Updates on management of availability of medicinal products

On February 18, 2025, Resolution No. 233/2025 of Infarmed’s Directive Board was published, approving the new Regulation on the Management of Availability of Medicinal Products, and revoking Resolution no. 93/CD/2019, of October 31, which approved the last version of this Regulation. The Regulation establishes new rules and procedures for managing the availability of medicinal products on the Portuguese market, aiming to ensure the effectiveness and continuous updating of the solutions to tackle availability problems.

The amendment to the Regulation on the Management of Availability of Medicinal Products was driven by several key factors such as the dialogue between Infarmed and sector stakeholders to address availability issues, and also the national and European efforts to tackle shortages of critical medicinal products and public health threats, in particular considering recent events of lack of availability of certain therapies on a global level.

The Regulation introduces a more evident and structured distribution of obligations and responsibilities between the different stakeholders and intervenient parties in the circuit of medicinal products on the market. In material terms, the Regulation presented certain changes, of which we highlight below the most impactful ones:

• Supply Assurance Plan by Marketing Authorization Holders (MAH): Marketing Authorization Holders are now endowed with maintaining a permanently updated supply assurance plan, in similar terms to the prior “prevention measures for shortages” (medidas de prevenção de escassez). These obligations were previously only established for those MAH whose manufacturing process bore characteristics which could pose a threat to the availability of the medicinal product with a risk to public health (such as, part of the manufacturing process being dependent on a single facility, or therapeutic alternatives not being available or being limited).

• Stock Management Plan: In critical situations of shortage or unavailability of medicinal products, Infarmed is now entrusted with establishing a Stock Management Plan with measures that are deemed appropriate to mitigate, and if possible, resolve the verified unavailability, which may include methods such as a controlled distribution of medicinal products to ensure the adequate supply of available units in relation to needs identified, the allocation of available stock under the guidance of Infarmed, issuance of guidelines for the distribution, prescription and dispensing of these medicinal products, as well as the identification of therapeutic alternatives, when applicable, amongst others.

• Stock monitoring: a platform will be created through which MAH, wholesale distributors, pharmacies and hospitals will be able to report their stocks daily.

It should also be noted that, in line with the above, and complementing the measures of management of the availability of medicinal products in the national market, the Resolution No. 234/2025 of Infarmed’s Directive Board was also published on the same date, approving the new Regulation on the Control of Transactions of Medicinal Products to outside of Portugal, and revoking the prior Resolution No. 391/2021, of April 22.

The new Regulation maintains many of the previous obligations imposed on the stakeholders in this matter. Nevertheless, the following changes are worth highlighting:

• Amendment of Criteria for the Prior Notification List: The factors to determine which medicinal products are included in the Prior Notification List have been amended, both becoming more clear and also taking into consideration new sources of information (for example, quantities prescribed will now be considered).
• Exceptional Export or Distribution to EU countries: The suspension of export or distribution of medicinal products may be exceptionally lifted by Infarmed, in duly justified cases such as disasters, conflicts, or urgent humanitarian aid.
• Communication of transaction via SIEXP: The communication of transactions of medicinal products supplied will now only be required from wholesale distributors, and MAH and pharmacies are no longer required to communicate the quantities supplied and dispensed, respectively.

The updates of the Regulation on the Management of Availability of Medicinal Products and of the Regulation on the Control of Transactions of Medicinal Products are a fundamental step in addressing the current and future challenges of product availability. These measures aim to ensure that the population has continuous and safe access to the necessary medications. With this update, it is expected not only an improvement in the management of medication stocks but also greater efficiency in the distribution and access to essential treatments, through the coordinated actions and collaboration among various stakeholders, including regulatory authorities, pharmaceutical companies, healthcare providers and citizens, to create a more efficient and reliable supply chain for medicinal products.