Legislation
Provisional Remedy

Provisional Remedy nº 2.039-20, of August 25, 2000
Published in the Official Journal of the Union on 25.8.2000

THE PRESIDENT OF THE REPUBLIC, in the use of the attributions vested in him under Article 62 of the Constitution, adopts the following Provisional Remedy:

Article 1 - The provisions of Law No. 9.782, of January 26, 1999, indicated below, shall henceforth be in force with the following changes:

"Article 7 - .............................................................................

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1. request, at its discretion, information about production, inputs, raw materials, sales and any other information held by private or public corporations which perform activities of production, distribution and marketing of goods and services provided for in this item, keeping legal secrecy whenever the case;
2. carry out examination of stock, papers and documents of any companies or private or public corporations which perform activities of production, distribution and marketing of goods and services provided for in this item, keeping legal secrecy whenever the case;
3. when evidence of the existence of infractions provided for in items III or IV of Article 20 of Law No. 8.884, of June 11, 1994, is verified, by means of unjustified rise of prices or imposition of excessive prices of goods and services referred to in these items, summon those responsible in order for them to justify their respective conduct within ten working days;
4. apply the penalties provided for in Article 26 of Law No. 8.884, 1994;

XXVI - to control, inspect and supervise, in the light of sanitary legislation, the advertising and publicity of products subject to the sanitary surveillance regimen.

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Paragraph 4 - The Agency may devolve to an organization within the Ministry of Health the discharge of functions listed in this article and pertaining to medical, out-patient and hospital services, provided for in Paragraphs 2 and 3 of Article 8 of Law No. 9.782, of 1999, provided that interdictions defined in Paragraph 1 of this Article are obeyed.

Paragraph 5 - The Agency shall always act in compliance with guidelines set out by Law No. 8.080, of September 19, 1990, in order to continue the development of the process of decentralization of activities towards the States, the Federal District and the Municipalities, provided that interdictions defined in Paragraph 1 of this Article are obeyed.

Paragraph 6 - Decentralization referred to in the previous Paragraph shall be carried out only after favorable opinions by the respective State, District and Municipality Health Councils. (Re-edition)."

"Article 8 - .............................................................................

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Paragraph 5 - The Agency may waive the registration of immune-biological products, insect killers, medicines and other strategic inputs whenever they are acquired through international multilateral organizations to be used in public health programs by the Ministry of Health and its related bodies.

Paragraph 6 - The Minister of Health may determine the development of activities under the competence of the National Sanitary Surveillance Agency, in specific cases that may jeopardize the health of the population.

Paragraph 7 - The deed mentioned in the previous paragraph must be published in the Official Journal of the Union." (Re-edition).

"Article 9 - ...............................................................

Only Paragraph - The Agency shall also count on an Advisory Council, that shall include, at least, representatives of the Union, of the States, of the Federal District, of the Municipalities, of producers, of traders, of the scientific community and of users, as provided for in regulation." (Re-edition).

"Article 15 - It is due to the Collegiate Board of Directors:

1. to establish the strategic guidelines of the Agency;
2. to propose to the Minister of Health governmental policies and guidelines meant to allow the Agency to fulfil its goals;
3. to enact norms on matters within the sphere of competence of the Agency;
4. to enforce and ensure enforcement of norms pertaining to sanitary surveillance;
5. to prepare and issue periodical reports on its activities;
6. to judge, at appeal level, upon decisions taken by the Agency, as per request by the parties concerned;
7. to refer the accounting statements of the Agency to the relevant bodies.

Paragraph 1 - The Board of Directors shall convene with the presence of at least three directors, amongst them the Chairperson or his or her lawful deputy, and shall decide by simple majority of votes.

Paragraph 2 - Deeds of the Agency shall be susceptible of appeal to the Collegiate Board of Directors, with suspending effect, as last administrative level." (Re-edition)

"Article 16 - It is due to the Chairperson:

1. to represent the Agency in and out of court;
2. to chair the meetings of the Collegiate Board of Directors;
3. to decide on urgent issues, ad referendum of the Collegiate Board of Directors;
4. to decide in cases of tie in the deliberations of the Collegiate Board of Directors;
5. to appoint and dismiss civil servants, filling effective commissioned grades and functions, and to exercise the disciplinary power, as provided for in the legislation in force;
6. to refer to the Advisory Council the periodical reports prepared by the Collegiate Board of Directors;
7. to sign contracts and agreements and to determine expenditure.
8. to elaborate, approve and promulgate the internal regulations, define the field of action of the organizational units and the executive structure of the Agency;
9. to perform the operational management of the Agency." (Re-edition)

"Article 19 - The Agency's management shall be governed by a management contract, negotiated between its Chairperson and the Minister of Health, the Ministers of Finance and of Planning, Budget and Management having been previously heard, within one hundred and twenty days after the appointment of the agency's Chairperson.

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"Article 22 - ............................................................................

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X - amounts obtained through investments in the financial market of revenues provided for in numerals I through IV and VI through IX of this Article.

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"Article 23 - ............................................................................

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Paragraph 6 - Laboratories created or controlled by the Public Power, producing medicines and inputs subject to Law No. 6.360, of September 23, 1976, in the interest of Public Health, are exempt from payment of the Sanitary Surveillance Inspection Fee.

Paragraph 7 - Renewals of registrations, authorizations and certificates are subject to the periodical schedule and to the amounts stipulated for the initial deeds, as provided for in Annex II.

Paragraph 8 - The provisions of the previous Article apply to the contents of Paragraphs 1 through 8 of Article 12 and to the Only Paragraph of Article 50 of Law No. 6.360, of 1976, of Paragraph 2 of Article 3 of Decree-Law No. 986, of October 21, 1969 and of Paragraph 3 of Article 41 of this Law." (Re-edition).

"Article 30 - The moment the National Sanitary Surveillance Agency is created, with the publication of its internal regulation by the Collegiate Board of Directors, the Autonomous Agency shall be automatically vested in the exercise of its functions, and the Secretariat for Sanitary Surveillance shall become extinct". (Re-edition).

"Article 41 - ..........................................................................

Paragraph 1 - The Agency may grant operation authorization to companies and registration to products applicable solely to producing factories and to merchandise geared to external markets, provided that they do not bring about risks for public health.

Paragraph 2 - The regulation referred to in the Caput of this Article includes within its coverage the exemption of registration.

Paragraph 3 - Companies subject to Decree-Law No. 986, of 1969, must also comply with Article 2 of Law No.6.360, of 1976, in what regards the authorization for operation by the Ministry of Health and the licensing by the sanitary bodies of the Units of the Federation where they are located". (Re-edition).

Article 2 - Law No. 9.782 shall henceforth be in force added of the following articles:

"Article 41-A - The registration of medicines with exclusively generic names shall have priority over that of the others, as provided for in a deed by the Collegiate Board of Directors of the National Sanitary Surveillance Agency". (Re-edition).

"Article 41-B - When the marketing of products subject to sanitary surveillance that are unfit for use is verified, the company responsible for them must issue advertisement containing a warning to the population, within the period of time and under the conditions indicated by the sanitary authority, and the company shall have to pay a fee corresponding to the examination and to the previous agreement on the informative contents by the National Sanitary Surveillance Agency". (Re-edition).

Article 3 - The National Institute for Quality Control in Health shall be technically subordinated to the National Sanitary Surveillance Agency, and administratively subordinated to the Oswaldo Cruz Foundation.

Only Paragraph - Appointments for commissioned grades and nominations for bonus-earning functions of the National Institute for Quality Control in Health shall be under the competence of the Minister of Health, as per nomination by the Chairperson of the National Sanitary Surveillance Agency, the President of Oswaldo Cruz Foundation having been heard.

Article 4 - Food imported in its original packing shall have as its dates of expiry, for the purposes of regularizing its registration situation vis-à-vis of the National Sanitary Surveillance Agency, March 1st, 2000.

Article 5 - Effective civil servants from the staff of the Ministry of Health who were in office on December 31, 1998, at the Secretariat for Sanitary Surveillance and in the Airport, Port and Border Stations are hereby redistributed to the National Sanitary Surveillance Agency.

Paragraph 1 - The civil servants from the National Health Foundation, redistributed according to the provisions in the Caput, shall be included in the same grade plan as the civil servants redistributed from the Ministry of Health.

Paragraph 2 - In the event that the result of the inclusion mentioned in the previous paragraph generates amounts inferior to those previously received, the difference shall be paid as a nominally identified advantage, the same percentages of general revision or anticipation of salary readjustment being applicable.

Article 6 - Annex I, regarding the Demonstrative Chart of Commissioned Functions of Sanitary Surveillance of the National Sanitary Surveillance Agency, and Annex II to Law 9.782, of 1999, shall respectively be henceforth in force in the form of the Annexes I and II to this Provisional Remedy.

Article 7 - Articles 2 and 3 of Law 9.294, of July 15th, 1996, shall be henceforth in force with the following language:

"Article 2 - ............................................................................

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Paragraph 2 - The use of products referred to in the Caput is for interdicted in aircraft and collective transport vehicles." (Re-edition)

Article 3 - ..............................................................................

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Paragraph 2 - Advertisement shall contain, in the media, and according to its characteristics, a warning, where possible oral and written, on the ill-effects of tobacco, alcoholic beverages, medicines, therapies and agricultural defensives, according to phrases established by the Ministry of Health, to be used sequentially, in simultaneous or rotational form". (Re-edition).

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Paragraph 6 - The National Sanitary Surveillance Agency, in order to prevent the circulation of false advertising of products and services subject to its control, may demand prior presentation of copies of the advertisements referring to these products and services, in compliance with regulation approved by its Collegiate Board of Directors" (Re-edition)

Article 8 - Articles 3 and 57 of Law No. 6.360, of September 23, 1976, altered by article 1 of Law No. 9.787 of February 10, 1999, shall henceforth be in force with the following language:

"Article 3 - ............................................................................

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XX - Similar Medicine - that which contains the same active principle(s), presents the same concentration, pharmaceutical form, means of administration, dosage and therapeutic indication, and which is equivalent to the reference medicine registered at the federal agency in charge of sanitary surveillance, being allowed to differ only in characteristics related to size and form of the product, expiry date, packaging, labeling, excipients and vehicles, always being identified by its trade mark;

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Only Paragraph - In the case of imported generic medicines, whose bio-equivalence tests have been carried out outside the Country, the comparative dissolution tests between the test-medicine, the international reference medicine used in the bio-equivalence study and the national reference medicine must be presented" (Re-edition)

"Article 57 - ...........................................................................

Only Paragraph - In addition to the trademark, medicines must display, in the pieces referred to in the Caput of this Article, in the packaginging and in the advertising material, the Brazilian Common Denomination or, when appropriate, the International Nonproprietary Name, in lettering and characters in a size never under half that of the lettering and characters of the trademark." (Re-edition)

Article 9 - The Caput of Article 2 of Law No. 9.787, of February 10, 1999, shall henceforth be in force with the following language:

"Article 2 - The federal agency responsible for sanitary surveillance shall regulate, within one hundred and eighty days, counting as from February 11, 1999". (Re-edition).

Article 10 - Provisions of Article 15 of Law No. 5.991, of December 17, 1973, apply to medicine distributing companies.

Article 11 - Deeds performed based upon Provisional Remedy 2.039-19, of July 28, 2000 are hereby validated.

Article 12 - This Provisional Remedy enters into force on the date of its publication.

Article 13 - Article 4 of Decree-Law No. 986, of October 21, 1969, Article 82 of Law No. 6.360, of September 23, 1976, Article 3 of Law No. 9.005, of March 16, 1995, the Only Paragraph of Article 5, numerals XI, XII and XIII of Article 7, Articles 32 and 39 and their paragraphs, of Law No. 9.782, of January 26, 1999 are hereby revoked.

Brasilia, August 25th, 2000; 179th of the Independence and 112th of the Republic.