0A4F4F9BD490A749D5437F821CF06DF1
Law Nº 9782/99 Defining the National Health Surveillance System
http://www.planalto.gov.br/ccivil_03/leis/L9782.htm
http://leaux.net/URLS/ConvertAPI Text Files/41423001C2801A088B6CBAA6892CC7A9.en.txt
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This file was generated: 2020-07-15 04:00:36
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
Searching for indicator criminal:
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p.000150: reappointment, pursuant to Law No. 9,986, of July 18, 2000. (Wording given by Law No. 13,848, of 2019)
p.000150: Single paragraph. The members of the Collegiate Board will be Brazilian, appointed by the President of the Republic and appointed by him, after prior approval by the Federal Senate,
p.000150: terms of item “f” of item III of art. 52 of the Federal Constitution, to fulfill a mandate of 5 (five) years, observing the provisions of Law No. 9,986, of July 18, 2000. (Editorial Staff
p.000150: given by Law No. 13,848, of 2019)
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic, from among the members of the Collegiate Board, and invested in the function for three years, or for the remainder of his term.
p.000150: mandate, a single reappointment is allowed for three years.
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic and invested in the function for 5 (five) years, renewal is prohibited, subject to the provisions of Law no.
p.000150: 9,986, of July 18, 2000. (Wording provided by Law No. 13,848, of 2019)
p.000150: Art. 12. The unreasonable dismissal of a Director of the Agency can only be promoted in the initial four months of the mandate, at the end of which his full and full exercise will be ensured, except in
p.000150: cases of practice of administrative misconduct, unappealable criminal conviction and unjustified non-compliance with the autarchy management contract. (Repealed by Law No. 13,848, of
p.000150: 2019) Term
p.000150: Art. 13. The directors of the Agency are prohibited from exercising any other professional, business, union or political party activity.
p.000150: Paragraph 1. It is also forbidden for managers to have a direct or indirect interest in a company related to the area of activity of the Health Surveillance, provided for in this Law, as provided in the regulation.
p.000150: § 2 The prohibition referred to in the caput of this article does not apply to cases in which the professional activity arises from a contractual relationship maintained with public entities destined to teaching and research,
p.000150: including those governed by private law.
p.000150: § 3 In the event of non-compliance with the obligation provided for in the caput and in § 1 of this article, the infringer will lose his position, without prejudice to responding to the applicable civil and criminal actions.
p.000150: Art. 14. Up to one year after leaving office, the former director is prohibited from representing any person or interest before the Agency.
p.000150: Single paragraph. During the term established in the caput, the former officer is also prohibited from using privileged information obtained as a result of the position held, under penalty of
p.000150: incur an act of administrative improbity.
p.000150: Art. 15. The Collegiate Board of Directors is responsible for:
p.000150: Art. 15. The Collegiate Board of Directors is responsible for: (See Provisional Measure nº 2.000-16, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: I - exercise the administration of the Agency;
p.000150: I - define the Agency's strategic guidelines; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: II - propose to the Minister of State for Health the governmental policies and guidelines aimed at enabling the Agency to fulfill its objectives;
p.000150: II - propose to the Minister of State for Health the governmental policies and guidelines aimed at enabling the Agency to fulfill its objectives; (See Provisional Measure No. 2000-16, 2000)
p.000150: (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: III - edit rules on matters within the Agency's competence;
p.000150: III - edit rules on matters within the Agency's competence; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: III - edit rules on matters within the Agency's competence, which must be accompanied by technical justifications and, whenever possible, studies of economic and technical impact in the regulated sector
...
Political / political affiliation
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p.000150: terms of item “f” of item III of art. 52 of the Federal Constitution, to fulfill a mandate of 5 (five) years, observing the provisions of Law No. 9,986, of July 18, 2000. (Editorial Staff
p.000150: given by Law No. 13,848, of 2019)
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic, from among the members of the Collegiate Board, and invested in the function for three years, or for the remainder of his term.
p.000150: mandate, a single reappointment is allowed for three years.
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic and invested in the function for 5 (five) years, renewal is prohibited, subject to the provisions of Law no.
p.000150: 9,986, of July 18, 2000. (Wording provided by Law No. 13,848, of 2019)
p.000150: Art. 12. The unreasonable dismissal of a Director of the Agency can only be promoted in the initial four months of the mandate, at the end of which his full and full exercise will be ensured, except in
p.000150: cases of practice of administrative misconduct, unappealable criminal conviction and unjustified non-compliance with the autarchy management contract. (Repealed by Law No. 13,848, of
p.000150: 2019) Term
p.000150: Art. 13. The directors of the Agency are prohibited from exercising any other professional, business, union or political party activity.
p.000150: Paragraph 1. It is also forbidden for managers to have a direct or indirect interest in a company related to the area of activity of the Health Surveillance, provided for in this Law, as provided in the regulation.
p.000150: § 2 The prohibition referred to in the caput of this article does not apply to cases in which the professional activity arises from a contractual relationship maintained with public entities destined to teaching and research,
p.000150: including those governed by private law.
p.000150: § 3 In the event of non-compliance with the obligation provided for in the caput and in § 1 of this article, the infringer will lose his position, without prejudice to responding to the applicable civil and criminal actions.
p.000150: Art. 14. Up to one year after leaving office, the former director is prohibited from representing any person or interest before the Agency.
p.000150: Single paragraph. During the term established in the caput, the former officer is also prohibited from using privileged information obtained as a result of the position held, under penalty of
p.000150: incur an act of administrative improbity.
p.000150: Art. 15. The Collegiate Board of Directors is responsible for:
p.000150: Art. 15. The Collegiate Board of Directors is responsible for: (See Provisional Measure nº 2.000-16, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: I - exercise the administration of the Agency;
p.000150: I - define the Agency's strategic guidelines; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
...
Searching for indicator political:
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p.000150: terms of item “f” of item III of art. 52 of the Federal Constitution, to fulfill a mandate of 5 (five) years, observing the provisions of Law No. 9,986, of July 18, 2000. (Editorial Staff
p.000150: given by Law No. 13,848, of 2019)
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic, from among the members of the Collegiate Board, and invested in the function for three years, or for the remainder of his term.
p.000150: mandate, a single reappointment is allowed for three years.
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic and invested in the function for 5 (five) years, renewal is prohibited, subject to the provisions of Law no.
p.000150: 9,986, of July 18, 2000. (Wording provided by Law No. 13,848, of 2019)
p.000150: Art. 12. The unreasonable dismissal of a Director of the Agency can only be promoted in the initial four months of the mandate, at the end of which his full and full exercise will be ensured, except in
p.000150: cases of practice of administrative misconduct, unappealable criminal conviction and unjustified non-compliance with the autarchy management contract. (Repealed by Law No. 13,848, of
p.000150: 2019) Term
p.000150: Art. 13. The directors of the Agency are prohibited from exercising any other professional, business, union or political party activity.
p.000150: Paragraph 1. It is also forbidden for managers to have a direct or indirect interest in a company related to the area of activity of the Health Surveillance, provided for in this Law, as provided in the regulation.
p.000150: § 2 The prohibition referred to in the caput of this article does not apply to cases in which the professional activity arises from a contractual relationship maintained with public entities destined to teaching and research,
p.000150: including those governed by private law.
p.000150: § 3 In the event of non-compliance with the obligation provided for in the caput and in § 1 of this article, the infringer will lose his position, without prejudice to responding to the applicable civil and criminal actions.
p.000150: Art. 14. Up to one year after leaving office, the former director is prohibited from representing any person or interest before the Agency.
p.000150: Single paragraph. During the term established in the caput, the former officer is also prohibited from using privileged information obtained as a result of the position held, under penalty of
p.000150: incur an act of administrative improbity.
p.000150: Art. 15. The Collegiate Board of Directors is responsible for:
p.000150: Art. 15. The Collegiate Board of Directors is responsible for: (See Provisional Measure nº 2.000-16, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: I - exercise the administration of the Agency;
p.000150: I - define the Agency's strategic guidelines; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
...
Health / Drug Usage
Searching for indicator drug:
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p.000150: to the population, within the period and under the conditions indicated by the health authority, subject to the payment of a fee corresponding to the examination and the prior consent of the information content by the National Health Agency.
p.000150: Health Surveillance. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 42. Art. 57 of Decree-Law No. 986, of 21 October 1969, becomes effective with the following wording:
p.000150: "Art. 57. The import of food, food additives and substances intended to be used in the manufacture of articles, utensils and equipment intended to enter
p.000150: in contact with food, is subject to the provisions of this Decree-law and its Regulations, and the control analysis is carried out by sampling, at the discretion of the health authority,
p.000150: at the time of landing in the country. "(NR)
p.000150: Art. 43. The Agency may seize goods, equipment, products and utensils used to commit crimes against public health, and to promote the respective judicial alienation, observed, with regard to
p.000150: applicable, the provisions of art. 34 of Law 6,368, of October 21, 1976, as well as requesting, in court, the blocking of bank accounts owned by the company and its owners and managers,
p.000150: responsible for those crimes.
p.000150: Art. 44. Arts. 20 and 21 of Law 6,360, of September 23, 1976, are effective with the following wording:
p.000150: "Art. 20. ............................................. .......................... "
p.000150: "Sole paragraph. A drug that does not have a substance that is known to be clinically or therapeutically beneficial cannot be registered." (NR)
p.000150: "Art. 21. The right to register medicines similar to others already registered is guaranteed, as long as they satisfy the requirements established in this Law." (NR)
p.000150: "§ 1 The similar drugs to be manufactured in the country, are considered registered after the end of one hundred and twenty days, counted from the presentation of the respective
p.000150: application, if it has not been rejected by then.
p.000150: Paragraph 2. The counting of the registration period will be interrupted until the satisfaction, by the interested company, of the requirement of the sanitary authority, which cannot exceed one hundred and
p.000150: eighty days.
p.000150: § 3 The registration, granted under the conditions of the preceding paragraphs, will lose its validity, regardless of notification or notification, if the product is not marketed
p.000150: within one year after the grant date, extendable for another six months, at the discretion of the health authority, upon written justification of the company's initiative
p.000150: interested.
p.000150: § 4 The request for a new product registration may be made two years after the verification of the fact that caused the loss of the validity of the previously granted, unless it is not
p.000150: attributable to the interested company.
p.000150: Paragraph 5. The provisions of this article apply to products registered and manufactured in a State which is part of the Southern Common Market - MERCOSUR, for the purpose of their
p.000150: commercialization in the country, if they correspond to a national similar already registered. "
p.000150: Art. 45. This Law comes into force on the date of its publication.
p.000150: Art. 46. Art. 58 of Decree-Law No. 986, of October 21, 1969.
p.000150: National Congress, on January 26, 1999; 178 th of Independence and 111 th of the Republic.
p.000150: ANTONIO CARLOS MAGALHÃES
p.000150: President
p.000150: This text does not replace the one published in the DOU of 27.1.1999
p.000150: ANNEX I
p.000150: (See Provisional Measure nº 1,912-7, of 1999) (See Provisional Measure nº 2,134-28, of 2001)
p.000150: (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: DEMONSTRATIVE FRAMEWORK FOR POSTS IN COMMISSION AND
p.000150: COMMISSIONED FUNCTIONS OF HEALTH SURVEILLANCE
p.000150: POSITIONS / NAME NE /
p.000150: FUNCTION UNIT CARGO / FUNCTION OF /
p.000150: FG No.
p.000150: BOARD 5 Director NE
p.000150: 5 Special Advisor 102.5
p.000150: 3 Auxiliary 102.1
p.000150: CABINET 1 Chief of Staff 101.4
p.000150: 1 Attorney 101.5
p.000150: 1 Corregidor 101.4
p.000150: 1 Ombudsman 101.4
p.000150: 1 Auditor 101.4
p.000150: 17 General Manager 101.5
p.000150: 38 Manager 101.4
p.000150: DEMONSTRATIVE FRAMEWORK OF COMMISSIONED FUNCTIONS OF SANITARY SURVEILLANCE OF THE NATIONAL SANITARY SURVEILLANCE AGENCY
p.000150: CODE / FCVS QTY. VALUE
p.000150: FCVS-V 42 1,170.00
p.000150: FCVS-IV 58 855.00
p.000150: FCVS-III 47 515.00
p.000150: FCVS-II 58 454.00
p.000150: FCVS-I 69 402.00
p.000150: TOTAL 274 177,005.00
p.000150: ANNEX II
p.000150: HEALTH SURVEILLANCE SURVEILLANCE RATE
p.000150: Taxable Facts Values in R $ Deadlines for Renewal
p.000150: 1. Authorization to operate a company, for each type of activity
p.000150: 1.1. Over the 40,000 annual drug industry
p.000150: 1.2. On equipment and correlates 20,000 annually
p.000150: 1.3. Medicine, drugstore and pharmacy distributors 15,000 annually
p.000150: 1.3. Other 10,000 annual
p.000150: 2. Change or increase in authorization (type of activity, data 6,600 undetermined
p.000150: cadastral,
p.000150: Business merger or incorporation)
p.000150: 3. Replacement of legal representative, resp. technical or cancellation of
p.000150: authorization
p.000150: Indeterminate exemption
p.000150: 4. Certification of good manufacturing and control practices for each
p.000150: establishment or plant, type of activity and production line /
p.000150: commercialization
p.000150: 4.1. In the Country and Mercosur
p.000150: 4.1.1. Medicines 30,000 annually
p.000150: 4.1.2. Equipment and related 12,000 annually
p.000150: 4.1.3. Other 4,000 per year
p.000150: 4.2. Other countries 37,000 annually
p.000150: 5. Registration of
p.000150: 5.1. Cosmetics 3,700 three years
p.000150: 5.2. Sanitizing 11,700 three years
p.000150: 5.3.1. Equipment, Apparatus and Instruments 65,000 three years
p.000150: 5.3.2. Others (diagnostic kits and blood bags) 16,300 three years
p.000150: 5.4. Medicines
p.000150: 5.4.1. New 80,000 five years
p.000150: 5.4.2. Similar 35,000 five years
p.000150: 5.4.3. Generic 10,600 five years
p.000150: 5.5. Food and Beverage 10,000 five years
p.000150: 5.6. Tobacco and Similar 100,000 annually
p.000150: 6. Addition or Modification to the Registry
p.000150: 6.1. Presentation 1,800 undetermined
p.000150: 6.2. Concentration and Pharmaceutical Form 4,500 undetermined
p.000150: 6.3. Label text, use form and labeling 2,200 undetermined
p.000150: 6.4. Expiry or cancellation period Undetermined
p.000150: 6.5. Any other 8,100 undetermined
p.000150: 7. Exemption from indeterminate 2,200 registration
p.000150: 8. Certificate, certificate, toxicological classification, extension of use, quota of
...
p.000300: Values Term for
p.000300: Items
p.000300: GENERATING FACTS in R $
p.000300: Renovation
p.000300: 1 X X X
p.000300: 1.1 Registration of food, food additives, beverages, bottled water and packaging
p.000300: 6,000 Five years
p.000300: recycled
p.000300: 1.2 Alteration, inclusion or exemption of food registration 1,800 ---
p.000300: 1.3 Revalidation or renewal of food registration 6,000 Five years
p.000300: 1.4 Certification of Good Manufacturing Practices for each establishment or plant,
p.000300: X See Law No. 11,972, of 2009
p.000300: by food production line
p.000300: 1.4.1 In the Country and MERCOSUR X X
p.000300: 1.4.1.1 Certification of Good Manufacturing and Control Practices for each establishment or
p.000300: manufacturing unit, by type of activity and production or marketing line for industries 15,000 Annual
p.000300: of food
p.000300: 1.4.2 Other countries 37,000 Annual
p.000300: 2 X X X
p.000300: 2.1 Cosmetics registration 2,500 Five years
p.000300: 2.2 Alteration, inclusion or exemption from registration of cosmetics 1,800 ---
p.000300: 2.3 Revalidation or renewal of cosmetics registration 2,500 Five years
p.000300: 2.4 Certification of Good Manufacturing Practices for each establishment or plant,
p.000300: X See Law No. 11,972, of 2009
p.000300: by cosmetics production line
p.000300: 2.4.1 In the Country and MERCOSUR X X
p.000300: 2.4.1.1 Certification of Good Manufacturing Practices for each establishment or plant
p.000300: 15,000 Annual
p.000300: by production line for cosmetics, hygiene products and perfumes
p.000300: 2.4.2 Other countries 37,000 Annual
p.000300: 3 X
p.000300: X X
p.000300: 3.1 Authorization and special authorization for the operation of the company, as well as the
p.000300: respective renewals ---
p.000300: ---
p.000300: (See Law No. 13,043, of 2014)
p.000300: 3.1.1 Drug industry ---
p.000300: 20,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: 3.1.2 Pharmaceutical input industry ---
p.000300: 20,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: 3.1.3 Distributor, importer, exporter, carrier, warehousing, packer and
p.000300: Yearly
p.000300: repackaging and others provided for in specific legislation on drugs and supplies 15,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: pharmacists
p.000300: Yearly
p.000300: 3.1.4 Fractionation of pharmaceutical inputs 15,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: Yearly
p.000300: 3.1.5 Drugstores and pharmacies 500
p.000300: (See Law No. 13,043, of 2014)
p.000300: 3.1.6 Cosmetics, hygiene products and perfumes industry ---
p.000300: 6,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: Distributor, importer, exporter, carrier, storage, packaging, and
p.000300: ---
p.000300: 3.1.7 repackaging and others provided for in specific legislation on cosmetics, hygiene products 6,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: and perfumes
p.000300: 3.1.8 Sanitizing industry ---
p.000300: 6,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: Distributor, importer, exporter, carrier, storage, packaging, and
p.000300: repacking and others provided for in specific sanitizing legislation ---
p.000300: 3.1.9 6,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: 3.2 Authorization and special authorization to operate an annual handling pharmacy
p.000300: 5,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: 4 X X X
p.000300: 4.1 Registration, revalidation and renewal of registration of medicines X X
p.000300: 4.1.1 New product 80,000 Five years
p.000300: 4.1.2 Similar product 21,000 Five years
p.000300: 4.1.3 Generic product 6,000 Five years
p.000300: 4.1.4 New association in the country 21,000 ---
p.000300: 4.1.5 Monodroga approved in association 21.000 ---
p.000300: 4.1.6 New route of drug administration in the country 21,000 ---
p.000300: 4.1.7 New concentration in the country 21,000 ---
p.000300: 4.1.8 New pharmaceutical form in the country 21,000 ---
p.000300: 4.1.9 Herbal medicines X X
p.000300: 4.1.9.1 New product 6,000 Five years
p.000300: 4.1.9.2 Similar product 6,000 Five years
p.000300: 4.1.9.3 Traditional product 6,000 Five years
p.000300: 4.1.10 Homeopathic medicines X X
p.000300: 4.1.10.1 New product 6,000 Five years
p.000300: 4.1.10.2 Similar product 6,000 Five years
p.000300: 4.1.11 New packaging in the country 1,800 ---
p.000300: 4.2 Alteration, inclusion or exemption from medication registration 1,800 ---
p.000300: 4.3 Certification of Good Manufacturing Practices for each establishment or plant,
p.000300: X See Law No. 11,972, of 2009
p.000300: by drug production line
p.000300: 4.3.1 In the Country and MERCOSUR X X
p.000300: 4.3.2 Certification of Good Manufacturing Practices for medicines and pharmaceutical supplies 15,000 Annual
p.000300: 4.3.3 Other countries 37,000 Annual
p.000300: 4.3.4 Certification of Good Distribution and Storage Practices for medicines and supplies
p.000300: 15,000 Annual
p.000300: pharmacists by establishment
p.000300: 5 X
p.000300: X X
p.000300: 5.1 Operating Authorization X X (See Law No. 13.043, 2014)
p.000300: 5.1.1 Authorization for the operation of companies providing storage and
p.000300: Yearly
p.000300: distribution of medicines, raw materials and pharmaceutical supplies in terminals 15,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: bonded goods for public use
p.000300: 5.1.2 Authorization to operate companies providing storage and storage services
p.000300: Yearly
p.000300: distribution of substances and drugs under special control in terminals 15,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: bonded goods for public use
p.000300: 5.1.3 Authorization for the operation of companies providing storage and
p.000300: Yearly
p.000300: distribution of cosmetics, hygiene products or perfumes and raw materials in 6,000 terminals
p.000300: (See Law No. 13,043, of 2014)
p.000300: bonded goods for public use
p.000300: 5.1.4 Authorization for the operation of companies providing storage and
p.000300: Yearly
p.000300: distribution of sanitizing products and raw materials in 6,000 terminals
p.000300: (See Law No. 13,043, of 2014)
p.000300: bonded goods for public use
p.000300: 5.1.5 Authorization to operate companies providing storage and storage services
p.000300: Yearly
p.000300: distribution of medical and hospital materials and equipment and diagnostic products of 6,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: "in vitro" (related) use in bonded terminals for public use
...
p.000300: a) fifteen percent, in the case of companies with annual sales of R $ or less
p.000300: 50,000,000.00 (fifty million reais) and more than R $ 20,000,000.00 (twenty million reais);
p.000300: b) thirty percent, in the case of companies with annual sales of R $ or less
p.000300: 20,000,000.00 (twenty million reais) and more than R $ 6,000,000.00 (six million reais);
p.000300: c) sixty percent, in the case of companies with annual sales equal to or less than R $
p.000300: 6,000,000.00 (six million reais);
p.000300: d) ninety percent, in the case of small companies;
p.000300: e) ninety-five percent, in the case of micro-enterprises, except for items 3.1, whose values,
p.000300: in the case of micro-enterprises, they are reduced by ninety percent.
p.000300: 2. In items 3.1.1, 3.1.2, 3.1.6, 3.1.8 and 7.1.1, the manufacturing process includes the activities necessary for the
p.000300: obtaining the products mentioned in these items.
p.000300: 3. In items 3.1.3, 3.1.7, 3.1.9 and 7.1.2, the distribution of medicines, cosmetics, hygiene products, perfume and
p.000300: household sanitizing includes storage and shipping activities.
p.000300: 4. For small and micro-enterprises, the fee for granting Certification of Good Manufacturing and Control Practices
p.000300: will be charged for each establishment or plant.
p.000300: 5. Until December 31, 2001, microenterprises will be exempt from the fee for the granting of Good Certificates.
p.000300: Manufacturing and Control Practices, Registration or Renewal of Registration of Products or Group of Products, as well as of
p.000300: rates related to the assumptions provided for in items 5.2.1 and 5.10.1, and this exemption may be extended until December 31,
p.000300: 2003, by decision of the ANVISA Collegiate Board.
p.000300: 6. For the purposes of Registration or Renewal of Registration, a drug containing a new molecule will be considered new
p.000300: and have patent protection.
p.000300: 7. The fee for Registration or Renewal of Registration of medications or a group of phototherapy drugs,
p.000300: Homeopathic, Large Volume Parenteral Solutions and Small Volume Parenteral Solutions will be that of the item
p.000300: 4.1.3. Generics.
p.000300: 8. The values of the Table for Renewal of Product Registration or Product Group will be reduced by ten percent
p.000300: in renovation.
p.000300: 9. The classification as a small and micro enterprise, for the purposes foreseen in item 1, will take place in
p.000300: in accordance with Law 9.841, of October 5, 1999.
p.000300: 10. It is exempt to collect fees for issuing certificates, certificates and other declaratory acts, unarchiving
p.000300: process and duplicate of document, when dealing with export-oriented activity.
p.000300: 11. It is exempt to collect a fee for adding or changing the registration, regarding the text of the package insert, use form
p.000300: and labeling, telephone number change, CGC / CNPJ number, or other legal information, as provided by the
p.000300: ANVISA Collegiate Board.
p.000300: 12. The reduction values provided for in item 1 do not apply to items 3.1.5 and 5.1.13 of the Table, and to companies
p.000300: located in countries other than MERCOSUR members.
p.000300: 13. To companies that perform express delivery activities (courier) and that are framed in the letters "a", "b" and "c"
p.000300: of item 1 of the Notes, regardless of invoicing, the single import consent fee for goods
p.000300: of items 5.3, 5.4, 5.6, 5.7 and 5.8 of this Annex, in the amount of R $ 40.00.
...
Searching for indicator substance:
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p.000150: to the population, within the period and under the conditions indicated by the health authority, subject to the payment of a fee corresponding to the examination and the prior consent of the information content by the National Health Agency.
p.000150: Health Surveillance. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 42. Art. 57 of Decree-Law No. 986, of 21 October 1969, becomes effective with the following wording:
p.000150: "Art. 57. The import of food, food additives and substances intended to be used in the manufacture of articles, utensils and equipment intended to enter
p.000150: in contact with food, is subject to the provisions of this Decree-law and its Regulations, and the control analysis is carried out by sampling, at the discretion of the health authority,
p.000150: at the time of landing in the country. "(NR)
p.000150: Art. 43. The Agency may seize goods, equipment, products and utensils used to commit crimes against public health, and to promote the respective judicial alienation, observed, with regard to
p.000150: applicable, the provisions of art. 34 of Law 6,368, of October 21, 1976, as well as requesting, in court, the blocking of bank accounts owned by the company and its owners and managers,
p.000150: responsible for those crimes.
p.000150: Art. 44. Arts. 20 and 21 of Law 6,360, of September 23, 1976, are effective with the following wording:
p.000150: "Art. 20. ............................................. .......................... "
p.000150: "Sole paragraph. A drug that does not have a substance that is known to be clinically or therapeutically beneficial cannot be registered." (NR)
p.000150: "Art. 21. The right to register medicines similar to others already registered is guaranteed, as long as they satisfy the requirements established in this Law." (NR)
p.000150: "§ 1 The similar drugs to be manufactured in the country, are considered registered after the end of one hundred and twenty days, counted from the presentation of the respective
p.000150: application, if it has not been rejected by then.
p.000150: Paragraph 2. The counting of the registration period will be interrupted until the satisfaction, by the interested company, of the requirement of the sanitary authority, which cannot exceed one hundred and
p.000150: eighty days.
p.000150: § 3 The registration, granted under the conditions of the preceding paragraphs, will lose its validity, regardless of notification or notification, if the product is not marketed
p.000150: within one year after the grant date, extendable for another six months, at the discretion of the health authority, upon written justification of the company's initiative
p.000150: interested.
p.000150: § 4 The request for a new product registration may be made two years after the verification of the fact that caused the loss of the validity of the previously granted, unless it is not
p.000150: attributable to the interested company.
p.000150: Paragraph 5. The provisions of this article apply to products registered and manufactured in a State which is part of the Southern Common Market - MERCOSUR, for the purpose of their
p.000150: commercialization in the country, if they correspond to a national similar already registered. "
p.000150: Art. 45. This Law comes into force on the date of its publication.
p.000150: Art. 46. Art. 58 of Decree-Law No. 986, of October 21, 1969.
...
Health / Motherhood/Family
Searching for indicator family:
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p.000150: mentioned in art. 8 of this Law.
p.000150: § 3 The fee will be due in accordance with the respective taxable event, amount and term referred to in the table that constitutes Annex II of this Law.
p.000150: § 4 The fee must be paid within the deadlines set out in the Agency's own regulation. (See Provisional Measure 2,134-31, of 2001)
p.000150: § 4 The fee must be paid in accordance with ANVISA's specific act. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 5 The collection and collection of the fee referred to in this article may be delegated to the States, the Federal District and the Municipalities, at the discretion of the Agency, in cases where they are being
p.000150: surveillance actions were carried out, respecting the provisions of § 1 of art. 7 of this Law.
p.000150: § 6 The laboratories instituted or controlled by the Public Power, producers of medicines and supplies subject to Law 6,360, of September 23, 1976, in view of the public health interest, are
p.000150: exempt from payment of the Health Surveillance Inspection Fee. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 7 To the renewals of registrations, authorizations and certificates, the periodicity and the values stipulated for the initial acts are applied in the manner provided for in the Annex. (Included by Provisional Measure nº
p.000150: 2,190-34, 2001)
p.000150: § 8 The provisions of § 7 apply to those contained in §§ 1 to 8 of art. 12 and sole paragraph of art. 50 of Law 6,360, of 1976, in § 2 of art. 3 of Decree-Law No. 986, of October 21, 1969, and § 3 of
p.000150: art. 41 of this Law. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 9 The family farmer, defined according to Law 11.326, of July 24, 2006, and identified by the Declaration of Aptitude to PRONAF - DAP, Physical or Legal, as well as the Micro-entrepreneur
p.000150: Individual, provided for in art. 18-A of Complementary Law No. 123, of December 14, 2006, and the solidarity economy entrepreneur are exempt from paying a Surveillance Inspection Fee
p.000150: Sanitary. (Included by Law No. 13,001, 2014)
p.000150: § 10. The operating authorizations of companies provided for in the items of items 3.1, 3.2, 5.1 and 7.1 of Annex II, are exempt from renewal. (Included by Law No. 13,097, 2015)
p.000150: Art. 24. The fee not paid within the deadlines set in the regulation, in the form of the previous article, will be charged with the following additions:
p.000150: I - arrears interest, in the administrative or judicial channels, counted from the month following the month of maturity, at the rate of 1% per month, calculated in accordance with the legislation applicable to federal taxes;
p.000150: II - late payment penalty of 20%, reduced to 10% if payment is made until the last working day of the month following the month of its maturity;
p.000150: III - charges of 20%, substituting the conviction of the debtor in attorney's fees, calculated on the total debt registered as Active Debt, which will be reduced to 10%, if the payment is
p.000150: carried out before filing the execution.
p.000150: § 1 The interest on late payment does not affect the amount of the late payment penalty.
p.000150: § 2 The debts related to the Fee may be paid in installments, at the discretion of the National Health Surveillance Agency, in accordance with the criteria established in the tax legislation.
p.000150: Art. 25. The Sanitary Surveillance Inspection Fee will be due as from January 1, 1999.
...
p.000300: factory for each type of activity (See Law No. 13,043, 2014)
p.000300: 7.1.1 For the establishment that manufactures one or more health product lines ---
p.000300: 10,000
p.000300: (equipment, materials and products for diagnostic use "in vitro") (See Law nº 13.043, of 2014)
p.000300: 7.1.2 Distributor, importer, exporter, carrier, storehouse, packer, ---
p.000300: 8,000
p.000300: repackaging and others provided for in specific legislation on health products (See Law 13,043, 2014)
p.000300: 7.1.3 By establishment of retail trade of health products ---
p.000300: 5,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: 7.2 Certification of Good Manufacturing Practices for health products, for each
p.000300: --- See Law No. 11,972, of 2009
p.000300: establishment or plant per production line
p.000300: 7.2.1 In the country and MERCOSUR --- ---
p.000300: 7.2.1.1 Certification of Good Manufacturing Practices for Health Products 15,000 Annual
p.000300: 7.2.2 Other countries 37,000 Annual
p.000300: 7.3 Certification of Good Practices for Distribution and Storage of health products by Annual
p.000300: 15,000
p.000300: establishment See Law No. 11,972, of 2009
p.000300: 7.4 Modi fi cation or increase in certi fi cation by including a new type of product line
p.000300: 5,000 ---
p.000300: (equipment, materials and products for diagnostic use "in vitro")
p.000300: 7.5 Registration, revalidation or renewal of registration of health products X X
p.000300: 7.5.1 Large equipment for diagnosis or therapy, such as nuclear medicine,
p.000300: 20,000 Five years
p.000300: computed tomography, magnetic resonance and cineangiocoro-nariography.
p.000300: 7.5.2 Other medium and small sized equipment for diagnosis or therapy, articles,
p.000300: 8,000 Five years
p.000300: materials, products for in-use diagnostic use and other health products
p.000300: 7.5.3 Family of large equipment for diagnosis or therapy 28,000 Five years
p.000300: 7.5.4 Family of medium and small sized equipment for diagnosis or therapy, articles,
p.000300: 12,000 Five years
p.000300: materials, diagnostic reagents for "in vitro" use and other health products
p.000300: 7.6 Alteration, inclusion or exemption in the registration of health products 1,800 ---
p.000300: 7.7 Issuance of export certificate EXEMPT ---
p.000300: 8 X X X
p.000300: 8.1 Toxicological evaluation for product registration end X X
p.000300: 8.1.1 Technical product of active ingredient not registered in the country 1,800 ---
p.000300: 8.1.2 Technical product of active ingredient already registered in the Country 1,800 ---
p.000300: 8.1.3 Product formulated 1,800 ---
p.000300: 8.2 Toxicological assessment for component registration 1,800 ---
p.000300: 8.3 Toxicological evaluation for the purpose of Temporary Special Registration 1,800 ---
p.000300: 8.4 Toxicological reclassification 1,800 ---
p.000300: 8.5 Revaluation of product registration, according to Decree nº 991/93 1,800 ---
p.000300: 8.6 Toxicological assessment for the purpose of including culture 1,800 ---
p.000300: 8.7 Dose change X X
p.000300: 8.7.1 Dose change, for greater, in application 1.800 ---
p.000300: 8.8 Dose change, for a minor, in the EXEMPT application ---
p.000300: 9 X X X
p.000300: 9.1 Registration, revalidation or renewal of smoke registration
p.000300: Registration, revalidation or renewal of smoke registration, with the exception of products 100,000 Annual
p.000300: exclusively for export. (Wording given by Law No. 12,546, of 2011)
p.000300: 10 Consent to transmit advertising containing alerts to the population, within the deadline and under the conditions
p.000300: 10,000 ---
p.000300: indicated by the health authority
...
Health / Pregnant
Searching for indicator pregnant:
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p.000150: b) proceed with the examination of stocks, papers and writings of any companies or persons of public or private law that are engaged in the activities of production, distribution and commercialization of goods
p.000150: and services provided for in this item, maintaining legal confidentiality when applicable; (See Provisional Measure No. 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: c) when the existence of indications of the occurrence of infractions provided for in items III or IV of art. 20 of Law 8,884, of June 11, 1994, through an unjustified increase in prices or
p.000150: the imposition of excessive prices, for the goods and services referred to in these items, summon those responsible to, within a maximum period of ten working days, justify the respective conduct; (See Provisional Measure nº
p.000150: 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: d) apply the penalty provided for in art. 26 of Law No. 8,884, of 1994; (See Provisional Measure No. 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVI - to control, inspect and monitor, from the point of view of health legislation, the advertising and publicity of products subject to the health surveillance regime; (See Provisional Measure No. 2000-17,
p.000150: 2000) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVII - to define, in a specific act, the places of entry and exit of narcotics, psychotropics and precursors in the country, after hearing the Federal Police Department and the Federal Revenue Secretariat. (See
p.000150: Provisional Measure No. 2,134-31, 2001) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVIII - monitor the establishment of the Registration, Surveillance and Monitoring Committees for Pregnant Women and Women at Risk within the scope of the National Registration, Surveillance and
p.000150: Monitoring of pregnant women and mothers for the prevention of maternal mortality by public and private health establishments, whether or not they are members of the Unified Health System - SUS. (Included
p.000150: by Provisional Measure 557, of 2011) Not effective
p.000150: § 1 The Agency may delegate to the States, the Federal District and the Municipalities the execution of its own attributions, except those provided for in items I, V, VIII, IX, XV, XVI, XVII, XVIII and
p.000150: XIX of this article.
p.000150: § 2 The Agency may advise, complement or supplement state, municipal and Federal District actions for the exercise of sanitary control.
p.000150: § 3 The activities of epidemiological surveillance and vector control related to ports, airports and borders, will be carried out by the Agency, under technical and normative guidance from the Ministry of
p.000150: Cheers.
p.000150: § 4 The Agency may delegate to the Ministry of Health agency the performance of the duties provided for in this article related to medical, ambulatory and hospital services, provided for in §§ 2 and 3 of art.
p.000150: 8, subject to the restrictions defined in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Paragraph 5. The Agency must always guide its performance in compliance with the guidelines established by Law No. 8,080, of September 19, 1990, in order to continue the process of decentralization of
p.000150: execution of activities for States, Federal District and Municipalities, observing the prohibitions listed in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 6 The decentralization referred to in § 5 will only be effective after a favorable manifestation by the respective State, District and Municipal Health Councils. (Included by Provisional Measure nº
...
Health / Terminally Ill
Searching for indicator terminal:
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p.000300: product registration
p.000300: 5.9.3 Consent to export, by legal entity, product samples or raw materials
p.000300: EXEMPT ---
p.000300: subject to health surveillance, for demonstration purposes at fairs or public events
p.000300: 5.9.4 Consent to export, by legal entity, product samples subject to surveillance
p.000300: EXEMPT ---
p.000300: for demonstration purposes to specialized professionals
p.000300: 5.9.5 Consent to export and import, by legal entity, human biological samples, X X
p.000300: for testing and laboratory experiments
p.000300: 5.9.5.1 Export and import of a maximum of twenty samples 100 ---
p.000300: 5.9.5.2 Export and import of twenty-one to fifty samples 200 ---
p.000300: 5.9.6 Consent to export, by public research institutions, biological samples
p.000300: EXEMPT ---
p.000300: for the purpose of carrying out tests and laboratory experiments
p.000300: 5.9.7 Consent in substitutive import license related to import processes of
p.000300: 50 ---
p.000300: products and raw materials subject to health surveillance
p.000300: 5.10 Collection and transportation of samples for laboratory analysis of imported products subject to
p.000300: control analysis
p.000300: 5.10.1 within Municipality 150 ---
p.000300: 5.10.2 another Municipality in the same State 300 ---
p.000300: 5.10.3 other State 600 ---
p.000300: 5.11 Inspection to verify compliance with sanitary requirements related to disinhibition
p.000300: d and imported products, stored outside the customs terminal for use X X
p.000300: public
p.000300: 5.11.1 within Municipality 150 ---
p.000300: 5.11.2 another Municipality in the same State 300 ---
p.000300: 5.11.3 other State 600 ---
p.000300: 5.12 Semi-annual inspection to verify compliance with sanitary requirements related to
p.000300: hygienic-sanitary conditions of platforms constituted of installation or structure, fixed
p.000300: or mobile, located in waters under national jurisdiction, intended for direct activity or 6,000 ---
p.000300: indirect research and mining of mineral resources from the inland waters
p.000300: or its subsoil, or the sea, the continental shelf or its subsoil
p.000300: 5.13 Consent for tax exemption in the process of importing or exporting products
p.000300: EXEMPT ---
p.000300: subject to health surveillance
p.000300: 5.14 Port health control activities X X
p.000300: 5.14.1 Issuance of an international ratification certificate and exemption from ratification of
p.000300: X X
p.000300: vessels carrying out navigation of
p.000300: 5.14.1.1 Long sea open sea, in international transit, with maritime, maritime-
p.000300: river or maritime-lacustrine, and that develop activities or transport services of 1000 ---
p.000300: cargo or passenger
p.000300: 5.14.1.2 Long sea open sea, in international transit, with maritime displacements,
p.000300: 1000 ---
p.000300: maritime-fluvial or maritime-lacustrine, and which carry out fishing activities
p.000300: 5.14.1.3 Long sea open sea, in international transit, with maritime, maritime-
p.000300: fl uvial or maritime-lacustrine, and that develop sports and recreational activities for non-EXEMPT purposes ---
p.000300: commercials
p.000300: 5.14.1.4 Interior, in international transit, with fluvial displacement and that develop activities
p.000300: 1000 ---
p.000300: or cargo or passenger transportation services
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.000300: 14. To companies that perform express delivery activities (courier) and that are covered by letters "a", "b" and "c"
p.000300: item 1 of the Notes, regardless of billing, the export consent fee for the goods
p.000300: treat items 5.9.5.1 and 5.9.5.2 of this Annex, in the following values:
p.000300: a) R $ 40.00, in the case of a maximum of 20 samples per consignment to recipient, proven
p.000300: per item, upon verification of the bill of lading by the health authority;
p.000300: b) R $ 80.00, in the case of 21 to 50 samples per shipment to the recipient, confirmed by item,
p.000300: by checking the bill of lading for cargo by the health authority.
p.000300: 15. ANVISA's Collegiate Board of Directors will adapt the provisions of item 5.14 and their discounts to the size of vessels by
p.000300: net tonnage and class, types of navigation, waterways and displacements made.
p.000300: 16. For the purposes of the provisions of the previous item, it is considered:
p.000300: 16.1. Net tonnage - AL: expression of a vessel's net capacity, determined in accordance with the
p.000300: requirements of these rules, depending on the volume of enclosed spaces intended for cargo transportation, the
p.000300: number of passengers transported, the place where the passengers will be transported, the draft / point ratio and
p.000300: of gross tonnage, understood net tonnage still as a dimensionless size.
p.000300: 16.2. Class of boats: recreational sport, fishing, passengers, cargo, mixed and others.
p.000300: 16.3. Navigation type:
p.000300: 16.3.1. Open Sea Navigation: carried out in maritime waters considered homeless, which may be:
p.000300: 16.3.1.1. Long Course: that carried out between Brazilian and foreign ports;
p.000300: 16.3.1.2. Cabotage: that carried out between ports or points in the Brazilian territory used by sea
p.000300: or this and inland waterways; and
p.000300: 16.3.1.3. Maritime Support: that carried out for logistical support to vessels and installations in waters
p.000300: national territories and in the exclusive economic zone, which act in research and mining activities
p.000300: minerals and hydrocarbons;
p.000300: 16.3.2. Inland Navigation: carried out on inland waterways thus considered rivers, lakes, channels, lagoons,
p.000300: bays, coves, coves and maritime areas considered sheltered;
p.000300: 16.3.3. Port Support Navigation: carried out exclusively in ports and waterway terminals for
p.000300: service of vessels and port facilities.
p.000300: 16.4. Inland waterways: sea, river, lake.
p.000300: 16.5. Displacements: municipal, intercity, interstate and international.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000150: § 1 The competence of the Union will be exercised:
p.000150: I - by the Ministry of Health, with regard to the formulation, monitoring and evaluation of the national health surveillance policy and the general guidelines of the National Health Surveillance System;
p.000150: II - by the National Health Surveillance Agency - ANVS, in accordance with the powers conferred on it by this Law; and
p.000150: III - by the other organs and entities of the Federal Executive Branch, whose areas of activity are related to the system.
p.000150: § 2 The Federal Executive Branch will define the allocation, among its organs and entities, of the other attributions and activities performed by the National Health Surveillance System, not covered by
p.000150: this Law.
p.000150: § 3 The States, the Federal District and the Municipalities will provide, by agreement, the information requested by the coordination of the National Health Surveillance System.
p.000150: CHAPTER II
p.000150: CREATION AND COMPETENCE OF THE NATIONAL AGENCY
p.000150: OF SANITARY SURVEILLANCE
p.000150: Art. 3 The National Health Surveillance Agency is created, an autarchy under a special regime, linked to the Ministry of Health, with headquarters and venue in the Federal District, for an indefinite period and
p.000150: operating throughout the national territory.
p.000150: Art. 3 The National Health Surveillance Agency - ANVISA is created, an autarchy under a special regime, linked to the Ministry of Health, with headquarters and venue in the Federal District, duration
p.000150: undetermined and operating throughout the national territory. (Wording given by Provisional Measure nº 2.039-24, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: Single paragraph. The nature of special agency granted to the Agency is characterized by administrative independence, stability of its directors and financial autonomy.
p.000150: Art. 4 The Agency will act as an independent administrative entity, being guaranteed, under the terms of this Law, the necessary prerogatives for the proper exercise of its attributions.
p.000150: Art. 5 It will be the responsibility of the Executive Branch to install the Agency, and its regulation, approved by decree of the President of the Republic, establish its organizational structure.
p.000150: Single paragraph. The edition of the regulation will mark the installation of the Agency, investing it, automatically, in the exercise of its attributions. (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 6 The Agency's institutional purpose will be to promote the protection of the population's health, through sanitary control of the production and commercialization of products and services submitted to
p.000150: health surveillance, including environments, processes, inputs and related technologies, as well as the control of ports, airports and borders.
p.000150: Art. 7 The Agency is responsible for implementing and carrying out the provisions of items II to VII of art. 2 of this Law, and must:
p.000150: I - coordinate the National Health Surveillance System;
p.000150: II - foster and carry out studies and research within the scope of its duties;
p.000150: III - establish norms, propose, monitor and execute health surveillance policies, guidelines and actions;
p.000150: IV - establish norms and standards on limits of contaminants, toxic residues, disinfectants, heavy metals and others that involve health risk;
p.000150: V - temporarily intervene in the administration of producing entities, which are financed, subsidized or maintained with public resources, as well as in service providers and or producers
p.000150: exclusive or strategic for supplying the national market, in compliance with the provisions of art. 5 of Law No. 6,437, of August 20, 1977, with the wording given by art. 2 of Law No. 9,695, of 20
p.000150: August 1998;
p.000150: VI - administer and collect the health surveillance inspection fee, established by art. 23 of this Law;
p.000150: VII - to authorize the operation of companies that manufacture, distribute and import the products mentioned in art. 6th of this Law;
...
p.000150: all phases of the production processes of goods and products subject to sanitary control and inspection, including the destination of the respective residues.
p.000150: § 4 The Agency may regulate other products and services of interest for the control of risks to the health of the population, achieved by the National Health Surveillance System.
p.000150: § 5 The Agency may exempt from registration the immunobiologicals, insecticides, medicines and other strategic inputs when acquired through international multilateral organizations, for
p.000150: use in public health programs by the Ministry of Health and its related entities. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 6 The Minister of Health of the State may determine the performance of actions foreseen in the competences of the National Health Surveillance Agency, in specific cases and that imply health risk
p.000150: of the population. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 7 The act referred to in § 6 must be published in the Federal Official Gazette. (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: § 8 Services and facilities subject to sanitary control and inspection are those related to the activities of ports, airports and borders and at customs stations and terminals
p.000150: customs, water, land and air transport services. (See Provisional Measure No. 2,134-31, of 2001) (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: CHAPTER III
p.000150: OF THE AUTHORCHY'S ORGANIZATIONAL STRUCTURE
p.000150: Section I
p.000150: Basic Structure
p.000150: Art. 9 The Agency will be directed by a Collegiate Directorate, and must also have a Prosecutor, a Corregidor and an Ombudsman, in addition to specialized units charged with different
p.000150: functions.
p.000150: Single paragraph. The Agency will also have an Advisory Board, as provided by regulation.
p.000150: Single paragraph. The Agency will also count on an Advisory Council, which should have, at least, representatives of the Union, the States, the Federal District, the Municipalities, the producers, the
p.000150: traders, the scientific community and users, in the form of the regulation. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: Section II
p.000150: From the Collegiate Board
p.000150: Art. 10. The management and administration of the Agency will be exercised by a Collegiate Directorate, composed of up to five members, one of whom being its Chief Executive Officer.
p.000150: Single paragraph. The Directors will be Brazilian, nominated and appointed by the President of the Republic after prior approval by the Federal Senate under the terms of art. 52, III, "f", of the Federal Constitution, for
p.000150: three-year term of office, with a single reappointment permitted.
p.000150: Art. 10. The management and administration of the Agency will be exercised by a Collegiate Board of Directors made up of 5 (five) members, one of whom being its Chief Executive Officer,
p.000150: reappointment, pursuant to Law No. 9,986, of July 18, 2000. (Wording given by Law No. 13,848, of 2019)
p.000150: Single paragraph. The members of the Collegiate Board will be Brazilian, appointed by the President of the Republic and appointed by him, after prior approval by the Federal Senate,
p.000150: terms of item “f” of item III of art. 52 of the Federal Constitution, to fulfill a mandate of 5 (five) years, observing the provisions of Law No. 9,986, of July 18, 2000. (Editorial Staff
p.000150: given by Law No. 13,848, of 2019)
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic, from among the members of the Collegiate Board, and invested in the function for three years, or for the remainder of his term.
p.000150: mandate, a single reappointment is allowed for three years.
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic and invested in the function for 5 (five) years, renewal is prohibited, subject to the provisions of Law no.
p.000150: 9,986, of July 18, 2000. (Wording provided by Law No. 13,848, of 2019)
p.000150: Art. 12. The unreasonable dismissal of a Director of the Agency can only be promoted in the initial four months of the mandate, at the end of which his full and full exercise will be ensured, except in
p.000150: cases of practice of administrative misconduct, unappealable criminal conviction and unjustified non-compliance with the autarchy management contract. (Repealed by Law No. 13,848, of
p.000150: 2019) Term
p.000150: Art. 13. The directors of the Agency are prohibited from exercising any other professional, business, union or political party activity.
p.000150: Paragraph 1. It is also forbidden for managers to have a direct or indirect interest in a company related to the area of activity of the Health Surveillance, provided for in this Law, as provided in the regulation.
p.000150: § 2 The prohibition referred to in the caput of this article does not apply to cases in which the professional activity arises from a contractual relationship maintained with public entities destined to teaching and research,
p.000150: including those governed by private law.
p.000150: § 3 In the event of non-compliance with the obligation provided for in the caput and in § 1 of this article, the infringer will lose his position, without prejudice to responding to the applicable civil and criminal actions.
p.000150: Art. 14. Up to one year after leaving office, the former director is prohibited from representing any person or interest before the Agency.
p.000150: Single paragraph. During the term established in the caput, the former officer is also prohibited from using privileged information obtained as a result of the position held, under penalty of
p.000150: incur an act of administrative improbity.
p.000150: Art. 15. The Collegiate Board of Directors is responsible for:
p.000150: Art. 15. The Collegiate Board of Directors is responsible for: (See Provisional Measure nº 2.000-16, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: I - exercise the administration of the Agency;
p.000150: I - define the Agency's strategic guidelines; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: II - propose to the Minister of State for Health the governmental policies and guidelines aimed at enabling the Agency to fulfill its objectives;
p.000150: II - propose to the Minister of State for Health the governmental policies and guidelines aimed at enabling the Agency to fulfill its objectives; (See Provisional Measure No. 2000-16, 2000)
p.000150: (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: III - edit rules on matters within the Agency's competence;
p.000150: III - edit rules on matters within the Agency's competence; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: III - edit rules on matters within the Agency's competence, which must be accompanied by technical justifications and, whenever possible, studies of economic and technical impact in the regulated sector
p.000150: and impact on public health, waiving this requirement in cases of serious risk to public health; (Wording given by Law nº 13.411, of 2017) (Effective)
...
p.000150: III - decide urgent issues ad referendum of the Collegiate Board; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: IV - decide in case of a tie in the deliberations of the Collegiate Board; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: V - appoint and dismiss civil servants, providing the effective positions, in commission and trust functions, and exercise disciplinary power, under the terms of the legislation in force; (See Provisional Measure No. 2,000-
p.000150: 16, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: VI - forward the periodic reports prepared by the Collegiate Board to the Advisory Board; (See Provisional Measure No. 2000-16, of 2000) (Wording provided by Provisional Measure No. 2,190-34,
p.000150: 2001)
p.000150: VII - sign contracts, agreements and order expenses; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: VIII - preparing, approving and promulgating the internal regulations, defining the area of operation of the organizational units and the executive structure of the Agency; (See Provisional Measure No. 2000-16, 2000)
p.000150: (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: IX - exercise the Agency's operational management. (See Provisional Measure No. 2000-16, of 2000) (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Section III
p.000150: Commission Positions and Commissioned Functions
p.000150: Art. 17. Positions are created in the Special Nature Commission and the Senior Management and Advisory Group - DAS, with the purpose of integrating the Agency's structure, listed in the
p.000150: Annex I of this Law.
p.000150: Single paragraph. The positions on the Commission of the Senior Management and Advisory Group will be held, preferably, by members of the staff of the municipality.
p.000150: Art. 18. Confidence functions called Commissioned Health Surveillance Functions - FCVS are created for the private exercise of public servants, in the quantity and values provided for in the Annex
p.000150: I of this Law. (Repealed by Law No. 9,986, of 2000)
p.000150: § 1 The Server invested in FCVS will notice the salaries of the effective position, plus the value of the function for which he has been assigned. (Repealed by Law No. 9,986, of 2000)
p.000150: § 2º It is incumbent upon the Agency's Collegiate Directorate to provide for the reallocation of the quantitative and distribution of FCVS within its organizational structure, observing the hierarchical levels, the values of
p.000150: corresponding remuneration and the respective global cost established in Annex I. (Repealed by Law No. 9,986, of 2000)
p.000150: § 3 The designation for the commissioned function of health surveillance is not cumulative with the designation or appointment for any other form of commissioning, ceasing payment during
p.000150: situations of absence from the server, including those considered effective, except for the periods referred to in items I, IV, VI and VIII, of art. 102 of Law No. 8,112, of December 11,
p.000150: 1990, with amendments to Law No. 9,527, of December 10, 1997. (Repealed by Law No. 9,986, of 2000)
p.000150: CHAPTER IV
p.000150: Management Contract
p.000150: Art. 19. The administration of the Agency will be governed by a management contract, negotiated between its Director-President and the Minister of State for Health, having previously consulted the Ministers of State of
p.000150: Finance and Budget and Management, within a maximum period of ninety days following the appointment of the CEO of the autarchy.
p.000150: Art. 19. The Agency's Administration will be governed by a management contract, negotiated between its Chief Executive Officer and the Minister of State for Health, after consultation with the Ministers of State of
p.000150: Finance and Planning, Budget and Management, within a maximum period of one hundred and twenty days following the appointment of the Chief Executive Officer of the municipality. (See Provisional Measure No. 1,912-6, 1999) (Wording
p.000150: given by Provisional Measure No. 2,190-34, of 2001) (Repealed by Law No. 13,848, of 2019)
p.000150: Single paragraph. The management contract is the instrument for evaluating the administrative performance of the municipality and its performance, establishing the parameters for the internal administration of the municipality
p.000150: as well as the indicators that allow objectively quantifying its periodic evaluation.
p.000150: Single paragraph. The management contract is the instrument for assessing Anvisa's administrative performance and performance, which sets the parameters for the internal administration of the municipality,
p.000150: as well as the indicators that allow objectively quantifying its periodic evaluation, and must specify, at least: (Wording given by Law nº 13.411, of 2017) (Term) (Repealed by Law nº
p.000150: 13,848, of 2019)
p.000150: I - goals and deadlines for administrative, operational and inspection performance; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: II - budget forecast and schedule of financial disbursement of the resources necessary to meet the agreed goals; (Included by Law No. 13,411, of 2017) (Effective) (Repealed
p.000150: by Law No. 13,848, of 2019)
p.000150: III - obligations and responsibilities of the parties in relation to the agreed goals; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: IV - systematic monitoring and evaluation; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: V - measures to be taken in the event of unjustified non-compliance with the agreed goals and obligations; (Included by Law No. 13,411, of 2017) (Term) (Repealed by Law No. 13,848,
p.000150: 2019)
p.000150: VI - effective period; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: VII - requirements and conditions for revising the management contract. (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: Art. 20. Unjustified non-compliance with the management contract will imply the dismissal of the Director-President, by the President of the Republic, upon request of the Minister of State for Health.
...
p.000150: Equity and Revenue
p.000150: Section I
p.000150: City Hall Revenue
p.000150: Art. 21. The assets and rights of its property, which are conferred on it or which it acquires or incorporates, constitute the Agency's assets.
p.000150: Art. 22. The Agency's revenue comprises:
p.000150: I - the product resulting from the collection of the sanitary surveillance inspection fee, pursuant to this Law;
p.000150: II - remuneration for services of any nature provided to third parties;
p.000150: III - the proceeds from the collection of revenue from fines resulting from inspection actions;
p.000150: IV - the proceeds from the execution of its active debt;
p.000150: V - the appropriations recorded in the General Budget of the Union, special credits, additional credits and transfers and transfers that are granted to it;
p.000150: VI - funds from agreements, agreements or contracts entered into with national and international entities and bodies;
p.000150: VII - donations, bequests, subsidies and other resources allocated to it;
p.000150: VIII - the amounts calculated on the sale or rental of movable and immovable property owned by it; and,
p.000150: IX - the proceeds from the sale of assets, objects and instruments used for the practice of infraction, as well as the assets of the offenders, seized as a result of the exercise of police power and
p.000150: incorporated into the Agency's assets under the terms of a court decision.
p.000150: X - the amounts calculated on investments in the financial market of the revenues provided for in items I to IV and VI to IX of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Single paragraph. The funds provided for in items I, II and VII of this article, will be collected directly from the Agency, as defined by the Executive Branch.
p.000150: Art. 23. The Sanitary Surveillance Inspection Fee is hereby established.
p.000150: Paragraph 1 It is a triggering event of the Sanitary Surveillance Inspection Fee the practice of acts within the competence of the National Sanitary Surveillance Agency set out in Annex II.
p.000150: Paragraph 2. The taxpayers referred to in the caput of this article are taxable persons for individuals and companies that carry out activities in the manufacture, distribution and sale of products and the provision of services.
p.000150: mentioned in art. 8 of this Law.
p.000150: § 3 The fee will be due in accordance with the respective taxable event, amount and term referred to in the table that constitutes Annex II of this Law.
p.000150: § 4 The fee must be paid within the deadlines set out in the Agency's own regulation. (See Provisional Measure 2,134-31, of 2001)
p.000150: § 4 The fee must be paid in accordance with ANVISA's specific act. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 5 The collection and collection of the fee referred to in this article may be delegated to the States, the Federal District and the Municipalities, at the discretion of the Agency, in cases where they are being
p.000150: surveillance actions were carried out, respecting the provisions of § 1 of art. 7 of this Law.
p.000150: § 6 The laboratories instituted or controlled by the Public Power, producers of medicines and supplies subject to Law 6,360, of September 23, 1976, in view of the public health interest, are
p.000150: exempt from payment of the Health Surveillance Inspection Fee. (Included by Provisional Measure No. 2,190-34, of 2001)
...
p.000150: III - charges of 20%, substituting the conviction of the debtor in attorney's fees, calculated on the total debt registered as Active Debt, which will be reduced to 10%, if the payment is
p.000150: carried out before filing the execution.
p.000150: § 1 The interest on late payment does not affect the amount of the late payment penalty.
p.000150: § 2 The debts related to the Fee may be paid in installments, at the discretion of the National Health Surveillance Agency, in accordance with the criteria established in the tax legislation.
p.000150: Art. 25. The Sanitary Surveillance Inspection Fee will be due as from January 1, 1999.
p.000150: Art. 26. The Sanitary Surveillance Inspection Fee will be collected in a bank account linked to the Agency.
p.000150: Section II
p.000150: Active Debt
p.000150: Art. 27. The amounts whose collection is attributed by law to the Agency and calculated administratively, not collected within the stipulated period, will be registered in the Agency's own outstanding debt and will serve as title
p.000150: executive for judicial collection, according to the Law.
p.000150: Art. 28. The tax enforcement of the active debt will be promoted by the Agency's Attorney.
p.000150: CHAPTER VI
p.000150: Of the final and transitional provisions
p.000150: Art. 29. In the first administration of the Autarchy, aiming to implement the transition to the system of non-coincident mandates:
p.000150: I - three directors of the Agency will be appointed by the President of the Republic, as indicated by the Minister of State for Health;
p.000150: II - two directors will be appointed in the form of the sole paragraph of art. 10, of this Law.
p.000150: Single paragraph. Of the three directors referred to in item I of this article, two will be appointed for a four-year term and one for two years.
p.000150: Art. 30. The National Health Surveillance Agency is constituted, with the publication of its Internal Regulations, by the Collegiate Directorate, the Health Surveillance Secretariat will be extinguished.
p.000150: Art. 30. The National Health Surveillance Agency is constituted, with the publication of its internal regulations by the Collegiate Directorate, the Autarchy will be automatically invested in the exercise of its duties.
p.000150: attributions, and the Health Surveillance Secretariat is extinguished. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 31. The Executive Branch is authorized to:
p.000150: I - transfer to the Agency the technical and patrimonial collection, obligations, rights and revenues of the Ministry of Health and its organs, necessary for the performance of its functions;
p.000150: II - reallocate, transfer or use the budget balances of the Ministry of Health to meet the Agency's structuring and maintenance expenses, using budget allocations as resources
p.000150: intended for finalistic and administrative activities, subject to the same subprojects, subactivities and groups of expenses provided for in the current Budget Law.
p.000150: Art. 32. The Oswaldo Cruz Foundation is transferred to the National Health Surveillance Agency, the National Institute for Quality Control in Health, as well as its institutional attributions,
p.000150: assets and budget allocations. (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: Single paragraph. The Osvaldo Cruz Foundation will provide all the necessary support to maintain the activities of the National Institute for Quality Control in Health, until the organization of the Agency.
p.000150: (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 32-A. The National Health Surveillance Agency may, through the signing of technical and scientific cooperation agreements, request the execution of technical and scientific works, including those of
p.000150: economic and legal nature, giving preference to higher education and research institutions maintained by the public authorities and international organizations with which Brazil has cooperation agreements
p.000150: technical. (Included by Law No. 12,090, 2009). Validity
p.000150: Art. 33. The Agency may hire specialists to carry out work in the technical, scientific, economic and legal areas, for projects or limited terms, in compliance with the legislation in force.
p.000150: Art. 34. The Agency may request, in the first three years of its installation, with charges, servers or contractors, from bodies of entities that are members of the direct, indirect Federal Public Administration
p.000150: or foundational, whatever the functions to be performed. (Repealed by Law No. 9,986, of 2000)
p.000150: § 1 During the first twenty-four months following the installation of the Agency, the requests referred to in the caput of this article will be undeniable when made to organs and entities of the Power
p.000150: Federal Executive, and provided they are approved by the Ministers of State for Health and the Budget and Management. (Repealed by Law No. 9,986, of 2000)
p.000150: § 2 When the requisition implies a reduction in the remuneration of the requested servant, the Agency is authorized to supplement it up to the limit of the remuneration of the effective position perceived in the
...
p.000150: § 3 For the purposes of perceiving the bonuses referred to in this article, the other criteria and rules established in the legislation in force will be observed. (Repealed by Provisional Measure No. 2,190-34,
p.000150: 2001)
p.000150: Paragraph 4. The provisions of this article apply only to Fundação Osvaldo Cruz servers employed at the National Institute for Quality Control in Health on December 31, 1998, and who come to
p.000150: be redistributed to the Agency. (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 40. The Federal Attorney General's Office and the Ministry of Health, through their Legal Consultancy, through a joint commission, will promote, within one hundred and eighty days, a survey of the
p.000150: legal actions in progress, involving matters whose competence has been transferred to the Agency, which will replace the Union in the respective processes.
p.000150: § 1 The substitution referred to in the caput, in those judicial processes, will be required through a petition signed by the Attorney General's Office, addressed to the competent Court or Court, requesting the
p.000150: summons from the Agency's Attorney's Office to assume the feat.
p.000150: § 2 As long as the substitution in the form of the previous paragraph has not been carried out, the Attorney General's Office will remain in the case, practicing all the necessary procedural acts.
p.000150: Art. 41. The registration of products covered by Law No. 6,360, of 1976, and Decree-Law No. 986, of October 21, 1969, may be subject to regulation by the Ministry of Health and the Agency
p.000150: aiming at reducing bureaucracy and agility in procedures, as long as this does not imply risks to the health of the population or to the condition of inspection of production and circulation activities.
p.000150: Single paragraph. The Agency may grant operating authorization to companies and registration for products that are applicable only to productive plants and to goods destined for markets.
p.000150: as long as it does not entail risks to public health.
p.000150: § 1 The Agency may grant operating authorization to companies and registration of products that are applicable only to productive plants and to goods destined for foreign markets, provided that
p.000150: that do not pose risks to public health. (Renumbered from the sole paragraph by Provisional Measure No. 2,190-34, 2001)
p.000150: Paragraph 2. The regulation referred to in the caput of this article also includes exemption from registration. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 3 The companies subject to Decree-Law nº 986, of 1969, are also obliged to comply with art. 2 of Law No. 6,360, of 1976, with regard to the authorization of operation by the Ministry of
p.000150: Health and licensing by the health agencies of the Federative Units in which they are located. (See Provisional Measure 1,814-4, 1999) (Included by Provisional Measure 2,190-34, 2001)
p.000150: Art. 41-A. The registration of medicines with exclusively generic denomination will have priority over the others, as provided in an act of the Collegiate Directorate of the National Surveillance Agency
p.000150: Sanitary. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 41-B. When the sale of products subject to sanitary surveillance, unfit for consumption is proven, the responsible company will be obliged to carry advertising containing an alert
...
p.000300: 2003, by decision of the ANVISA Collegiate Board.
p.000300: 6. For the purposes of Registration or Renewal of Registration, a drug containing a new molecule will be considered new
p.000300: and have patent protection.
p.000300: 7. The fee for Registration or Renewal of Registration of medications or a group of phototherapy drugs,
p.000300: Homeopathic, Large Volume Parenteral Solutions and Small Volume Parenteral Solutions will be that of the item
p.000300: 4.1.3. Generics.
p.000300: 8. The values of the Table for Renewal of Product Registration or Product Group will be reduced by ten percent
p.000300: in renovation.
p.000300: 9. The classification as a small and micro enterprise, for the purposes foreseen in item 1, will take place in
p.000300: in accordance with Law 9.841, of October 5, 1999.
p.000300: 10. It is exempt to collect fees for issuing certificates, certificates and other declaratory acts, unarchiving
p.000300: process and duplicate of document, when dealing with export-oriented activity.
p.000300: 11. It is exempt to collect a fee for adding or changing the registration, regarding the text of the package insert, use form
p.000300: and labeling, telephone number change, CGC / CNPJ number, or other legal information, as provided by the
p.000300: ANVISA Collegiate Board.
p.000300: 12. The reduction values provided for in item 1 do not apply to items 3.1.5 and 5.1.13 of the Table, and to companies
p.000300: located in countries other than MERCOSUR members.
p.000300: 13. To companies that perform express delivery activities (courier) and that are framed in the letters "a", "b" and "c"
p.000300: of item 1 of the Notes, regardless of invoicing, the single import consent fee for goods
p.000300: of items 5.3, 5.4, 5.6, 5.7 and 5.8 of this Annex, in the amount of R $ 40.00.
p.000300: 14. To companies that perform express delivery activities (courier) and that are covered by letters "a", "b" and "c"
p.000300: item 1 of the Notes, regardless of billing, the export consent fee for the goods
p.000300: treat items 5.9.5.1 and 5.9.5.2 of this Annex, in the following values:
p.000300: a) R $ 40.00, in the case of a maximum of 20 samples per consignment to recipient, proven
p.000300: per item, upon verification of the bill of lading by the health authority;
p.000300: b) R $ 80.00, in the case of 21 to 50 samples per shipment to the recipient, confirmed by item,
p.000300: by checking the bill of lading for cargo by the health authority.
p.000300: 15. ANVISA's Collegiate Board of Directors will adapt the provisions of item 5.14 and their discounts to the size of vessels by
p.000300: net tonnage and class, types of navigation, waterways and displacements made.
p.000300: 16. For the purposes of the provisions of the previous item, it is considered:
p.000300: 16.1. Net tonnage - AL: expression of a vessel's net capacity, determined in accordance with the
p.000300: requirements of these rules, depending on the volume of enclosed spaces intended for cargo transportation, the
p.000300: number of passengers transported, the place where the passengers will be transported, the draft / point ratio and
p.000300: of gross tonnage, understood net tonnage still as a dimensionless size.
p.000300: 16.2. Class of boats: recreational sport, fishing, passengers, cargo, mixed and others.
p.000300: 16.3. Navigation type:
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Social / Mothers
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p.000150: the imposition of excessive prices, for the goods and services referred to in these items, summon those responsible to, within a maximum period of ten working days, justify the respective conduct; (See Provisional Measure nº
p.000150: 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: d) apply the penalty provided for in art. 26 of Law No. 8,884, of 1994; (See Provisional Measure No. 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVI - to control, inspect and monitor, from the point of view of health legislation, the advertising and publicity of products subject to the health surveillance regime; (See Provisional Measure No. 2000-17,
p.000150: 2000) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVII - to define, in a specific act, the places of entry and exit of narcotics, psychotropics and precursors in the country, after hearing the Federal Police Department and the Federal Revenue Secretariat. (See
p.000150: Provisional Measure No. 2,134-31, 2001) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVIII - monitor the establishment of the Registration, Surveillance and Monitoring Committees for Pregnant Women and Women at Risk within the scope of the National Registration, Surveillance and
p.000150: Monitoring of pregnant women and mothers for the prevention of maternal mortality by public and private health establishments, whether or not they are members of the Unified Health System - SUS. (Included
p.000150: by Provisional Measure 557, of 2011) Not effective
p.000150: § 1 The Agency may delegate to the States, the Federal District and the Municipalities the execution of its own attributions, except those provided for in items I, V, VIII, IX, XV, XVI, XVII, XVIII and
p.000150: XIX of this article.
p.000150: § 2 The Agency may advise, complement or supplement state, municipal and Federal District actions for the exercise of sanitary control.
p.000150: § 3 The activities of epidemiological surveillance and vector control related to ports, airports and borders, will be carried out by the Agency, under technical and normative guidance from the Ministry of
p.000150: Cheers.
p.000150: § 4 The Agency may delegate to the Ministry of Health agency the performance of the duties provided for in this article related to medical, ambulatory and hospital services, provided for in §§ 2 and 3 of art.
p.000150: 8, subject to the restrictions defined in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Paragraph 5. The Agency must always guide its performance in compliance with the guidelines established by Law No. 8,080, of September 19, 1990, in order to continue the process of decentralization of
p.000150: execution of activities for States, Federal District and Municipalities, observing the prohibitions listed in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 6 The decentralization referred to in § 5 will only be effective after a favorable manifestation by the respective State, District and Municipal Health Councils. (Included by Provisional Measure nº
p.000150: 2,190-34, 2001)
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Social / Police Officer
Searching for indicator officer:
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p.000150: of the population. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 7 The act referred to in § 6 must be published in the Federal Official Gazette. (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: § 8 Services and facilities subject to sanitary control and inspection are those related to the activities of ports, airports and borders and at customs stations and terminals
p.000150: customs, water, land and air transport services. (See Provisional Measure No. 2,134-31, of 2001) (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: CHAPTER III
p.000150: OF THE AUTHORCHY'S ORGANIZATIONAL STRUCTURE
p.000150: Section I
p.000150: Basic Structure
p.000150: Art. 9 The Agency will be directed by a Collegiate Directorate, and must also have a Prosecutor, a Corregidor and an Ombudsman, in addition to specialized units charged with different
p.000150: functions.
p.000150: Single paragraph. The Agency will also have an Advisory Board, as provided by regulation.
p.000150: Single paragraph. The Agency will also count on an Advisory Council, which should have, at least, representatives of the Union, the States, the Federal District, the Municipalities, the producers, the
p.000150: traders, the scientific community and users, in the form of the regulation. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: Section II
p.000150: From the Collegiate Board
p.000150: Art. 10. The management and administration of the Agency will be exercised by a Collegiate Directorate, composed of up to five members, one of whom being its Chief Executive Officer.
p.000150: Single paragraph. The Directors will be Brazilian, nominated and appointed by the President of the Republic after prior approval by the Federal Senate under the terms of art. 52, III, "f", of the Federal Constitution, for
p.000150: three-year term of office, with a single reappointment permitted.
p.000150: Art. 10. The management and administration of the Agency will be exercised by a Collegiate Board of Directors made up of 5 (five) members, one of whom being its Chief Executive Officer,
p.000150: reappointment, pursuant to Law No. 9,986, of July 18, 2000. (Wording given by Law No. 13,848, of 2019)
p.000150: Single paragraph. The members of the Collegiate Board will be Brazilian, appointed by the President of the Republic and appointed by him, after prior approval by the Federal Senate,
p.000150: terms of item “f” of item III of art. 52 of the Federal Constitution, to fulfill a mandate of 5 (five) years, observing the provisions of Law No. 9,986, of July 18, 2000. (Editorial Staff
p.000150: given by Law No. 13,848, of 2019)
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic, from among the members of the Collegiate Board, and invested in the function for three years, or for the remainder of his term.
p.000150: mandate, a single reappointment is allowed for three years.
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic and invested in the function for 5 (five) years, renewal is prohibited, subject to the provisions of Law no.
p.000150: 9,986, of July 18, 2000. (Wording provided by Law No. 13,848, of 2019)
p.000150: Art. 12. The unreasonable dismissal of a Director of the Agency can only be promoted in the initial four months of the mandate, at the end of which his full and full exercise will be ensured, except in
p.000150: cases of practice of administrative misconduct, unappealable criminal conviction and unjustified non-compliance with the autarchy management contract. (Repealed by Law No. 13,848, of
p.000150: 2019) Term
p.000150: Art. 13. The directors of the Agency are prohibited from exercising any other professional, business, union or political party activity.
p.000150: Paragraph 1. It is also forbidden for managers to have a direct or indirect interest in a company related to the area of activity of the Health Surveillance, provided for in this Law, as provided in the regulation.
p.000150: § 2 The prohibition referred to in the caput of this article does not apply to cases in which the professional activity arises from a contractual relationship maintained with public entities destined to teaching and research,
p.000150: including those governed by private law.
p.000150: § 3 In the event of non-compliance with the obligation provided for in the caput and in § 1 of this article, the infringer will lose his position, without prejudice to responding to the applicable civil and criminal actions.
p.000150: Art. 14. Up to one year after leaving office, the former director is prohibited from representing any person or interest before the Agency.
p.000150: Single paragraph. During the term established in the caput, the former officer is also prohibited from using privileged information obtained as a result of the position held, under penalty of
p.000150: incur an act of administrative improbity.
p.000150: Art. 15. The Collegiate Board of Directors is responsible for:
p.000150: Art. 15. The Collegiate Board of Directors is responsible for: (See Provisional Measure nº 2.000-16, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: I - exercise the administration of the Agency;
p.000150: I - define the Agency's strategic guidelines; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: II - propose to the Minister of State for Health the governmental policies and guidelines aimed at enabling the Agency to fulfill its objectives;
p.000150: II - propose to the Minister of State for Health the governmental policies and guidelines aimed at enabling the Agency to fulfill its objectives; (See Provisional Measure No. 2000-16, 2000)
p.000150: (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: III - edit rules on matters within the Agency's competence;
p.000150: III - edit rules on matters within the Agency's competence; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: III - edit rules on matters within the Agency's competence, which must be accompanied by technical justifications and, whenever possible, studies of economic and technical impact in the regulated sector
p.000150: and impact on public health, waiving this requirement in cases of serious risk to public health; (Wording given by Law nº 13.411, of 2017) (Effective)
p.000150: IV - approve the internal regulations and define the area of operation, organization and structure of each Executive Board;
p.000150: IV - comply with and enforce the rules on health surveillance; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: V - comply with and enforce the rules on health surveillance;
p.000150: V - prepare and disseminate periodic reports on its activities; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: VI - prepare and disseminate periodic reports on its activities;
p.000150: VI - judge the Agency's decisions, at the level of appeal, by provoking the interested parties; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, of
p.000150: 2001)
p.000150: VII - judge, on an appeal level, the decisions of the Executive Board, by provoking the interested parties;
p.000150: VII - forward the Agency's accounting statements to the competent bodies. (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: VIII - forward the Agency's accounting statements to the competent bodies.
p.000150: VIII - preparing, approving and promulgating the internal regulations, defining the area of operation of the organizational units and the executive structure of the Agency. (Included by Law No. 13,097, 2015)
p.000150: § 1 The Executive Board will meet with the presence of at least four officers, including the Chief Executive Officer or his legal substitute, and will deliberate with at least three favorable votes.
p.000150: § 1 The Board of Executive Officers will meet with the presence of at least three Officers, including the Chief Executive Officer or their legal substitute, and will deliberate by simple majority. (Wording given by Measure
p.000150: Provisional No. 2,190-34, of 2001)
p.000150: § 1 The Executive Board will meet with the presence of at least 3 (three) Directors, including the Chief Executive Officer or his legal substitute, and will deliberate by an absolute majority. (Essay
p.000150: given by Law No. 13,848, of 2019)
p.000150: § 2º Of the acts performed by the Agency, the Collegiate Board of Directors may appeal, with suspensive effect, as the last administrative instance.
p.000150: § 2 The acts practiced by the Agency may be appealed to the Collegiate Board, with suspensive effect, as the last administrative instance. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: Paragraph 3. Unless otherwise provided, the period for filing the administrative appeal provided for in Paragraph 2 shall be thirty days, counting from the official publication of the contested decision. (Included by Law
p.000150: nº 13.411, of 2017) (Effective)
p.000150: § 4 The final decision on the administrative appeal must be published within a maximum period of ninety days, counting from the date of filing the appeal. (Included by Law No. 13,411, of 2017)
p.000150: (Validity)
p.000150: § 5 The term provided for in § 4 may be extended for an equal period, upon publication of the respective justification. (Included by Law No. 13,411, of 2017) (Effective)
p.000150: § 6 The non-compliance with the deadlines established in §§ 4 and 5 implies the determination of the functional responsibility of the responsible person or persons responsible in each of the specialized areas
p.000150: process analysis. (Included by Law No. 13,411, of 2017) (Effective)
p.000150: Art. 16. The Chief Executive Officer is responsible for:
p.000150: I - represent the Agency in or out of court;
p.000150: II - preside over the meetings of the Board of Directors;
p.000150: III - comply with and enforce the decisions of the Collegiate Board;
p.000150: IV - decide ad referendum of the Collegiate Board of Directors on urgent matters;
p.000150: V - decide in case of a tie in the deliberations of the Collegiate Board;
p.000150: VI - appoint and dismiss civil servants, providing effective positions, in commission and functions of trust, and exercise disciplinary power, under the terms of the legislation in force;
p.000150: VII - forward the periodic reports prepared by the Collegiate Board to the Advisory Board;
p.000150: VIII - sign contracts, agreements and order expenses.
p.000150: Art. 16. It is incumbent upon the Chief Executive Officer: (See Provisional Measure nº 2,000-16, of 2000) (Wording given by Provisional Measure nº 2,190-34, of 2001)
p.000150: I - represent the Agency in or out of court; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: II - preside over the meetings of the Board of Directors; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: III - decide urgent issues ad referendum of the Collegiate Board; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: IV - decide in case of a tie in the deliberations of the Collegiate Board; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: V - appoint and dismiss civil servants, providing the effective positions, in commission and trust functions, and exercise disciplinary power, under the terms of the legislation in force; (See Provisional Measure No. 2,000-
p.000150: 16, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: VI - forward the periodic reports prepared by the Collegiate Board to the Advisory Board; (See Provisional Measure No. 2000-16, of 2000) (Wording provided by Provisional Measure No. 2,190-34,
p.000150: 2001)
p.000150: VII - sign contracts, agreements and order expenses; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
p.000150: VIII - preparing, approving and promulgating the internal regulations, defining the area of operation of the organizational units and the executive structure of the Agency; (See Provisional Measure No. 2000-16, 2000)
p.000150: (Wording given by Provisional Measure No. 2,190-34, of 2001)
...
p.000150: Art. 18. Confidence functions called Commissioned Health Surveillance Functions - FCVS are created for the private exercise of public servants, in the quantity and values provided for in the Annex
p.000150: I of this Law. (Repealed by Law No. 9,986, of 2000)
p.000150: § 1 The Server invested in FCVS will notice the salaries of the effective position, plus the value of the function for which he has been assigned. (Repealed by Law No. 9,986, of 2000)
p.000150: § 2º It is incumbent upon the Agency's Collegiate Directorate to provide for the reallocation of the quantitative and distribution of FCVS within its organizational structure, observing the hierarchical levels, the values of
p.000150: corresponding remuneration and the respective global cost established in Annex I. (Repealed by Law No. 9,986, of 2000)
p.000150: § 3 The designation for the commissioned function of health surveillance is not cumulative with the designation or appointment for any other form of commissioning, ceasing payment during
p.000150: situations of absence from the server, including those considered effective, except for the periods referred to in items I, IV, VI and VIII, of art. 102 of Law No. 8,112, of December 11,
p.000150: 1990, with amendments to Law No. 9,527, of December 10, 1997. (Repealed by Law No. 9,986, of 2000)
p.000150: CHAPTER IV
p.000150: Management Contract
p.000150: Art. 19. The administration of the Agency will be governed by a management contract, negotiated between its Director-President and the Minister of State for Health, having previously consulted the Ministers of State of
p.000150: Finance and Budget and Management, within a maximum period of ninety days following the appointment of the CEO of the autarchy.
p.000150: Art. 19. The Agency's Administration will be governed by a management contract, negotiated between its Chief Executive Officer and the Minister of State for Health, after consultation with the Ministers of State of
p.000150: Finance and Planning, Budget and Management, within a maximum period of one hundred and twenty days following the appointment of the Chief Executive Officer of the municipality. (See Provisional Measure No. 1,912-6, 1999) (Wording
p.000150: given by Provisional Measure No. 2,190-34, of 2001) (Repealed by Law No. 13,848, of 2019)
p.000150: Single paragraph. The management contract is the instrument for evaluating the administrative performance of the municipality and its performance, establishing the parameters for the internal administration of the municipality
p.000150: as well as the indicators that allow objectively quantifying its periodic evaluation.
p.000150: Single paragraph. The management contract is the instrument for assessing Anvisa's administrative performance and performance, which sets the parameters for the internal administration of the municipality,
p.000150: as well as the indicators that allow objectively quantifying its periodic evaluation, and must specify, at least: (Wording given by Law nº 13.411, of 2017) (Term) (Repealed by Law nº
p.000150: 13,848, of 2019)
p.000150: I - goals and deadlines for administrative, operational and inspection performance; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: II - budget forecast and schedule of financial disbursement of the resources necessary to meet the agreed goals; (Included by Law No. 13,411, of 2017) (Effective) (Repealed
p.000150: by Law No. 13,848, of 2019)
p.000150: III - obligations and responsibilities of the parties in relation to the agreed goals; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: IV - systematic monitoring and evaluation; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: V - measures to be taken in the event of unjustified non-compliance with the agreed goals and obligations; (Included by Law No. 13,411, of 2017) (Term) (Repealed by Law No. 13,848,
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p.000150: activities of production, distribution and commercialization of the goods and services provided for in this item, maintaining legal confidentiality when applicable; (See Provisional Measure No. 1,912-9, 1999) (Included by Measure
p.000150: Provisional No. 2,190-34, of 2001)
p.000150: b) proceed with the examination of stocks, papers and writings of any companies or persons of public or private law that are engaged in the activities of production, distribution and commercialization of goods
p.000150: and services provided for in this item, maintaining legal confidentiality when applicable; (See Provisional Measure No. 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: c) when the existence of indications of the occurrence of infractions provided for in items III or IV of art. 20 of Law 8,884, of June 11, 1994, through an unjustified increase in prices or
p.000150: the imposition of excessive prices, for the goods and services referred to in these items, summon those responsible to, within a maximum period of ten working days, justify the respective conduct; (See Provisional Measure nº
p.000150: 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: d) apply the penalty provided for in art. 26 of Law No. 8,884, of 1994; (See Provisional Measure No. 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVI - to control, inspect and monitor, from the point of view of health legislation, the advertising and publicity of products subject to the health surveillance regime; (See Provisional Measure No. 2000-17,
p.000150: 2000) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVII - to define, in a specific act, the places of entry and exit of narcotics, psychotropics and precursors in the country, after hearing the Federal Police Department and the Federal Revenue Secretariat. (See
p.000150: Provisional Measure No. 2,134-31, 2001) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVIII - monitor the establishment of the Registration, Surveillance and Monitoring Committees for Pregnant Women and Women at Risk within the scope of the National Registration, Surveillance and
p.000150: Monitoring of pregnant women and mothers for the prevention of maternal mortality by public and private health establishments, whether or not they are members of the Unified Health System - SUS. (Included
p.000150: by Provisional Measure 557, of 2011) Not effective
p.000150: § 1 The Agency may delegate to the States, the Federal District and the Municipalities the execution of its own attributions, except those provided for in items I, V, VIII, IX, XV, XVI, XVII, XVIII and
p.000150: XIX of this article.
p.000150: § 2 The Agency may advise, complement or supplement state, municipal and Federal District actions for the exercise of sanitary control.
p.000150: § 3 The activities of epidemiological surveillance and vector control related to ports, airports and borders, will be carried out by the Agency, under technical and normative guidance from the Ministry of
p.000150: Cheers.
p.000150: § 4 The Agency may delegate to the Ministry of Health agency the performance of the duties provided for in this article related to medical, ambulatory and hospital services, provided for in §§ 2 and 3 of art.
...
p.000150: Collegiate by the President of the Republic, at the request of the Minister of State for Health. (Wording given by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: Validity
p.000150: CHAPTER V
p.000150: Equity and Revenue
p.000150: Section I
p.000150: City Hall Revenue
p.000150: Art. 21. The assets and rights of its property, which are conferred on it or which it acquires or incorporates, constitute the Agency's assets.
p.000150: Art. 22. The Agency's revenue comprises:
p.000150: I - the product resulting from the collection of the sanitary surveillance inspection fee, pursuant to this Law;
p.000150: II - remuneration for services of any nature provided to third parties;
p.000150: III - the proceeds from the collection of revenue from fines resulting from inspection actions;
p.000150: IV - the proceeds from the execution of its active debt;
p.000150: V - the appropriations recorded in the General Budget of the Union, special credits, additional credits and transfers and transfers that are granted to it;
p.000150: VI - funds from agreements, agreements or contracts entered into with national and international entities and bodies;
p.000150: VII - donations, bequests, subsidies and other resources allocated to it;
p.000150: VIII - the amounts calculated on the sale or rental of movable and immovable property owned by it; and,
p.000150: IX - the proceeds from the sale of assets, objects and instruments used for the practice of infraction, as well as the assets of the offenders, seized as a result of the exercise of police power and
p.000150: incorporated into the Agency's assets under the terms of a court decision.
p.000150: X - the amounts calculated on investments in the financial market of the revenues provided for in items I to IV and VI to IX of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Single paragraph. The funds provided for in items I, II and VII of this article, will be collected directly from the Agency, as defined by the Executive Branch.
p.000150: Art. 23. The Sanitary Surveillance Inspection Fee is hereby established.
p.000150: Paragraph 1 It is a triggering event of the Sanitary Surveillance Inspection Fee the practice of acts within the competence of the National Sanitary Surveillance Agency set out in Annex II.
p.000150: Paragraph 2. The taxpayers referred to in the caput of this article are taxable persons for individuals and companies that carry out activities in the manufacture, distribution and sale of products and the provision of services.
p.000150: mentioned in art. 8 of this Law.
p.000150: § 3 The fee will be due in accordance with the respective taxable event, amount and term referred to in the table that constitutes Annex II of this Law.
p.000150: § 4 The fee must be paid within the deadlines set out in the Agency's own regulation. (See Provisional Measure 2,134-31, of 2001)
p.000150: § 4 The fee must be paid in accordance with ANVISA's specific act. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 5 The collection and collection of the fee referred to in this article may be delegated to the States, the Federal District and the Municipalities, at the discretion of the Agency, in cases where they are being
p.000150: surveillance actions were carried out, respecting the provisions of § 1 of art. 7 of this Law.
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Social / Property Ownership
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p.000150: execution of activities for States, Federal District and Municipalities, observing the prohibitions listed in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 6 The decentralization referred to in § 5 will only be effective after a favorable manifestation by the respective State, District and Municipal Health Councils. (Included by Provisional Measure nº
p.000150: 2,190-34, 2001)
p.000150: Paragraph 7. In order to comply with the provisions of item X of this article, the Agency may use confidential information on inspections received within the scope of agreements or arrangements with authority
p.000150: health authorities in other countries, as well as to authorize inspections and inspections of manufacturing plants by national or international institutions accredited by the Agency for such activities. (Included
p.000150: by Law No. 13,097, of 2015)
p.000150: Article 8. It is incumbent upon the Agency, with due regard for the legislation in force, to regulate, control and inspect products and services that involve risk to public health.
p.000150: § 1 The following are considered to be goods and products submitted to health control and inspection by the Agency:
p.000150: I - medicines for human use, their active substances and other inputs, processes and technologies;
p.000150: II - food, including beverages, bottled water, its inputs, its packaging, food additives, limits for organic contaminants, pesticide residues and veterinary medicines;
p.000150: III - cosmetics, personal hygiene products and perfumes;
p.000150: IV - sanitizers intended for hygiene, disinfection or disinfestation in home, hospital and collective environments;
p.000150: V - kits, reagents and supplies for diagnosis;
p.000150: VI - medical-hospital, dental and blood therapy equipment and materials for laboratory and imaging diagnosis;
p.000150: VII - immunobiologicals and their active substances, blood and blood products;
p.000150: VIII - human and veterinary organs, tissues for use in transplants or reconstructions;
p.000150: IX - radioisotopes for in vivo diagnostic use and radiopharmaceuticals and radioactive products used in diagnosis and therapy;
p.000150: X - cigarettes, cigarillos, cigars and any other smoking product, derived or not from tobacco;
p.000150: XI - any products that involve the possibility of health risk, obtained by genetic engineering, by another procedure or still submitted to radiation sources.
p.000150: § 2 Services considered to be subject to sanitary control and inspection by the Agency, those aimed at outpatient care, whether routine or emergency, those performed on a
p.000150: hospitalization, diagnostic and therapeutic support services, as well as those that involve the incorporation of new technologies.
p.000150: § 3 Without prejudice to the provisions of §§ 1 and 2 of this article, the physical facilities, equipment, technologies, environments and procedures involved in health surveillance are subject to the health surveillance regime.
p.000150: all phases of the production processes of goods and products subject to sanitary control and inspection, including the destination of the respective residues.
p.000150: § 4 The Agency may regulate other products and services of interest for the control of risks to the health of the population, achieved by the National Health Surveillance System.
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p.000150: II - budget forecast and schedule of financial disbursement of the resources necessary to meet the agreed goals; (Included by Law No. 13,411, of 2017) (Effective) (Repealed
p.000150: by Law No. 13,848, of 2019)
p.000150: III - obligations and responsibilities of the parties in relation to the agreed goals; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: IV - systematic monitoring and evaluation; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: V - measures to be taken in the event of unjustified non-compliance with the agreed goals and obligations; (Included by Law No. 13,411, of 2017) (Term) (Repealed by Law No. 13,848,
p.000150: 2019)
p.000150: VI - effective period; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: VII - requirements and conditions for revising the management contract. (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: Art. 20. Unjustified non-compliance with the management contract will imply the dismissal of the Director-President, by the President of the Republic, upon request of the Minister of State for Health.
p.000150: Art. 20. Unjustified non-compliance with the goals and obligations agreed in the management contract in two consecutive financial years will imply the exoneration of the members of the Executive Board
p.000150: Collegiate by the President of the Republic, at the request of the Minister of State for Health. (Wording given by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: Validity
p.000150: CHAPTER V
p.000150: Equity and Revenue
p.000150: Section I
p.000150: City Hall Revenue
p.000150: Art. 21. The assets and rights of its property, which are conferred on it or which it acquires or incorporates, constitute the Agency's assets.
p.000150: Art. 22. The Agency's revenue comprises:
p.000150: I - the product resulting from the collection of the sanitary surveillance inspection fee, pursuant to this Law;
p.000150: II - remuneration for services of any nature provided to third parties;
p.000150: III - the proceeds from the collection of revenue from fines resulting from inspection actions;
p.000150: IV - the proceeds from the execution of its active debt;
p.000150: V - the appropriations recorded in the General Budget of the Union, special credits, additional credits and transfers and transfers that are granted to it;
p.000150: VI - funds from agreements, agreements or contracts entered into with national and international entities and bodies;
p.000150: VII - donations, bequests, subsidies and other resources allocated to it;
p.000150: VIII - the amounts calculated on the sale or rental of movable and immovable property owned by it; and,
p.000150: IX - the proceeds from the sale of assets, objects and instruments used for the practice of infraction, as well as the assets of the offenders, seized as a result of the exercise of police power and
p.000150: incorporated into the Agency's assets under the terms of a court decision.
p.000150: X - the amounts calculated on investments in the financial market of the revenues provided for in items I to IV and VI to IX of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Single paragraph. The funds provided for in items I, II and VII of this article, will be collected directly from the Agency, as defined by the Executive Branch.
p.000150: Art. 23. The Sanitary Surveillance Inspection Fee is hereby established.
p.000150: Paragraph 1 It is a triggering event of the Sanitary Surveillance Inspection Fee the practice of acts within the competence of the National Sanitary Surveillance Agency set out in Annex II.
p.000150: Paragraph 2. The taxpayers referred to in the caput of this article are taxable persons for individuals and companies that carry out activities in the manufacture, distribution and sale of products and the provision of services.
p.000150: mentioned in art. 8 of this Law.
p.000150: § 3 The fee will be due in accordance with the respective taxable event, amount and term referred to in the table that constitutes Annex II of this Law.
p.000150: § 4 The fee must be paid within the deadlines set out in the Agency's own regulation. (See Provisional Measure 2,134-31, of 2001)
p.000150: § 4 The fee must be paid in accordance with ANVISA's specific act. (Wording given by Provisional Measure No. 2,190-34, of 2001)
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Social / Religion
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p.000150: reappointment, pursuant to Law No. 9,986, of July 18, 2000. (Wording given by Law No. 13,848, of 2019)
p.000150: Single paragraph. The members of the Collegiate Board will be Brazilian, appointed by the President of the Republic and appointed by him, after prior approval by the Federal Senate,
p.000150: terms of item “f” of item III of art. 52 of the Federal Constitution, to fulfill a mandate of 5 (five) years, observing the provisions of Law No. 9,986, of July 18, 2000. (Editorial Staff
p.000150: given by Law No. 13,848, of 2019)
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic, from among the members of the Collegiate Board, and invested in the function for three years, or for the remainder of his term.
p.000150: mandate, a single reappointment is allowed for three years.
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic and invested in the function for 5 (five) years, renewal is prohibited, subject to the provisions of Law no.
p.000150: 9,986, of July 18, 2000. (Wording provided by Law No. 13,848, of 2019)
p.000150: Art. 12. The unreasonable dismissal of a Director of the Agency can only be promoted in the initial four months of the mandate, at the end of which his full and full exercise will be ensured, except in
p.000150: cases of practice of administrative misconduct, unappealable criminal conviction and unjustified non-compliance with the autarchy management contract. (Repealed by Law No. 13,848, of
p.000150: 2019) Term
p.000150: Art. 13. The directors of the Agency are prohibited from exercising any other professional, business, union or political party activity.
p.000150: Paragraph 1. It is also forbidden for managers to have a direct or indirect interest in a company related to the area of activity of the Health Surveillance, provided for in this Law, as provided in the regulation.
p.000150: § 2 The prohibition referred to in the caput of this article does not apply to cases in which the professional activity arises from a contractual relationship maintained with public entities destined to teaching and research,
p.000150: including those governed by private law.
p.000150: § 3 In the event of non-compliance with the obligation provided for in the caput and in § 1 of this article, the infringer will lose his position, without prejudice to responding to the applicable civil and criminal actions.
p.000150: Art. 14. Up to one year after leaving office, the former director is prohibited from representing any person or interest before the Agency.
p.000150: Single paragraph. During the term established in the caput, the former officer is also prohibited from using privileged information obtained as a result of the position held, under penalty of
p.000150: incur an act of administrative improbity.
p.000150: Art. 15. The Collegiate Board of Directors is responsible for:
...
p.000150: § 7 To the renewals of registrations, authorizations and certificates, the periodicity and the values stipulated for the initial acts are applied in the manner provided for in the Annex. (Included by Provisional Measure nº
p.000150: 2,190-34, 2001)
p.000150: § 8 The provisions of § 7 apply to those contained in §§ 1 to 8 of art. 12 and sole paragraph of art. 50 of Law 6,360, of 1976, in § 2 of art. 3 of Decree-Law No. 986, of October 21, 1969, and § 3 of
p.000150: art. 41 of this Law. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 9 The family farmer, defined according to Law 11.326, of July 24, 2006, and identified by the Declaration of Aptitude to PRONAF - DAP, Physical or Legal, as well as the Micro-entrepreneur
p.000150: Individual, provided for in art. 18-A of Complementary Law No. 123, of December 14, 2006, and the solidarity economy entrepreneur are exempt from paying a Surveillance Inspection Fee
p.000150: Sanitary. (Included by Law No. 13,001, 2014)
p.000150: § 10. The operating authorizations of companies provided for in the items of items 3.1, 3.2, 5.1 and 7.1 of Annex II, are exempt from renewal. (Included by Law No. 13,097, 2015)
p.000150: Art. 24. The fee not paid within the deadlines set in the regulation, in the form of the previous article, will be charged with the following additions:
p.000150: I - arrears interest, in the administrative or judicial channels, counted from the month following the month of maturity, at the rate of 1% per month, calculated in accordance with the legislation applicable to federal taxes;
p.000150: II - late payment penalty of 20%, reduced to 10% if payment is made until the last working day of the month following the month of its maturity;
p.000150: III - charges of 20%, substituting the conviction of the debtor in attorney's fees, calculated on the total debt registered as Active Debt, which will be reduced to 10%, if the payment is
p.000150: carried out before filing the execution.
p.000150: § 1 The interest on late payment does not affect the amount of the late payment penalty.
p.000150: § 2 The debts related to the Fee may be paid in installments, at the discretion of the National Health Surveillance Agency, in accordance with the criteria established in the tax legislation.
p.000150: Art. 25. The Sanitary Surveillance Inspection Fee will be due as from January 1, 1999.
p.000150: Art. 26. The Sanitary Surveillance Inspection Fee will be collected in a bank account linked to the Agency.
p.000150: Section II
p.000150: Active Debt
p.000150: Art. 27. The amounts whose collection is attributed by law to the Agency and calculated administratively, not collected within the stipulated period, will be registered in the Agency's own outstanding debt and will serve as title
p.000150: executive for judicial collection, according to the Law.
p.000150: Art. 28. The tax enforcement of the active debt will be promoted by the Agency's Attorney.
p.000150: CHAPTER VI
p.000150: Of the final and transitional provisions
p.000150: Art. 29. In the first administration of the Autarchy, aiming to implement the transition to the system of non-coincident mandates:
p.000150: I - three directors of the Agency will be appointed by the President of the Republic, as indicated by the Minister of State for Health;
p.000150: II - two directors will be appointed in the form of the sole paragraph of art. 10, of this Law.
p.000150: Single paragraph. Of the three directors referred to in item I of this article, two will be appointed for a four-year term and one for two years.
...
Social / Trade Union Membership
Searching for indicator union:
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p.000150: Presidency of the Republic
p.000150: Civil House
p.000150: Sub-branch for Legal Affairs
p.000150: LAW No. 9,782, OF JANUARY 26, 1999.
p.000150: Compiled text
p.000150: Regulation Defines the National Health Surveillance System, creates the National Health Surveillance Agency, and gives
p.000150: other measures.
p.000150: Conversion of Provisional Measure 1,791, 1998
p.000150: Let me know that the PRESIDENT OF THE REPUBLIC adopted Provisional Measure 1,791, of 1998, which the National Congress approved, and I, Antonio Carlos Magalhães, President, for the purposes of
p.000150: the sole paragraph of art. 62 of the Federal Constitution, I enact the following Law:
p.000150: CHAPTER I
p.000150: Art. 1 The National Health Surveillance System comprises the set of actions defined by § 1 of art. 6th and by arts. 15 to 18 of Law 8,080, of September 19, 1990, executed by institutions
p.000150: of the direct and indirect Public Administration of the Union, the States, the Federal District and the Municipalities, which exercise activities of regulation, standardization, control and inspection in the area of health surveillance.
p.000150: Article 2. It is incumbent upon the Union within the scope of the National Health Surveillance System:
p.000150: I - define the national health surveillance policy;
p.000150: II - define the National Health Surveillance System;
p.000150: III - standardize, control and inspect products, substances and services of interest to health;
p.000150: IV - exercise health surveillance of ports, airports and borders, and this attribution may be supplemented by the States, the Federal District and the Municipalities;
p.000150: V - monitor and coordinate state, district and municipal health surveillance actions;
p.000150: VI - provide technical and financial cooperation to the States, the Federal District and the Municipalities;
p.000150: VII - act in special health risk circumstances; and
p.000150: VIII - maintain a health surveillance information system, in cooperation with the States, the Federal District and the Municipalities.
p.000150: § 1 The competence of the Union will be exercised:
p.000150: I - by the Ministry of Health, with regard to the formulation, monitoring and evaluation of the national health surveillance policy and the general guidelines of the National Health Surveillance System;
p.000150: II - by the National Health Surveillance Agency - ANVS, in accordance with the powers conferred on it by this Law; and
p.000150: III - by the other organs and entities of the Federal Executive Branch, whose areas of activity are related to the system.
p.000150: § 2 The Federal Executive Branch will define the allocation, among its organs and entities, of the other attributions and activities performed by the National Health Surveillance System, not covered by
p.000150: this Law.
p.000150: § 3 The States, the Federal District and the Municipalities will provide, by agreement, the information requested by the coordination of the National Health Surveillance System.
p.000150: CHAPTER II
p.000150: CREATION AND COMPETENCE OF THE NATIONAL AGENCY
p.000150: OF SANITARY SURVEILLANCE
p.000150: Art. 3 The National Health Surveillance Agency is created, an autarchy under a special regime, linked to the Ministry of Health, with headquarters and venue in the Federal District, for an indefinite period and
p.000150: operating throughout the national territory.
p.000150: Art. 3 The National Health Surveillance Agency - ANVISA is created, an autarchy under a special regime, linked to the Ministry of Health, with headquarters and venue in the Federal District, duration
p.000150: undetermined and operating throughout the national territory. (Wording given by Provisional Measure nº 2.039-24, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
...
p.000150: § 5 The Agency may exempt from registration the immunobiologicals, insecticides, medicines and other strategic inputs when acquired through international multilateral organizations, for
p.000150: use in public health programs by the Ministry of Health and its related entities. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 6 The Minister of Health of the State may determine the performance of actions foreseen in the competences of the National Health Surveillance Agency, in specific cases and that imply health risk
p.000150: of the population. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 7 The act referred to in § 6 must be published in the Federal Official Gazette. (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: § 8 Services and facilities subject to sanitary control and inspection are those related to the activities of ports, airports and borders and at customs stations and terminals
p.000150: customs, water, land and air transport services. (See Provisional Measure No. 2,134-31, of 2001) (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: CHAPTER III
p.000150: OF THE AUTHORCHY'S ORGANIZATIONAL STRUCTURE
p.000150: Section I
p.000150: Basic Structure
p.000150: Art. 9 The Agency will be directed by a Collegiate Directorate, and must also have a Prosecutor, a Corregidor and an Ombudsman, in addition to specialized units charged with different
p.000150: functions.
p.000150: Single paragraph. The Agency will also have an Advisory Board, as provided by regulation.
p.000150: Single paragraph. The Agency will also count on an Advisory Council, which should have, at least, representatives of the Union, the States, the Federal District, the Municipalities, the producers, the
p.000150: traders, the scientific community and users, in the form of the regulation. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: Section II
p.000150: From the Collegiate Board
p.000150: Art. 10. The management and administration of the Agency will be exercised by a Collegiate Directorate, composed of up to five members, one of whom being its Chief Executive Officer.
p.000150: Single paragraph. The Directors will be Brazilian, nominated and appointed by the President of the Republic after prior approval by the Federal Senate under the terms of art. 52, III, "f", of the Federal Constitution, for
p.000150: three-year term of office, with a single reappointment permitted.
p.000150: Art. 10. The management and administration of the Agency will be exercised by a Collegiate Board of Directors made up of 5 (five) members, one of whom being its Chief Executive Officer,
p.000150: reappointment, pursuant to Law No. 9,986, of July 18, 2000. (Wording given by Law No. 13,848, of 2019)
p.000150: Single paragraph. The members of the Collegiate Board will be Brazilian, appointed by the President of the Republic and appointed by him, after prior approval by the Federal Senate,
p.000150: terms of item “f” of item III of art. 52 of the Federal Constitution, to fulfill a mandate of 5 (five) years, observing the provisions of Law No. 9,986, of July 18, 2000. (Editorial Staff
p.000150: given by Law No. 13,848, of 2019)
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic, from among the members of the Collegiate Board, and invested in the function for three years, or for the remainder of his term.
p.000150: mandate, a single reappointment is allowed for three years.
p.000150: Art. 11. The Chief Executive Officer of the Agency will be appointed by the President of the Republic and invested in the function for 5 (five) years, renewal is prohibited, subject to the provisions of Law no.
p.000150: 9,986, of July 18, 2000. (Wording provided by Law No. 13,848, of 2019)
p.000150: Art. 12. The unreasonable dismissal of a Director of the Agency can only be promoted in the initial four months of the mandate, at the end of which his full and full exercise will be ensured, except in
p.000150: cases of practice of administrative misconduct, unappealable criminal conviction and unjustified non-compliance with the autarchy management contract. (Repealed by Law No. 13,848, of
p.000150: 2019) Term
p.000150: Art. 13. The directors of the Agency are prohibited from exercising any other professional, business, union or political party activity.
p.000150: Paragraph 1. It is also forbidden for managers to have a direct or indirect interest in a company related to the area of activity of the Health Surveillance, provided for in this Law, as provided in the regulation.
p.000150: § 2 The prohibition referred to in the caput of this article does not apply to cases in which the professional activity arises from a contractual relationship maintained with public entities destined to teaching and research,
p.000150: including those governed by private law.
p.000150: § 3 In the event of non-compliance with the obligation provided for in the caput and in § 1 of this article, the infringer will lose his position, without prejudice to responding to the applicable civil and criminal actions.
p.000150: Art. 14. Up to one year after leaving office, the former director is prohibited from representing any person or interest before the Agency.
p.000150: Single paragraph. During the term established in the caput, the former officer is also prohibited from using privileged information obtained as a result of the position held, under penalty of
p.000150: incur an act of administrative improbity.
p.000150: Art. 15. The Collegiate Board of Directors is responsible for:
p.000150: Art. 15. The Collegiate Board of Directors is responsible for: (See Provisional Measure nº 2.000-16, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: I - exercise the administration of the Agency;
p.000150: I - define the Agency's strategic guidelines; (See Provisional Measure No. 2000-16, 2000) (Wording provided by Provisional Measure No. 2,190-34, 2001)
...
p.000150: 2019)
p.000150: VI - effective period; (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: VII - requirements and conditions for revising the management contract. (Included by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: Art. 20. Unjustified non-compliance with the management contract will imply the dismissal of the Director-President, by the President of the Republic, upon request of the Minister of State for Health.
p.000150: Art. 20. Unjustified non-compliance with the goals and obligations agreed in the management contract in two consecutive financial years will imply the exoneration of the members of the Executive Board
p.000150: Collegiate by the President of the Republic, at the request of the Minister of State for Health. (Wording given by Law No. 13,411, 2017) (Term) (Repealed by Law No. 13,848, 2019)
p.000150: Validity
p.000150: CHAPTER V
p.000150: Equity and Revenue
p.000150: Section I
p.000150: City Hall Revenue
p.000150: Art. 21. The assets and rights of its property, which are conferred on it or which it acquires or incorporates, constitute the Agency's assets.
p.000150: Art. 22. The Agency's revenue comprises:
p.000150: I - the product resulting from the collection of the sanitary surveillance inspection fee, pursuant to this Law;
p.000150: II - remuneration for services of any nature provided to third parties;
p.000150: III - the proceeds from the collection of revenue from fines resulting from inspection actions;
p.000150: IV - the proceeds from the execution of its active debt;
p.000150: V - the appropriations recorded in the General Budget of the Union, special credits, additional credits and transfers and transfers that are granted to it;
p.000150: VI - funds from agreements, agreements or contracts entered into with national and international entities and bodies;
p.000150: VII - donations, bequests, subsidies and other resources allocated to it;
p.000150: VIII - the amounts calculated on the sale or rental of movable and immovable property owned by it; and,
p.000150: IX - the proceeds from the sale of assets, objects and instruments used for the practice of infraction, as well as the assets of the offenders, seized as a result of the exercise of police power and
p.000150: incorporated into the Agency's assets under the terms of a court decision.
p.000150: X - the amounts calculated on investments in the financial market of the revenues provided for in items I to IV and VI to IX of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Single paragraph. The funds provided for in items I, II and VII of this article, will be collected directly from the Agency, as defined by the Executive Branch.
p.000150: Art. 23. The Sanitary Surveillance Inspection Fee is hereby established.
p.000150: Paragraph 1 It is a triggering event of the Sanitary Surveillance Inspection Fee the practice of acts within the competence of the National Sanitary Surveillance Agency set out in Annex II.
p.000150: Paragraph 2. The taxpayers referred to in the caput of this article are taxable persons for individuals and companies that carry out activities in the manufacture, distribution and sale of products and the provision of services.
p.000150: mentioned in art. 8 of this Law.
...
p.000150: Tecnologia - GDCT, created by Law nº 9.638, of May 20, 1998. (Repealed by Provisional Measure nº 2.190-34, of 2001)
p.000150: § 1 The bonus referred to in the caput will also be due to the occupants of the intermediate positions of the Technological Development career in the exercise of activities inherent to the
p.000150: their duties at the Agency. (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 2 The Gratification of Performance of Science and Technology Activity - GDCT, for the occupants of the effective positions of intermediate level of the career of Management, Planning and Infrastructure in
p.000150: Science and Technology, created by Law No. 9,647, of May 26, 1998, will be due to these civil servants exercising activities inherent to the attributions of the respective positions in the Agency. (Repealed by
p.000150: Provisional Measure No. 2,190-34, of 2001)
p.000150: § 3 For the purposes of perceiving the bonuses referred to in this article, the other criteria and rules established in the legislation in force will be observed. (Repealed by Provisional Measure No. 2,190-34,
p.000150: 2001)
p.000150: Paragraph 4. The provisions of this article apply only to Fundação Osvaldo Cruz servers employed at the National Institute for Quality Control in Health on December 31, 1998, and who come to
p.000150: be redistributed to the Agency. (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 40. The Federal Attorney General's Office and the Ministry of Health, through their Legal Consultancy, through a joint commission, will promote, within one hundred and eighty days, a survey of the
p.000150: legal actions in progress, involving matters whose competence has been transferred to the Agency, which will replace the Union in the respective processes.
p.000150: § 1 The substitution referred to in the caput, in those judicial processes, will be required through a petition signed by the Attorney General's Office, addressed to the competent Court or Court, requesting the
p.000150: summons from the Agency's Attorney's Office to assume the feat.
p.000150: § 2 As long as the substitution in the form of the previous paragraph has not been carried out, the Attorney General's Office will remain in the case, practicing all the necessary procedural acts.
p.000150: Art. 41. The registration of products covered by Law No. 6,360, of 1976, and Decree-Law No. 986, of October 21, 1969, may be subject to regulation by the Ministry of Health and the Agency
p.000150: aiming at reducing bureaucracy and agility in procedures, as long as this does not imply risks to the health of the population or to the condition of inspection of production and circulation activities.
p.000150: Single paragraph. The Agency may grant operating authorization to companies and registration for products that are applicable only to productive plants and to goods destined for markets.
p.000150: as long as it does not entail risks to public health.
p.000150: § 1 The Agency may grant operating authorization to companies and registration of products that are applicable only to productive plants and to goods destined for foreign markets, provided that
p.000150: that do not pose risks to public health. (Renumbered from the sole paragraph by Provisional Measure No. 2,190-34, 2001)
p.000150: Paragraph 2. The regulation referred to in the caput of this article also includes exemption from registration. (Included by Provisional Measure No. 2,190-34, of 2001)
...
Social / Women
Searching for indicator women:
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p.000150: and services provided for in this item, maintaining legal confidentiality when applicable; (See Provisional Measure No. 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: c) when the existence of indications of the occurrence of infractions provided for in items III or IV of art. 20 of Law 8,884, of June 11, 1994, through an unjustified increase in prices or
p.000150: the imposition of excessive prices, for the goods and services referred to in these items, summon those responsible to, within a maximum period of ten working days, justify the respective conduct; (See Provisional Measure nº
p.000150: 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: d) apply the penalty provided for in art. 26 of Law No. 8,884, of 1994; (See Provisional Measure No. 1,912-9, 1999) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVI - to control, inspect and monitor, from the point of view of health legislation, the advertising and publicity of products subject to the health surveillance regime; (See Provisional Measure No. 2000-17,
p.000150: 2000) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVII - to define, in a specific act, the places of entry and exit of narcotics, psychotropics and precursors in the country, after hearing the Federal Police Department and the Federal Revenue Secretariat. (See
p.000150: Provisional Measure No. 2,134-31, 2001) (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: XXVIII - monitor the establishment of the Registration, Surveillance and Monitoring Committees for Pregnant Women and Women at Risk within the scope of the National Registration, Surveillance and
p.000150: Monitoring of pregnant women and mothers for the prevention of maternal mortality by public and private health establishments, whether or not they are members of the Unified Health System - SUS. (Included
p.000150: by Provisional Measure 557, of 2011) Not effective
p.000150: § 1 The Agency may delegate to the States, the Federal District and the Municipalities the execution of its own attributions, except those provided for in items I, V, VIII, IX, XV, XVI, XVII, XVIII and
p.000150: XIX of this article.
p.000150: § 2 The Agency may advise, complement or supplement state, municipal and Federal District actions for the exercise of sanitary control.
p.000150: § 3 The activities of epidemiological surveillance and vector control related to ports, airports and borders, will be carried out by the Agency, under technical and normative guidance from the Ministry of
p.000150: Cheers.
p.000150: § 4 The Agency may delegate to the Ministry of Health agency the performance of the duties provided for in this article related to medical, ambulatory and hospital services, provided for in §§ 2 and 3 of art.
p.000150: 8, subject to the restrictions defined in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Paragraph 5. The Agency must always guide its performance in compliance with the guidelines established by Law No. 8,080, of September 19, 1990, in order to continue the process of decentralization of
p.000150: execution of activities for States, Federal District and Municipalities, observing the prohibitions listed in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 6 The decentralization referred to in § 5 will only be effective after a favorable manifestation by the respective State, District and Municipal Health Councils. (Included by Provisional Measure nº
p.000150: 2,190-34, 2001)
...
Social / Youth/Minors
Searching for indicator minor:
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p.000300: 7.5.1 Large equipment for diagnosis or therapy, such as nuclear medicine,
p.000300: 20,000 Five years
p.000300: computed tomography, magnetic resonance and cineangiocoro-nariography.
p.000300: 7.5.2 Other medium and small sized equipment for diagnosis or therapy, articles,
p.000300: 8,000 Five years
p.000300: materials, products for in-use diagnostic use and other health products
p.000300: 7.5.3 Family of large equipment for diagnosis or therapy 28,000 Five years
p.000300: 7.5.4 Family of medium and small sized equipment for diagnosis or therapy, articles,
p.000300: 12,000 Five years
p.000300: materials, diagnostic reagents for "in vitro" use and other health products
p.000300: 7.6 Alteration, inclusion or exemption in the registration of health products 1,800 ---
p.000300: 7.7 Issuance of export certificate EXEMPT ---
p.000300: 8 X X X
p.000300: 8.1 Toxicological evaluation for product registration end X X
p.000300: 8.1.1 Technical product of active ingredient not registered in the country 1,800 ---
p.000300: 8.1.2 Technical product of active ingredient already registered in the Country 1,800 ---
p.000300: 8.1.3 Product formulated 1,800 ---
p.000300: 8.2 Toxicological assessment for component registration 1,800 ---
p.000300: 8.3 Toxicological evaluation for the purpose of Temporary Special Registration 1,800 ---
p.000300: 8.4 Toxicological reclassification 1,800 ---
p.000300: 8.5 Revaluation of product registration, according to Decree nº 991/93 1,800 ---
p.000300: 8.6 Toxicological assessment for the purpose of including culture 1,800 ---
p.000300: 8.7 Dose change X X
p.000300: 8.7.1 Dose change, for greater, in application 1.800 ---
p.000300: 8.8 Dose change, for a minor, in the EXEMPT application ---
p.000300: 9 X X X
p.000300: 9.1 Registration, revalidation or renewal of smoke registration
p.000300: Registration, revalidation or renewal of smoke registration, with the exception of products 100,000 Annual
p.000300: exclusively for export. (Wording given by Law No. 12,546, of 2011)
p.000300: 10 Consent to transmit advertising containing alerts to the population, within the deadline and under the conditions
p.000300: 10,000 ---
p.000300: indicated by the health authority
p.000300: 11 Consent in clinical research process 10,000 ---
p.000300: 12 Alteration or addition to the operating authorization 4,000 ---
p.000300: 13 Replacement of legal representative, responsible technician or cancellation of exempt authorization ---
p.000300: 14 Certificate, certificate and other declaratory acts 1,800 ---
p.000300: 15 Unarchiving process and duplicate document ---
p.000300: 1,800
p.000300: Grades:
p.000300: 1. The values in the Table are reduced by:
p.000300: a) fifteen percent, in the case of companies with annual sales of R $ or less
p.000300: 50,000,000.00 (fifty million reais) and more than R $ 20,000,000.00 (twenty million reais);
p.000300: b) thirty percent, in the case of companies with annual sales of R $ or less
p.000300: 20,000,000.00 (twenty million reais) and more than R $ 6,000,000.00 (six million reais);
p.000300: c) sixty percent, in the case of companies with annual sales equal to or less than R $
p.000300: 6,000,000.00 (six million reais);
p.000300: d) ninety percent, in the case of small companies;
p.000300: e) ninety-five percent, in the case of micro-enterprises, except for items 3.1, whose values,
p.000300: in the case of micro-enterprises, they are reduced by ninety percent.
...
Social / education
Searching for indicator education:
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p.000150: attributions, and the Health Surveillance Secretariat is extinguished. (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 31. The Executive Branch is authorized to:
p.000150: I - transfer to the Agency the technical and patrimonial collection, obligations, rights and revenues of the Ministry of Health and its organs, necessary for the performance of its functions;
p.000150: II - reallocate, transfer or use the budget balances of the Ministry of Health to meet the Agency's structuring and maintenance expenses, using budget allocations as resources
p.000150: intended for finalistic and administrative activities, subject to the same subprojects, subactivities and groups of expenses provided for in the current Budget Law.
p.000150: Art. 32. The Oswaldo Cruz Foundation is transferred to the National Health Surveillance Agency, the National Institute for Quality Control in Health, as well as its institutional attributions,
p.000150: assets and budget allocations. (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: Single paragraph. The Osvaldo Cruz Foundation will provide all the necessary support to maintain the activities of the National Institute for Quality Control in Health, until the organization of the Agency.
p.000150: (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 32-A. The National Health Surveillance Agency may, through the signing of technical and scientific cooperation agreements, request the execution of technical and scientific works, including those of
p.000150: economic and legal nature, giving preference to higher education and research institutions maintained by the public authorities and international organizations with which Brazil has cooperation agreements
p.000150: technical. (Included by Law No. 12,090, 2009). Validity
p.000150: Art. 33. The Agency may hire specialists to carry out work in the technical, scientific, economic and legal areas, for projects or limited terms, in compliance with the legislation in force.
p.000150: Art. 34. The Agency may request, in the first three years of its installation, with charges, servers or contractors, from bodies of entities that are members of the direct, indirect Federal Public Administration
p.000150: or foundational, whatever the functions to be performed. (Repealed by Law No. 9,986, of 2000)
p.000150: § 1 During the first twenty-four months following the installation of the Agency, the requests referred to in the caput of this article will be undeniable when made to organs and entities of the Power
p.000150: Federal Executive, and provided they are approved by the Ministers of State for Health and the Budget and Management. (Repealed by Law No. 9,986, of 2000)
p.000150: § 2 When the requisition implies a reduction in the remuneration of the requested servant, the Agency is authorized to supplement it up to the limit of the remuneration of the effective position perceived in the
p.000150: source. (Repealed by Law No. 9,986, of 2000)
p.000150: Art. 35. ANVS is prohibited from hiring personnel with employment or contractual ties with entities subject to the action of the Health Surveillance, as well as the respective owners or responsible persons,
p.000150: with the exception of participation in work commissions created for a specific purpose, with a fixed duration and not part of its organizational structure.
...
Social / employees
Searching for indicator employees:
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p.000150: evaluation of projects and programs of a final character in the area of health surveillance, the regulation and standardization of products, substances and services of interest to health, essential to the
p.000150: implementation of the Agency. (See Provisional Measure No. 155, of 2003) (Repealed by Law 10,871, of 2004)
p.000150: § 1 ANVS is authorized to perform temporary contracting, for the performance of the activities referred to in the caput of this article, for a period not exceeding thirty-six months from its
p.000150: installation. (Repealed by Law 10,871, of 2004)
p.000150: § 2 The hiring of temporary staff may be carried out in view of the professional's notorious technical or scientific capacity, through analysis of the curriculum vitae. (Repealed by Law 10,871, of
p.000150: 2004)
p.000150: § 3 Temporary hires will be made for a fixed period and subject to a maximum period of twelve months, which may be extended as long as their duration does not exceed the final term of the contract.
p.000150: authorization referred to in § 1. (Repealed by Law 10,871, of 2004)
p.000150: § 4 The remuneration of the temporarily hired personnel will have as reference values defined in a joint act of ANVS and the central body of the Civil Personnel System of the Federal Administration
p.000150: (SIPEC). (Repealed by Law 10,871, of 2004)
p.000150: § 5 The provisions of arts. Apply to personnel temporarily hired by ANVS. 5th and 6th, in the sole paragraph of art. 7, in arts. 8, 9, 10, 11, 12 and 16 of Law No. 8,745, of December 9, 1993.
p.000150: (Repealed by Law 10,871, of 2004)
p.000150: Art. 37. The staff of the Agency may have redistributed employees from organs and entities of the Federal Executive Branch. (Repealed by Law No. 9,986, of 2000)
p.000150: Art. 38. In a period not exceeding five years, the inspection of products, services, producers, distributors and traders, inserted in the National Health Surveillance System, may be
p.000150: performed by a requested server or belonging to the ANVS board, by designation of the Board, according to regulation.
p.000150: Art. 39. The occupants of the senior positions in the careers of Research in Science and Technology, Technological Development and Management, Planning and Infrastructure in Science and Technology
p.000150: Technology, created by Law 8,691, of July 28, 1993, exercising activities inherent to the respective attributions at the Agency, are entitled to the Gratification of Performance of Science and Technology Activity
p.000150: Tecnologia - GDCT, created by Law nº 9.638, of May 20, 1998. (Repealed by Provisional Measure nº 2.190-34, of 2001)
p.000150: § 1 The bonus referred to in the caput will also be due to the occupants of the intermediate positions of the Technological Development career in the exercise of activities inherent to the
p.000150: their duties at the Agency. (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 2 The Gratification of Performance of Science and Technology Activity - GDCT, for the occupants of the effective positions of intermediate level of the career of Management, Planning and Infrastructure in
p.000150: Science and Technology, created by Law No. 9,647, of May 26, 1998, will be due to these civil servants exercising activities inherent to the attributions of the respective positions in the Agency. (Repealed by
p.000150: Provisional Measure No. 2,190-34, of 2001)
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.000150: II - by the National Health Surveillance Agency - ANVS, in accordance with the powers conferred on it by this Law; and
p.000150: III - by the other organs and entities of the Federal Executive Branch, whose areas of activity are related to the system.
p.000150: § 2 The Federal Executive Branch will define the allocation, among its organs and entities, of the other attributions and activities performed by the National Health Surveillance System, not covered by
p.000150: this Law.
p.000150: § 3 The States, the Federal District and the Municipalities will provide, by agreement, the information requested by the coordination of the National Health Surveillance System.
p.000150: CHAPTER II
p.000150: CREATION AND COMPETENCE OF THE NATIONAL AGENCY
p.000150: OF SANITARY SURVEILLANCE
p.000150: Art. 3 The National Health Surveillance Agency is created, an autarchy under a special regime, linked to the Ministry of Health, with headquarters and venue in the Federal District, for an indefinite period and
p.000150: operating throughout the national territory.
p.000150: Art. 3 The National Health Surveillance Agency - ANVISA is created, an autarchy under a special regime, linked to the Ministry of Health, with headquarters and venue in the Federal District, duration
p.000150: undetermined and operating throughout the national territory. (Wording given by Provisional Measure nº 2.039-24, of 2000) (Wording given by Provisional Measure nº 2.190-34, of 2001)
p.000150: Single paragraph. The nature of special agency granted to the Agency is characterized by administrative independence, stability of its directors and financial autonomy.
p.000150: Art. 4 The Agency will act as an independent administrative entity, being guaranteed, under the terms of this Law, the necessary prerogatives for the proper exercise of its attributions.
p.000150: Art. 5 It will be the responsibility of the Executive Branch to install the Agency, and its regulation, approved by decree of the President of the Republic, establish its organizational structure.
p.000150: Single paragraph. The edition of the regulation will mark the installation of the Agency, investing it, automatically, in the exercise of its attributions. (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 6 The Agency's institutional purpose will be to promote the protection of the population's health, through sanitary control of the production and commercialization of products and services submitted to
p.000150: health surveillance, including environments, processes, inputs and related technologies, as well as the control of ports, airports and borders.
p.000150: Art. 7 The Agency is responsible for implementing and carrying out the provisions of items II to VII of art. 2 of this Law, and must:
p.000150: I - coordinate the National Health Surveillance System;
p.000150: II - foster and carry out studies and research within the scope of its duties;
p.000150: III - establish norms, propose, monitor and execute health surveillance policies, guidelines and actions;
p.000150: IV - establish norms and standards on limits of contaminants, toxic residues, disinfectants, heavy metals and others that involve health risk;
p.000150: V - temporarily intervene in the administration of producing entities, which are financed, subsidized or maintained with public resources, as well as in service providers and or producers
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000150: Article 8. It is incumbent upon the Agency, with due regard for the legislation in force, to regulate, control and inspect products and services that involve risk to public health.
p.000150: § 1 The following are considered to be goods and products submitted to health control and inspection by the Agency:
p.000150: I - medicines for human use, their active substances and other inputs, processes and technologies;
p.000150: II - food, including beverages, bottled water, its inputs, its packaging, food additives, limits for organic contaminants, pesticide residues and veterinary medicines;
p.000150: III - cosmetics, personal hygiene products and perfumes;
p.000150: IV - sanitizers intended for hygiene, disinfection or disinfestation in home, hospital and collective environments;
p.000150: V - kits, reagents and supplies for diagnosis;
p.000150: VI - medical-hospital, dental and blood therapy equipment and materials for laboratory and imaging diagnosis;
p.000150: VII - immunobiologicals and their active substances, blood and blood products;
p.000150: VIII - human and veterinary organs, tissues for use in transplants or reconstructions;
p.000150: IX - radioisotopes for in vivo diagnostic use and radiopharmaceuticals and radioactive products used in diagnosis and therapy;
p.000150: X - cigarettes, cigarillos, cigars and any other smoking product, derived or not from tobacco;
p.000150: XI - any products that involve the possibility of health risk, obtained by genetic engineering, by another procedure or still submitted to radiation sources.
p.000150: § 2 Services considered to be subject to sanitary control and inspection by the Agency, those aimed at outpatient care, whether routine or emergency, those performed on a
p.000150: hospitalization, diagnostic and therapeutic support services, as well as those that involve the incorporation of new technologies.
p.000150: § 3 Without prejudice to the provisions of §§ 1 and 2 of this article, the physical facilities, equipment, technologies, environments and procedures involved in health surveillance are subject to the health surveillance regime.
p.000150: all phases of the production processes of goods and products subject to sanitary control and inspection, including the destination of the respective residues.
p.000150: § 4 The Agency may regulate other products and services of interest for the control of risks to the health of the population, achieved by the National Health Surveillance System.
p.000150: § 5 The Agency may exempt from registration the immunobiologicals, insecticides, medicines and other strategic inputs when acquired through international multilateral organizations, for
p.000150: use in public health programs by the Ministry of Health and its related entities. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 6 The Minister of Health of the State may determine the performance of actions foreseen in the competences of the National Health Surveillance Agency, in specific cases and that imply health risk
p.000150: of the population. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 7 The act referred to in § 6 must be published in the Federal Official Gazette. (Included by Provisional Measure No. 2,190-34, 2001)
p.000150: § 8 Services and facilities subject to sanitary control and inspection are those related to the activities of ports, airports and borders and at customs stations and terminals
p.000150: customs, water, land and air transport services. (See Provisional Measure No. 2,134-31, of 2001) (Included by Provisional Measure No. 2,190-34, of 2001)
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000150: by Provisional Measure 557, of 2011) Not effective
p.000150: § 1 The Agency may delegate to the States, the Federal District and the Municipalities the execution of its own attributions, except those provided for in items I, V, VIII, IX, XV, XVI, XVII, XVIII and
p.000150: XIX of this article.
p.000150: § 2 The Agency may advise, complement or supplement state, municipal and Federal District actions for the exercise of sanitary control.
p.000150: § 3 The activities of epidemiological surveillance and vector control related to ports, airports and borders, will be carried out by the Agency, under technical and normative guidance from the Ministry of
p.000150: Cheers.
p.000150: § 4 The Agency may delegate to the Ministry of Health agency the performance of the duties provided for in this article related to medical, ambulatory and hospital services, provided for in §§ 2 and 3 of art.
p.000150: 8, subject to the restrictions defined in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Paragraph 5. The Agency must always guide its performance in compliance with the guidelines established by Law No. 8,080, of September 19, 1990, in order to continue the process of decentralization of
p.000150: execution of activities for States, Federal District and Municipalities, observing the prohibitions listed in § 1 of this article. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 6 The decentralization referred to in § 5 will only be effective after a favorable manifestation by the respective State, District and Municipal Health Councils. (Included by Provisional Measure nº
p.000150: 2,190-34, 2001)
p.000150: Paragraph 7. In order to comply with the provisions of item X of this article, the Agency may use confidential information on inspections received within the scope of agreements or arrangements with authority
p.000150: health authorities in other countries, as well as to authorize inspections and inspections of manufacturing plants by national or international institutions accredited by the Agency for such activities. (Included
p.000150: by Law No. 13,097, of 2015)
p.000150: Article 8. It is incumbent upon the Agency, with due regard for the legislation in force, to regulate, control and inspect products and services that involve risk to public health.
p.000150: § 1 The following are considered to be goods and products submitted to health control and inspection by the Agency:
p.000150: I - medicines for human use, their active substances and other inputs, processes and technologies;
p.000150: II - food, including beverages, bottled water, its inputs, its packaging, food additives, limits for organic contaminants, pesticide residues and veterinary medicines;
p.000150: III - cosmetics, personal hygiene products and perfumes;
p.000150: IV - sanitizers intended for hygiene, disinfection or disinfestation in home, hospital and collective environments;
p.000150: V - kits, reagents and supplies for diagnosis;
p.000150: VI - medical-hospital, dental and blood therapy equipment and materials for laboratory and imaging diagnosis;
p.000150: VII - immunobiologicals and their active substances, blood and blood products;
p.000150: VIII - human and veterinary organs, tissues for use in transplants or reconstructions;
p.000150: IX - radioisotopes for in vivo diagnostic use and radiopharmaceuticals and radioactive products used in diagnosis and therapy;
p.000150: X - cigarettes, cigarillos, cigars and any other smoking product, derived or not from tobacco;
...
p.000150: Single paragraph. The Agency may grant operating authorization to companies and registration for products that are applicable only to productive plants and to goods destined for markets.
p.000150: as long as it does not entail risks to public health.
p.000150: § 1 The Agency may grant operating authorization to companies and registration of products that are applicable only to productive plants and to goods destined for foreign markets, provided that
p.000150: that do not pose risks to public health. (Renumbered from the sole paragraph by Provisional Measure No. 2,190-34, 2001)
p.000150: Paragraph 2. The regulation referred to in the caput of this article also includes exemption from registration. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: § 3 The companies subject to Decree-Law nº 986, of 1969, are also obliged to comply with art. 2 of Law No. 6,360, of 1976, with regard to the authorization of operation by the Ministry of
p.000150: Health and licensing by the health agencies of the Federative Units in which they are located. (See Provisional Measure 1,814-4, 1999) (Included by Provisional Measure 2,190-34, 2001)
p.000150: Art. 41-A. The registration of medicines with exclusively generic denomination will have priority over the others, as provided in an act of the Collegiate Directorate of the National Surveillance Agency
p.000150: Sanitary. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 41-B. When the sale of products subject to sanitary surveillance, unfit for consumption is proven, the responsible company will be obliged to carry advertising containing an alert
p.000150: to the population, within the period and under the conditions indicated by the health authority, subject to the payment of a fee corresponding to the examination and the prior consent of the information content by the National Health Agency.
p.000150: Health Surveillance. (Included by Provisional Measure No. 2,190-34, of 2001)
p.000150: Art. 42. Art. 57 of Decree-Law No. 986, of 21 October 1969, becomes effective with the following wording:
p.000150: "Art. 57. The import of food, food additives and substances intended to be used in the manufacture of articles, utensils and equipment intended to enter
p.000150: in contact with food, is subject to the provisions of this Decree-law and its Regulations, and the control analysis is carried out by sampling, at the discretion of the health authority,
p.000150: at the time of landing in the country. "(NR)
p.000150: Art. 43. The Agency may seize goods, equipment, products and utensils used to commit crimes against public health, and to promote the respective judicial alienation, observed, with regard to
p.000150: applicable, the provisions of art. 34 of Law 6,368, of October 21, 1976, as well as requesting, in court, the blocking of bank accounts owned by the company and its owners and managers,
p.000150: responsible for those crimes.
p.000150: Art. 44. Arts. 20 and 21 of Law 6,360, of September 23, 1976, are effective with the following wording:
p.000150: "Art. 20. ............................................. .......................... "
p.000150: "Sole paragraph. A drug that does not have a substance that is known to be clinically or therapeutically beneficial cannot be registered." (NR)
p.000150: "Art. 21. The right to register medicines similar to others already registered is guaranteed, as long as they satisfy the requirements established in this Law." (NR)
p.000150: "§ 1 The similar drugs to be manufactured in the country, are considered registered after the end of one hundred and twenty days, counted from the presentation of the respective
p.000150: application, if it has not been rejected by then.
p.000150: Paragraph 2. The counting of the registration period will be interrupted until the satisfaction, by the interested company, of the requirement of the sanitary authority, which cannot exceed one hundred and
p.000150: eighty days.
p.000150: § 3 The registration, granted under the conditions of the preceding paragraphs, will lose its validity, regardless of notification or notification, if the product is not marketed
p.000150: within one year after the grant date, extendable for another six months, at the discretion of the health authority, upon written justification of the company's initiative
p.000150: interested.
p.000150: § 4 The request for a new product registration may be made two years after the verification of the fact that caused the loss of the validity of the previously granted, unless it is not
p.000150: attributable to the interested company.
p.000150: Paragraph 5. The provisions of this article apply to products registered and manufactured in a State which is part of the Southern Common Market - MERCOSUR, for the purpose of their
p.000150: commercialization in the country, if they correspond to a national similar already registered. "
p.000150: Art. 45. This Law comes into force on the date of its publication.
p.000150: Art. 46. Art. 58 of Decree-Law No. 986, of October 21, 1969.
p.000150: National Congress, on January 26, 1999; 178 th of Independence and 111 th of the Republic.
p.000150: ANTONIO CARLOS MAGALHÃES
p.000150: President
p.000150: This text does not replace the one published in the DOU of 27.1.1999
p.000150: ANNEX I
p.000150: (See Provisional Measure nº 1,912-7, of 1999) (See Provisional Measure nº 2,134-28, of 2001)
p.000150: (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: DEMONSTRATIVE FRAMEWORK FOR POSTS IN COMMISSION AND
p.000150: COMMISSIONED FUNCTIONS OF HEALTH SURVEILLANCE
p.000150: POSITIONS / NAME NE /
p.000150: FUNCTION UNIT CARGO / FUNCTION OF /
p.000150: FG No.
p.000150: BOARD 5 Director NE
p.000150: 5 Special Advisor 102.5
p.000150: 3 Auxiliary 102.1
p.000150: CABINET 1 Chief of Staff 101.4
p.000150: 1 Attorney 101.5
p.000150: 1 Corregidor 101.4
p.000150: 1 Ombudsman 101.4
p.000150: 1 Auditor 101.4
p.000150: 17 General Manager 101.5
p.000150: 38 Manager 101.4
p.000150: DEMONSTRATIVE FRAMEWORK OF COMMISSIONED FUNCTIONS OF SANITARY SURVEILLANCE OF THE NATIONAL SANITARY SURVEILLANCE AGENCY
p.000150: CODE / FCVS QTY. VALUE
p.000150: FCVS-V 42 1,170.00
p.000150: FCVS-IV 58 855.00
...
p.000300: 12,000 Five years
p.000300: materials, diagnostic reagents for "in vitro" use and other health products
p.000300: 7.6 Alteration, inclusion or exemption in the registration of health products 1,800 ---
p.000300: 7.7 Issuance of export certificate EXEMPT ---
p.000300: 8 X X X
p.000300: 8.1 Toxicological evaluation for product registration end X X
p.000300: 8.1.1 Technical product of active ingredient not registered in the country 1,800 ---
p.000300: 8.1.2 Technical product of active ingredient already registered in the Country 1,800 ---
p.000300: 8.1.3 Product formulated 1,800 ---
p.000300: 8.2 Toxicological assessment for component registration 1,800 ---
p.000300: 8.3 Toxicological evaluation for the purpose of Temporary Special Registration 1,800 ---
p.000300: 8.4 Toxicological reclassification 1,800 ---
p.000300: 8.5 Revaluation of product registration, according to Decree nº 991/93 1,800 ---
p.000300: 8.6 Toxicological assessment for the purpose of including culture 1,800 ---
p.000300: 8.7 Dose change X X
p.000300: 8.7.1 Dose change, for greater, in application 1.800 ---
p.000300: 8.8 Dose change, for a minor, in the EXEMPT application ---
p.000300: 9 X X X
p.000300: 9.1 Registration, revalidation or renewal of smoke registration
p.000300: Registration, revalidation or renewal of smoke registration, with the exception of products 100,000 Annual
p.000300: exclusively for export. (Wording given by Law No. 12,546, of 2011)
p.000300: 10 Consent to transmit advertising containing alerts to the population, within the deadline and under the conditions
p.000300: 10,000 ---
p.000300: indicated by the health authority
p.000300: 11 Consent in clinical research process 10,000 ---
p.000300: 12 Alteration or addition to the operating authorization 4,000 ---
p.000300: 13 Replacement of legal representative, responsible technician or cancellation of exempt authorization ---
p.000300: 14 Certificate, certificate and other declaratory acts 1,800 ---
p.000300: 15 Unarchiving process and duplicate document ---
p.000300: 1,800
p.000300: Grades:
p.000300: 1. The values in the Table are reduced by:
p.000300: a) fifteen percent, in the case of companies with annual sales of R $ or less
p.000300: 50,000,000.00 (fifty million reais) and more than R $ 20,000,000.00 (twenty million reais);
p.000300: b) thirty percent, in the case of companies with annual sales of R $ or less
p.000300: 20,000,000.00 (twenty million reais) and more than R $ 6,000,000.00 (six million reais);
p.000300: c) sixty percent, in the case of companies with annual sales equal to or less than R $
p.000300: 6,000,000.00 (six million reais);
p.000300: d) ninety percent, in the case of small companies;
p.000300: e) ninety-five percent, in the case of micro-enterprises, except for items 3.1, whose values,
p.000300: in the case of micro-enterprises, they are reduced by ninety percent.
p.000300: 2. In items 3.1.1, 3.1.2, 3.1.6, 3.1.8 and 7.1.1, the manufacturing process includes the activities necessary for the
p.000300: obtaining the products mentioned in these items.
p.000300: 3. In items 3.1.3, 3.1.7, 3.1.9 and 7.1.2, the distribution of medicines, cosmetics, hygiene products, perfume and
p.000300: household sanitizing includes storage and shipping activities.
p.000300: 4. For small and micro-enterprises, the fee for granting Certification of Good Manufacturing and Control Practices
p.000300: will be charged for each establishment or plant.
...
p.000300: in renovation.
p.000300: 9. The classification as a small and micro enterprise, for the purposes foreseen in item 1, will take place in
p.000300: in accordance with Law 9.841, of October 5, 1999.
p.000300: 10. It is exempt to collect fees for issuing certificates, certificates and other declaratory acts, unarchiving
p.000300: process and duplicate of document, when dealing with export-oriented activity.
p.000300: 11. It is exempt to collect a fee for adding or changing the registration, regarding the text of the package insert, use form
p.000300: and labeling, telephone number change, CGC / CNPJ number, or other legal information, as provided by the
p.000300: ANVISA Collegiate Board.
p.000300: 12. The reduction values provided for in item 1 do not apply to items 3.1.5 and 5.1.13 of the Table, and to companies
p.000300: located in countries other than MERCOSUR members.
p.000300: 13. To companies that perform express delivery activities (courier) and that are framed in the letters "a", "b" and "c"
p.000300: of item 1 of the Notes, regardless of invoicing, the single import consent fee for goods
p.000300: of items 5.3, 5.4, 5.6, 5.7 and 5.8 of this Annex, in the amount of R $ 40.00.
p.000300: 14. To companies that perform express delivery activities (courier) and that are covered by letters "a", "b" and "c"
p.000300: item 1 of the Notes, regardless of billing, the export consent fee for the goods
p.000300: treat items 5.9.5.1 and 5.9.5.2 of this Annex, in the following values:
p.000300: a) R $ 40.00, in the case of a maximum of 20 samples per consignment to recipient, proven
p.000300: per item, upon verification of the bill of lading by the health authority;
p.000300: b) R $ 80.00, in the case of 21 to 50 samples per shipment to the recipient, confirmed by item,
p.000300: by checking the bill of lading for cargo by the health authority.
p.000300: 15. ANVISA's Collegiate Board of Directors will adapt the provisions of item 5.14 and their discounts to the size of vessels by
p.000300: net tonnage and class, types of navigation, waterways and displacements made.
p.000300: 16. For the purposes of the provisions of the previous item, it is considered:
p.000300: 16.1. Net tonnage - AL: expression of a vessel's net capacity, determined in accordance with the
p.000300: requirements of these rules, depending on the volume of enclosed spaces intended for cargo transportation, the
p.000300: number of passengers transported, the place where the passengers will be transported, the draft / point ratio and
p.000300: of gross tonnage, understood net tonnage still as a dimensionless size.
p.000300: 16.2. Class of boats: recreational sport, fishing, passengers, cargo, mixed and others.
p.000300: 16.3. Navigation type:
p.000300: 16.3.1. Open Sea Navigation: carried out in maritime waters considered homeless, which may be:
p.000300: 16.3.1.1. Long Course: that carried out between Brazilian and foreign ports;
p.000300: 16.3.1.2. Cabotage: that carried out between ports or points in the Brazilian territory used by sea
p.000300: or this and inland waterways; and
p.000300: 16.3.1.3. Maritime Support: that carried out for logistical support to vessels and installations in waters
p.000300: national territories and in the exclusive economic zone, which act in research and mining activities
p.000300: minerals and hydrocarbons;
p.000300: 16.3.2. Inland Navigation: carried out on inland waterways thus considered rivers, lakes, channels, lagoons,
p.000300: bays, coves, coves and maritime areas considered sheltered;
p.000300: 16.3.3. Port Support Navigation: carried out exclusively in ports and waterway terminals for
p.000300: service of vessels and port facilities.
...
Orphaned Trigger Words
p.000150: II - foster and carry out studies and research within the scope of its duties;
p.000150: III - establish norms, propose, monitor and execute health surveillance policies, guidelines and actions;
p.000150: IV - establish norms and standards on limits of contaminants, toxic residues, disinfectants, heavy metals and others that involve health risk;
p.000150: V - temporarily intervene in the administration of producing entities, which are financed, subsidized or maintained with public resources, as well as in service providers and or producers
p.000150: exclusive or strategic for supplying the national market, in compliance with the provisions of art. 5 of Law No. 6,437, of August 20, 1977, with the wording given by art. 2 of Law No. 9,695, of 20
p.000150: August 1998;
p.000150: VI - administer and collect the health surveillance inspection fee, established by art. 23 of this Law;
p.000150: VII - to authorize the operation of companies that manufacture, distribute and import the products mentioned in art. 6th of this Law;
p.000150: VII - to authorize the operation of companies that manufacture, distribute and import the products mentioned in art. 8th of this Law and of commercialization of medicines; (Wording given by Measure
p.000150: Provisional No. 2,190-34, of 2001)
p.000150: VIII - agree with the import and export of the products mentioned in art. 8 of this Law;
p.000150: IX - grant product registrations, according to the rules of its area of operation;
p.000150: X - grant and cancel the certificate of compliance with good manufacturing practices;
p.000150: XI - require, by means of specific regulations, the certification of conformity within the scope of the Brazilian Certification System - SBC, of products and services under the health surveillance regime according to
p.000150: your risk class; (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: XII - require accreditation, within the scope of SINMETRO, of diagnostic and therapeutic support services laboratories and others of interest for the control of risks to the health of the population, as well as
p.000150: those that involve the incorporation of new technologies; (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: XIII - require the accreditation of public fiscal analysis laboratories within the scope of SINMETRO; (Repealed by Provisional Measure No. 2,190-34, of 2001)
p.000150: XIV - prohibit, as a health surveillance measure, the places of manufacture, control, import, storage, distribution and sale of products and services related to health, in case of
p.000150: violation of relevant legislation or imminent health risk;
p.000150: XV - prohibit the manufacture, import, storage, distribution and sale of products and supplies, in case of violation of the relevant legislation or of imminent health risk;
p.000150: XVI - cancel the operating authorization and the special operating authorization of companies, in case of violation of the relevant legislation or of imminent health risk;
p.000150: XVII - coordinate health surveillance actions carried out by all laboratories that make up the official network of quality control laboratories in health;
p.000150: XVIII - establish, coordinate and monitor toxicological and pharmacological surveillance systems;
p.000150: XIX - promote the periodic review and update of the pharmacopoeia;
p.000150: XX - maintain a continuous and permanent information system to integrate its activities with other health actions, with priority to epidemiological surveillance and outpatient care and
p.000150: hospital;
p.000150: XXI - monitor and audit the state, district and municipal bodies and entities that are part of the National Health Surveillance System, including the official quality control laboratories in
p.000150: Cheers;
p.000150: XXII - coordinate and carry out the quality control of goods and products listed in art. 8 of this Law, by means of analyzes foreseen in the sanitary legislation, or special programs of
p.000150: monitoring of health quality;
p.000150: XXIII - encourage the development of human resources for the system and national and international technical-scientific cooperation;
p.000150: XXIV - assess and apply the penalties provided for by law.
p.000150: XXV - monitor the evolution of prices of medicines, equipment, components, supplies and health services, being able to do so: (Included by Provisional Measure nº 2,190-34, of 2001)
p.000150: a) request, when deemed necessary, information on production, inputs, raw materials, sales and any other data, held by persons of public or private law who are dedicated to
p.000150: activities of production, distribution and commercialization of the goods and services provided for in this item, maintaining legal confidentiality when applicable; (See Provisional Measure No. 1,912-9, 1999) (Included by Measure
p.000150: Provisional No. 2,190-34, of 2001)
...
p.000150: cadastral,
p.000150: Business merger or incorporation)
p.000150: 3. Replacement of legal representative, resp. technical or cancellation of
p.000150: authorization
p.000150: Indeterminate exemption
p.000150: 4. Certification of good manufacturing and control practices for each
p.000150: establishment or plant, type of activity and production line /
p.000150: commercialization
p.000150: 4.1. In the Country and Mercosur
p.000150: 4.1.1. Medicines 30,000 annually
p.000150: 4.1.2. Equipment and related 12,000 annually
p.000150: 4.1.3. Other 4,000 per year
p.000150: 4.2. Other countries 37,000 annually
p.000150: 5. Registration of
p.000150: 5.1. Cosmetics 3,700 three years
p.000150: 5.2. Sanitizing 11,700 three years
p.000150: 5.3.1. Equipment, Apparatus and Instruments 65,000 three years
p.000150: 5.3.2. Others (diagnostic kits and blood bags) 16,300 three years
p.000150: 5.4. Medicines
p.000150: 5.4.1. New 80,000 five years
p.000150: 5.4.2. Similar 35,000 five years
p.000150: 5.4.3. Generic 10,600 five years
p.000150: 5.5. Food and Beverage 10,000 five years
p.000150: 5.6. Tobacco and Similar 100,000 annually
p.000150: 6. Addition or Modification to the Registry
p.000150: 6.1. Presentation 1,800 undetermined
p.000150: 6.2. Concentration and Pharmaceutical Form 4,500 undetermined
p.000150: 6.3. Label text, use form and labeling 2,200 undetermined
p.000150: 6.4. Expiry or cancellation period Undetermined
p.000150: 6.5. Any other 8,100 undetermined
p.000150: 7. Exemption from indeterminate 2,200 registration
p.000150: 8. Certificate, certificate, toxicological classification, extension of use, quota of
p.000150: marketing by company of controlled product other acts
p.000150: declaratory 10,000 undetermined
p.000150: 9. Unarchiving of process and duplicate of document 2,200 undetermined
p.000150: 10. Consent in the notification of advertising of products for placement
p.000150: maximum 6 months
p.000150: 8,800 undetermined
p.000150: 11. Consent in import or export process for research 10,000
p.000150: clinic
p.000150: 12. Consent for tax exemption and in the process of import or Indeterminate exemption
p.000150: export of products. subject to Health Surveillance.
p.000150: 13. Consent in import and export process for the purposes of
p.000150: commercialization of a product subject to Health Surveillance
p.000150: 100 undetermined
p.000150: 14. Collection and transportation of samples for product control analysis
p.000150: imported.
p.000150: 150
p.000150: - within the municipality
p.000300: 300
p.000300: - another municipality in the same state
p.000300: 600 Undetermined
p.000300: - another state
p.000300: 15. Inspection to verify compliance with sanitary requirements 500 undetermined
p.000300: 16. Sanitary Control Activities of Ports, Airports and Borders
p.000300: 16.1. Issuance of Ratification Certificate and Exemption from Ratification of 1000 Undetermined
p.000300: Vessel
p.000300: 16.2. Issuance of 500 Passengers and Crew Disembarkation Guide
p.000300: Aircraft vessels and land vehicles of international transit.
p.000300: 16.3. Issuance of Indeterminate 600 Free Practice Certificate
p.000300: 16.4. Issuance of a Corpse Transfer Guide - in Aircraft and 150 Undetermined Vessels
p.000300: land vehicles in interstate and international transit
p.000300: The table values are reduced, except 16.1, 16.2, 16.3, 16.4, in:
p.000300: a) 30% in the case of medium-sized companies as defined by Law 9,531 of December 10, 1997;
p.000300: b) 60% in the case of small companies as defined in Law 9,317 of December 5, 1996;
p.000300: c) 90% in the case of micro companies as defined in Law 9,317 of December 5, 1996.
p.000300: Note: In the case of companies that are in the process of being installed, the collection will be made by self-declaration, to be proven in the year
p.000300: subsequent period, without which the discounted amount will be due.
p.000300: ANNEX II
p.000300: (Wording given by Provisional Measure No. 2,190-34, of 2001)
p.000300: See Law No. 11,972, of 2009
p.000300: (See Law No. 13,043, of 2014)
p.000300: HEALTH SURVEILLANCE SURVEILLANCE RATE
p.000300: Values Term for
...
p.000300: of waste resulting from the treatment of wastewater and waste at port terminals and Annual
p.000300: 6,000
p.000300: cargo and traveler airports, customs terminals for public use and stations and (See Law No. 13,043, 2014)
p.000300: border crossings
p.000300: 5.1.11 Authorization for the operation of companies that provide sewage services and
p.000300: treatment of sanitary effluents from aircraft, vessels and land vehicles in Annual
p.000300: 6,000
p.000300: transit through stations and border crossings at airport, port and terminals (See Law No. 13,043, 2014)
p.000300: border stations and crossings
p.000300: 5.1.12 Authorization for the operation of companies that provide segregation, collection,
p.000300: conditioning, storage, transport, treatment and final disposal of waste
p.000300: Yearly
p.000300: solids resulting from aircraft, land vehicles in transit through stations and passages 6,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: border, vessels, port and airport terminals for cargo and travelers,
p.000300: customs terminals for public use and border stations and crossings
p.000300: 5.1.13 Authorization to operate companies that provide services in the areas
p.000300: port, airport and border stations and crossings, laundry, service
p.000300: Yearly
p.000300: doctor, hospitality, drugstores, pharmacies and herbalists, trade in materials and equipment 500
p.000300: (See Law No. 13,043, of 2014)
p.000300: hospitals, barbers and hairdressers' salons, pedicures and beauty institutes and
p.000300: congeners
p.000300: 5.1.14 Authorization to operate companies intended to manage, represent or administer
p.000300: Yearly
p.000300: business, on behalf of a shipping company, taking the necessary steps to the 6,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: ship dispatch in port (shipping agency)
p.000300: 5.2 Consent in the process of importing products subject to health surveillance X X
p.000300: 5.2.1 Consent to import, by legal entity, goods, products, raw materials and inputs
p.000300: X X
p.000300: subject to health surveillance, for the purposes of commercialization or industrialization
p.000300: 5.2.1.1 Imports of up to ten items of goods, products, raw materials or inputs 100 ---
p.000300: 5.2.1.2 Imports of eleven to twenty items of goods, products, raw materials or inputs 200 ---
p.000300: 5.2.1.3 Imports of twenty-one to thirty items of goods, products, raw materials or inputs 300 ---
p.000300: 5.2.1.4 Imports of thirty-one to fifty items of goods, products, raw materials or inputs 1,000 ---
p.000300: 5.2.1.5 Imports of fifty one to one hundred items of goods, products, raw materials or inputs 2,000 ---
p.000300: 5.3 Consent to import, by individuals, medical-medical materials and equipment
p.000300: hospital and diagnostic products for "in vitro" use, subject to health surveillance, 100 ---
p.000300: for the purpose of offering and trading services to third parties
p.000300: 5.4 Consent to import, by hospitals and private health establishments, materials and
p.000300: medical-hospital equipment and products for diagnostic use "in vitro", subjects 100 ---
p.000300: health surveillance, for the purpose of offering and trading services to third parties
p.000300: 5.5 Import and export consent, by individuals, of products or raw materials
p.000300: EXEMPT ---
p.000300: subject to health surveillance, for the purpose of individual or own use
p.000300: 5.6 Consent to import, by legal entity, product samples or raw materials
p.000300: 100 ---
p.000300: subject to health surveillance, for analysis and experiments, with a view to product registration
p.000300: 5.7 Consent to import, by legal entity, product samples or raw materials
p.000300: 100 ---
p.000300: subject to health surveillance, for demonstration purposes at fairs or public events
p.000300: 5.8 Consent to import, by legal entity, product samples subject to surveillance
p.000300: 100 ---
p.000300: for demonstration purposes to specialized professionals
p.000300: 5.9 Consent in the process of exporting products subject to health surveillance --- ---
p.000300: 5.9.1 Export consent, by legal entity, of goods, products, raw materials and inputs
p.000300: EXEMPT ---
p.000300: subject to health surveillance, for the purposes of commercialization or industrialization
p.000300: 5.9.2 Consent to export, by legal entity, samples of goods, products, raw materials
p.000300: raw materials or inputs subject to health surveillance, for analysis and experiments, with a view to EXEMPTION ---
p.000300: product registration
p.000300: 5.9.3 Consent to export, by legal entity, product samples or raw materials
p.000300: EXEMPT ---
p.000300: subject to health surveillance, for demonstration purposes at fairs or public events
p.000300: 5.9.4 Consent to export, by legal entity, product samples subject to surveillance
p.000300: EXEMPT ---
p.000300: for demonstration purposes to specialized professionals
p.000300: 5.9.5 Consent to export and import, by legal entity, human biological samples, X X
p.000300: for testing and laboratory experiments
p.000300: 5.9.5.1 Export and import of a maximum of twenty samples 100 ---
p.000300: 5.9.5.2 Export and import of twenty-one to fifty samples 200 ---
p.000300: 5.9.6 Consent to export, by public research institutions, biological samples
p.000300: EXEMPT ---
p.000300: for the purpose of carrying out tests and laboratory experiments
p.000300: 5.9.7 Consent in substitutive import license related to import processes of
p.000300: 50 ---
p.000300: products and raw materials subject to health surveillance
p.000300: 5.10 Collection and transportation of samples for laboratory analysis of imported products subject to
p.000300: control analysis
p.000300: 5.10.1 within Municipality 150 ---
p.000300: 5.10.2 another Municipality in the same State 300 ---
p.000300: 5.10.3 other State 600 ---
p.000300: 5.11 Inspection to verify compliance with sanitary requirements related to disinhibition
...
p.000300: passengers
p.000300: 5.14.4.13 Port support interior, in exclusively national transit and with displacement
p.000300: 600 ---
p.000300: sea or sea-lake
p.000300: 5.14.4.14 Port support interior, in exclusively national transit and with displacement
p.000300: 600 ---
p.000300: maritime-fluvial, fluvial or fluvial-lacustrine
p.000300: 5.14.4.15 Interior who carry out another activity or service, in transit exclusively nationally and
p.000300: 600 ---
p.000300: with maritime or maritime-lake displacement
p.000300: 5.14.4.16 Interior who develop another activity or service, in transit exclusively nationally and
p.000300: 600 ---
p.000300: with maritime-fluvial, fluvial or fluvial-lacustrine displacement
p.000300: 5.14.4.17 Open or inland sea, which develop fishing activity, with departure and entry between
p.000300: 600 ---
p.000300: ports other than the national territory
p.000300: 5.14.4.18 Open or inland sea, which develop fishing activity, with departure and return to the same
p.000300: EXEMPT ---
p.000300: port of national territory and without intermediate stopovers
p.000300: 5.14.4.19 Interiors that develop sports and recreational activities with non-commercial purposes, in
p.000300: municipal, intercity or interstate transit, with maritime or maritime displacement - EXEMPT ---
p.000300: lake
p.000300: 5.14.4.20 Interior that develop sports and recreational activities with non-commercial purposes in transit
p.000300: municipal, intermunicipal or interstate, with maritime-lacustrine, maritime- EXEMPTION ---
p.000300: fluvial, fluvial or fluvial-lacustrine
p.000300: 5.14.4.21 Any vessel of the Brazilian Navy, or under its invitation, used for purposes other than
p.000300: EXEMPT ---
p.000300: commercials
p.000300: 6 X X X
p.000300: 6.1 Registration of sanitizers X X
p.000300: 6.1.1 Risk Grade II Product 8,000 Five years
p.000300: 6.2 Alteration, inclusion or exemption of sanitizing registration 1,800 ---
p.000300: 6.3 Sanitizing registry revalidation or renewal X X
p.000300: 6.3.1 Risk Grade II Product 8,000 Five years
p.000300: 6.4 Certification of Good Manufacturing Practices for each establishment or plant
p.000300: X See Law No. 11,972, of 2009
p.000300: by sanitizing production line
p.000300: 6.4.1 In the Country and MERCOSUR X X
p.000300: 6.4.1.1 Certification of Good Manufacturing Practices by establishment or manufacturing unit per line
p.000300: 15,000 Annual
p.000300: of production for household cleaning products
p.000300: 6.4.2 Other countries 37,000 Annual
p.000300: 7 X X X
p.000300: 7.1 Authorization and renewal of operation of companies by establishment or unit ---
p.000300: ---
p.000300: factory for each type of activity (See Law No. 13,043, 2014)
p.000300: 7.1.1 For the establishment that manufactures one or more health product lines ---
p.000300: 10,000
p.000300: (equipment, materials and products for diagnostic use "in vitro") (See Law nº 13.043, of 2014)
p.000300: 7.1.2 Distributor, importer, exporter, carrier, storehouse, packer, ---
p.000300: 8,000
p.000300: repackaging and others provided for in specific legislation on health products (See Law 13,043, 2014)
p.000300: 7.1.3 By establishment of retail trade of health products ---
p.000300: 5,000
p.000300: (See Law No. 13,043, of 2014)
p.000300: 7.2 Certification of Good Manufacturing Practices for health products, for each
p.000300: --- See Law No. 11,972, of 2009
p.000300: establishment or plant per production line
p.000300: 7.2.1 In the country and MERCOSUR --- ---
p.000300: 7.2.1.1 Certification of Good Manufacturing Practices for Health Products 15,000 Annual
p.000300: 7.2.2 Other countries 37,000 Annual
p.000300: 7.3 Certification of Good Practices for Distribution and Storage of health products by Annual
p.000300: 15,000
p.000300: establishment See Law No. 11,972, of 2009
p.000300: 7.4 Modi fi cation or increase in certi fi cation by including a new type of product line
p.000300: 5,000 ---
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| conviction | Religion |
| criminal | criminal |
| drug | Drug Usage |
| education | education |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| home | Property Ownership |
| homeless | Homeless Persons |
| minor | Youth/Minors |
| mothers | Mothers |
| officer | Police Officer |
| party | political affiliation |
| police | Police Officer |
| political | political affiliation |
| pregnant | Pregnant |
| property | Property Ownership |
| single | Marital Status |
| substance | Drug Usage |
| terminal | Terminally Ill |
| union | Trade Union Membership |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| home | ['property'] |
| officer | ['police'] |
| party | ['political'] |
| police | ['officer'] |
| political | ['party'] |
| property | ['home'] |
| substance | ['drug'] |
Trigger Words
capacity
consent
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input