Have you heard about important changes in Latvian Regulations No.416 “Procedures regarding the distribution and quality control of medicinal products” that were approved in July 2025?

The amendments to Regulation No. 416 “Procedures for the Distribution and Quality Control of Medicines” approved on 8 of July expand the possibilities for restricting exports, simplify the circulation of compassionate use medicines, and clarify the procedure for distributing unregistered medicines.

• Until now, export restrictions could only be applied to those medicines for which the National Health Service (NHS) and MAH or wholesaler had concluded an agreement on financial participation. It is planned that in the future, the application of such restrictions will also be possible in the case of other medicines if the State Agency of Medicines (SAM) determines the risk of unavailability.

The SAM identifies medicines whose absence or insufficient stocks of medicines in medicinal wholesalers in Latvia pose a risk to the health protection of the population and, if necessary, determines the restriction of deliveries to a European Union (EU) member state or export, export to third countries. The SAM indicates that the unavailability of medicines is increasing in connection with the export of medicines from Latvia and it is not always possible for patients in Latvia to receive the prescribed medicines.

The amendments also stipulate that wholesalers will be obliged to register medicines in a unified database before exporting them, ensuring the possibility for the State Agency of Medicines to assess the availability of medicines on the local market in a timely manner. More flexible regulation will improve the availability of medicines and reduce the risks of unavailability, and it also includes procedures for controlling and restricting the export of medicines to ensure that necessary medicines remain in Latvia and are also available in a timely manner to people with rare diseases.

• The Ministry of Health has found that so far in Latvia, the use of innovative medicines on compassionate grounds – namely, in situations where the medicines have not yet been registered, but for a patient with a serious, life-threatening or chronic disease they may be the only treatment option – has been difficult. This is due to the fact that the medicine is considered a donation, which means that in addition to the permit issued by the Ministry of Health, the distribution of unregistered medicines also requires a written permit from the Ministry of Health to accept the donation and individual agreements with medical institutions.

Consequently, a clarification has been made so that medicines for compassionate use would no longer be classified as a donation. This would remove the requirement for an additional permit from the Ministry of Health and donation agreements with medical institutions. At the same time, this will speed up the availability of medicines to patients and prevent situations where these medicines are available in Latvia significantly later than in other Baltic countries.

In the future, a permit issued by the Ministry of Health, based on the assessment of the European Medicines Agency and the submitted registration or clinical trial documentation, will serve as a sufficient basis for the use of medicines for compassionate use.

This strengthens compliance with EU legal norms, which stipulate that compassionate medicines must be available to patients even before they are placed on the market, without the condition of ensuring treatment until the medicine is included in the list of reimbursed medicines.

The provision that previously considered medicinal products for compassionate use as a gift and imposed an obligation on the donor to provide treatment until the medicinal product is included in the list of reimbursable medicines has been repealed. Such a restriction is no longer in force, as the circulation of compassionate medicinal products is already supervised by the SAM in accordance with the EU regulation, and the distribution of these medicinal products is free of charge, based on a permit.

• At the same time, the procedure for the circulation of unregistered medicinal products has also been simplified. In many cases, SAM`s distribution permit will no longer be required – instead, in certain cases, a notification to the SAM will be sufficient or no additional steps will be required at all. Exceptions where a permit is not required include, for example, when the medicine is supplied to a pharmacy or medical institution and no analogues are available in Latvia.

The amendments also strengthen the right of merchants to distribute unregistered medicines to other countries and wholesalers, thus promoting flexibility and the availability of medicines, which will be monitored by the SAM. This applies to situations where medicines registered in Latvia are not available, although their distribution has already begun. If a patient urgently needs these medicines, but the holder of the registration of the medicine or a parallel distributor is temporarily unable to provide them, it is allowed to supply the medicine to another wholesaler of medicines who is not the holder of the registration, if the volume is previously agreed and the consent of the holder has been received.

If you would like to know more information about these changes, State Agency of Latvia organised training on 30 July 2025 and presentations from this training is available here – Video prezentācijas, biežāk uzdotie jautājumi | Zāļu valsts aģentūra