Tanzania - Obtain Pharmaceutical Manufacturing Permit

Advertisement

Procedure

Apply In-Person:

1. Application form for obtaining pharmaceutical manufacturing permit in Tanzania is available in Tanzania Medicines and Medical Devices Authority contact link
2. Applicant must provide all information that is necessary in the application form.
3. Applicant should make sure to carry photocopies and originals of documents that are necessary for completing this procedure.
4. Documents that are needed for completing this procedure are mentioned under “Required Documents” section of this page.
5. Applicant must attach photocopies of all documents (whichever is necessary) along with the application form while submitting the form at the office.
6. Fee for this procedure is listed in detail under “Fees” section of this page.
7. If all the above-mentioned procedures were followed properly by the applicant, an inspection date will be fixed by concerned authorities.
8. During the date of inspection, the applicant must be present at the office premises for explaining about various manufacturing details in the premises to the inspection officer.
9. Once the applicant passes the inspection test, they will be notified regarding their permit availability within 21 days.
10. If there is no information regarding the permit is provided, applicant can visit the office to know status of their application.

Advertisement

Required Documents

• Certificate of Incentives
• Memorandum
• Environmental Clearance Certificate
• Scoping report approval letter
• Plan layout
• TFDA Invoice
• Bank Slip
• TFDA Receipts

Office Locations & Contacts

Tanzania Medicines and Medical Devices Authority
Location: Dar es Salaam
Address:
TMDA HQ, Nelson Mandela Rd,
Dar es Salaam,
Tanzania
Contact: (+255) 222450512
Contact link
Location link

Eligibility

• Any individual who is willing to engage in Pharmaceutical manufacturing business in Tanzania are eligible.

Fees

• TZS 700,000 for Business permit fee of a large pharmaceutical factory.
• TZS 150,000 for Good manufacturing practice GMP Inspection fee per year.
• TZS 6,926,710.91 for Good manufacturing practice GMP inspection for facilities within the East African Region.
• TZS 577,225 for GMP inspection fee for domestic / local pharmaceutical manufacturing plant.

Validity

• The permit 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 within 21 days.

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.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicant must provide genuine information while applying for this procedure.
• Applicant should make sure to follow all instructions as mentioned by concerned authorities properly.

Required Information

• Full Name
• Date of Birth
• Business Premises Address
• Amount Invested
• Source of the Manufacturer
• Signature

Need for the Document

• This permit is necessary for manufacturing pharmaceutical products in Tanzania.

Information which might help

• Tanzania Medicines and Medical Devices Authority (TMDA) is responsible for providing licenses and permits for medical manufacturers in Tanzania.

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 (TMDA) link

Others

More information which might help