Legislation
Administrative Order

Administrative Order nº 331, of May 6, 1998 (*)
of 20/8/1998

The Secretary of Sanitary Surveillance of the Ministry of Health, in the use of the attributions vested in him and WHEREAS the need to standardize and simplify the proceedings requested by sanitary authorities, pursuant to the release of imported products for the purposes of research or scientific investigations not involving human beings, decides:

1. To authorize the clearance, by the Sanitary Surveillance Office of the Ministry of Health, of products imported directly or by third party means, for institutions or agencies interested in carrying out researches or scientific investigations, subject to the presentation, at the site of clearance of the products, of a statement in compliance with the attached model, signed by the researcher responsible for the execution of the research within the institution, taking on full responsibility:
a) for the packaging, transport, manipulation and storage of imported substances and products, as well as for eventual damage caused to the health of people and to the environment due to their use;
b) for not involving human beings in research using the imported products;
c) for the fulfillment of procedures and rules pursuant to the development of researches.

2. This Administrative Order does not apply to narcotic substances or substances which determine physical or psychic addiction, as well as products and substances aimed at clinical trial.

3. The non compliance with the rules hereby approved, constitutes sanitary infraction under Law No. 6.437, of August 20, 1977, the infractor being subjected to the penalties foreseen, without hazard to other sanctions , both civil or penal.

4. This Administrative Order goes into force on the date of its publication, all other dispositions in contrary being hereby revoked, particularly Administrative Order SVS No. 555/97, of November 4, 1997.

GONZALO VECINA NETO

ANNEX

STATEMENT
I, hereby, state, before the Service of Sanitary Surveillance of the Ministry of Health, in the state of _____________________________ (name of the federate unit) that the products and substances mentioned in the Cargo Information form No. ________________, imported by ___________________________________, are aimed at (name of the importer)
scientific research at ______________________________ (name of the research institution).
The products shall not be used on human beings. I, hereby, take on full administrative responsibility, both civil and penal, for the information contained in this Statement, as well as for the packaging, transport, manipulation and storage of the imported products and substances, and for eventual damage caused to the health of people and to the environment.

Place and date

Signature
Name of the Researcher
Registration Number at the respective Regional Council
Signature of the head of discipline or the dean of the institution
____________________

(*) Republished due to incorrectness of the original, in the Official Journal of the Union - D.O.U. of May 8, 1998.