Tanzania - Obtain License to Produce, Export or Import Controlled Substances (Industrial Chemicals, Pesticides, Fertilizers and Drugs)

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Procedure

Apply In-Person:

1. To Obtain a License to Produce, Export, or Import Controlled Substances (Industrial Chemicals, Pesticides, Fertilizers, and Drugs), the applicant must visit the Tanzania Medicine and Medical Devices Authority (TMDA) contact link
2. Applicant must obtain the application form from the office and fill it up with all the necessary information in it.
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 are mentioned under the “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. The Fee for this procedure must be paid as per the authority’s request.
7. Once the fee is paid, the applicant will receive a receipt from the respective officer, the receipt must be kept safe for future use.
8. Once the application process is done, the processing time for receiving the license will be provided by the concerned authorities at the office.
9. The applicant will also receive a notification from the office via SMS or E-Mail regarding the availability of the license.
10. The applicant can visit the office to get their license once they get the notification from the office.
11. If there is no information regarding the license is provided to the applicant, then, they can visit the office to know the status of their application.

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Required Documents

• Completed Application Form
• Proforma Invoices for controlled drugs
• Details about all products
• Certificate of Analysis
• Local Purchase Order
• Ownership certificate or Lease Agreement of the office premises
• ID Proof – National ID/Driving License/Passport

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
Contact No: +255 222 450 512 / 2450751 / 2452108
Fax: +255 222 450 793
Email: [email protected]
Contact link

Eligibility

• Any business owners or manufacturers of controlled substances like Industrial Chemicals, Pesticides, Fertilizers, and Drugs are eligible to apply for this procedure.

Fees

• The fee for this procedure must be paid as per the authority’s request

Validity

• This license is valid for the period mentioned in it.

Documents to Use

Please provide some 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 will be provided by the concerned authorities.

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 must provide any other additional documents if requested by the concerned authorities.

Required Information

• Name of the Applicant
• Proforma Invoice Number
• Country of Origin
• Details of controlled substances
• Contact Number
• Email Address
• Address of the ownership premises
• Name of the Product
• Name and Address of the Supplier
• Name and Address of the Manufacturer
• API specifications
• The quantity to be imported for each raw material, pack size, unit value, total value, and acceptance currency

Need for the Document

• License to Produce, Export, or Import Controlled Substances is necessary for any manufacturers of Controlled Substances in Tanzania to produce, import, and export their products legally.

Information which might help

• More information on controlled substances guidelines are 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.