ANVISA Resolution – RDC n. 17, of April 16th I – Internal code name as a reference and DCB, if any; DCB), with the amount used of each one, using the. ANVISA. BRAZILIAN HEALTH REGULATORY AGENCY. Brazilian . List of Brazilian Non proprietary Names (DCB). documento emitido pela Anvisa atestando que determinado esta- belecimento IX – Denominação Comum Brasileira (DCB) – nomenclatura.
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Medicinal product regulation and product liability in Brazil: For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and competition law in Brazil: What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?
Legislation The Brazilian regulatory framework regarding pharmaceuticals is evolving steadily to become more transparent, efficient and convergent with international standards.
Two constitutional clauses establish the foundation for the framework:. Article of the Federal Constitution FC This underpins citizens’ constitutional right and the government’s duty to implement health policies aimed at reducing the risk of illness and other hazards for the whole population, as well as to provide equal and universal access to programmes and services to promote, protect and recover health.
Medicinal product regulation and product liability in Brazil: overview
Article of the FC This enshrines the government’s duty to regulate the provision of health services and products, whether directly or through third parties, and provides for the Brazilian regulatory framework for pharmaceutical products, medical devices and pharmaceutical active ingredients.
This is the main statute related to pharmaceutical products in Brazil. It provides for, among other things, the production, commercialisation, advertising, labelling, inspection, quality control, penalties, importation and marketing approvals of medicines, drugs, pharmaceutical active ingredients, medical devices, cosmetics, household products and other products. This law is regulated by Decree No. This establishes sanitary control related to the trade of drugs, medicines, pharmaceutical active ingredients and medical devices.
This sets out the penalties for infringing sanitary federal statutes and corresponding regulations, including criminal sanctions. This imposes restrictions on the use and advertising of smoking products, alcoholic beverages, medicines, therapies and agricultural pesticides. Regulatory authorities Law No. It is linked to the Ministry of Health, but operates as a financially autonomous regulatory agency.
ANVISA’s statutory role is to protect and promote public health by regulating the production and marketing authorisation of pharmaceuticals, foodstuff, household products, cosmetics, medical devices, smoking products, and new technologies relating to its mandate.
This law was recently amended by Law No. In general, an authorisation from ANVISA is required to produce and commercialise pharmaceutical products in Brazil, or import pharmaceutical products into Brazil. Among other activities, ANVISA is responsible for the sanitary control of the production and marketing of products and services subject to sanitary surveillance, including related premises, processes, pharmaceutical active ingredients and technologies, as well as:.
Ministério da Saúde
Controlling ports, airports and borders and co-ordinating the National System of Sanitary Surveillance. Establishing rules, proposing, monitoring and executing policies and activities concerning health anvisw. Authorising the operations of companies manufacturing, distributing and importing medicines.
Approving the import and export of medicines, granting marketing approval for medicines and granting and cancelling GxP certificates. Closing down, as a sanitary surveillance anviea, manufacturing plants and any premises involved in the management, importation, storage, distribution and sale of health-related products and services, if the relevant legislation is violated, or if they constitute a likely health risk.
Analysing patent applications related to pharmaceutical products and processes, jointly with the Brazilian Patent and Trademark Office BPTO Instituto Nacional da Propriedade Industrial prior consent analysisaccording to the updated proceedings set out in Resolution No. Briefly outline how biologicals and combination products are regulated in your jurisdiction. InANVISA updated the regulations for biological products, and different regulatory pathways for new biological products and biosimilars were established Resolution No.
For new biological products, the usual pathway, based on a full dossier submitted anvis the applicant, is required.
For similar biological products, the following two regulatory pathways were introduced:. Ccb reduced dossier can be submitted. The applicant must submit full data regarding quality issues but this does not have to be comparative. The number of non-clinical and clinical studies submitted can be reduced, depending on how much data is available on the pharmacological properties, safety and efficacy of the originator product.
At least one comparative phase III study equivalence, dcn or non-inferiority with the originator biological product is mandatory except for hemoderivatives, vaccines and biological products for oncological use. When available, the results of phase Anvias studies should be submitted.
A comparator product must be elected. The applicant must use comparability in terms of quality, safety and efficacy between the comparator biological product and the biological product. Two other pieces of legislation dcn also relevant:. This provides for post-registration changes and inclusions, suspensions and reactivations of manufacture and cancellation of registration of biological products.
This provides for procedures and conditions for conducting stability studies for registration or post-registration changes of biological products. Combination products are not subject to a specific regulation. However, rcb establish the pathway, a relevant aspect to be considered is whether the device would be commercialised within the drug packaging or independently.
In the latter case, the device will need to comply with Resolution No. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications? Medical devices and diagnostics, except diagnostic reactants for in vitro use, avnisa regulated by Resolution No.
Class I includes devices with the lowest risk and Class IV includes those dvb the greatest risk. Recordal of such devices need not be renewed. In addition, all medical devices, regardless of the class must comply with principles of safety and effectiveness, as provided by Resolution No. Mobile medical applications created to generate diagnostics are considered by ANVISA as medical devices and must comply with the regulations, seeking approval. Conversely, ANVISA abvisa issued a brief statement that mobile applications with leisure and sporting purposes are not subject to its anvjsa.
Pricing, state funding and reimbursement 4. What is the structure of the national healthcare system, and how is it funded? Although the Constitution establishes that health is everyone’s right, the Brazilian public health care system is mostly used by citizens who cannot afford private health care.
Decentralisation, with a single management in each sphere of government.
Full service, with priority given to preventive activities. Care provided under SUS is split between the public and private sectors. Its statutory definition comprises “health activities and services, provided by public and federal entities and institutions, both by states and counties, of the direct and indirect administration of the foundations maintained by the government”.
When the public structure is insufficient, the private sector may act as a supplementary resource. Federal, state and county executive governments maintains SUS through a variety of taxes and contributions. Funds are transferred from the National Health Insurance Fund to the other regional governments.
SUS relies on publicly owned facilities, such as hospitals, hiring private contractors for specific needs. The health activities and services provided by SUS are organised regionally and hierarchically with a unified management structure, exercised by each government sphere of the following institutions:. In relation to the Federal Union, by the Ministry of Health. In relation to the states, Federal District and municipalities, by their respective health offices.
How are the prices of medicinal products regulated?
ajvisa The prices of new medicinal products and new presentations of medicines are strictly regulated in Brazil. CMED is responsible for monitoring and regulating the pharmaceutical market and establishing parameters and criteria for setting and adjusting the prices of medicines in Brazil, to stimulate competition in the market.
Prices are reviewed annually in March and this review considers diverse factors, such as level of inflation, productivity and sector competition. Infor the first time the price readjustment index was above inflation, reaching a maximum of The price readjustment reached a maximum of 4.
The price charged by the company in foreign countries. The cost per patient of treatment with the product. The potential number of patients to be treated with the product.
The price that the company intends to charge in the market, including tax. The commercialisation plan, including advertising and sales costs. ddcb
Medicinal product regulation and product liability in Brazil: overview | Practical Law
The list of all competitor products with their respective prices. Information on intellectual property, especially patents covering the product.
CMED is currently working on a review of the main regulation, which is expected to be submitted to public consultation shortly.
When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services? There is no direct or indirect reimbursement to end users or pharmacists anvisq Brazil. Generally, medicines in Brazil are subject to the same tax burden as other non-essential goods, such as navisa beverages or clothes. Article 6, clause D of Law No.
The Brazilian population therefore has the right to receive free medicines. Anviza distribution is made by the federal, state and county public hospitals. The purchase of medicines by the Ministry of Health and public health institutions is carried out through competitive bidding in a procurement process under the FC Federal Law No.
The supplier with the lowest price who proves that the medicine meets the legal and technical requirements of the procurement wins the bid. A system called low-cost pharmacy was also introduced under Decree No. It is currently regulated by Ordinance No. Under this system, the federal government buys medicines from the industry and distributes or sells them to patients at a lower cost, through a network of pharmacies. However, integral and universal access anvis therapeutic assistance does not mean access to all kinds of treatments.
There are several medicines and treatments that SUS does not provide. HTA is a continuous process of analysing and summarising the potential health benefits and the economic and social consequences inherent in employing certain technologies, anvlsa considering the following aspects: However, the existing HTA route has some pitfalls and is dcbb a barrier to citizens’ access to health care.
The Supreme Federal Ccb STF is currently assessing two appeals, recognised as matters of general application, focusing on the economic burden of such treatments and whether the government could be qnvisa to provided medicines not approved by ANVISA. In Maythe Superior Court of Justice STJ suspended all lawsuits in progress and highlighted the obligation of the state to provide high and low costs medicines not available through the SUS. This measure does not prevent judges from considering urgent cases.