Tanzania - Obtain License or Permit for Large Pharmaceuticals Manufacturers

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Procedure

Apply In-Person:

1. To Obtain License or Permit for Large Pharmaceuticals Manufacturers, the applicant must visit the Tanzania Medical Devices Authority link.
2. Applicant must obtain the application form from the office and fill it up with all the necessary information in it.
3. Applicant must carry both photocopies and originals of all the documents that are needed for completing this procedure.
4. Documents that are needed for completing this procedure are mentioned under the “Required Documents” section of this page.
5. Applicant must attach needed photocopies and originals along with the application form while submitting it at the office.
6. Fee for this procedure can be paid as per the authority’s request.
7. If all the above-mentioned procedures were followed properly by the applicant, the license will be provided within a stipulated period of time.
8. If there is no information regarding the license is provided within a stipulated period of time, applicant can visit the office to know status of their application.
9. After getting the notification of license availability at the office from concerned authorities, applicant can visit the office for getting their license.

NOTE: Notifications will be provided via E-mail or SMS or Postal letters.

Apply Online

1. Application for obtaining license or permit for large pharmaceuticals manufacturers is available in online in the following link.
2. If applicant is an existing user, they can Sign In using their “Trader No”, “Email Address” and “Password”.
3. If applicant is a new user, they have to click on “Sign-Up” (Create Account) for creating a new account.
4. The next page consists of the application form for creating a new account; the applicant must provide all information that is requested in the online registration form.
5. Finally, they have to click on “Submit Account Registration Details” button for submitting their registration.
6. After a successful registration, applicant will get a message in their mobile which provides the new Trader Number.
7. Applicant can use that number along with their registered E-mail Id and Password that they created for signing in.
8. Once the applicant Sign In successfully, application form for license or permit for annual dealers permit or license for small scale distributors is available under the list of “Forms”.
9. Applicant must choose “Premises Registration” for getting the online application.
10. Applicant should complete the application form by providing all needed details in them.
11. Applicant must upload digital copies of all documents (whichever is necessary) along with the application form.
12. Fee for this procedure can be paid online.
13. Finally, applicant must click on “Submit” button for submitting their application form.
14. If all these procedures were followed properly by the applicant, the license will be provided within a stipulated period of time.
15. Applicant can get their license by either visiting the office or via post.
16. If there is no information regarding license is provided within a stipulated period of time, applicant can visit the office to know the status of their application.

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Required Documents

• Completed Application Form
• A Ledger book or any other appropriate inventory control system
• Sales Book
• Inspection reports file complaints handling book
• Expired Drugs register
• Controlled Drugs Register
• Financial Invoices with corresponding certificate of importation
• Recall book
• Copies of delivery notes

Office Locations & Contacts

Tanzania Medicines and Medical Devices Authority,
Physical Address: P.O. Box 1253, Dodoma or P.O. Box 77150, Dar es Salaam, Tanzania
Hotline: +255 222 450 512 / 2450751 / 2452108
Fax No: +255 222 450 793
Email Address: [email protected]
Contact link

Eligibility

• Any pharmaceutical manufacturer business owner who is doing a large scale business is eligible.

Fees

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

Validity

• This license is valid for 2 years.

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 a stipulated period of time.

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

• Application form must be completely filled before submitting.
• Applicant must make sure to follow all instructions provided by concerned authorities properly.

Required Information

• Name of the Applicant
• Mobile Number
• TIN Number
• Signature
• Email Address
• Postal and Physical Address
• Address of the Company premises
• Signature

Need for the Document

• This license or permit is a legal procedure that has to be undergone by any large scale pharmaceuticals manufacturer in Tanzania.

Information which might help

• The following link provides guidelines for premises registration 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 Medical Devices Authority link

Others

More information which might help people.