Renewal of Marketing Authorization of Medicinal Products (QUESTIONS AND ANSWERS)
THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY AND CHILDREN
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
ISO 9001: 2015 CERTIFIED
RENEWAL OF MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS
QUESTIONS AND ANSWERS
These questions and answers have been prepared to provide guidance only and should be read in conjunction with applicable guidelines and regulations related to the medicine’s registration requirements in Tanzania.
In accordance with Sub-regulation 13 (1) of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015, a certificate of registration issued under regulation (12) sub-regulation (5) (c) shall, unless earlier suspended or revoked, and subject to payment of prescribed annual retention fees be valid for a period of five (5) years from the date of issuance and may thereafter be renewed.
In accordance with Sub-regulation 17 (1), (2) and (3) of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015, Application for renewal of registration shall be made to the Authority at least ninety (90) days before its expiry.
Several different types of potential vaccines for COVID-19 are in development, includingA grace period for renewal shall extend to ninety (90) days after the specified expiry date. Defaulters shall pay a penalty as stipulated in Fees and Charges Regulations in force after the expiry of grace:
To access renewal of registration guidelines, please Click here.
Applicants shall pay renewal of registration fees of medicinal products as stipulated in Fees and Charges Regulations in force.
In the event, the GMP inspection is required, please note that in addition to the renewal application, the applicant should apply for GMP inspection which should include submission of the current site master file along with payment of the fees.
All variations to a registered medicinal product shall be made according to requirements stipulated in the Application Guidelines for Variation of Registered Medicinal Products. No variation will be accepted during submission of renewal of registration.
In the renewal application, only the TMDA approved variations of a medicinal product is required to be included.
Applicants are advised to plan, when possible, the submission of variation applications outside the period of the submission of the renewal application and during assessment and approval process. However, where the need for a variation of a registered product has been identified, in particular in the context of safety concerns, the applicant is advised to contact the Authority in advance of the submission of the variation application to agree on the procedural aspects for handling these parallel applications.
If a variation procedure is finalized before or upon finalization of the renewal process, the approved changes should be reflected in the renewal application.
Assessment of renewal application is performed within 30 working days. The outcome of the review is communicated via TMDA online trader portal. In addition, the approved renewal of registration of a respective medicinal product is reflected in the list of approved medicines published in TMDA website.
In the event applicants do not want to renew registration of medicinal product, withdrawal of marketing authorization application of a respective product should be submitted via TMDA online submission portal. The application should include a cover letter and reasons for withdrawal of the marketing authorization.
Who should I contact if I have a question when preparing my renewal application and during assessment of renewal application?
If you cannot find the answer to your question in the Question and Answer (Q&A) when preparing your application or during the renewal process, please contact us through 0800 110 084 (Toll Free Services) or send email to the following email address: firstname.lastname@example.org.
Tanzania Medicines and Medical Devices Authority (TMDA),
P. O. Box 1253, Dodoma
P.O. Box 77150, Dar es Salaam
Tell: +255-658 445222/777 700002