Tanzania - Report about Variation of Human and Veterinary Medicine

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Procedure

Apply In-Person:

1. Application for Report about Variation of Human and Veterinary Medicine in Tanzania is available in Tanzania Medical Devices Authority (TMDA) contact link
2. Applicant must provide all information that is requested in the application form.
3. Applicant should make sure to carry both photocopies and originals of all documents that are needed for completing this procedure.
4. Documents that are needed for completing this procedure is mentioned under “Required Documents” section of this page.
5. Applicant must attach photocopies of all documents (whichever is necessary) along with the application form before submitting the application form.
6. Fee for this procedure has to be paid as per authority’s request.
7. If all these steps were followed properly by the applicant, the registration will be provided within 1 month.
8. If there is no information regarding the document is provided within the mentioned time period, then, the applicant can visit the office to know status of their application.

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Required Documents

• Cover Letter
• Table of Contents of the Application
• Letter of Authorization by the manufacturer
• Certificate of Pharmaceutical Product
• Certificate of Suitability
• Product Information
• Clinical Study Reports

Office Locations & Contacts

TMDA HQ,
Location: Dar es Salaam
Address: Nelson Mandela Rd,
Dar es Salaam, Tanzania
Contact No: +255-222-450-512
Contact link
Location link

Eligibility

• Any medicine production businesses or an individual who is producing medicine for human and veterinary animals are eligible.

Fees

• Fee for this procedure has to be paid as per authority’s request.

Validity

• This Report about Variation is valid for 1 year.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The processing time for this procedure is 1 month.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&>
from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicant should make sure to provide genuine information while applying for this procedure.
• Applicant must complete the application form completely before submitting it at the office, incomplete applications will be rejected.
• Applicant should make sure to follow all instructions provided by concerned authorities properly for getting the procedure to be done quicker.

Required Information

• Name of the Applicant
• Age
• Address
• Mobile Number
• Email Address
• Signature

Need for the Document

• This registration is necessary for manufacturing or selling any human and veterinary medicines in Tanzania.

Information which might help

• Downloadable documents stating the medicine registration guidelines is available in the following link

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g., Birth Certificate can be used as proof of identity.

External Links

• Tanzania Medicines and Medical Devices Authority link

Others

More information which might help people.