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PROVISIONAL MEASURE NO. 2.000-17, of June 9, 2000.
Altera devices of the Law No. 9,782 of January 26, 1999, which defines the National Health Surveillance System, creates the National Health Surveillance Agency and gives other arrangements.
THE PRESIDENT OF THE REPUBLIC, in the use of the assignment that confers it on art. 62 of the Constitution, adopts the following Provisional Measure, with force of law:
Art. 1º The devices to be followed by Law No. 9,782 of January 26, 1999, go on to invigorate with the following amendments:
?Art. 7º .....................................................................................................................................
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VII-authorize the operation of companies of manufacture, distribution and import of the products mentioned in art. 8º of this Law and the marketing of medicinal products;
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XXV-monitor the evolution of prices of medications, equipment, components, inputs and health services, and may for so much:
a) apply for, when judging necessary, information on production, inputs, raw materials, sales and any other data, in power of people of public or private law who dedicate themselves to the activities of production, distribution and marketing of the goods and services provided for in this inciso, while maintaining legal secrecy when it is the case;
b) proceed to the examination of stockpiles, roles and written of any companies or persons of public or private law that lay down to the activities of production, distribution and marketing of the goods and services provided for in this inciso, maintaining legal secrecy when it is the case;
c) when there is verified the existence of indications of the occurrence of infractions foreseen in the incisions III or IV of the art. 20 of Law No. 8,884 of June 11, 1994, by unwarranted increase in the prices or imposition of excessive prices, of the goods and services referred to in these incisees, to convene those responsible to, within the maximum of ten working days, justify the respective conduct;
d) apply the forecasted penalty on the art. 26 of Law No. 8,884, of 1994;
XXVI-control, scrutinize and follow up, under the prism of health legislation, the advertisement and advertising of products submitted to the health surveillance regime.
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§ 4º The Agency will be able to delegate the organ of the Ministry of Health the execution of assignments provided in this article relating to medical-ambulatory-hospital services, provided for in § § 2º and 3º of the art. 8º, observed the gaskets set out in Paragraph 1º of this article.
§ 5º The Agency should pauper its acting always in observance of the guidelines laid down by Law No. 8,080 of September 19, 1990 to follow up on the Process of decentralization of the execution of activities for states, Federal District and Municipalities, observed the related gaskets in § 1º of this article.
§ 6º The decentralization of which treats the preceding paragraph will be effective only after favorable manifestation of the respective State, District and Municipal Board of Health Councils.? (NR)
?Art. 8º .....................................................................................................................................
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§ 5º The Agency will be able to dispense with registration os immunobiology, insecticides, medications and other strategic inputs when acquired through international multilateral bodies, for use in public health programs by the Ministry of Health and its linked entities.
§ 6º The Minister of State for Health will be able to determine the achievement of actions provided for in the competences of the National Health Surveillance Agency, in specific cases and which involve risk to the health of the population.
§ 7º The act of which treats the preceding paragraph is to be published in the Journal Official of the Union.? (NR)
?Art. 9º .....................................................................................................................................
Single Paragraph. The Agency shall, still, with an Advisory Board, which shall have at the very least representatives of the Union, the States, the Federal District, the Municipalities, the producers, the traders, the scientific community and the users, in the form of the regulation.? (NR)
?Art. 15. It is incumbent on the Colegified Directorate:
I-define the Agency's strategic guidelines;
II-propose to the Minister of State for Health the government policies and guidelines intended to enable the Agency to length of your goals;
III-edit standards on matters of competence the Agency;
IV-comply and enforce the standards regarding sanitary surveillance;
V-elaboration and to disseminate periodic reports on their activities;
VI-judging, in a degree of appeal, the decisions of the Agency, upon provocation from those concerned;
VII-forward the accounting demonstratives of the Agency to the competent bodies
§ 1º The Directorate shall meet with the presence of at least three Directors, among them the Director-President or his legal substitute, and shall act by a simple majority.
§ 2º Of The acts practiced by the Agency will fit recourse to the Colegiated Directorate, with suspensive effect, as the last administrative instance.? (NR)
?Art. 16. Compete with the Director-President:
I-represent the Agency in judgment or outside of it;
II-chair the meetings of the Colegiated Board;
III-decide ad referendum of the Directorate Collegiate matters of urgency;
IV-decide in case of a tie in the deliberations of the Colegiated Board;
V-appoint and exonerate servers, probing the effective posts, in commission and functions of trust, and exercise disciplinary power, pursuant to the current legislation;
VI-refer to the Advisory Board the periodic reports drawn up by the Colegiated Board;
VII-sign contracts, congeniums and order expenses;
VIII-elaborate, approve and promulgate the internal regiment, define the area of acting, the organization and the executive structure of the Agency;
IX-exercise the operational management of the Agency.? (NR)
?Art. 19. The Administration of the Agency shall be governed by a management contract, negotiated between its Chief Executive Officer and the Minister of State for Health, previously heard from the State Ministers of Finance and Planning, Budget and Management, at the maximum time of one hundred and twenty days following the appointment of the Director-President of the municipality.
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?Art. 22. ...................................................................................................................................
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X-the values ascertained in applications in the market financial of the revenue provided for in the incisos I to IV and VI to IX of this article.
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?Art. 23. ...................................................................................................................................
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§ 6º The laboratories instituted or controlled by the Public Power, producers of medicinal products and inputs subject to Law No. 6,360 of September 23, 1976, in view of the public health interest, are exempt from the payment of the Sanitary Surveillance Surveillance Fee.
§ 7º To the renewals of records, authorisations and certificates apply to the periodicities and values stipulated for the initial acts in the form provided for in Annex II.
§ 8º The provisions of the preceding paragraph shall apply to the contained in the § § 1º to 8º of the art. 12 and single paragraph of the art. 50 of Law No. 6,360, 1976, in § 2º of the art. 3º of the Decree-Law No. 986 of October 21, 1969, and § 3º of the art. 41 of this Law.? (NR)
?Art. 30. Constituted the National Health Surveillance Agency, with the publication of its internal regiment by the Colegiada Directorate, will become the Autarquia, automatically, vested in the exercise of its assignments, and extinguishes the Registry of Surveillance Sanitary.? (NR)
?Art. 41. ...................................................................................................................................
§ 1º The Agency will be able to grant operating authorization to companies and registration to products that are applicable only to productive plants and to goods destined for external markets, as long as they do not entail public health risks.
§ 2º The regulations referred to in the caput of this article reach inclusive of the registration exemption.
§ 3º The companies subject to the Decree-Law No. 986, 1969, stay, too, obliged to comply with art. 2º of Law No. 6,360 of 1976 with regard to the operating permit by the Ministry of Health and the licensing by the sanitary bodies of the Federative Units located.? (NR)
Art. 2º Law No. 9,782, of 1999, passes on increased invigoration of the following articles:
?Art. 41-A. The registration of uniquely generic denomination medications will have priority over those of the rest, as per act of the Colegiated Directorate of the National Health Surveillance Agency's Colegiated Board.? (NR)
?Art. 41-B. When it becomes proven the marketing of products subject to health surveillance, unfit for consumption, it will become the responsible company obliged to vehicular advertising containing alert to the population, within the period and under the conditions indicated by the health authority, by subjecting itself to the payment of fee corresponding to the examination and prior annuence of the informative content by the National Health Surveillance Agency.? (NR)
Art. 3º The National Institute of Quality Control in Health will be technically subordinate to the National Health Surveillance Agency and administratively to the Oswaldo Cruz Foundation.
Single paragraph. Nominations for the posts in committee and the assignments for gratified functions of the National Institute of Quality Control in Health will be of competence of the Minister of State for Health, per appointment of the Director-Chairman of the National Agency of Health Surveillance, listened to the President of the Oswaldo Cruz Foundation.
Art. 4º The imported foods in their original packaging will have as a cut-off date for regularization of their registration situation with the National Agency of Sanitary Vigilance the day 1º of March 2000.
Art. 5º The effective servers of the staff cadres of the Ministry of Health and the National Health Foundation, in exercise, on December 31, 1998, at the Registry of Health Surveillance and the Airport, Port and Border Posts stay redistributed to the National Health Surveillance Agency.
§ 1º The servers of the National Health Foundation, redistributed consonant disposed of the caput, will be framed in the same job plan of the servers coming from the Ministry of Health.
§ 2º Case the result of the framework of which it treats the preceding paragraph manages values lower than the previously perceived, the difference will be paid as nominally identified advantage, applying to the same percentage of general review or anticipation of the maturity reset.
Art. 6º The Annex I, in the part on the Demonstrstrative Framework of Commissioned Functions of Sanitary Vigilance of the National Health Surveillance Agency, and Annex II to Law No. 9,782 of 1999, passes the vigour, respectively, in the form of Annexes I and II to this Measure Provisional.
Art. 7º The arts. 2º and 3º of the Law No. 9,294 of July 15, 1996, they go on to invigorate with the following essay:
?Art. 2º .....................................................................................................................................
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§ 2º It is vetted the use of the products mentioned in the caput on the aircraft and collective transport vehicles.? (NR)
?Art. 3º .....................................................................................................................................
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§ 2º The advertisement will contain, in the means of communication and in function of its characteristics, warning, whenever possible spoken and written, about the maleffices of smoke, alcoholic beverages, medicines, therapies and agricultural defensives, second phrases established by the Ministry of Health, used sequentially, in a concurrent or rotating way.
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§ 6º The National Agency for Health Surveillance, to prevent the vehiculation of deceptive advertisement of products and services submitted to their control, may require prior presentation of copies of the advertising parts concerning these products and services, as per regulation approved by your Collegiate Board.? (NR)
Art. 8º The arts. 3º and 57 of the Law No. 6,360 of September 23, 1976 amended by art. 1º of Law No. 9,787 of February 10, 1999, they go on to invigorate with the following essay:
?Art. 3º .....................................................................................................................................
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XX-Similar Medicine-the one that contains the even or the same active principles, presents the same concentration, pharmaceutical form, route of administration, posology, and therapeutic indication, and which is equivalent to the medicine registered in the federal body responsible for health surveillance, may differ only in characteristics relating to the size and shape of the product, shelf life, packaging, labelling, excipients and vehicles, and shall always be identified by trade name or brand;
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?Art. 57. ...................................................................................................................................
Single paragraph. In addition to the trade name or trade mark, medicinal products must compulsorily display, in the parts referred to in the caput of this article, in the packaging and promotional materials the Brazilian Common Denomination or, where the case is the case, the Common Designation International, in letters and characters with size never less than half the size of the letters and characters of the trade name or brand.? (NR)
Art. 9º The caput of the art. 2º of Law No. 9,787 of February 10, 1999, passes the vigour with the following essay:
?Art. 2º The federal body responsible for health surveillance shall regulate, within the period of one hundred and eighty days, counted from February 11, 1999.? (NR)
Art. 10. The dispensing of medicinal products applies to the provisions of the art. 15 of Law No. 5,991, of December 17, 1973.
Art. 11. They are convalidated the acts practiced on the basis of the Provisional Measure No. 2.000-16 of May 11, 2000.
Art. 12. This Interim Measure shall come into force on the date of its publication.
Art. 13. The art is revoked. 4º of the Decree-Law No. 986 of October 21, 1969, the art. 82 of Law No. 6,360 of September 23, 1976, the art. 3º of Law No. 9,005 of March 16, 1995, the single paragraph of art. 5º, the incisos XI, XII and XIII of the art. 7º, the arts. 32 and 39 and its paragraphs of Law No. 9,782, of January 26, 1999.
Brasilia, June 9, 2000; 179º of Independence and 112º of the Republic.
FERNANDO HENRIQUE CArDOSO
José Serra
Martus Tavares
