• to coordinate the National System of Health Surveillance;
  
• to foster and carry out studies and research in line with the Agency's range of agreed functions;
  
• to establish norms and standards regarding restrictions on contaminants, toxic waste, disinfectants, heavy metals and other materials which constitute a health risk;
  
• to intervene on a temporary basis in the administration of manufacturing entities financed, subsidised or maintained at public expense, as well as in that of service providers and/or those manufacturers which produce materials on an exclusive or strategic basis for the Brazilian market, as set forth in specific legislation [ covered by Article 5 of Law 6.437, dated 20 August 1977, based upon the text of Article 2 of Law 9.695, dated 20 August 1998];
  
• to administer and collect the Health Surveillance Inspection Fee [in accordance with Article 23 of Law 9.782 of 26 January 1999];
  
• to authorise the operation of manufacturing, distribution and importing firms concerned with the products detailed in Article 4 of the Statute of the National Health Surveillance Agency [Decree 3029 dated 16 April 1999];
  
• to give assent to the importation and exportation of the products listed in the Statute of the National Health Surveillance Agency [Decree 3029, dated 16 April 1999];
  
• to grant product registration permits in accordance with the norms ascribed to the Agency's area of activity;
  
• to grant and to withdraw certificates of good manufacturing practice;
  
• to demand on the basis of specific rules the accreditation by the National System of Weights and Measures, Standards and Industrial Quality (SINMETRO), or the certificate of authorisation issued by the same body, of institutions, products and services subject to health surveillance, according to their category of risk;
  
• to proscribe, as a health surveillance measure, manufacturing plants and those premises involved in the management, importation, storage, distribution and sale of health related products and services in the event of violation of the relevant legislation, or on account of their constituting a likely health risk ;
  
• to prohibit the manufacture, importation, warehousing, distribution and marketing of products and inputs in the event of any violation of the relevant legislation or because such products and services constitute a likely health risk ;
  
• to cancel the operating permits, including special permits, of companies in the event of violation of the relevant legislation or because of an impending health risk ;
  
• to coordinate the health surveillance activities carried out by laboratories comprising the official network of health and hygiene quality control laboratories;
  
• to set up, coordinate and monitor toxicological and pharmaceutical surveillance systems;
  
• to take the lead in revising, and periodically bringing up to date, the pharmacopeia;
  
• to run an ongoing and permanent information system with the aim of integrating it into the whole range of health activities, with priority placed upon those information activities concerned with epidemiological surveillance and out-patient and hospital care;
  
• to monitor and audit state, district and municipal bodies comprising the National System of Health Surveillance, including the official health quality control laboratories;
  
• to coordinate and carry out quality control in respect of goods and products listed in Article 4 of the Statute of the National Health Surveillance Agency [Decree 3.029 of 16 April 1999], through a variety of analytical procedures provided for in health legislation or through the implementation of specifically defined health quality control programmes;
  
• to foster and develop staff resources for the National System of Health Surveillance and to carry out domestic and international technical cooperation activities;
  
• to summonse offenders and apply the penalties foreshadowed in law;
  
• to monitor the prices of medical drugs, items of equipment, components, inputs and health services;
  
• the Agency can delegate in accordance with a decision by the Collegiate Directorate, to the Federal District, the States, and Municipalities the execution of certain activities falling within its remit, with the exception of those covered by Article 3, sub-section 2, of the Statute of the National Health Surveillance Agency;
  
• the Agency can advise upon, or complement or supplement activities by the Federal District, by the States or municipalities, in the area of health inspection;
  
• epidemiological surveillance and vector inspection activities in respect of ports, airports and border crossing points shall be carried out by the Agency acting in accordance with the technical and normative guidance of the epidemiological and environmental divisions of the Ministry of Health;
  
• the Agency can delegate to the appropriate body within the Ministry of Health the execution of those functions set forth in Article 3 of the Statute of the National Health Surveillance Agency [Decree 3.029 of 16 April 1999] in respect of medical out-patient and hospital services covered by Article 4 , sub-sections 2 and 3 of the Statute. Note that the text of Article 3 under reference was redrafted by Decree 3.571 of 21 August 2000.
  
• the Agency shall carry out its activities fully in accordance with the guidelines established by Law 8.080 of 19 September 1990 in order to ensure continuation of the process of decentralisation of activities for the Federal District, States and municipalities, while observing the restricitions set forth in Article 3, sub-section 2, of the Statute. Decentralisation will only be given effect providing the respective State, District and Municipal Health Councils grant their respective approval;
  
• the Agency can dispense with the registration of immunobiologicals, insecticides, drugs and other strategic inputs when acquired through international or multilateral organisations for use by the Ministry of Health and its associated organs in the course of public health programmes.
  
• The Minister of Health can determine that certain activities within the remit of the Agency be carried out in specific circumstances which involve a public health risk.

Regulating, controlling and inspecting products and services which involve risks to public health are within the proper remit of the Agency.

The following are goods and products subject to health control and enforcement:

• Medical drugs for human use, their active substances and other related inputs, processes and technologies;
  
• Foods, including drinks, bottled waters and their inputs, packaging, food or drink additives, levels of organic pollutants, residues of pesticides and veterinary drugs;
  
• Cosmetics, personal hygiene products and perfumes;
  
• Cleaning products for sanitisation, disinfection or disinfestation in domestic, hospital and public premises;
  
• Kits, reagents and inputs to be used for diagnosis;
  
• Medical-hospital, odontological, haemotherapic, and laboratory and imaging equipment and materials;
  
• Immunobiologicals and their active substances, blood and blood products;
  
• Organs, human and animal tissue for use in transplants or reconstructions;
  
• Radioisotopes for in vivo diagnostic use, radiopharmaceuticals and radioactive products for use in diagnosis and therapy;
  
• Cigarettes, cigarillos, cigars and any other type of smoking product, derived or not from tobacco;
  
• Any products which involve the possibility of risk to health obtained as the result of genetic engineering, by any other procedure or submitted to sources of radiation.

Services subject to health inspection and enforcement are as follows:

• Those involving routine or emergency out-patient care, hospitalisation, diagnostic and therapeutic support services, as well as those services which involve employment of new technology;
  
• Physical installations, equipment, technologies, premises and procedures used in connection with every phase of the production of goods and products subject to health inspection and enforcement, including the final disposal of their respective waste matter.

Notwithstanding the rules and regulations outlined above, the Agency can include other products and services of interest in the control of risks to public health within the remit of the National Health Surveillance Agency.