Obligation to register medicinal products

Essential medicines are subject to mandatory notification and storage. The National Economic Supply (WL) has decided to make changes to this. The number of active substances that are subject to mandatory reporting will increase by more than 60% to around 320. And in future, mandatory stocks must be available for around 120 active substances, an increase of almost a quarter. The amendments to the ordinance, which will help improve the supply situation, will come into force on January 15, 2024.

The WL (Therapeutic Products Division) actually reviews and adapts the ordinances on mandatory reporting and storage every two years. Due to the COVID-19 pandemic, the 2021/2022 review had to be postponed. Four years after the last review, a number of amendments were therefore necessary.

Bottlenecks must be reported

Now 124 active substances are subject to the notification requirement. The obligation to notify has been lifted for five active substances. This means that around 320 active substances are now subject to mandatory reporting. If an active substance is subject to mandatory notification by ordinance, supply shortages or supply interruptions must be reported to the WL's notification office. Anyone who manufactures or distributes these active ingredients must also provide information on how long the supply will be disrupted and whether alternative remedies are available until then. The Reporting Office records this information and, in return, regularly informs all stakeholders about the latest status of the supply situation.

During the review of the prescriptions, the storage obligation was also extended to 23 additional active ingredients. The stockpiling obligation was lifted for the active substance pethidine and combination preparations. As a result, the obligation to build up strategic reserves now applies to around 120 active substances. If the market can be

If, in the event of a shortage, it is no longer possible to ensure supplies itself, these compulsory stocks can be used.

Ongoing improvement of the supply situation

The extension of the reporting and storage obligation will lead to additional work for both the national economic supply and the companies subject to the reporting obligation. In order to cope with this additional workload, the processes are to be automated in future. The risk of missing supply-critical medicinal products will be reduced with the extensive expansion of the reporting and stockpiling obligation that has now taken place.

The cantons, healthcare organizations and pharmaceutical companies were consulted last summer on the planned changes to the reporting and storage obligation. The extension of the reporting and stockpiling obligation was welcomed in principle. Nevertheless, not all of the concerns expressed could be taken into account. However, these are being incorporated into ongoing work, such as the proposals to extend the reporting obligation to all prescription-only medicines or to provide financial support for compulsory stocks from the federal government.

Source: Federal Office for National Economic Supply