Table 1.
National registers to notify shortages as of March / April 2020.
| Country | In place | Obligation | Managed by | Reports from | Medicines covered | Reporting time-lines |
|---|---|---|---|---|---|---|
| Austria | Yes | Obligatory (since April 2020; before: voluntary), no sanctions | Medicines Agency | MAH | POM | At least 2 months in advance if known; “immediately” for unforeseen shortages |
| Albania | No | Not appl. | Not appl. | Not appl. | Not appl. | Not appl. |
| Bulgaria | No | Not appl. | Not appl. | Not appl. | Not appl. | Not appl. |
| Canada | Yes | Obligatory, sanctions possible | Medicines Agency | MAH | POM and NPM administered under practitioner’s supervision | 6 months in advance, if known or within 5 days of becoming aware |
| Cyprus | Yes | Obligatory, no sanctions (but their introduction is being discussed) | MoH and Health Insurance Organisation | Local distributors | Reimbursed POM | “Immediately” |
| Czech Republic | Yes | Obligatory, sanctions possible | Medicines Agency | MAH | Any medicine | At least 3 months in advance |
| Denmark | Yes | Obligatory, sanctions possible | Medicines Agency | MAH | Any medicine if shortage is expected to influence the treatment of patients | At least 2 months in advance |
| Finland | Yes | Obligatory, no sanctions (but their introduction is being discussed) | Medicines Agency | MAH | Any medicine | 2 months in advance |
| Germany | Yes | Obligatory (since April 2020; earlier: voluntary), sanctions possible | Medicines Agency | MAH, wholesalers | POM that are relevant or critical for supply | Existing or upcoming shortage (no timeline defined) |
| Israel | Yes | Obligatory, sanctions possible | MoH | MAH | Any medicine | 3 or 6 months in advance (unless “immediately” in case of immediate shortage) |
| Italy | Yes | Obligatory, sanctions possible | Medicines Agency | MAH | Any medicine | At least 4 months in advance except for unpredictable circumstancesa |
| Latvia | Yes | Obligatory, sanctions possible | Medicines Agency | MAH, wholesalersb | Any medicine | 2 months in advance |
| Lithuania | Yes | Obligatory | Medicines Agency | MAH | Any medicine | “Immediately”, in some cases at least 3 months in advance |
| Malta | Yes | Voluntary | Medicines Agency | MAH | Any medicine | As soon as possible, but at least 2 months in advance |
| Moldova | No | Not appl. | Not appl. | Not appl. | Not appl. | Not appl. |
| Netherlands | Yes | Obligatoryc, sanctions possible | Medicines Agency | MAH | Any medicine | 2 months in advance |
| Norway | Yes | Obligatory, no sanctions | Medicines Agency | MAH | Any medicine | As soon as possible, but at least 2 months in advance |
| Portugal | Yes | Obligatory, sanctions possible in cases of non-reporting or delayed reporting without justification | Medicines Agency | MAH | Any medicine | 2 months in advance |
| Romania | Yes | Obligatory, sanctions possible | Medicines Agency | MAH | Any medicine | Apart from exceptional cases, at least 6 months (and 12 months for commercial reasons) |
| Russia | No | Not appl. | Not appl. | Not appl. | Not appl. | Not appl. |
| Slovenia | Yes | Obligatory, sanctions possible | Medicines Agency | MAH | Any medicine | At least 2 months in advance |
| Sweden | Yes | Obligatory, no sanctions | Medicines Agency | MAH | POM | At least 3 months in advance |
| Switzerland | Yes | Obligatoryc, no sanctions | Medicines Agencyc | MAH | Defined essential medicines, including vaccines | 5 days in advance for a shortage of a defined medicine to last for more than 14 days |
| UK | Yes | Obligatory (since January 2010), sanctions possible | Department of Health | MAH | Any health service (i.e. reimbursed) medicine | At least 6 months in advance (or at least, as soon as the MAH becomes aware) |
MAH = marketing authorisation holders, not appl. = not applicable, NPM = non-prescription medicines, POM = prescription-only medicines.
aLegal change in 2019: timeline of reporting was changed from 2 to 4 months in advance.
bAnyone can report to the register but MAH are obliged to do so; wholesalers have to report about their stock on a daily basis.
cIn addition, voluntary registers are run by the Dutch Pharmacy Association (in the Netherlands) as well as a hospital pharmacy in Basel and a private consultancy firm (in Switzerland). Any medicine can be reported to the voluntary registers.
Further information on the accessibility of the shortages registers maintained by public authorities and their contents is provided in Supplementary Materials 3.