Legislation
Administrative Order

Administrative Order nº 911, of November 12, 1998

The Secretary of Sanitary Surveillance of the Ministry of Health, in the use of his attributions and WHEREAS
provisions in Administrative Order SVS No. 424 of May 21, 1998, decides:

Article1- To approve the list, annexed to this Administrative Order, of documents needed for the instruction of authorization requests to carry out Clinical Research with Pharmaceutical Substances, Medicaments, Vaccines and New Diagnosis Tests.

Article 2 - That this Administrative Order shall enter into force on the date of its publication.

GONZALO VECINA NETO

List of documents needed for the instruction of authorization requests to carry out Clinical Research with Pharmaceutical Substances, Medicaments, Vaccines and New Diagnosis Tests

Document 01:
Official forwarding letter of the Clinical Research Project originated from the Main Researcher or sponsor, if applicable, to the Secretariat of Sanitary Surveillance, mentioning the Title of the Research, the Main Researcher and the Institution where it shall be carried out.

Document 02:
The sponsor's statement, if applicable, signed by the Director of the area of national or international research, informing the Title of the Research, the Main Researcher and the Institution where it shall be carried out.

Document 03:
Petition Form 1 and Petition Form 2 (FP1 and FP2) properly filled out (original).

Document 04:
Proof of payment of public price - DARF (code 6470), properly registered and/or stamped (original)

Document 05:
Proof that the Committee of Ethics in Research - CEP of the Institution where the research shall be carried out is properly registered and approved by the National Commission of Ethics in Research - CONEP, of the National Health Council (copy of the letter of approval of CONEP)

Document 06:
Opinion issued by the Committee of Ethics in Research - CEP of the Institution where the research shall be carried out, approving the Clinical Protocol and its Informed and Exempt Consent, assessing the scientific background and the adequacy of the previous study phases, including the pre-clinical one, with emphasis on safety, toxicity, reactions or adverse effects, effectiveness and results, informing the name of the researcher in charge of the research.

Document 07:
Research Protocol in the Portuguese language, in compliance with Resolution No. 196 of October 10, 1996, of the National Health Council/MS and with Resolution No. 251 of August 07, 1997, of the National Health Council/MS.

Document 08:
Information on the status of the registration of the pharmaceutical substance, medication, vaccines or diagnosis test in other countries, whenever applicable.

Document 09:
Number of the registration process of the pharmaceutical substance, medication, vaccines or diagnosis test at SVS/MS, whenever applicable.

Document 10:
Information about the development of the research in other countries, as well as the situation of researches which have been/are being carried out, with the pharmaceutical substance, medication, vaccines or diagnosis test.

Document 11:
Description of the total planning of the research, informing other participating centers in the country, researchers and their situation in relation to SVS/MS

Observations:
a. The whole documentation must be signed, as well as all pages initialed by the researcher or by the sponsor's representative, if applicable. The pages relating to Document 07 of this Normative Regulation must be initialed by the Committee of Ethics in Research - CEP, whose initials must be properly identified.
b. In case of multicenter study, the documentation of each institution must be recorded in separate processes, one tax form - DARF- having been paid for each process related to the CEP where the research shall be carried out.
c. When importation/exportation is needed, SVS/MS must be informed of the number of the Importing License - LI or the Exportation Registration - RE in Siscomex, their contents, and the number of respective approval CE.
d. In LI, the field "Complement" must present the following data: Number of the Process in SVS/MS, title of the research, name of the Main Researcher, CEP for which the importation is being done and the number of the Special Communication - CE which has authorized its execution.