Marketing Authorization
MARKET AUTHORIZATION OF VETERINARY MEDICINES UNDER NATIONAL PROCEDURE IN TANZANIA AND MUTUAL RECOGNITION PROCEDURE (MRP) IN EAST AFRICA COMMUNITIES (EAC)

MARKET AUTHORIZATION OF VETERINARY MEDICINES UNDER NATIONAL PROCEDURE IN TANZANIA AND MUTUAL RECOGNITION PROCEDURE (MRP) IN EAST AFRICA COMMUNITIES (EAC)

MRP:

Is application procedure for an applicant wishes to have MA granted in more than one partner state simultaneously.

MARKET AUTHORIZATION (MA):

An official approval of the medical product to be marketed or distributed in a respective country.

MARKET AUTHORIZATION HOLDER (MAH):

In other name called “APPLICANT” simply means a person or Company who/which submits an application for registration of a Veterinary 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”

LOCAL TECHNICAL REPRESENTATIVE (LTR):

Every applicant who is not resident in the country where the product is to be marketed shall appoint a company authorized by NRAs to deal in medicinal products to be a Local Technical Representative (LTR). The appointment shall be notified to the Authority by submitting a letter of appointment supported by original copy of power of attorney.

REFERENCE COUNTRY (RC):

Is the country where a good market exists and is competent, experienced, and stringent-applicable for new product application, but for the market expansion RC is a country that has already issued the MA for the product.

NOTE:

  • Qualification to be RC is all EAC Partner States with systems of registration of Veterinary Medicinal. Currently, Kenya, Rwanda, Tanzania and Uganda have fully functional agencies and are participating as RCs and CCs.
  • At present, not all Partner States are ready to act as the RC in an MRP. Some NRAs have agreed to act as CCs for the moment to gain experience in the process.
  • If you require further guidance on the choice of the RC, you can contact the EAC Mutual Recognition Coordinator (MR-C) or your LTR in the Partner States (PS) where you have interests.

CONCERNED COUNTRY (CC):

Are the other countries where the applicant wants to sell the product.

Authorization Procedures:

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

A: National procedure

B: EAC Mutual Recognition Procedure – EAC-MRP

A: National procedures:

Under national procedure is the same procedure as applies to Human Medicinal Product however the applicable guideline is specifically for Veterinary product which can be accessed in TMDA official website www.tmda.go.tz

or EAC official website https://www.eac.int/documents/category/livestock for the National procedure kindly refer to our previous posted article as can be referred to this link

B: EAC Mutual Recognition Procedure – EAC-MRP:

There are two types of MRP, however both types follow the same MA procedures.

New Licenses (MAs): When an applicant wishes to obtain MAs for a new product in several Partner States simultaneously at first time.

Extending a Current License (MA) to another EAC Country: When an applicant already has the MA in one Partner State and wishes to have this mutually recognized to expand sales into one or more additional Partner States.

TYPES OF VETERINARY MEDICINAL PRODUCT ELIGIBILE FOR MRP:

For now, this procedure is covering only Veterinary Pharmaceutical product and Veterinary Immunological product (Veterinary Vaccine).

NOTE: MRP anticipate in near future to include also veterinary Pesticides

Application Process for registration of Veterinary product under MRP can be categorize in

Short and Medium Processing Time (120 – 280 days)

Extended Processing Times (210 – 330)

Below is the flow chart for Short and Medium Processing Time (120 – 280 days)

Below is the flow chart for Extended Processing Times (210 – 330 days)

Below is summary flow chart of two Application processing:

During submission of technical documentation for Veterinary Pharmaceutical product dossier should be submitted in CTD format according to the guideline but for Veterinary Immunological has different format for dossier submission as per specific guideline for immunological product and the same can be accessed from EAC official website

https://www.eac.int/documents/category/livestock

According to the MRP project design, it is the RC alone who carries out the GMP inspection on behalf of the other EAC Partner States (PSs) participating in the procedure. Then prepare the report and share it with the other countries participating in the MRP. However, the applicant should pay GMP inspection fees to RC and CCs. And each NRA issues their own national GMP certificate once a positive decision on GMP status has been agreed. Fees paid as per each NRA fee structure.

After product approval, within 60 calendar days, it is recommended that the applicant submit an update technical document capturing all issues that had been raised during the evaluation process by the RC. This is a requirement to facilitate repeat use procedures in future.

DURATION OF MA AND GMP CERTIFICATE UNDER MRP:

MAs are valid for 5 years and GMP certificates are valid for 3 years

POST MA UNDER MRP:

Renewal Application: MA are valid for 5 years from the date of first issue, for the authorization to remain valid it should be renewed at the end of 5 years period. The renewal application date will be processed by the individual Partner States according to their regulatory framework. This is the responsibility of individual NRA.

Authorization of variations:

  • Any variations that the applicant subsequently applies for are processed through the original RC and, if successful, are approved simultaneously in the RC and CCs
  • The applicant approaches the RC who in turn informs the CCs and the MR-C of the change(s) applied for. The applicant is required to pay the variation fees to all the MRP Partner States and submit the changes.
  • It should also be noted that some EAC Partner States consider changes in the manufacturing sites as new registration applications, therefore, such changes will not be processed as Variations.

NOTE: For all variations or notification to a registered product (Veterinary Pharmaceutical product or Veterinary Immunological product), the applicants should refer to relevant variation guidelines as can be accessed on EAC official website

https://www.eac.int/documents/category/livestock

GROUNDS FOR SUSPENSION OR REVOCATION OF A MARKETING AUTHORISATION ISSUED THROUGH THE MRP

  1. If the authorized veterinary medicinal product (VMP) continually fails to satisfactorily meet the finished product batch testing specification when samples from the market are tested, the Partner State may suspend the Marketing Authorization and may alert the other Partner States in which the VMP is registered through the MR-C.
  2. If the authorized VMP has been found to have safety and efficacy issues in the field contrary to the declared specification, the Partner State may suspend the Marketing Authorization and alert the other Partner States in which the VMP is registered through the MR-C.

ADVANTAGE FOR THE APPLICANT TO USE MRP:

Reduce duplication of effort and maximize resources through joint assessments and Joint site inspections therefore the applicant will take short time to gain MA in more than one NRA compares when applied separately under a national procedure.

NOTE: On how to apply and other technical support you can consult www.petalitepharma.com

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