On 10 December 2021, the Royal Decree (“RD”) of 29 November 2021 on transparency of the stock of medicines intended for public service obligations was published.
This Royal Decree aims to implement a stock monitoring system for wholesaler-distributors as part of their public service obligations, and to further specify the duty to notify in the event of an unavailability.
Its objective is to get a clear picture of the stocks held by wholesaler-distributors and their movements in the context of the public service obligation that is entrusted to them. This should allow the FAMHP to get an insight into the needs of patients in Belgium, perform analyses, and adjust its policy accordingly to reduce the unavailability of medicines as much as possible.
To this end, wholesaler-distributors are requested to provide specific data about sales and purchases(*):
- In order to obtain a first set of basic data, some historical data are requested (2019-2020; 2021 – until the month preceding the entry into force of the Royal Decree);
- As of the entry into force of the Royal Decree, wholesaler-distributors should send monthly overviews to the FAMHP.
In addition, the procedure for notifications about medicines that are unavailable is worked out in more detail. This is, to a large extent, based on the current practice of the FAMHP and the functioning of the Pharmastatus website. It is enacted that a pharmacist or wholesaler-distributor can report shortages. This notification should be assessed by the marketing authorisation holder (MAH), and can then possibly lead to a notification by the MAH if it is substantiated. Furthermore, the data that the MAH is requested to notify to the FAMHP, is further detailed.
The RD also includes a number of technical corrections or updates (outdated references are corrected).
(*) Royal Decree of 29 November 2021
The wholesale distributor provides the FAMHP with the following information at the latest on the first day of the third month following the publication of this decree in the Belgian Official Gazette:
1° a detailed overview of the destination of the stock of medicines for human use for the years 2019, 2020 and 2021 (up to the month before the RD enters into force) broken down by month. The wholesaler-distributor classifies this destination of the medicine under the headings “person authorised to supply medicines to the public established in Belgium”, “wholesaler-distributor”, “return supplier” and “other”, classified per CNK code;
2° a detailed overview per month of the (quantity of) purchased medicines referred to under 1°, classified per CNK code
This information shall be submitted electronically to the FAMHP. The FAMHP shall provide to this end:
1° either a standard file (e.g. xls or xml) available on its website which is submitted by e-mail to the address firstname.lastname@example.org;
2° or an automated form or software, via which the data are uploaded.
The wholesale distributor shall submit on a monthly basis, at the latest by the 15th of the month (X), the following information to the FAMHP:
1° the detailed overview of the stock of medicines for human use, determined on the last day of the previous month (X-1), classified per CNK code;
2° a detailed overview of the destination of the (quantity of) medicines referred to under 1°, delivered between the last day of the past month (month X – 1) and the last day of the month before that (month X – 2), classified per CNK code. The wholesaler-distributor classifies this destination under the
person authorised to supply medicines to the public established in Belgium”,”wholesaler-distributor”, “return supplier” and “others”;
3° a detailed overview of the (quantity of) medicines referred to under 1° purchased between the last day of the past month (month X – 1) and the last day of the previous month (month X – 2), classified per CNK code
This information shall also be submitted electronically as described under article 1.
Source: Justel: 2021-11-26/07 (fgov.be)