Mexico: Recognition of certain requirements established under US and Canadian health laws.
Description
On October 25, 2010, the Ministry of Health of Mexico published in the Diario Oficial an agreement that recognizes certain requirements established under U.S. and Canadian health regulation as equivalent to those provided for in Mexican laws.
In accordance with Mexican Law, medicines and other health products are required to obtain from the health authorities an authorization called sanitary register (“registro sanitario”) prior to their marketing.
The publication establishes that as of November 25, 2010, the Mexican health authorities recognize that:
• The requirements established under certain sections of the U.S. Federal Food, Drug and Cosmetic Act, the Code of Federal Regulations, as well as certain tests an inspections of the Food and Drug Administration are equivalent to the requirements established under the Mexican laws to allow for the marketing of medical equipment.
• The requirements established under certain sections of the Canadian Food and Drugs Act and Medical Devoices Regulations are equivalent to the requirements established under the Mexican laws to allow for the marketing of medical equipment.
Any Evidence-Based Deliberation:
| Question | Result |
|---|---|
| Is there anything in the public record to suggest that evidence of the effectiveness of the proposed measure was considered during official deliberations? | |
| Is there any evidence that alternatives to the proposed measure were considered? | |
| Is there anything in the public record that suggests that empirical evidence informed the comparison across the alternatives available to government? | |
| Was such evidence identified? | |
| Is such evidence publicly available? | |
| Did the official decision-maker in question provide an explanation as to why a chosen measure was favoured over alternatives? | |
| Is there any evidence to suggest that potentially affected trading partners were consulted before the measures were taken? | |
| Is there any evidence that safeguards have been put in place to ensure that implementation of the initiative is transparent and non-discriminatory? | |
| Did the government state its intention to review the measure within one year of implementation? |
Date Discovered:
Implemented: Yes
Date of inception: 25 Oct 2010
GTA Evaluation: Green
Source:
Fuente: Secretaría de Economía http://www.iqom.com.mx/documents/1010/DOF%2026%20octubre.doc
Government Response:
- 424 reads
