TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
ISO 9001: 2015 CERTIFIED
25th June, 2020
NOTICE ON THE PROCEDURE FOR GRANTING APPROVALS TO VARIATIONS OF REGISTERED MEDICINAL PRODUCTS FOLLOWING IMPLEMENTATION OF THE CURRENT VARIATION GUIDELINES
- TMDA wishes to inform all marketing authorization holders of registered medicinal products that, Since January 2019, the Authority had approved for use the new Guidelines for Variations to Registered Medicinal Products which became effective in July same year and as amended in March 2020. Following the implementation of these guidelines. The new procedure for granting approval through an automatic mail notification to applicants had been implemented. This was done in order to shorten approval process and communication to applicants.
- In order to provide a clear guidance on implementation of requested changes, the current guidelines have categorized changes into four types namely: Notifications (which are further categorized into immediate notifications (IN) and Annual notifications (AN)), Minor Changes, Major Changes and Changes that requires submission of a new application.
- Changes denoted by a letter IN are considered as "Immediate Notifications" and AN as "Annual Notification". IN can be implemented immediately at the time of submission and they can be considered accepted if an objection is not issued by the Authority within two (2) months from the date of acknowledgement of receipt of the application. AN can be implemented at anytime but must be notified to the Authority within 12 months following implementation.
- For AN, applicants must satisfy themselves that they meet all of the prescribed conditions before implementation while for IN applicants must satisfy themselves that they meet all of the prescribed conditions for the change and submit to the Authority all required documentation with the notification application.
- It should be noted that each submitted immediate notifications or annual notification submitted once in a calendar year will be considered as one minor variation and will be charged as such as per the TMDA's Fees and Charges Regulations in force at the time of submission.
- With regards to minor variations, these are changes that may have minor effects on the overall safety, efficacy and quality of the FPP. Such variations can be implemented if no objection letter has been issued within three (3) months from the date of acknowledgement of receipt. Should questions arise during the specified period; the change can only be implemented on receipt of a letter of acceptance from the Authority.
- According to these guidelines, changes are classified as major only in those instances where the level of risk is considered to be high and it is deemed necessary to provide the Authority with adequate time for an assessment of the supporting documentation. Decisions on such changes shall be made by the Authority and prior acceptance is required before the changes can be implemented. A letter of acceptance will be issued for all major variations when the variation is considered acceptable. These variations are handled within a time period of six (6) months from the date of acknowledgement of receipt.
- The Authority would also like to remind applicants that, implementation of changes related to manufacturing sites of the FPP such as multiple manufacturing sites will only commence after amendment of TMDA (Registration of Medicinal Products) Regulations, 2015 and TMDA (Fees and Charge) Regulations, 2015 to align them with the changes proposed in the current guidelines.
- We thank you for your continued cooperation.
Acting Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
PSSSF Building, Makole
P. O. Box 1253, Dodoma Or
P. O. Box 77150, Dar es Salaam
Phone: +255 22 2452108/2450512/2450751
Fax: +255 22 2450793