1. Scope of new requirements
1.1. Will all medicines require safety features? The requirement for unique identifiers and anti-tamper devices will apply mainly to prescription-only medicines, with some limited exceptions (see Annex I to Delegated Regulation 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.
1.2. Will anti-tamper devices be allowed on OTCs and other out-of-scope products after February 2019? There have been concerns that anti-tamper devices would have to be removed from out-of-scope products (which are mostly OTCs) after 9th February 2019 when the new safety feature requirements become mandatory. The HPRA has confirmed that anti-tamper devices may continue to be placed on out-of-scope products after 9th February 2019 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.
2.1. 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.
2.2. 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.
2.3. Does the system support scanning of aggregated codes on pallets by wholesalers or hospitals? The EMVS does not currently support scanning of aggregated codes.
3. Operation of system
3.1. 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.
3.2. How will manufacturers upload unique identifiers to the national repository system? Data will be uploaded by manufacturers to IMVO’s national repository via the EU Hub. There is no facility for direct national upload.
The European Commission publishes and regularly updates a Q&A on Safety Features to facilitate consistent implementation of the new safety feature requirements across Europe. Version 13 was published in January 2019.
EMVO has prepared a Knowledge Database for manufacturers and MA holders who need to connect to the EU Hub.
The Irish Pharmacy Union which represents community pharmacy and is a member of IMVO published an article on medicines authentication in its monthly magazine, the IPU Review, and drawn up a FAQ to help its members understand the new requirements