March 5, 2025
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Two new diplomas were recently published and entered in force as from 19/02/2025: Deliberation no. 233/2025 on Regulation on Management of Medicines Availability and Deliberation no. 234/2025 on Regulation of Control of Transactions of Medicines Abroad. These two pieces of legislation intend to ensure the monitoring of the Portuguese market and patients’ access to medicines. Therefore, some new legal obligations are required to be met by the stakeholders.
Deliberation no. 233/2025 (revoking Deliberation no. 93/CD/2019) is updated with the reinforcement of the importance of the Shortage Prevention Plan required to be permanently updated by the companies for each medicine, which allows the identification of measures to prevent the occurrence of a shortage and mitigation actions in case it happens. The safety stock to cover or mitigate the occurrence of a shortage, respond to an unexpected increase in demand or to a constraint of another nature should be included in this plan. This regulation introduces the Supply Assurance Plan, as a document that should contain, among other information, the vulnerabilities in the medicine's manufacturing and distribution chain, the assessment of risks to the health of citizens in the event of medicine’s unavailability and the risk analysis of unavailability (risk, history of shortages in the last 3 years, delays in supply, average manufacturing and supply times, mechanisms for monitoring and managing stocks of medicines). The Stock Management Plan that will be created by INFARMED in cases of critical shortages or lack of medicines was also presented. Among the MAHs obligations, it is important to highlight the need to maintain the supply assurance plan and to manage all activities related with their medicine’s storage at logistics operators. Wholesaler distributors will have additional responsibilities, such as the quarterly basis communication to INFARMED of the medicines and respective quantity exported to third countries, through an electronic platform dedicated to this purpose (still under development), MAHs and Wholesaler distributors must communicate on a daily basis the available stocks of medicines previously identified by INFARMED as critical situations.
Deliberation no. 234/2025 defines the criteria underlying the creation of two lists, that will be critical to ensure the appropriate monitoring of the Portuguese market, and the notification process to INFARMED for the medicines included on those two lists: List of medicines whose export, or distribution to other Member States of the European Union, depends on prior notification to INFARMED and List of medicines whose export or distribution is suspended.
