Frequently Asked Questions

  1. Scope of FMD requirements 
    1. Do all medicines require safety features? The requirement for unique identifiers and anti-tamper devices applies mainly to prescription-only medicines, with some limited exceptions (see Annex I to Commission Delegated Regulation (EU) 2016/161 for listing of relevant products). Non-prescription medicines (also known as over-the-counter or ‘OTC’ medicines) will 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. Annex I and II may be reviewed and updated from time to time.
    2. Can anti-tamper devices be included on OTCs and other out-of-scope products? The HPRA has confirmed that anti-tamper devices may continue to be placed on out-of-scope 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. Similarly, anti-tamper devices may be placed on new out-of-scope products introduced to the market after February 2019, based on a similar risk assessment.
  2. Barcodes
    1. Do reimbursement codes have to be included in unique identifiers in Ireland?
      The Department of Health has confirmed to IMVO that reimbursement codes do not have to be included in unique identifiers on packs placed on the Irish market. 
    2. What is the required product coding system?
      There is no national coding scheme in Ireland. GTINs from GS1 are widely used in the pharmaceutical sector in Ireland. 
    3. Does the system support scanning of aggregated codes by wholesalers or hospitals? 
      The EMVS does not currently support scanning of aggregated codes.
  3. Operation of system
    1. Can the system be used by manufacturers and wholesalers to reconcile batches? 
      The system is not a track and trace system and does not have the functionality to reconcile batches of medicines.
    2. How do manufacturers upload unique identifiers to the national repository system?
      Data is uploaded by manufacturers to the Irish Medicines Verification System via the EU Hub. There is no facility for direct national upload.