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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 a manufacturer or a person to whose order and specifications, the product is manufactured. After the product is registered the applicant shall be “marketing authorization holder”

Authorization Procedures:

There are several different authorization procedures that a company may use to obtain a marketing authorization for a medicinal product depending on the consent of the company.

A: National procedure

B: Harmonization and Collaborative procedures

A: National procedures:

A company can submit an application for a marketing authorization directly to the TMDA if the company only wishes to market a medicine in Tanzania. The procedure for marketing authorization of medicinal product in Tanzania are described below: –

  1. New Product
  2. Authorization of Variations
  3. Renewal applications
  4. Withdrawal of marketing Authorization
  1. NEW PRODUCT:

Authorizations to market new medicinal products are granted by the     TMDA and this Authorization for a medicinal product is according to the   regulation and guideline which can be referenced in TMDA website. All      applications have to be submitted in accordance with the CTD (Common        Technical Document) format.

Process flow:

  1. Authorization of Variations

After a medicine has been authorized, the terms of the marketing           authorization may subsequently be varied. The procedures around such variations are governed by Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations and in product specific          variation guidelines include human medicine, herbal medicine and        veterinary medicine, granted marketing authorization all of which are          available on the The TMDA website.

Process Flow:

  1. Renewal applications

Marketing authorizations are valid for five years from the date of first issue. For the authorization to remain valid, it should be renewed at the             end of this five year period.

Renewal applications should be submitted to the TMDA at least three (3)         months before the expiry of the authorization, although earlier renewals             are acceptable in order to facilitate a common renewal date for a range of    products. Renewal applications should be accompanied by the Application             form for renewal of a marketing authorization and this should be done        according to the Regulation and guideline.

Process flow

  1. Withdrawal of marketing authorization:

Withdrawal of an authorization or certificate may occur during the period       of validity of the authorization or certificate or during the renewal when      marketing authorization holder (MAH) decide not to renew it or any     reason. In each case, the Authority should be notified of the intention to            withdraw.

This withdrawal can be classified into two:

  1. Voluntary withdrawal
  2. Mandatory withdrawal
  1. Voluntary withdrawal (withdrawal initiated by marketing authorization holder):

Holder must initiate the withdrawal of authorization through TMDA    trader portal by attaching an official letter which should indicate the           reason for withdrawal, which can be             commercial or may relate to        concerns regarding the quality (including GMP status), safety or        efficacy of the product.

  1. Mandatory withdrawal (withdrawal initiated by the Authority)

Withdrawal of an authorization or certificate may occur during the period       of validity of the authorization or certificate when the MAH     contravened the regulations or any provision of the Act or any reason          relate to concerns regarding the quality (including GMP status), safety          or        efficacy of the product the registration of the products shall be withdrawn,   suspended or revoked.

B: Harmonization and collaborative procedure:

A company can submit an application for a marketing authorization to TMDA and other Regional Economic Communities (RECs) member state if the company wishes to market a medicines within the regional.

RECs Community members

  • EAC: Burundi, Kenya, Rwanda, South Sudan, Uganda, the Democratic Republic of Congo, and the United Republic of Tanzania.
  • SADC: Angola, Botswana, Comoros, the Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe. In other word this collaboration is called ZAZIBONA

There are four different procedures for Harmonization and collaborative.

  1. African Medicine Agency (AMA)
  2. African Medicine Regulatory Harmonization (AMRH)
  3. WHO – Collaborative Procedure
  4. East African Community Mutual Recognition Procedure (EAC-MRP)

The main Objectives for these harmonization and collaborative procedures are;

  • To reduce timelines for registration of medicines;
  • To efficiently utilize available regional resources; and
  • To ensure the availability of good quality medicines within the region.

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