According to the Ministry of Health, the Information System for Monitoring Drug Stocks (SIMSM) will gather data on the availability of drugs throughout the entire supply chain – from manufacturers and importers to wholesale distributors, pharmacies and public and private medical institutions.

The data will be reported daily and will include the available quantity, the batch, the expiration date, and the location of the stocks. The information can be transmitted automatically by connecting the computer systems of the operators or by uploading them to the platform.

SIMSM will generate alerts when the stock of a medicine reaches a critical level, but also in case of missing reports or the approach of the expiration date of some products.

The system will be functionally administered by the Agency for Medicines and Medical Devices, and the Ministry of Health will be the holder. The collected data may also be used by other public institutions in the health sector, within the limits of established access rights.

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In a press release, AMDM specifies that, until the completion of the checks, hospitals will be informed about any precautionary measures regarding the use of the batches under investigation.

The Agency urges medical staff, patients, medical institutions, and economic operators to report any incident or suspicion regarding the quality of medical devices. At the same time, it requests the preservation of products, packaging, and batch identification data for the conduct of investigations.

AMDM states that it will not comment on individual accusations for the time being, so as not to affect the checks. The results of the control will be made public, and if violations are found, the institution affirms that it will apply the measures provided by law. These may include restricting or withdrawing medical devices from the market, administrative or disciplinary sanctions, and notifying the competent authorities.

The Ministry of Health ordered the inspection of AMDM after information appeared in the press regarding alleged irregularities in the institution’s activity. The investigation targets possible problems in the medical device evaluation process, as well as accusations of unfair competition and favoritism of certain economic agents.

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According to the Ministry of Health, the institution treats with “utmost seriousness” the notifications that target the safety of patients and the integrity of subordinate institutions. Thus, the authorities will check the process of registering medical devices, contracts with external experts, and signals regarding the quality of certain products used in hospitals. At the same time, the circumstances under which AMDM gave up the appeal in a case that targeted two types of catheters whose use was banned in 2024 will be verified.

The Ministry has also announced an emergency assessment of signals regarding the quality of intravenous catheters used in pediatric medical institutions in the city of Chisinau. The targeted medical units will have to present existing complaints and reports, and the authorities will collect samples and identify an accredited laboratory for their testing. In parallel, the conflict of interest and confidentiality statements of the specialists involved in the evaluation of medical devices will be analyzed, including those who are concurrently active in other institutions within the health system.

The Ministry specifies that the results of the checks will be made public. If irregularities are identified, the measures provided by law will be applied, and the information related to the competence of the legal bodies or the integrity authorities will be passed on to them.

Furthermore, the institution asks medical staff to report, through the national vigilance system, any case where medical devices with possible quality deficiencies are identified. In the event of confirmed non-conformities, the authorities say they can order the restriction or withdrawal of products from the market.

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According to AMDM, the withdrawal of registration certificates for these products was ordered after it was found that the use of levamisole can cause leukoencephalopathy – a serious condition of the central nervous system.

The Authority specifies that, in the absence of effective risk reduction measures, the benefit-risk ratio of drugs containing levamisole is no longer favorable for the treatment of helminthic infections. In the Republic of Moldova, the drugs targeted are Decaris, in doses of 50 mg and 150 mg.

AMDM states that the symptoms of leukoencephalopathy can appear from one day to several months after administration and may include muscle weakness, speech disorders, cognitive dysfunctions or impaired coordination.

The institution encourages patients and medical staff to report any suspected adverse reaction through the national system available on the official agency’s page.

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Among the newly authorized medications is Symra, indicated for neuropathic pain associated with diabetes or shingles, but also used in certain forms of epilepsy in adults and in the treatment of generalized anxiety disorder.

Furthermore, Tofacitinib-WM has been authorized for chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, as well as for polyarticular juvenile idiopathic arthritis in children over 2 years old.

Among the drugs authorized for the first time is also Medolapram, an antidepressant from the class of selective serotonin reuptake inhibitors. It is used in the treatment of depression and anxiety disorders, including panic, social anxiety, generalized anxiety, and obsessive-compulsive disorder.

The complete list of authorized medicines is available on the AMDM website.

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According to the Agency of Medicines and Medical Devices, the two mandatory acts are the manufacturing and import authorization and the certificate of compliance with good manufacturing practice, granted following inspections that attest to the adherence to quality and safety standards.

The new rules establish the framework for the organization of manufacturing and import activities of human use medicines, including products intended for clinical investigations. According to AMDM, the authorization, inspection, and certification procedures are regulated, as well as the responsibilities of manufacturers and importers.

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According to PRAC, levamisole can cause leukoencephalopathy – a rare but serious adverse reaction that affects the white matter of the brain and can occur even after a single dose. The institution warns that the drug is used in the treatment of mild forms of parasitic diseases.

The Agency of Medicines and Medical Devices notes that in Moldova two products containing levamisole are authorized – Decaris 50 mg and Decaris 150 mg, owned by the company Gedeon Richter PLC.

The institution specified that it is monitoring the situation and will inform specialists and the general public about any measures applied at a national level.

Patients undergoing treatment with levamisole are advised to seek immediate medical assistance if they exhibit symptoms such as muscle weakness, speech difficulties, confusion or coordination disorders. They are also recommended to consult their doctor or pharmacist for therapeutic alternatives.

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Germany remains the main supplier of medicines to the Moldovan market, followed by Romania and Slovenia. Other important exporting countries are Hungary and Turkey.

According to the report, imported drugs account for 92.89% of the market value and 86.22% of the total volume traded. At the same time, local manufacturers provide approximately 13.8% of the volume, but only 7.1% of the value, indicating more affordable prices for domestic drugs.

The best-selling imported drugs, according to the international common name, were Dapagliflozinum – used for type 2 diabetes and heart failure, Ibuprofenum – for pain relief and fever reduction, and Rivaroxabanum – used in the prevention and treatment of blood clots, including after surgical interventions.

In the case of local production, the top of the drugs was led by Rivaroxabanum, followed by Famotidinum – used in gastric ulcer, duodenal, reflux esophagitis and Zollinger-Ellison syndrome, and Bicalutamidum – antiandrogen for the treatment of advanced prostate cancer.

The report also shows that the evolution of the market is influenced by the policy of reimbursed medicines, managed by the National Health Insurance Company, which directs demand towards products included in the public reimbursement system.

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Among the authorized medications is Febuxostat, a preparation used in the treatment of gout. It is indicated for patients with high levels of uric acid in the blood and is used to prevent painful crises and complications caused by the accumulation of urate crystals in the joints and kidneys.

Another authorized drug is Mirzaten, which contains the active substance mirtazapine and is used in the treatment of depression. It belongs to the category of antidepressants, being administered according to medical indications.

The list also includes Desmop, a drug used in the treatment of diabetes insipidus, a condition characterized by intense thirst and excessive urination. The medication is also indicated in some diagnostic situations, such as assessing the kidney’s concentration capacity or in cases that occur after surgical interventions on the pituitary gland.

The complete list of drugs authorized this month can be consulted on the AMDM website.

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The new online form offers the possibility to send petitions directly from the institution’s website and allows the attachment of documents, up to 15 MB. Citizens can choose the type of request, they can even send reports or notifications.

There is also the option of anonymous submission, which ensures the protection of the identities of those who report certain situations.

For those who desire an official response, the contact field via email is available.

AMDM warns that the provision of erroneous data and false statements are sanctioned according to the law.

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