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Update on Prior Notification of Medicines Transactions Abroad

On March 11, 2025, Information Circular No. 022/CD/100.20.200 was published, bringing important updates on the export of medicines. Check out the main points:

Updating the Lists annexed to the Regulation:

The lists that form part of the Regulation on the prior notification of drug transactions abroad have been updated. These changes have an impact on the export and distribution of medicines to other EU member states.

Medicines with Compulsory Prior Notification:

The first list presents the medicines whose export, or distribution to other European Union countries, and respective quantities, depend on prior notification to INFARMED, I.P. This measure was regulated by Deliberation no. 027/CD/2025.

Medicines with Temporary Suspension of Export:

The second list features medicines whose export is temporarily suspended. It covers all the critical medicines that were in short supply in February and also includes medicines that are being supplied by means of an authorization for exceptional use. This decision was regulated by Resolution 028/CD/2025.

Effective Date of Amendments:

The updates take effect on the business day following the publication of the circular, i.e. as of March 12, 2025.

SiExp Platform update:

In line with the updates to the lists, the SiExp platform will also be adjusted to reflect these changes, facilitating the notification process.

Access to Lists in Electronic Format:

The updated lists are available in electronic format in the “Management of drug availability” section of the INFARMED, I.P. website.

These changes aim to ensure better control and monitoring of drug transactions outside the country, ensuring the continuous and adequate supply of essential products to the national and international markets.

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ANVISA Resolution No. 964/2025 published: Requirements for Forced Degradation Studies on Medicines

ANVISA Resolution No. 964 was published in the Federal Official Gazette (DOU) on February 24, 2025, establishing general requirements for conducting Forced Degradation Studies on medicines containing synthetic and semi-synthetic active pharmaceutical ingredients (APIs).

The resolution also defines the parameters for the notification, identification and qualification of degradation products in these drugs. Below, we summarize the most important points of this new regulation.

Resolution’s goal

The main objective of ANVISA Resolution No. 964/2025 is to define the guidelines for carrying out Forced Degradation Studies on medicines.

These studies are essential to guarantee the stability of medicines, assessing the formation of degradation products that could impact the safety and efficacy of the product over time.

Medicines covered

The resolution applies exclusively to medicines containing synthetic and/or semi-synthetic active pharmaceutical ingredients in their composition, including when associated with other APIs.

In combined medicines’ case, the resolution’s criteria should only be applied to the synthetic and semi-synthetic APIs present in the formula.

Exceptions to Applicability

The resolution does not apply to:

  • Isolated APIs;
  • Isolated excipients;
  • Medicines used in the development stages of clinical studies;
  • Medicines containing biological/biotechnological APIs, peptides, oligonucleotides, vitamins, minerals, amino acids, proteins, inorganic compounds, among other atypical APIs or those derived from fermentation.

Repeal of previous resolutions

The new resolution repeals the following previous resolutions:

  • RDC No. 53, of December 4, 2015;
  • RDC no. 171, of August 22, 2017.

Date of Entry into Force

ANVISA Resolution No. 964/2025 comes into force on the date of its publication, i.e. February 24, 2025.

Recommended reading

It also recommend to read the Vote No. 47/2025/SEI/DIRE4/Anvisa, which was issued during the 2nd Ordinary Public Meeting of Dicol – 2025, held on February 19, 2025. This vote offers a detailed explanation and contextualization of the resolution.

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PGEU has published the 2024 Medicine Shortages’s annual report

The Pharmaceutical Group of the European Union (PGEU) has published its annual report on medicine shortages, revealing that all 28 participating countries reported difficulties in the supply of drugs in community pharmacies throughout 2024. The situation remained as serious as the previous year, the worst ever recorded.

Key Findings

  • Widespread shortages: All European countries faced shortages of medicines, especially antibiotics, cardiovascular and nervous system drugs.
  • Impact on pharmacies: Pharmacists spend an average of 10.6 hours a week dealing with shortages – an alarming increase compared to previous years.
  • Damage to patients: Drug shortages cause interruptions in treatment, increased costs for patients and a loss of confidence in the healthcare system.
  • Disparity between countries: While some nations have implemented emergency measures, many still don’t have an efficient monitoring system or agile alternatives to mitigate the crisis.

Main causes of shortages

  • Manufacturing problems (68%)
  • National pricing and purchasing strategies (54%)
  • Unexpected increase in demand (50%)

What can be done?

The PGEU is calling for urgent measures from governments and the European Union to ensure a more stable supply of medicines. Recommendations include:

  • Greater transparency and sharing of information on shortages
  • Expanding the role of pharmacists in replacing unavailable medicines
  • Reforms to pharmaceutical legislation to prevent supply disruptions
  • Better financial compensation for pharmacies dealing with the crisis

Drug shortages are a public health crisis that requires rapid and effective responses. The PGEU report, which people can acess here, reinforces the urgency of coordinated action to prevent millions of Europeans from being left without access to the treatments they need.

Portugal is already tackling this challenge. INFARMED I.P. has announced new rules to strengthen the management of medication availability, showing a proactive commitment to mitigating the shortage and protecting patients.

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Sammed available for 2024 H2 Marketing Report Submission – Ensure Compliance for 2025

The Executive Secretariat of the Medicines Market Regulation Chamber (SCMED) has informed that the Medicines Market Monitoring System (Sammed) will be available from next week for the submission of the marketing report convering the second half of 2024.

Deadline for submission

The deadline for submitting the report will be between 00:01 a.m. on Monday, February 3, and 11:59 p.m. on March 14, 2025. It is important to note that reports submitted after this deadline will not be accepted.

Importance of submitting on time

Only companies that submit the report on time will be entitled to the maximum adjustment of drug prices in 2025, according to CMED Communiqué No. 11 of August 12, 2015.

How to Submit

Shipments must be made exclusively through Sammed. To ensure that the process is carried out correctly, consult the Commercialization Report Manual, which contains all the guidelines on filling in and sending the report.

If you have any questions, please contact Anvisa at sammed@anvisa.gov.br. To speed up the service, don’t forget to include the following in the message title: [SCMEDCOMERCIALIZAÇÃO-2025-2s2024-DÚVIDA].

In addition, Anvisa’s other service channels are also available to answer additional questions. Make sure your company is compliant for the price adjustment in 2025!

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APMC Conducts Innovative Study on Medicinal Cannabis for Osteoporosis and Chronic Pain in Women

The Pan American Association of Cannabinoid Medicine (APMC) is leading an innovative study to investigate the use of medicinal Cannabis in the treatment of osteoporosis and chronic pain in women, conditions that affect a significant number of women, especially after menopause.
 
The project, supported by R$ 284,428.00 from the 2024 parliamentary amendments public notice of the Parliamentary Front for Medicinal Cannabis, focuses on the study of bone biomarkers and genetic polymorphisms in CB2 and TRPV1 receptors, aiming to understand how these factors may influence the treatment of these conditions.
 Genetic Polymorphisms and Treatment Personalization

The study goes beyond observing the effects of Cannabis on pain. The goal is also to evaluate its effects on bone metabolism and the participants’ quality of life, considering aspects such as sleep, anxiety, and cognitive functions.

Women will be monitored over the course of one year with quarterly exams of inflammatory biomarkers, bone densitometry, and genetic analyses, with a special focus on the genetic polymorphisms of the CB2 and TRPV1 receptors. These polymorphisms may determine the response to treatment, making the study relevant for precision medicine.

 Women in Focus: The Impact of Menopause

Women are the main focus of the research, as they represent 80% of patients with chronic pain and 90% of osteoporosis cases. Menopause, with its hormonal changes, significantly increases the risk of these conditions.

It is important to explore Cannabis not only to relieve pain but also to improve the quality of life for women facing a combination of chronic pain, sleep disorders, and anxiety.

Academic Collaboration and Access Expansion

APMC’s study is being conducted in partnership with the Faculty of Medicine of ABC and the Presbyterian Mackenzie University, which contribute to a multidisciplinary environment for the development of the project.

The research goes beyond pain relief and seeks to understand how Cannabis can impact health more broadly. Additionally, the researchers hope that the results will help expand access to Cannabis treatments within the Unified Health System (SUS).

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Resolution No. 954: Changes to Drug Registration Take Effect

The Brazilian Official Gazette has published Anvisa’s Resolution No. 954, establishing new guidelines for the simplified process of drug registration, post-registration, and renewal in Brazil.

Coming into effect on January 21, 2025, the regulation introduces significant innovations and adjustments aimed at enhancing regulatory process management and sanitary control within the pharmaceutical sector.

What changes with Resolution No. 954?

The resolution restricts the simplified procedure to companies within the same economic group, ensuring uniformity in safety, quality, and efficacy standards between the original product and its simplified registered counterparts.

This restriction seeks to mitigate health risks identified by GGMED.

Audits and Transparency

Among its highlights, the resolution allows Anvisa to audit simplified registrations at any time.

Companies holding registrations must submit the complete dossier or parts thereof within 60 days of request.

Pricing and Registration Renewal

The resolution reinforces that price evaluation criteria remain unchanged, regardless of the registration pathway, as defined by CMED Resolution No. 2/2004.

Additionally, companies will have 30 days to file post-registration changes for the primary process.

Other Key changes

  • The primary petition must be linked to a currently valid drug registration.
  • Specific conditions were established for delinking processes from the simplified model.
  • Issues related to dual branding will be addressed in future regulatory revisions.

Why are these changes important?

In addition to protecting public health, these measures provide greater predictability and security for drug manufacturers—marking a significant step toward enhancing transparency and efficiency in Brazil’s regulatory processes.

Learn more about the resolution here.

For more information about regulatory issues in Brazil, we can help.

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Anvisa Updates Procedures for Borderline Products

Anvisa Updates Procedures for Borderline Products

The National Health Surveillance Agency (Anvisa) has recently updated its guidelines on the procedures for classifying borderline products. This revision is part of the 2024-2025 Regulatory Agenda, with the aim of making the process more agile, efficient and predictable, thus facilitating the Brazilian population’s access to new health technologies.

What are borderline products?

These are products which, although they are of interest to health, have specific characteristics (such as composition, mechanism of action or indication for use) which make it difficult to fit them into the traditional categories of products subject to health surveillance, such as medicines, medical devices, food, cosmetics, among others.

This makes the regulatory process more complex and requires careful analysis by Anvisa to define the best regulatory route to follow in order to guarantee their safety and efficacy.

What has changed?

The main change brought about by the updated guidelines refers to the application process and the minimum information required on the Product Classification Form.

Anvisa has clarified in more detail how companies should proceed to apply for their products to be classified, as well as reinforcing the importance of prior consultation with the agency’s service channels. This step helps to ensure that the information and documents submitted comply with the Agency’s requirements.

In addition, the revision has been incorporated into the Regulatory Agenda 2024-2025, which aims to revise regulatory procedures in order to make them more efficient and predictable, promoting innovation in the country.

This change is in line with Anvisa’s strategic objectives of supporting the development of new technologies in Brazil, especially those with the potential to transform healthcare.

How does the classification of border products work?

Currently, the classification of border products is carried out by the Comitê de Enquadramento de Produtos sujeitos à Vigilância Sanitária (Comep), an advisory body to Anvisa. This committee helps define the regulatory framework for products that do not easily fit into the traditional health surveillance categories.

Comep is made up of representatives from various technical areas of Anvisa, such as registration, inspection, regulatory quality and product monitoring, and its decisions serve as input for Anvisa’s Collegiate Board (Dicol).

The committee was established by Anvisa Ordinance 1,354 of 2016 and its workflow is regulated by Anvisa Ordinance 1,744 of the same year.

Benefits of the Update

The revision of the guidelines for the classification of frontier products brings significant benefits for companies and society, including:

  1. Agility and Clarity: The new format of the application process brings greater transparency and predictability for companies, reducing bureaucracy and increasing efficiency in the regularization process.
  2. Easier Access to Innovations: With faster and clearer procedures, it is possible to promote faster access to new innovative products in Brazil, contributing to the advancement of the health sector.
  3. Support for National Innovation: The change reflects Anvisa’s commitment to boosting the development of promising technologies in Brazil, especially those with the potential to bring significant benefits to public health.

Updating the guidelines for the classification of frontier products is an important step towards improving Anvisa’s regulatory processes and stimulating innovation in the health sector. This changes bring greater clarity, efficiency and predictability, benefiting both companies and society by facilitating access to new products and technologies.

If you are involved in the development or marketing of innovative health products, it is essential to be aware of the new guidelines and seek the appropriate advice to ensure that your product is correctly framed and regularized before Anvisa.

For more information about regulatory issues, we can help.