PROCEDURES FOR REGISTERING NUTRACEUTICAL PRODUCT OR FOOD SUPPLEMENT BY TANZANIA BUREAU OF STANDARD (TBS) IN TANZANIA

PROCEDURES FOR REGISTERING NUTRACEUTICAL PRODUCT OR FOOD SUPPLEMENT BY TANZANIA BUREAU OF STANDARD (TBS) IN TANZANIA

TBS: Is the Tanzania Bureau of Standards established by section 3 of the Act (standard Act,          CAP.130) NUTRACEUTICAL PRODCT: According to FDA this falls in the group of Food Supplement (Dietary Supplement) since they are not intended to treat, diagnose, prevent or cure diseases. Otherwise, will be categorized as medicine and should be regulated as a Drug and should…

HUGE BUSINESS ADVANTAGE IN-VITRO DIAGNOSTIC (IVD) APPLICANT/MANUFACTURER GAINED BY PERTICIPATING IN WHO PREQUALIFICATION

HUGE BUSINESS ADVANTAGE IN-VITRO DIAGNOSTIC (IVD) APPLICANT/MANUFACTURER GAINED BY PERTICIPATING IN WHO PREQUALIFICATION

WHY PARTICIPATE? Obtaining prequalification of an in vitro diagnostic (IVD) may demand considerable investment, in terms of both financial investment and staff time (to improve production quality and/or to prepare a dossier for submission and deal with any requests for further information from WHO). But benefits may accrue to a manufacturer during and following product prequalification.  I.      Increased technical capacity…

PROCEDURES FOR MARKETING AUTHORIZATION OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC DEVICES IN TANZANIA BY TANZANIA MEDICINE AND MEDICAL DEVICES AUTHORITY (TMDA)

PROCEDURES FOR MARKETING AUTHORIZATION OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC DEVICES IN TANZANIA BY TANZANIA MEDICINE AND MEDICAL DEVICES AUTHORITY (TMDA)

What is Market Authorization: An official approval of the medicinal product to be marketed or distributed in a respective country. What is Market Authorization Holder (MAH): In other name called “APPLICANT” simply means a person or Company who/which submits an application for registration of a medicine, an update or amendment to an existing registration to the Authority who may be…

PROCEDURES FOR MARKETING AUTHORIZATION OF MEDICINE IN TANZANIA BY TMDA

PROCEDURES FOR MARKETING AUTHORIZATION OF MEDICINE IN TANZANIA BY TMDA

What is Market Authorization? An official approval of the medicinal product to be marketed or distributed in a respective country. What is Market Authorization Holder (MAH)? In other name called “APPLICANT” simply means a person or Company who/which submits an application for registration of a medicine, an update or amendment to an existing registration to the Authority who may be…