Section 15 of the Act on Mandatory Reserve Supplies contains provisions on situations in which the party required to maintain reserve supplies may apply for an exemption to stock a lower quantity of medicines than otherwise required. Such situations may include temporary disruptions in the availability of medicinal products beyond the control of the party required to maintain reserve supplies. Additionally, an exemption to maintain lower stocks may be granted if there is a risk that the medicinal product involved becomes unsuitable for the intended use.
The party required to maintain the reserve supplies must actively monitor its performance in fulfilling this obligation. If it is foreseeable that the required stock levels cannot be maintained, the application for an exemption must be filed well in advance. However, the stocks cannot be reduced until the exemption permitting this is granted.
An application for an exemption may be filed by a pharmaceuticals company, importer or The National Institute for Health and Welfare for a fixed-period of time or for a maximum period of one year at a time. The application for exemption is filed by completing the form available on Fimea's website which must be signed and submitted to the Fimea's registry. The application must clearly indicate the grounds invoked in support of the exemption as required by law.
The exemption procedure does not apply to health care units that may make use of the stocked products if this is necessary for the operations of the unit, for example due to disruptions in deliveries. As soon as the disruptions are over, the health care unit is required to promptly restore the stock levels.