RESOLUTION – RDC No. 208, OF JANUARY 5, 2018
Provides for the simplification of procedures for the importation of goods and products subject to Sanitary Surveillance
The Collegiate Board of the National Health Surveillance Agency, in the use of the attribution conferred by Art. 15, III and IV allied to Art. 7, III, and IV, of Law No. 9,782, of January 26, 1999, Art. 53, V, §§ Paragraph 1 and 3 of the Internal Regulations approved in accordance with Annex I of the Resolution of the Collegiate Board of Directors – RDC No. 61 of February 3, 2016, resolves to adopt the following Resolution of the Collegiate Board of Directors, as deliberated at a meeting held on December 12, 2017, and I, the Chief Executive Officer, determined its publication.
Art. 1 This Resolution amends the Resolutions of the Collegiate Board of Directors – RDC No. 46, of May 18, 2000, No. 81, of November 5, 2008, No. 58, of December 17, 2010, No. 68, of March 28 2003 and No. 204 of July 6, 2005, aimed at simplifying procedures for the import of goods and products subject to sanitary surveillance.
Art. 2 Amend Art. 3 of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“Article 3. The Mercosur Common Nomenclature (NCM) of goods subject to administrative treatment by Anvisa shall be made available on the Agency”s Internet Portal.
“Single paragraph. The importer must select the appropriate administrative procedure for the type of merchandise, when making the request and the instructions for the import process. “(NR)
Art. 3 Included in item 1.2 of Chapter II of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, sub-item 1.2.1 with the following wording:
“1.2.1 In the event of an application by manual petition, it is mandatory to present the Union Collection Guide (GRU), the National Treasury Department and its respective proof of payment, as provided in the legislation, as well as in the instrument of proxy of the importer, with delegation of powers to ANVISA, to the legal representative responsible for the clearance.”
Art. 4 Amend item 3.5 of Subsection II of Section I of Chapter III of Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“3.5 When importing products under sanitary surveillance that can be regularized before Anvisa, the importer must register in the appropriate field of the petition for inspection and sanitary release, electronic or manual, and the regularization number of the product, as well as the number of the lot, or of departure or series or part number. ” (NR)
Art. 5 Amend item 5 of Subsection II, Section I, of Chapter III of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“5. The importation of goods and products, when subject to non-automatic licensing-LI – SISCOMEX, disposed in Common Nomenclature of the MERCOSUR (NCM), shall comply with the administrative procedures and documentary requirements that are part of this Regulation.” (NR)
Art. 6 Amend item 7 of Chapter VII of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“7. The outsourced importation will take place with the consent of the sanitary authority, upon submission of the following documentation for each import:
a) Petition for Health Surveillance and Release referred to in sub-item 1.2 of Chapter II of this Resolution;
b) declaration of the legal entity holding the product regularization with ANVISA, authorizing the importation, and shall mandatorily:
i) be bound to one (1) sole and exclusive legal entity, being forbidden the transfer of such authorization;
ii) have legal validity, and can not have validity more than ninety (90) days as of its signature;
iii) be subscribed by its legal officer or legal representative, and by its technical officer; and
iv) express a commitment to observation and compliance with the norms and procedures established by sanitary legislation, as well as the understanding of penalties, which shall be subject, pursuant to Law No. 6.437, of August 20, 1977.
c) Import Authorization through predetermined intermediation, according to Chapter VIII. “(NR)
Art. 7 Amend item 1 of Chapter IX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“1. Direct importation by a hospital unit or health care establishment that provides therapeutics and diagnostic services for products belonging to the classes of medicines, medical products and in vitro diagnostic products shall be preceded by registration of Import Licensing in SISCOMEX , according to Chapter III, Section I, Subsection II. ” (NR)
Art. 8 Amend subsection 1.1 of Chapter IX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
1.1 The Import Licensing dealt with in this Chapter must be submitted to the sanitary authority, through the Petition for Sanitary Inspection and Sanitary Import of the subitem
1.2. of Chapter II of this Resolution, and the following requirements must be met:
a) The product must be cleared by ANVISA, upon its arrival in the national territory;
b) presentation by the importer of the licensing document by a competent sanitary surveillance body, or Sanitary License, with the State, Federal District or Municipality;
c) The company must be approved by ANVISA, regarding Special Operation Authorization (AE) for the activity of importing drugs under special control, in accordance with Portaria SVS / MS No. 344, of May 12, 1998;
d) declaration of the legal entity holding the product approval, along with ANVISA authorizing the importation, and must:
i) be bound to one (1) sole and exclusive legal entity, being forbidden the transfer of such authorization;
ii) have legal validity, and can not have validity more than ninety (90) days as of its signature;
iii) be subscribed by its legal officer or legal representative, and by its technical officer; and
iv) “express a commitment to observation and compliance with the norms and procedures established by sanitary legislation, as well as the knowledge of penalties, which shall be subject, pursuant to Law No. 6.437, of August 20, 1977.”
Art. 9 Amend sub-item 3.1 of Chapter IX of the Resolution of the Collegiate Board of Directors – RDC nº 81, of 2008, which shall become effective with the following wording:
“3.1 The import referred to in this item shall be subsidized by technical-scientific report containing justification of the need for importation;
technical-scientific evidence based on official compendia that demonstrate the efficacy and safety of the drug; and proof of registration of the medicinal product in the country of origin or in the country in which it is marketed. “(NR)
Article 10 To amend Chapter XV of the Resolution of the Collegiate Board of Directors – RDC nº 81, of 2008, which shall become effective with the following wording:
“LABELING OF GOOD OR IMPORTED PRODUCT – FINISHED PRODUCT”
1. The labeling of imported products will be allowed in national territory, subject to the relevant legislation.
1.1. The delivery of imported products with identification or labeling in a foreign language shall be prohibited, except for imports for non-commercial purposes covered by Chapters IX, X, XII, XIX, XX and XXI of this Resolution.
1.2. The products covered in this item, when exposed or delivered for consumption, must be labeled according to the health legislation pertinent to the product class.
2. The primary or secondary packaging or transport must contain the following
minimum information when entering the national territory, according to the class of product to which it belongs:
2.1 Food:
a) Commercial name in use abroad;
b) Name of manufacturer and place of manufacture;
c) batch number; and
d) Expiration date.
2.2 Cosmetics / Perfumes / Hygiene Products:
a) Commercial name in use abroad;
b) Country of manufacture; and
c) batch number or code.
2.3 Sanitation:
a) Commercial name in use abroad;
b) Name of manufacturer and place of manufacture;
c) batch number; and
d) Expiration date.
2.4 Health Products:
a) Commercial name in use abroad;
b) Name of manufacturer and place of manufacture;
c) batch number or code or part number;
d) Date of manufacture; and
e) Expiration date.
2.5 In Vitro Diagnostic Products:
a) Commercial name in use abroad;
b) Name of manufacturer and place of manufacture;
c) batch number or code or part number;
d) Date of manufacture; and
e) Expiration date.
2.6 Medications:
a) Commercial name;
b) Name of manufacturer and place of manufacture;
c) the lot code or number or batch;
d) date of manufacture; and
e) expiration date
3. For the purposes of the provisions of item 2 of this Chapter, the health authority may request the translation of the respective label of the imported good or product, signed by the responsible technician and by the person in charge or legal representative of the company holding the product regularization together to the National Health Surveillance System.
3.1. In food cases, the translation of the label may be subscribed by the legal representative of the importing company.
4. In case of absence on the foreign language label of imported product belonging to the category of products for in vitro diagnostics, the information referred to in sub-item 2.5, item “d” of this Chapter shall be required by the importer to present a declaration signed by the technical responsible of the importing company, informing the date of manufacture of the lot or batch, for each imported product; or analytical report of quality control, by lot or batch, for each imported product, with information regarding the date of manufacture.
5. The importation of product with Portuguese language label in disagreement with what is foreseen in the sanitary/health legislation may result in a deferment, with limitation, of the import licensing in SISCOMEX, as well as in leaving the product in the authorized customs area, upon subjection of the importer to the Term of Guard and Responsibility.
5.1. The limitation addressed in item 5 of this Chapter should be registered in the field concerning the situation of the Import License in SISCOMEX with the following text:
“PRODUCT WITH HEALTH REQUIREMENT. RELEASE TO INDUSTRIALIZATION, EXPOSURE TO SALES OR DELIVERY TO CONSUMPTION SHALL BE PERFORMED BY EXPRESS MANIFESTATION OF THE SANITARY/HEALTH AUTHORITY”. “(NR)
Article 11 To amend Chapter XVIII of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“REFURBISHED OR USED MEDICAL PRODUCTS AND SEALED RADIOACTIVE SOURCES”
SECTION I
OF THE GENERAL PROVISIONS
1. The importation by companies of goods or products belonging to the classes of medical products, used and refurbished, components and accessories, shall comply with the provisions of relevant health legislation.
SECTION II
REFURBISHED MEDICAL PRODUCTS
2. The importation of refurbished medical products shall be compulsory through SISCOMEX, and shall comply with the application and processing formalities, in accordance with Procedure 4 of Chapter XXXIX of this Resolution and pertinent sanitary legislation.
3. The importation of refurbished medical products, by a company that does not have approval by ANVISA, will depend on the presentation of a declaration by the legal entity holding the goods or product approval with ANVISA, authorizing the importation, and must:
a) be bound to a single and exclusive legal entity, being forbidden the transfer of such authorization;
b) have legal validity, including not having a term of validity more than 90 (ninety) days as of its signature;
c) be subscribed by its legal officer or legal representative, and by its technical officer;
d) to express the commitment of observation and compliance with the norms and procedures established by the sanitary or health legislation, as well as of the penalties to which it will be subject, under the terms of Law No. 6,437, August 20, 1977.
SECTION III
USED MEDICAL PRODUCTS
4. The importation of used medical products is prohibited.
4.1. The authorization for the import, by the company holding the respective approval with ANVISA, of a used medical product, for the purpose of refurbishing in the national territory, shall be based on a conclusive and satisfactory opinion of the competent technical area of ANVISA at its headquarters.
SECTION IV
RADIOACTIVE SOURCES SEALED FOR USE IN HEALTH SERVICES
5. The importer of the sealed radioactive sources covered by this Chapter, in addition to the requirements set forth in Procedure 4 of Chapter XXXIX of this Resolution, shall be submitted, within a period of 60 (sixty) days from the health or sanitary authority”s approval, import licensing, statement, signed by the legal guardian and the technical officer, containing the following information:
a) source specifications: radionuclide, amount and shape;
b) purpose of the use of the source;
c) radionuclide activity: value and date of measurement; and
d) destination of the source: name of the institution, CNES number, full address of the place where it is installed.
5.1. The sanitary authority shall draw up a legal term of Notification to the importer and/or make available in Siscomex information directing it to comply with the requirements referred to in item 5 of this Section.
6. In compliance with the provisions of this Section, the NCMs subject to the sanitary or health control of complementary imports are defined:
(a) NCM code: 2844.40.20,
a.1) Description: Cobalt 60;
(b) NCM code 2844.40.90,
b.1) Description: Other;
b.2) Description of the Highlight – NCM: Radio (Ra-226), Césio (Cs 137), Iodine (I-125), Gold (Au-198), Strontium and other sources sealed for use in health services;
(c) NCM code 9022.2,
c.1) Description: Apparatus using alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus (NR)
Article 12 to amend item 1 of Chapter XX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“1. The importation of a standard and reference material shall be subject to inspection by the health authority, upon submission of a Petition for Sanitary Surveillance and Release provided for in Chapter II, sub-item 1.2, instructed by the Term of Responsibility contained in Chapter XX, of this Resolution.” (NR)
Art. 13 to amend subsection 1.3.1 of Chapter XX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“1.3.1 Excluded from this sub-item are the imports of goods and products that are part of procedures 1 and 1A of Chapter XXXIX.” (NR)
Art. 14 to amend item 1.4 of Chapter XX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“1.4 The Term of Responsibility of Chapter XX-A, which is dealt with in this Chapter, shall be presented with the signature of the legal representative and the technical responsible.” (NR)
Art. 15 to amend Chapter XXI of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
SECTION I
OF MEDICINES
1. The importation of samples of finished products, in bulk or raw material, belonging to the class of medicines not regularized in ANVISA, intended for testing, shall be submitted for analysis and approval of the Import Licensing by the health authority, upon presentation of Petition for Sanitary/ Health Inspection and Release, outlined by Term of Responsibility contained in Chapter XXII of this Resolution.
2. The importation of samples of non-approved medicines shall comply with the health requirements set forth in procedures 1, 1A, 2A, 2B, 2B, 2C, 3, 5.3 and 6, whichever is applicable, of Chapter XXXIX of this Resolution.
2.1. Exempt from the provisions of item 2 of this Section, the documents related to the approval of the drug by ANVISA, provided for in the procedures of Chapter XXXIX of this Resolution.
3. The importation referred to in this Section shall be in a quantity compatible with the stated purpose.
4. The importation of medicines unapproved by ANVISA for market research is prohibited.
SECTION II
OF MEDICAL PRODUCTS AND PRODUCTS FOR IN VITRO DIAGNOSTICS
5. Importation of samples of finished products belonging to the class of health products not approved by ANVISA, intended for testing, teaching or training, shall be submitted to the analysis and approval of the Import Licensing by the health authority, upon submission of a Petition for Supervision and Health Release, as outlined by Term of Responsibility in Chapter XXII, of this Resolution.
5.1. The importation of the product will be exempt of authorization of shipment abroad.
6. The commercialization of the samples of products covered by this Section, as well as the alteration of the intended purpose, outlined in the import procedure, are prohibited.
SECTION III
OF SANITIZERS
7. The importation of samples of products, in the form of finished product belonging to the class of sanitizing agents, not approved by ANVISA, and that are not expressly prohibited in the national territory, for analysis for the purposes of registration, quality control test, proficiency, development of new products or of equipment participating in the manufacturing or laboratory process, will occur through submission of Petition for Sanitary Surveillance and Release, provided for in Chapter II, sub-item 1.2, as outlined by Term of Responsibility in Chapter XXII of this Resolution.
7.1. The provisions of item 7 of this Section include the importation of samples of raw materials, active ingredients that are part of sanitizing formulations not authorized for human consumption and are under technical analysis for registration with ANVISA, exclusively for quality control in an analytical laboratory installed in the national territory.
7.2. Excluded from the provisions of item 7 of this Section are products for market research, which will be submitted to the opinion of the competent technical area of ANVISA at its headquarters, prior to its clearance.
7.3. The importation of the products covered by this Section will be done through Siscomex or Remessa Expressa (Express Shipping).
7.4. The importation of the product covered by this Section shall be exempted from an authorization to ship abroad.
8. The commercialization of samples of products covered by this Section, as well as the alteration of the purpose for which importation is intended, informed in the import procedure, shall be prohibited.
SECTION IV
OF COSMETICS, PERFUMES AND PERSONAL HYGIENE PRODUCTS
9. The provisions of this Section shall cover the importation of samples of products, in the form of finished product or bulk, belonging to the class of cosmetics, perfumes and personal hygiene products, not regularized with ANVISA, and not expressly prohibited in the territory national, for laboratory analysis of quality control and evaluation of packaging and labeling; analysis for registration purposes; new product development and market research; or safety and efficacy trials.
9.1 The importation referred to in item 9 of this Section shall be subject to inspection by the health authority, upon submission of a Petition for Sanitary Surveillance and Release, provided for in Chapter II, sub-item 1.2, which shall be outlined by Term of Responsibility, contained in Chapter XXII of this Resolution.
9.2. The importation of the products covered by this Section will be done through SISCOMEX or Express
Shipping.
9.3. The importation of the products referred to in this Section shall be exempt from an authorization to ship abroad.
10. The importation referred to in this Section shall be provided to a laboratory authorized by the Brazilian Network of Analytical Laboratories in Health (REBLAS), upon presentation of a declaration of authorization of the legal entity interested in the performance of the tests and of Petition for Sanitary Surveillance and Release, provided for in Chapter II, sub-item 1.2, which shall be outlined by the Statement of Responsibility, contained in Chapter XXII, of this Resolution.
10.1. The importer referred to in item 10 of this Section will be released from the operating authorization for import activity.
11. The commercialization of the samples of products covered by this Section, as well as the alteration of the purpose for which importation is intended, informed in the import procedure, shall be prohibited.
SECTION V
OF FOODS
12. The importation of samples of raw material and finished product, belonging to the food category, for analysis for the purpose of registration, quality control test, evaluation of packaging or labeling, development of new products or equipment involved in the process factory or laboratory, or market research, shall be subject to inspection by the health authority, upon presentation of a Petition for Sanitary Surveillance and Release, provided for in Chapter II, sub-item 1.2, which shall be instructed by the Statement of Responsibility, Chapter XXII of this Resolution.
12.1. The import for market research will depend on a favorable opinion granted by the competent technical department of ANVISA at its headquarters.
12.2. The requirement referred to in sub-item 12.1 of this Section shall not depend on the obligation to register the product.
12.3. The importation of product covered by this Section shall be done by means of the SISCOMEX import modalities or Remessa Expressa (Express Shipping).
12.4. The importation of product covered by this Section shall be exempt from foreign shipping authorization.
12.5. It will not be allowed to import a food sample with mandatory registration with ANVISA, whose purpose is market research.
13. It is prohibited to commercialize the samples of products covered by this Section, as well as to change the purpose for which importation is intended, as outlined in the import procedure.
SECTION VI
OF FINAL PROVISIONS
14. The Petition for Sanitary Inspection and Release referred to in Sections I, II, III and IV of this Chapter shall be outlined by a document signed by the technical officer and legal representative of the importing Company, which shall include the following information:
a) purpose of importation;
b) the total quantity, justified, for the number of samples imported;
c) details of the qualitative and quantitative formula of the imported sample, except in the case of medical products;
d) technical specifications of the imported sample;
e) lot numbers, or batches, and number of units produced per lot;
f) description of the tests to be carried out in the national territory, with the summary of the protocol justifying the quantity requested, when applicable;
g) description of the research methodology, if applicable;
h) occurrence of excess resulting from the operationalization of the proposed import purpose, adequate inactivation treatment methodology; and
i) name of the technical responsible for the imported product and respective information regarding the Individual Register and Professional Council of its registration, with identification of the registration number. “(NR)
Art. 16 Amend Chapter XXVI of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“CLINICAL RESEARCH”
SECTION I
OF THE OBJECTIVE PRODUCT OF THE CLINICAL RESEARCH
1. The importation of products belonging to the categories of medicinal products, medical products or in vitro diagnostic products under investigation, for exclusive use in clinical research, shall be submitted to the analysis and approval of the Import Licensing by the health authority, upon presentation of Petition for Health Inspection and Release, with SISCOMEX.
1.1 The importer must indicate in the product description the number of the Special Communiqué (CE) or Specific Special Communiqué (CEE) or Document for Importation of Product (s) under investigation of the Clinical Drug Development Dossier (DDCM) or Clinical Investigation Dossier of Medical Device (DICD), issued by the competent technical area of Anvisa at its headquarters.
1.2. The following are mandatory documents for processing the import process covered by this Section:
a) Knowledge of cargo on board;
b) Commercial invoice; and
c) In cases of imports made by others other than the holder of the DDCM or DICD, document of delegation of import responsibilities.
2. It is forbidden to enter into the national territory of products under investigation not foreseen in the EC, EEC or Product Import Document under investigation of the Clinical Drug Development Dossier (DDCM) or Medical Device Clinical Investigation Dossier (DICD).
3. It is prohibited to change the purpose of importation of the goods and products referred to in this Section.
SECTION II
OF MEDICAL PRODUCTS AND IN VITRO DIAGNOSTIC PRODUCTS IMPORTED FOR THE MONITORING OR EVALUATION OF CLINICAL RESEARCH
4. The importation of goods and products under sanitary surveillance belonging to the categories of medical products and products for in vitro diagnostics, linked to the monitoring and evaluation of the development of approved clinical research, will occur through the submission of Petition for Inspection and Sanitary Release provided for in Chapter II, sub-item 1.2 and compliance with the indications of labeling, packaging, transport and storage.
SECTION III
OF THE KITS FOR COLLECTING BIOLOGICAL MATERIAL RELATED TO MONITORING OR EVALUATION OF CLINICAL RESEARCH
5. The importation of kits for the collection of biological material, linked to the monitoring and evaluation of the development of approved clinical research, shall be subject to inspection by the health authority, upon submission of a Petition for Sanitary Inspection and Release, provided for in Chapter II, sub-item 1.2, which shall be instructed by the Statement of Responsibility, contained in Chapter XXVII of this Resolution.
5.1 The importer shall, in the product description, indicate the number of the Special Communiqué (CE) or Specific Special Communiqué (CEE) or Document for Importation of Product (s) under investigation from the Clinical Drug Development Dossier (DDCM) or Clinical Investigation of Medical Device (DICD), issued by the competent technical area of Anvisa at its headquarters.
5.2. The following documents are mandatory documents for the import process covered by this Section:
a) Knowledge of cargo on board;
b) Commercial invoice; and
c) In cases of imports made by others other than the holder of the DDCM or DICD, document of delegation of import responsibilities.
5.3. The importation referred to in this Section shall be made through SISCOMEX, Express Shipping or Postal Shipment and shall be exempt from foreign shipping authorization.
6. It is prohibited to commercialize the products covered by this Section, as well as to change the purpose for which importation is intended, informed in the import procedure.
7. The goods or products covered by this Section are exempt from regularization before ANVISA.
SECTION IV
OF HUMAN BIOLOGICAL MATERIAL LINKED TO CLINICAL RESEARCH IN DEVELOPMENT ABROAD, INTENDED FOR CLINICAL LABORATORY DIAGNOSIS
8. The
importation of human biological material, linked to the monitoring and evaluation of research development, destined to clinical laboratory diagnosis, should be subject to inspection by the health authority, by means of the submission of Petition for Sanitary Inspection and Release, foreseen in Chapter II, sub-item 1.2, which shall be outlined by the Statement of Responsibility, contained in Chapter XXVII of this Resolution, accompanied by the following documents:
a) Declaration of the Importer with the information of the number of the Special Communiqué (CE) or Special Specific Notice (CEE);
b) Knowledge of cargo on board; and
c) Commercial invoice.
8.1. The importation of goods and products covered by this Section will be done through SISCOMEX, Express Shipping or Postal Shipment.
8.2. The importation of goods or products covered by this Section is exempt from foreign shipping authorization.
9. It is prohibited to commercialize the products covered by this Section, as well as to change the purpose for which importation is intended, as stated in the import procedure.
10. The granting of the Import Licensing or the sanitary release of the material shall be done by complying with the provisions of this Resolution, as well as compliance with the indications of labeling and packaging, transportation and storage, according to the information indicated by the exporter of the material and regulated by national and international transport standards.
SECTION V
OF FINAL PROVISIONS
11. The imports covered by this Chapter shall be subject to physical inspection at the discretion of the health authority.
12. Secondary and external packaging used for handling and transporting the materials covered by this Chapter shall include:
a) Number of the clinical protocol of the research to which the product is submitted;
b) information on care for storage, such as temperature, humidity and brightness; and
c) batch number or identification code or serial number enabling traceability of the imported product.
12.1 Medicines imported only in primary packaging and containing QR Code or other identifier must comply with the minimum requirements described in items a and b, on their external or transport packaging.
12.2 The information linked to the QR Code or other identifier must allow the complete traceability of the product to the research center. “(NR)
Art. 17 Amend Chapter XXVIII of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
SECTION I
OF CUSTOMS TRANSIT
1. The Customs transit regime through the International Customs Transit and Freight Shipping Manifest (MIC / DTA), Customs Transit Order (DTA), Knowledge – International Cargo Charter – Customs Transit Declaration (TIF-DTA), Transit Transfer Statement (DTT) or Container Transit Declaration (DTC) is exempt from consent or authorization by ANVISA.
2. It is forbidden to apply a customs transit regime in the importation of goods and products belonging to the following classes and categories:
a) substances and medicines subject to special control, included in Procedures 1 and 1A of Chapter XXXIX of this Resolution;
b) Thalidomide and medicinal products based on this active principle;
c) human cells and tissues for therapeutic purposes; and
d) goods or products suspected of compromising the identity and quality standard, or in emergency and provisional situations, by measures related to the international health and epidemiological context.
2.1. For the situation described in item “d” of item 2 of this Section, at the discretion of the health authority, the goods or material may at any time be subject to inspection.
SECTION II
OF TEMPORARY ADMISSION
3. The importation of goods or products under sanitary surveillance and subject to non-automatic licensing in SISCOMEX, under Special Temporary Admission Scheme, shall comply with the application and processing formalities, in accordance with the provisions of Chapter XXXIX of this Resolution.
4. The importer shall submit the following additional information to the other members of this Resolution:
a) name of the technical responsible for the goods or product during the period of their stay in the national territory;
b) quantity of the good or product;
c) period of validity or expiration date of the good or product;
d) purpose of importation;
e) period of permanence of the product in the national territory, indicating the date of its return to the exterior; and
f) place of storage or exhibition of the product within the period subject to Temporary Admission.
4.1. The importer must present the respective proof of export within a maximum period of 10 (ten) business days from the shipment of the goods abroad.
5. The nationalization of the good or product admitted under the Special Customs Regimen of Temporary Admission that does not comply with the sanitary/health legislation in force is prohibited.
SECTION III
CUSTOMS WAREHOUSE
6. The application of Special Regime of Customs Warehouse to the importation of goods and products belonging to the following classes and categories is prohibited:
a) substances and medicines subject to special control, contained in Procedures 1 and 1-A, of Chapter XXXIX of this Resolution;
b) human cells and tissues for therapeutic purposes;
c) bulk, semi-finished or finished medicaments belonging to the categories of blood derivatives and biologicals, and the raw materials that integrate them, contained in Procedures 2, 2-A, 2-B and 2-C of Chapter XXXIX of this Resolution;
d) thalidomide and medicinal products based on this active principle.
6.1. Exempt from item “c” of item 7 of this Section, imports destined to public health programs, linked to the Ministry of Health and State and Municipal Secretariats.
7. The nationalization of the good or imported product under the Special Customs Warehouse Regime shall be subject to sanitary/health inspection, in accordance with the criteria of Chapter XXXIX of this Resolution.
SECTION IV
FROM PARCELED DELIVERY
8. The importation of goods or products under sanitary surveillance with parceled delivery, in compliance with health/sanitary conditions, shall be subject to the granting of Import Licensing, subject to SISCOMEX, by the health authority, upon the arrival of the first imported parcel.
8.1. The fractional imports referred to in item 9 of this Section shall be communicated to the health authority at least 12 (twelve) hours before the estimated date and time of arrival.
8.2. The communication within a period shorter than that indicated in sub-item 9.1 of this Section shall subject the importer to sanitary/health sanctions.
8.3. The limitation addressed in item 9 of this Section should be registered in the field related to the Import Licensing situation in SISCOMEX, with the following text:
“PRODUCT UNDER PARCELED DELIVERY: THE RELEASE TO THE EXPOSURE OR DELIVERY TO THE CONSUMPTION OF THE PARCELED REMITTANCES INTEGRATED FROM THIS IMPORT LICENSING WILL BE DONE THROUGH SATISFACTORY SUPERVISION OF THE SANITARY/HEALTH AUTHORITY”.
9. The importation referred to in this Section shall be outlined by the importer”s declaration and shall be responsible for communicating the entry of each parcel of the total goods or products indicated in the Import Licensing, signed by the legal representative of the company.
SECTION V
CARNÊ ATA
10. The customs regime for the temporary admission of goods transported under cover of Carnê ATA, provided for in Decree No. 7,545 of August 2, 2011, which promulgates the Istanbul Convention, shall be applied in accordance with the provisions of this Section.
11.The provisions of
this Section, under the terms established in Annexes B.1, B.5 and B.6 of Decree no. 7,545, of August 02, 2011, the following goods and products under sanitary surveillance:
a) Goods and products subject to health surveillance for exhibitions, fairs, congress or similar events;
b) health products and in vitro diagnostic products intended for educational, scientific or cultural purposes; and
c) Goods and products subject to health surveillance for sporting purposes, provided that the quantity is compatible with personal use.
12. The inspection and release by the health authority of goods transported under Decree no. 7,545, of August 02, 2011 will be made based exclusively on what constitutes the Carnê ATA.
a) The ATA Carnet shall be presented by the importer or his representative to the health authority at the place of clearance;
b) The physical verification of the merchandise will only be carried out when the health authority understands that this procedure is necessary;
c) Once the sanitary/health conditions have been complied with, the health authority will stamp and sign, if appropriate, the voucher that makes up the Carnê ATA, considering the goods ready to be delivered to the beneficiary.
13. The registration of medical equipment not regulated by ANVISA, intended for exhibition in fairs, congresses or similar events, may also be submitted to the Carnê ATA regime.
13.1 The medical equipment covered by this item, during its stay in the national territory, must be under the assistance of the responsible professional technician, and the professional training of the responsible technician must meet the requirements of the pertinent health legislation in force.
14. The beneficiary of the scheme is a natural person or legal entity that appears in the Carnê ATA as the holder.
15. The beneficiary may bring to the country only part of the assets described in the General List contained in the Carnê ATA.
16. The manifestation of the health authority will produce effects on all the goods of sanitary/health interest described in the General List of Carnê ATA.
17. No assets that, during their stay in the country, may be admitted or maintained in the regime covered by this Section:
a) are subject to, or suffer any change, other than the normal depreciation resulting from their use; or
b) are subject to consumption.
18. The importation of professional materials for purposes subject to sanitary surveillance under the regime of this Section is prohibited.
SECTION VI
DUTY-FREE SHOPS
19. The importation for exhibition or sale for consumption of goods or products under health supervision at Duty-free Shops shall comply with the pertinent sanitary/health requirements, including:
a) Conditions of use and consumption described by the manufacturer;
b) Shelf life, if existing on the packaging; and
c) Storage in an adequate environment, in order to guarantee and maintain its identity and quality standards.
20. The products on display in Duty-free Shops do not require formal regularization with the SNVS.
21. The good or product exposed to the sale or delivered for consumption in a Duty-free Shop may be subject to tax or control analysis, in the form of this Resolution.
22. The maintenance of the information of the goods or products under sanitary/health surveillance, by class, commercial name, quantity, lot or batch number, name of the manufacturer and identification of the buyer, for a period of five (5) years shall be compulsory at Duty-free Shops from the date of its sale or its exposure to consumption. “(NR)
Art. 18 Amend item 6 of Section II of Chapter XXX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“6. The importation of products belonging to the categories of personal hygiene products, sanitizing products or foodstuffs intended for consumption or the provision of on-board services on vessels, aircraft and land vehicles operating international collective passenger transport shall be subject to ANVISA”s inspection, by submitting a Petition for Sanitary Inspection and Release provided for in sub-item 1.2 of Chapter II of this Resolution. ” (NR)
Art. 19 Amend item 10 of Section IV of Chapter XXX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“10. The importation of products belonging to the classes of medicaments, medical products and products for in vitro diagnostics, for the supply and replacement of terrestrial vehicles forming part of a fleet of foreign companies operating international collective passenger transport, or flagged vessel or aircraft shall submit to ANVISA”s inspection, by submitting a Petition for Sanitary Surveillance and Release provided for in sub-item 1.2 of Chapter II of this Resolution. “(NR)
Art.20 to amend Chapter XXXII of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“EXPORTED GOODS OR PRODUCTS PRODUCED IN THE NATIONAL TERRITORY AND RETURNED”
1. The good or product under sanitary/health surveillance exported that, for any reason, is returned to the national territory must have the registration of Import Licensing with SISCOMEX – Import Module, being exempted from authorization of shipment abroad.
1.1. Section 1 of this Chapter includes the importation of representative samples of the good or product exported, under refusal, for purposes of quality control in the national territory.
2. The importer shall submit to the health authority the information regarding the return and destination of the good or product, as well as the Analytical Report of Quality Control carried out abroad, if applicable.
3. The health authority shall rule on the granting of the Import Licensing, deferment with Guard and Responsibility, or issuance of the legal terms of seizure or prohibition, according to the case, for purposes of fiscal or control analysis.
3.1 The health authority can carry out sample collection and send it to official or accredited laboratories.
3.1.1. If it is impossible to carry out the fiscal or control analysis in official laboratories, it will be possible to carry out analytical quality control tests in the manufacturer”s own laboratory or by subcontractors, observing the pertinent health legislation, as long as justified and authorized by the relevant technical sector of ANVISA at its headquarters.
3.2. The deferment with Term of Guard and Responsibility must be registered in Siscomex with the following text:
“PRODUCT EXPORTED RETURNED TO THE NATIONAL TERRITORY, UNDER THE GUARANTEE AND RESPONSIBILITY OF THE IMPORTER. RELEASE TO EXPOSURE OR DELIVERY TO CONSUMPTION SHALL BE PERFORMED THROUGH PRESENTATION OF LABORATORY REPORT OF THE CONCLUSIVE AND SATISFACTORY PRODUCT.”
4. When a laboratory analysis by the health authority is of unsatisfactory report, the national and international distribution map should be presented for the batch analyzed and proof of full return of the total exported.
5. “The cases omitted concerning the importation referred to in this Chapter shall be examined jointly by the General Management of Ports, Airports and Borders (GGPAF) and the competent technical department of ANVISA at its headquarters.” (NR)
Art.21 to amend Chapter XXXIV of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“RETURN OF GOOD OR EXPORTED PRODUCT FOR THE PURPOSE OF THE PROVISION OF SERVICE OR REPAIR OR AMENDMENT OR EXTERNAL RESTORATION”
1. The request for the release of the import of the goods and products referred to in this Chapter shall be submitted using the Petition for Sanitary Surveillance and Release provide
d for in Chapter II, sub-item 1.2, which shall be accompanied by the following documents:
a) invoice of purchase or declaration of ownership of the good or product, in which its technical specifications are described, such as trade name, brand, model and manufacturer, signed by the person responsible, physical or legal entity, in the latter case, by his legal representative; and
b) Export declaration or equivalent customs document proving the departure of the good or product.
2. The importation referred to in this Chapter shall be exempt from an authorization to embark abroad. “(NR)
Art.22 To amend item 2 of Chapter XXXVII of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“2. Imports with a declared purpose by the importer, not subject to ANVISA sanitary intervention, whose tariff classification – NCM / SH – is included in the listing and procedures provided for in Chapter XXXIX of this Resolution, shall be subject to ANVISA”s inspection, through Submission 1.2 for Chapter II, as outlined by the Statement of Responsibility described in Chapter XXXVIII of this Resolution. “
2.1. The Term of Responsibility referred to in item 2 of this Chapter shall be subscribed by the legal representative and/or technical responsible of the Importer and must describe the purpose and use of the imported product.
2.2. The goods or products not subject to ANVISA sanitary/health intervention referred to in item 2 of this Chapter, will not be considered as an incidence hypothesis for the collection, at importation, of the Sanitary Surveillance Inspection Fee with ANVISA.
2.3. Substances included in Lists of Ordinances SVS / MS No. 344 of May 12, 1998, and their updates, with exemption from control provided for in that same Ordinance, when used exclusively for legitimate industrial purposes, other than therapeutic or medicinal products, are not subject to the sanitary/health intervention of ANVISA.
2.4. The approval of the Import Licensing shall take place after satisfactory analysis of the information required in this Resolution, with the following text being registered in the field related to the import licensing situation in SISCOMEX:
“GOOD OR IMPORTED PRODUCT WITH PURPOSE NOT SUBJECT TO ANVISA”S HEALTH INTERVENTION, AS TERMS OF LIABILITY PRESENTED BY THE IMPORTER.” (NR)
Art. 23 To amend the title of Section I of Chapter XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
SECTION I
PROCEDURE
1 – GOODS AND PRODUCTS SUBJECT TO THE SPECIAL CONTROL OF THE PORTFOLIO SVS / MS No. 344, OF 1998 AND ITS UPDATES, IN ITS LISTS “A1”, “A2”, “A3”, “B1”, “B2″, ” C3 “E” D1 “(NR)
Article 24 To amend Chapter XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, giving new wording to the provisions of item 16 of Section III, item 18 of Section IV, item 22 of Section V, item 31 of Section VII, item 39 of Section IX, item 42 of Section IX, item 45 of Section IX, item 49 of Section IX, item 52 of Section IX, item 55 of Section IX, item 59 of Section X and item 65 of Section XI, read as follows: “The import process shall be accompanied by the following documents:” (NR)
Article 25 To amend items 25 and 26 of Section VI of CHAPTER XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall be in force with the following wording:
“25. The importation of biological products obtained by biotechnological procedures, monoclonal antibodies, medicaments containing live, attenuated or killed microorganisms and probiotics in the form of raw material, semi-finished product, bulk product or finished product shall be subject to the Licensing Import into SISCOMEX, subject to inspection by the sanitary/health authority before its customs clearance.
26. The import process must be accompanied by the following documents:
a) Petition for Sanitary Inspection and Release referred to in sub-item 1.2. of Chapter II of this Resolution;
b) Commercial Invoice – “Invoice”;
c) Knowledge of Shipped Cargo;
d) summary protocol for the production of the product (according to OMS standard protocol, if the product is included therein);
e) certificate of analysis of the quality control of the raw material (active principle) issued by the manufacturer;
f) certificate of analysis of the quality control of the finished product, issued by the manufacturer;
g) certificate of release of the product batch, issued by the health authority of the country of origin, when applicable; and
h) the following technical documents of the blood product used as stabilizer, when applicable: declaration of origin of the plasma used; certificate of analysis of the quality control of the plasma used; and certificate of release of the serology of the plasma used. “(NR)
Art. 26 To amend the title of Section VII of CHAPTER XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
SECTION VII
PROCEDURE
3 – PRODUCTS SUBJECT TO SPECIAL CONTROL WHICH ISSUES PORTFOLIO SVS / MS No. 344 OF 1998 AND ITS UPDATES, IN ITS LISTS “C1”, “C2” AND “C5” “(NR)
Article 27 To amend item 29 of Section VII of CHAPTER XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“29. The importation of products subject to the special control referred to in Portaria SVS / MS No. 344, dated May 12, 1998, and its updates, in the form of raw material, semi-finished product or finished product, shall be subject to registration of Import Licensing in SISCOMEX, submitting for inspection by the sanitary authority before its customs clearance. ” (NR)
Art. 28 To amend item 33 of Section VIII of CHAPTER XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“33. The importation of health products, in the form of raw material, semi-finished product, bulk product or finished product, shall be subject to registration of Import Licensing in SISCOMEX, subject to inspection by the health authority before its clearance of customs. ” (NR)
Art.29 To amend section 36 of Section VIII of CHAPTER XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“36. The import process shall be accompanied by the following documents:
a) Petition for Sanitary Inspection and Release referred to in sub-item 1.2. of Chapter II of this Resolution;
b) Commercial Invoice – “Invoice”;
c) Knowledge of Shipped Cargo;
d) Proof of sterility of the product, for sterile products; and
e) Declaration of the holder of the regularization authorizing the importation by third party. “(NR)
Art.30 To amend section 57 of Section X of CHAPTER XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of 2008, which shall become effective with the following wording:
“57. The importation of raw material, semi-processed product, bulk product or finished product, of any product classes, according to the product framework available on the ANVISA Portal, shall be subject to registration of Import Licensing in SISCOMEX, subject to inspection by the health authority prior to customs clearance. “(NR)
Art.31 To amend paragraph 2 of art. 6 of the Resolution of the Collegiate Board of Directors – RDC No. 204, of July 6, 2005, which shall become effective with the following wording:
“Paragraph 2- The period referred to in the heading of this article shall be 30 (thirty) days, non-extendable, counted from the date of registration of the requirement in computerized systems for petitions related to i
mport procedures.” (NR)
Art. 32 To amend Art. 17 of the Resolution of the Collegiate Board of Directors – RDC No. 58, of December 17, 2010, which shall become effective with the following wording:
“Art. 17 It is the responsibility of the holder of the registration or authorized importer to collect and send the samples to the National Institute for Quality Control in Health (INCQS).” (NR)
Art. 33 To amend the heading and §(Paragraph) 2 of Art. 18 of the Resolution of the Collegiate Board of Directors – RDC No. 58, 2010, which shall become effective with the following wording:
“Article 18. After the customs clearance by the health authority, all lots will be submitted to the quality control analysis for the specific activity, chemical, serological and documentary tests.
Paragraph 2 – Blood products for human use are subject to physical inspection at the discretion of the sanitary/health authority, prior to customs clearance. “(NR)
Art. 34 The following provisions of the Resolution of the Collegiate Board of Directors – RDC No. 81, of November 5, 2008, are revoked: item 3.4 of Subsection II of Section I of Chapter III; item 5.4 of Section IV of Chapter XVIII; sub-items 2.1 and 2.1.1 of Chapter XXIV; Chapter XXIX; item 2, sub-items 6.2 and 10.2 of Chapter XXX; Chapter XXXV; item 11, sub-items 11.1 and 11.2 of Chapter XXXVII.
Single paragraph. The following provisions of Chapter XXXIX of the Resolution of the Collegiate Board of Directors – RDC No. 81, of November 5, 2008, are revoked: item 3, items 4, 5, 4, 4, 4, sub-items 4.1, 4.2 and item 5 of the Section I; items b, c, h, j, l of item 10, sub-items 10.1, 10.2 and item 11 of Section II; points b, c, f, i, j of item 16 of Section III; items 13, sub-items 13.1, 13.2, 13.3 and item 14 of Section III; item 17, items b, c, f, i, j, l of item 18, sub-items 18.1, 18.2, 18.3 and item 19 of Section IV; items b, c, f, h, i of item 22, sub-items 22.1, 22.2, 22.3 and item 23 of Section V; sub-items 25.1, 25.2, 25.3, 26.1, 26.2, 26.3 and item 27 of Section VI; item 30, sub-item 30.1, items b, c, d, g, i, j, l of item 31, sub-items 31.1, 31.2, 31.3 and item 32 of section VII; item 34, sub-item 34.1, item 35, sub-items 35.1, 35.2, 35.3, 36.1, 36.2, 36.3 and item 37 of Section VIII; paragraphs b, c, f, g, h, l, m of item 39, sub-items 39.1, 39.2, 39.3 and item 40 of subsection I of Section IX; paragraphs b, c, f, g, i and j of item 42, sub-items 42.1, 42.2, 42.3 and item 43 of subsection II of Section IX; paragraphs b, c, f, h, j and l of item 45, sub-items 45.1, 45.2, 45.3 and item 46 of subsection III of Section IX; points b, c, f, g, i, j of item 49; sub-items 49.1, 49.2, 49.3, item 50 of Subsection IV of Section IX; paragraphs b, c, f, g, j and l of item 52, sub-items 52.1, 52.2, 52.3 and sub-item 53 of subsection V of section IX; Paragraphs a, b, c, e, f of sub-item 54.1, items b, c, f, g, h, i of item 55, sub-items 55.1, 55.2, item 56 of subsection VI of Section IX; item 58, sub-items 58.1 and 58.2, items b, c, f, g, h, j, l of item 59, sub-items 59.1, 59.2 and 59.3, item 60 of Section X; items b, c, f, j, l of item 65, sub items 65.1, 65.2, 65.3 and item 66 of Section XI.
Art. 35 Art. 4 and Annex II of the Resolution of the Collegiate Board of Directors – RDC No. 46, of May 18, 2000.
Art. 36 The Arts. 19, 22 and 23 of the Resolution of the Collegiate Board of Directors – RDC
No. 58, of December 17, 2010.
Art. 37 The sole paragraph of art. 1, art. 4th, art. 5 and art. 6 of the Resolution of the Collegiate Board of Directors – RDC No. 68, March 28, 2003.
Art. 38 This Resolution shall enter into force on the date of its publication.
JARBAS BARBOSA DA SILVA JR.