Marketing Authorization
PROCEDURES FOR MARKETING AUTHORIZATION OF MEDICINE IN TANZANIA BY TMDA UNDER HARMONIZATION AND COLLABORATIVE PROCEDURE

PROCEDURES FOR MARKETING AUTHORIZATION OF MEDICINE IN TANZANIA BY TMDA UNDER HARMONIZATION AND COLLABORATIVE PROCEDURE

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:

Under national procedure kindly refer to our previous posted document as can be referred to this link

B: Harmonization and collaborative procedure:

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)
  1. African Medicine Agency (AMA): Is the African Agency established under the African Union to contribute to the improvement of access to medicines within the continent.

Functions or Responsibility of AMA:

  1. Marketing authorization: Shall be responsible for evaluation and decision making regarding selected medical products for treatment of priority diseases/conditions as determined by the African Union.
  2. Inspection: Shall undertake coordination on the inspection of manufacturing sites, and share information on a regular basis regarding all products that it has authorized for marketing.
  3. Market surveillance: Shall coordinate the collection and sharing of information on all medical products including Substandard and Falsified (SF) medical products.
  4. Safety monitoring: Shall be responsible for making regulatory decisions concerning products selected for treatment of priority diseases/conditions as determined by Member States, based on available safety information. In addition, the AMA will collect and store information on the quality and safety of medical products and share them with all its States Parties as well as globally. It will also establish collaboration with global and regional centers in safety monitoring.
  5. Oversight of clinical trials: Shall coordinate joint reviews of applications for the conducting of clinical trials.
  6. Quality control: Shall coordinate and network quality control laboratory services for national and regional regulatory authorities.

NOTE: In this time of writing this directive document, AMA is still under establishment has not yet started to execute its duties, therefore after the fully establishment, we will provide the full details on how to apply market authorization of your product in TANZANIA under harmonization and collaborative procedure through AMA.

  • African Medicine Regulatory Harmonization (AMRH): Is the initiative project under AUDA-NEPAD Agency and key component of Pharmaceutical Manufacturing Plan for Africa (PMPA) with the commitment to stream-line medicine regulation and build regulatory capacity across partner state.

Implementation has been done in Region Economic Communities as listed below:

  1. EAC-MRH
  2. SADC-MRH
  3. ECOWAS-MRH
  4. ECCAS-MRH
  5. IGAD-MRH

NOTE: The implementation in EAC and SADC region in which both TANZANIA is the member has shown a tremendous progression.

Objective of this MRH is reducing time for registering Medicine and obtain your MA across the region member state.

Priority has been given to essential medicines, medicine for treatment priority diseases identified by MRH, list of medicines in UN Commision for live-Saving Commodities for Women and Children, Prescription medicine manufactured domestic within the region and other medicines that will be considered important at that time (this considered case by case basis)

General Eligibility criteria for Applicant to use MRH-Collaborative process.

  1. Applicant should lodge application at least two MRH participating countries
  2. Product registered by Stringent Regulatory Authority (SRA)

NOTE: Apart from general eligibility criteria there are specific steps to be followed to a specific REC-MRH as presented in brief below.

SADC (ZAZIBONA)-MRH Flow Chart:

ECOWAS (WA)-MRH Flow Chart:

For other RECs the collaborative process implementation is still under establishment in regarding the time of this article prepared.

NOTE: A company can submit an application for a marketing authorization in TANZANIA Through NRA, TMDA and other RECs (EAC or SADC) member states if the company wishes to market a medicine within the regional by following either EAC-MRH or SADC-MRH procedures as shown in the flow chart above.

On how to Apply and other technical support you can consult www.petalitepharma.com

RECs in which Tanzania is a member.

  1. EAC: Burundi, Kenya, Rwanda, South Sudan, Uganda, the Democratic Republic of Congo, and the United Republic of Tanzania.
  2. 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
  • WHO-Collaborative procedure:  Is the collaborative procedure that allow National Regulatory Authorities (NRAs) to leverage the work performed by WHO on assessment and inspection output on the prequalified product to decide on medical product approvals within their jurisdiction using concept reliance.

By doing that it tends to eliminate duplicative regulatory work, speedup registration of medicines in a respective country eventually increases medicine availability.

Principles of the collaborative procedure for FPPs.

  1. voluntary: A manufacturer of a prequalified product(s) voluntarily expresses interest in applying the procedure to facilitate registration of its product(s) with a specific NRA i.e., TMDA
  2. confidential: NRA e.g., TMDA signs a participation agreement and confidentiality undertaking with WHO, whereby it adheres to the provisions of the procedure. The manufacturer, through written consent, authorizes WHO to share prequalification assessment reports for the specific product(s) with a specific NRA e.g., TMDA which accelerated registration is sought.
  3. based on product sameness: A manufacturer must submit the same product version as the one prequalified. Product sameness is a mandatory prerequisite for applying of a collaborative procedure.

NOTE:

For applicant want to register their product through WHO – Collaborative Registration Procedure (CRP) in Tanzania should make sure have at minimum the following supportive documents.

  1. Signed agreements/ consent
  2. Quality information summary (QIS)
  3. Assessment and inspections report from the WHO Prequalification Team (PQT)
  4. WHO public assessment reports and WHO public inspection reports (publicly available from the PQT website)

On how to Apply and other technical support you can consult www.petalitepharma.com

  • EAST AFRICAN COMMUNITY MUTUAL RECOGNITION PROCEDURES (EAC-MRP): Is the initiative focused on harmonization of registration procedure of Immunological Veterinary Product (IVP).

By doing that it tends to eliminate duplicative regulatory work, speedup registration of Veterinary medicines in a respective country within EAC member state eventually increases Veterinary medicine availability.

The procedure will be followed according to EAC guidelines on Procedural Aspects for Applications for Marketing Authorization of Veterinary Immunological and Pharmaceutical Product.

For more detail kindly see our published document concerning Markert Authorization for Veterinary product which found in our official website www.petalitepharma.com

Leave a Reply

Your email address will not be published. Required fields are marked *