PROVISIONAL MEASURE NO. 2.039-21, OF September 26, 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 aimed at enabling the Agency to fulfillment of its objectives;

III-edit standards on Agency competence matters;

IV-comply and enforce the standards regarding health 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 Board 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 acting area of the organizing units and the executive structure of the Agency;

IX-exercise management operational 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 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, reversed in the exercise of its assignments, extinguished the Registry of Sanitary Vigilance.? (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, 1976, in the case of 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 be given priority over that of the rest, as per act of the Colegiated Directorate of the National Health Surveillance Agency?. (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. The appointments to the posts in committee and the assignments for the gratified functions of the National Institute for Quality Control in Health will be of competence of the Minister of State for Health, per appointment of the Director-President of the National Agency of Sanitary Vigilance, 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 Agency National Health Vigilance Day 1º of March 2000.

Art. 5º The effective servers of the personnel cadres of the Ministry of Health and the National Health Foundation, in exercise, on December 31, 1998, at the The Office of Sanitary Vigilance and the Airports, Port and Border Posts stay redistributed to the National Health Surveillance Agency.

§ 1º The servers of the National Health Foundation, redistributed depending on the provisions of the caput, they 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 lower values to 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 your control, may require prior presentation of copies of the advertising pieces referring to 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 same 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 organ responsible for health surveillance, and 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;

.................................................................................................................................................? (NR)

Single paragraph. In the case of imported generic drugs, whose bioequivalence tests have been carried out outside the Country, the comparative dissolution trials between the medication-test, the international reference medicine used, should be presented in the study of bioequivalence and the national reference medicine.? (NR)

?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. 2.039-20, of August 26, 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, September 26, 2000; 179º of Independence and 112º of the Republic.

FERNANDO HENRIQUE CARDOSO

Barjas Negri

Martus Tavares

ANNEX I

DEMONSTRATIVE FRAMEWORK OF COMMISSIONED FUNCTIONS OF HEALTH SURVEILLANCE OF THE AGENCY NATIONAL HEALTH WATCHDOG

CÓDIGO/FCVS	QUANTITY	VALOR
FCVS V	42	1.170,00
FCVS IV	58	855.00
FCVS III	47	664.00
FCVS II	58	585.00
FCVS I	69	518.00
TOTAL	274	199,610.00

ANNEX II

TAXA DE AUDITING AND SANITARY SURVEILLANCE

ITEM	GENERATIVE FACTS	VALUES IN R$	DEADLINE FOR RENEWAL
1.	Authorization of operation of companies by establishment or unit fapril and for each type of activity	-
1.1	About the medications industry	20,000	annual
1.2	About the cordation industry	-
1.2.1	Equipment (nuclear medicine, computerized tomography, magnetic resonance and cineangiocoronagrafia	10,000	annual
1.2.2	Others equipment, instruments, and sets for diagnostics	5,000	annual
1.3	Distributors of medications	15,000	annual
1.4	Drogarias, pharmacies and trade retailer of medico-hospital material	5,000	annual
1.5	About the food and beverage industry	6.000	annual
1.6	About the cosmetics industry	6.000	annual
1.7	About the saneans industry	6.000	annual
1.8	Demals	6,000	annual
2.	Change to the addition in the authorization (type of activity, data cadastral, merger or business incorporation)	4,000	undetermined
3.	Substitution of legal representative, technical officer, or authorization cancellation	ISENTO
4.	Certification of good manufacturing and control practices for each establishment or unit fApril, type of activity and production line / commercialization.	-
4.1	In the Country and Mercosur	-
4.1.1	Medicaments	15,000	annual
4.1.2	Correports	-
4.1.2.1	Equipment (nuclear medicine, computerized tomography, magnetic resonance and cineangiocoronagrafia	10,000	annual
4.1.2.2	Others equipment, instruments, and sets for diagnostics	5,000	annual
4.1.3	Food and beverages	3.000	annual
4.1.4	Cosmetics	3.000	annual
4.1.5	Saneantes	3,000	annual
4.1.6	Demals	3,000	annual
4.2	Other countries	37,000	annual
5.	Registration or Renewal Of Product Registration or Group of Products	-
5.1	Cosmetics	2,500	five years
5.2.1	Saneantes-category 1	3,000	five years
5.2.2	Saneantes-category 2	8,000	five years
5.3	Correports	-
5.3.1	Equipment (nuclear medicine, computerized tomography, magnetic resonance and cineangiocoronagrafia)	20,000	five years
5.3.2	Others equipment, instruments, and sets for diagnostics	8,000	five years
5.4	Medicines	-
5.4.1	New	80,000	five years
5.4.2	Similars	21,000	five years
5.4.3	Generics	6,000	five years
5.5	Food and beverages	6,000	five years
5.6	Tobacco and similar	100,000	annual
6.	Addition or modification to the registry	-
6.1	Presentation	1,800	undetermined
6.2	Concentration and pharmaceutical form	1,800	undetermined
6.3	Bula text, usage form, and labeling	1.800	indetermined
6.4	Validity of validity or cancellation	ISENTO
6.5	Any other	1,800	indetermination
7.	Exemption from registration	1,800	indetermination
8.	Certify, attestative, toxicological classification, extension of use, marketing quota by controlled product company and too many declaratory acts	1,800	indeterminant
9.	Process and second document disarchiving	1,800	undetermined
10.	Annuence in advertising notification of products for maximum vehiculation of six months in the cases of notice to the population	8,800	indetermination
11.	Anuence in clinical research process	10,000	indetermination
12.	Annuence for tax exemption in process for importing or exporting products subject to Sanitary Vigilance	ISENTO
13.	Anuence in import and export process for product marketing purposes subject to Sanitary Vigilance	100	undetermined
14.	Collection and transport of samples for control analysis of imported products:	-
	-inside the Municipality	150	undetermined
	-other Municipality in the same state	300	undetermined
	-another state	600	undetermined
15.	Vistoria for fulfilment check of requirements sanitary	ISENTO
16.	Ports Sanitary Control Activities, Airports and Borders
16.1	Issuance of Disratization Certification and Exemption from Disratization of Vessel	1.000	undetermined
16.2	Issue of Disembarkation Guide for Passengers and Vessels, Aircraft and Ground Vehicles and International Transit	500	undetermined
16.3	Free Practice Certificate Issuance	600	undetermined
16.4	Issuance of Trasside Guide to Corpse in Vessels, Aircraft and Interstate and International Transit Ground Vehicles	ISENTO

Notes:

1. Table values are reduced in:

a) fifteen percent, in the case of companies with annual turnover not exceeding R$ 50,000,000.00 (fifty million reais);

b) thirty percent, in the case of companies averages with billing above R$ 6,000,000.00 (six million reais);

c) sixty percent, in the case of average companies with billing equal to or less than R$ 6,000,000.00 (six million reais);

d) ninety percent, in the case of small businesses;

e) ninety five percent, in the case of micro-companies, except for items 1.3 and 1.4, whose values, in the case of micro-enterprise, get reduced by ninety percent.

2. The drinks and food will be registered in the case of competence of the Ministry of Health.

3. For small and micro-enterprises, the fee for granting Certification of Good Manufacturing Practice and Control, item 4, will be charged for each establishment or unit fapril.

4. By December 31, 1999, micro-companies will be exempt from the fee for granting of Good Practice Certificates of Manufacture and Control, Registration or Renewal Of Product Registration or Group of Products, items 4 and 5. The exemption may be extended, until December 31, 2000, by decision of the Colegiated Board of ANVS.

5. The fee for Registration or Renewal of Registration of medications or group of phytopathic, homeopathic medications, Large Volume Parenteral Solutions, and Small Volume Parenteral Solutions will be that of item 5.4.3. Generics.

6. It will be considered new, for Record or Registration Renewal effect, the medicine that contains new molecule and has patentary protection.

7. Table values for Product Registration Renewal or Product Group, will be reduced by ten percent to each renewal up to the total limit of fifty percent.

8. The framework of the companies in the ports provided for in the letters of?b? a?d? of item I shall be made from the one establishing the Laws 9,317, of December 5, 1996, and 9,531, of December 10, 1997.

9. The Collegiate Board will suit the provisions of items 16.1, 16.2 and 16.3 and their discounts to the waybill of the vessels by amount of passengers, weight of the loads or mixes.

10. In the case of export, it becomes exempt the fee pick-up for the gerker facts of items 8 and 13.

11. The Special Health Permits for commercialization of controlled drugs will have a discount of eighty percent on the value of item 1.4, with subsequent cumulative application of the reduction provided for in Note 1.

12. In cases of need for two or more operating permits for the same company by establishment or for operating permits where only part of the activities are regulated by ANVS, constant of item I and its sub-items, will granted discounts as per the expended act of your Colegiated Board.

13. It is exempt from fee pick-up for addition or change of registration, regarding the text of bula, use form and labeling, constant of item 6.3, in the case of telephone number change, CGC/CNPJ, or other legal information, as expends act of the Colegiated Directorate of ANVS.

14. The reduction values set out in this Table shall not apply to companies located in other countries, provided for in subitem 4.2.