Safety features FAQS – Article 23
Safety features will become obligatory in Ireland and in all other EEA countries (with the exception of Italy and Greece) from the 9th February 2019. In effect this means that a Qualified Person (QP) certifying batches of medicinal products within the scope of the Commission Delegated Regulation (EU) 2016/16, for these markets, on or after the 9 February 2019, must ensure that the packs bear the 2D unique identifier and anti-tampering device.
Wholesalers must be prepared to verify the safety features present on prescription only medicine packs for human use from 9th February 2019. From that date, wholesalers who physically handle medicinal products bearing the safety features must be connected to the central repository managed by the Irish Medicines Verification Organisation (IMVO). They must have the necessary software, scanners and procedures in place to perform these tasks. The requirements apply almost exclusively to prescription only medicines but there are a small number of exceptions. Further details on products impacted are included under Annexes 1 and 2 (the ‘white’ and ‘black’ list) of the Delegated Regulation (EU) 2016/161.
Article 23 Update
The HPRA wish to update Irish wholesalers that the Department of Health has confirmed that the totality of Article 23 of the Delegated Regulation will be transposed into national legislation in advance of 9th February 2019. This means that wholesalers will be obliged to verify and decommission the unique identifier of all medicines bearing the safety features prior to supplying them to customers which fall under the categories in (a)-(k) of Article 23 (see article 23 text below for ease of reference).
In relation to the customers that may fall under Article 23(a), please be advised that the Delegated Regulation defines a healthcare institution in Article 3 as ‘a hospital, in- or outpatient clinic or health centre’. The national legislation will further define ‘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;
In summary, this means that wholesalers will be required to verify and decommission medicines bearing safety features prior to the supply to all those entities listed in (b)-(k) and also persons authorised or entitled to supply medicinal products to the public who are NOT a hospital or an in- or outpatient/day patient clinic or health centre under the management or control of a hospital. For example, GP surgeries. Hospitals and in- or outpatient/day patient clinic and health centres under the management or control of a hospital are required to verify and decommission medicines themselves prior to dispensing/administration.
Wholesalers are advised to review their customer database as soon as possible to determine which customers will require verification and decommissioning of medicines bearing the safety features prior to supply.
If you have any queries, please email firstname.lastname@example.org.