Goods and products subject to sanitary control and inspection and products subject to special control
- Document symbol
- G/LIC/N/3/BRA/12
- Original language
- English
- Published on
- 21/09/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
The import licensing system of the National Sanitary Surveillance Agency (ANVISA) is based on Law No. 9.782 of 1999, which defines the national sanitary surveillance system and creates ANVISA. According to the law, ANVISA has the institutional purpose of promoting the protection of the health of the population, through the sanitary control of the production and commercialization of products and services submitted to sanitary surveillance, including the environments, processes, inputs and related technologies, as well as the control of ports, airports and borders. Among ANVISA's competencies are: a) to prohibit the manufacture, import, storage, distribution and marketing of products and inputs, in case of violation of relevant legislation or imminent risk to health; b) to consent the import and export of products and services that involve public health risks; c) to prohibit, as a sanitary surveillance measure, the places of manufacture, control, import, storage, distribution and sale of products and services related to health, in the event of violation of relevant legislation or imminent risk to health.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The import licensing system of ANVISA applies to goods and products subject to sanitary control and inspection by the Agency, namely: I - medicines for human use, their active substances and other inputs, processes and technologies; II - foods, including beverages, bottled water, their inputs, packaging, food additives, limits of organic contaminants, pesticide residues and veterinary medicines; III - cosmetics, personal hygiene products and perfumes; IV - sanitizers intended for hygiene, disinfection or disinfestation in home, hospital and collective environments; V - sets, reagents and inputs intended for diagnosis; VI - medical-hospital, dental and hemotherapy equipment and materials and image-based laboratory diagnosis ; VII - immunobiologicals and their active substances, blood and blood derivatives; VIII - organs, human and veterinary tissues for use in transplants or reconstitutions; IX - radioisotopes for in vivo diagnostic use and radiopharmaceuticals and radioactive products used in diagnosis and therapy; X - cigarettes, cigarillos, cigars and any other tobacco product, whether derived or not from tobacco; XI - any products involving the possibility of health risk, obtained by genetic engineering, by another procedure or still subjected to radiation sources.
Products subject to special control in import licensing from ANVISA are provided for in Annex I of Ordinance SVS/MS No. 344 of 1998.
(https://bvsms.saude.gov.br/bvs/saudelegis/svs/1998/prt0344_12_05_1998_rep.html) which includes substances used in scientific research, drugs, narcotics, psychotropics, and precursors.
Q3. The system applies to goods originating in and coming from which countries?
ANVISA's import licensing system applies to products originating in and coming from all countries without distinction.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The ANVISA's import licensing system does not aim to restrict quantity or value. Some products, however, are subject to special control.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The import licensing system of the National Sanitary Surveillance Agency (ANVISA) is based on Law No. 9.782 of 1999. The system is mandatory by law and cannot be abolished without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
The rules regarding import licensing are provided for in the Resolution of the Board of Directors RDC/ANVISA No. 81 of 5 November 2008 and may vary according to product characteristics.
ANVISA has a Panel available with general access on the deadline of the first step in the import process in the SISCOMEX modality (https://www.gov.br/anvisa/pt-br/acessoainformacao/dadosabertos/informacoes-analiticas/importacao/tempo-de-analise).
Q7.b. Can a licence be granted immediately on request?
The licenses analysis follows chronological order.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
The analysis is performed only by ANVISA.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
An application for a licence will not be refused other than failure to meet the ordinary criteria. The reasons for the refusal are presented and the applicant may appeal to the body itself.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
Companies authorized by ANVISA for such activity (import) may import the goods and products subject to sanitary surveillance, except in the case of companies importing food, raw food materials or food products, which must be presented on the arrival of the goods or products, official document of regularization of the company issued by the state or municipal authority.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
The information required for import license applications is provided for in the Resolution of the Collegiate Board – RDC/ANVISA No. 81 of 5 November 2008
(http://antigo.anvisa.gov.br/documents/10181/2718376/RDC_81_2008_COMP_.pdf/d031f6d6-3664-4d66-ae0b-d1d0ad106178), which lays down the technical regulation on imported goods and products for the purpose of health surveillance, specifically in Chapter XXXIX, on administrative procedures for framing products with the integrated system of foreign trade. Information may vary depending on product rating. In general, the following ones are requested: a) Petition for Sanitary Surveillance and Release; b) Commercial Invoice - "Invoice"; c) Bill of Lading.
Q11. What documents are required upon actual importation?
The documents required for effective import may vary according to the product classification. The list of documents is contained in RDC/ANVISA No. 81/2008, Chapter XXXIX.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
Yes there is a licensing fee. Law No. 9.782 of 1999, provides in Article 23, the Sanitary Surveillance Inspection Fee, and, in Annex 2, the generating facts. The rate value depends on the generating fact and size of the company and can be found in RDC ANVISA No. 222 of 28 December 2006 (http://antigo.anvisa.gov.br/documents/10181/2718376/%282%29RDC_222_2006_COMP.pdf/87ee071c-886e-47ac-94af-5590aaa2011e). For example, the consent to import and export, per individual person, of products or raw materials subject to sanitary surveillance, for the purposes of individual or own use, is exempt from charges. The consent to import, by legal entity, samples of product or raw materials subject to sanitary surveillance, for analysis and experiments, with a view to product registration, is subject to fees, the value of which may vary from R$ 8.86 to R$ 177.29, depending on the size of the company.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No deposit or advance payment requirement.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The license is valid for 90 days, extendable for 90 days.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licenses are not transferable.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
The conditions are those laid down in the legislation.