COFEPRIS definition
Examples of COFEPRIS in a sentence
The previous opinion issued by the COFEPRIS of the Secretariat for Health at the beginning of the validity of the Agreement, through its Comisión de Autorización Sanitaria [Health Authorization Committee], based on Articles 14 sections VI; VII; VIII; 62, sections II, III, IV, V, VI, VII; 64 sections I, II, III, IV, V and 98 of the Regulation of the General Health Act for Health Research.
El dictamen previo que emita la Comisión Federal para la Protección contra Riesgos Sanitarios, de la Secretaría de Salud (COFEPRIS) al inicio de la vigencia del Convenio, a través de su Comisión de Autorización Sanitaria, con fundamento en los artículos 14 fracciones VI; VII; VIII; 62, fracciones II, III, IV, V, VI, VII; 64 fracciones I, II, III, IV, V y 98 del Reglamento de ▇▇ ▇▇▇ General de Salud en Materia de Investigación para la Salud.
By “THE SPONSOR” at any time, provided that the COFEPRIS is formally notified of the reasons for the early termination of “THE PROTOCOL”, if it has requested authorization for its execution from that authority.
The following annexes are part of this Collaboration Agreement: Annex A: Favorable opinion from the COFEPRIS through its Health Authorization Committee; Annex B: Research Protocol; Annex C: Use of RESOURCES; Annex D: Authorization from the Relevant Committees; Annex E: Informed Consent Form; Annex F: Delegation of Powers Letter THIRTY-SIX.
El presente Acuerdo finalizará tras la aprobación del Producto en Investigación por parte de la COFEPRIS; para el uso descrito en el Protocolo, no obstante, dicha finalización no se producirá hasta que el paciente hayapasado a utilizar el producto disponible comercialmente a través del seguro del paciente o de un programa de asistencia al paciente de ULTRAGENYX.
Any dispute between the Parties regarding specifications of the Product delivered hereunder shall be referred, in the case of Mexico, in first instance to a mutually acceptable third party expert authorized by COFEPRIS, if no agreement is reached between the Parties with respect to such appointment, then such dispute shall be referred to Lambda Científica, S.A. de C.V. or Laboratorios B▇▇▇▇ ▇.▇.
In the case that the submitted documents are not complete, COFEPRIS will notify the applicant within a time period equal to a third part of the time period granted to resolve the application, when the problem is of an administrative nature, and two thirds if of a technical nature, based on the terms of the article 156 of the Regulation.
Except in the cases mentioned in the following paragraph, COFEPRIS will not require any additional documentation besides that mentioned in the previous article, in order to process the registration application that is submitted on the basis of this Agreement, regardless of the Medical Device country of origin, for whose health registration is being applied.
Notwithstanding the above, Ultragenyx will collaborate with the Institution and the Physician to obtain the authorization issued by COFEPRIS for the supply of the Investigational Product.
The Target Companies have not received written notice of any investigation, claim or proceeding that is ongoing or being initiated, or threatened to be initiated, by COFEPRIS or any Governmental Authority regarding a breach of a Sanitary License.