From 9th February 2019, pharmaceutical wholesalers across Europe will be 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. They will also have to decommission packs in certain circumstances, including when they are being supplied to specific customers as per Article 23 of the Delegated Regulation (see note below).
To be able do this, you must have a software system that is connected to the Irish Medicines Verification System (IMVS) operated by IMVO. The IMVS is sometimes called the IMVO repository or ‘national system’.
If you are a wholesaler and haven’t already done so, you need to start your preparations now to ensure that you are ready by 9th February 2019, when the new requirements become legally binding. At a high level, the steps involved include:
IMVO has prepared a Support Guide which sets out where to go for advice if you have any queries or problems. Please check this guide before contacting IMVO or your IT support provider if any issues arise.
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), 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.
Article 23: “Member States may require, where necessary to accommodate the particular characteristics of the supply chain on their territory, that a wholesaler verifies the safety features and decommissions the unique identifier of a medicinal product before he supplies that medicinal product to any of the following persons or institutions:
(a) persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;
(b) veterinarians and retailers of veterinary medicinal products;
(c) dental practitioners;
(d) optometrists and opticians;
(e) paramedics and emergency medical practitioners;
(f) armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;
(g) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions;
(k) nursing homes.”
HPRA guidance for wholesalers
The HPRA has a special section on falsified medicines on its website. Information about wholesalers’ obligations with regard to safety features was also included in the HPRA Human Medicines Newsletter No.60 (May-Aug 2018).
Pharmacy with wholesaler’s authorisation
Some pharmacies also have a wholesaler’s authorisation from the HPRA. If you are one of these pharmacies, please note that you will have to register with IMVO as a pharmacy and as a wholesaler (i.e. two registrations). We have contacted pharmacies separately about IMVO registration, including pharmacies who have a wholesaler’s authorisation.
IMVO is running a series of 30 minute registration webinars by Skype for wholesalers to explain the IMVO registration process in more detail and how to avoid common errors – see our Events page for a list of dates. We strongly recommend that you attend one of these webinars before you submit your online registration form. The registration webinar slides will be available for download on this page after the first webinar.
The registration webinars are designed as a follow-on to the introductory webinars held during September and October 2018 to introduce wholesalers to the IMVS and provide information on your obligations in relation to safety features. If you have not attended an introductory webinar, the slides are available to download by clicking on the icon shown: