. How should UK packs be managed in pharmacies and hospitals after 1 January 2025?

The following guidance has been agreed with the HPRA, PSI and Department of Health: 

  • It is expected that most UK packs supplied as ULMs in Ireland will continue to carry 2D barcodes and the only way to avoid an alert with these packs is not to scan them.  
  • If you inadvertently do scan a UK pack, you will get an amber or red alert message on your FMD software. Notwithstanding this, you may supply the pack unless: 
    • You have overriding concerns that a falsified medicine is involved or believe the pack has been interfered with; or 
    • The pack has expired. Your FMD software will not be able to flag that the pack is expired because of the UK system having been disconnected. 
  • Always check the anti-tampering device on the pack (if there is one). If you have any reason to believe the pack has been interfered with, please report this to the HPRA as a product quality defect and do not supply the pack. Email qualitydefects@hpra.ie to report this. 

Q127. Where can I get more information about the Windsor Framework?

More information about the Windsor Framework can be found at the following links: