Federal Official Gazette
On November 11TH, Secretariat of Health (SS) published the aforementioned agreement in the Federal Official Gazette (DOF), which is issued under the same terms in which it was released in its preliminary version through the National Commission for Regulatory Improvement (CONAMER).
Therefore, the following considerations are confirmed:
1. The Secretariat of Health and the Federal Commission for the Protection against Sanitary Risks are instructed to resolve the appropriateness of granting applicants the sanitary registration of health supplies in a period shorter than that mentioned in the equivalence Agreements that until the date was issued by the first, as well as for shorter terms to be established in those issued later.
2. The Secretariat of Health and the Federal Commission for the Protection against Sanitary Risks must analyze, in accordance with the applicable legal framework, the relevance of reducing the documents required in equivalence Agreements, without implying that the guarantee of the quality, safety and efficacy that the medicines and health supplies indicated therein must satisfy.
3. This Agreement shall enter into force on the day following its publication in the Federal Official Gazette.
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