Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
Guidance for the preparation and submission of dossiers
Trastornos del desarrollo
Capítulo C.4
Otros Trastornos
Capítulo H.1
Edición 2016
Edición: Matías Irarrázaval & Andres Martin
Revisión: Fernanda Prieto-Tagle & Jasna Raventós
Trastornos de ansiedad
Capítulo F.3
Editores: Laura Revert, Matías Irarrázaval & Andres Martin
Traducción: Régis Villegas, Paula Placencia, José Ángel Alda & Paula Cox
To understand the mental health treatment gap in the Region of the Americas by examining the prevalence of mental health disorders, use of mental health services, and the global burden of disease.
Otros trastornos
Capítulo H.2
Editores: Matías Irarrázaval, Daniel F. Martínez Uribe, Andres Martin
Traducción: Jaime J. Gómez Alamán, Begoña Arenas Tuzón, Beatriz Ortega
Otros trastornos
Capítulo H.5.1
Edición: Matías Irarrázaval & Andres Martin
Traductores: Fernanda Prieto-Tagle & Iván Olle Llopis