Tanzania - Apply for Good Manufacturing Practice (GMP) Inspection

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Procedure

Apply In-Person:

1. To apply for getting Good Manufacturing Practice (GMP) inspection is available in Tanzania Medicines & Medical Devices Authority Link
2. Applicants should obtain the application form from the office and fill it up with all the necessary information in it.
3. Applicants must carry 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. The Fee for this procedure has to be provided as per the authority’s request.
6. If all these procedures were followed properly by the Applicants, the inspection will be done as per the authority’s instructions.
7. During the inspection, the Applicants or the owner of the Inspection premises must be present at the site.
8. The inspection will be conducted by concerned authorities and if the pharmaceutical passes the inspection, the authority will provide a certificate to the owner or the Applicants stating that they can operate their pharmaceutical.
9. The applicant will later get a notification via SMS or E-mail regarding the availability of their certificate.
10. Once the notification is received by the applicant, they can visit the office to get their certificate.
11. If there is no information regarding the certificate is provided, the applicant can visit the office to know the status of their application.

Apply Online

1. Online application for GMP Inspection is available in the following online portal
2. If the applicant is a registered user, they can login directly by providing their “Trader No”, “Email Address”, “Password” and then by clicking on “Sign-In”.
3. If the applicant is a new user, they have to register first by clicking on “Sign-up (Create Account” option.
4. Link for new registration is available in the following link
5. The applicant should provide their “Email Address”, “Trader Name”, “Country”, Region/City”, “Postal Address”, “Telephone No”, “Mobile No”, “TIN No”, “Contact Person”, “Contact Person Email”, “Physical Address” and then by clicking on “Submit Account Registration Details” option.
6. Once the registration is successful, the applicant can login directly using their “Email Address”, “Password”, and “Trader No”.
7. After logging in, the applicant should click on “GMP Application” option.
8. The applicant should provide all information that is requested in the online application form.
9. The applicant must upload digital copies of all documents that are needed for completing this procedure.
10. The fee for this procedure can be paid online.
11. Finally, the applicant should click on “Submit” option for submitting their registration form.
12. If all these procedures were followed properly by the Applicants, the inspection will be done as per the authority’s instructions.
13. During the inspection, the Applicants or the owner of the Domestic Pharmaceutical premises must be present at the site.
14. The inspection will be conducted by concerned authorities and if the pharmaceutical passes the inspection, the authority will provide a certificate to the owner or the Applicants stating that they can operate their pharmaceutical legally.

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Required Documents

• Completed Application Form
• TIN Certificate
• National ID Card/Driving License/Passport
• Ownership Certificate or Lease Agreement or Tenant Agreement of the business premises
• Current GMP Certificate (if any)
• Manufacturing License
• List and GMP status of regulatory inspections conducted within the past three years
• Copy of the most recent inspection (not older than 2 years)
• Market complaints register
• Details of any regulatory action
• PQR report for each product
• Process validation report
• Batch manufacturing records for products manufactured in the last 6 to 12 months
• Validation Master Plan
• Long and short-term stability studies raw data at Zone IVB for batches applied for marketing registration
• Aseptic processing and filling validation report this is for terminal sterilization process
• For botanical ingredients, enclose evidence to authenticate standards reference that are used

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 22 2450512 / 2450751 / 2452108
Fax: Nō: +255 22 2450793
Email Address:[email protected]
Contact Link
Location Link
Official Link

Eligibility

• Any individual who is manufacturing goods within Tanzania is eligible for this procedure.

Fees

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

Validity

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

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 depends upon the time as instructed by inspection officers.

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

Please provide other instructions related to the certificate/documents.
e.g. The state office holds birth records since january 1908.

Required Information

• Applicant name
• Physical Address of the Head Office
• Post Code
• Country
• Contact Person
• Telephone and Mobile Number
• Fax
• E-mail Address
• Website
• Particulars of the Manufacturing Site

Need for the Document

• GMP Inspection is necessary for legally manufacturing and selling goods in Tanzania.

Information which might help

• Guidelines of applying and other information 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 & Medical Devices Authority Link

Others

More information which might help people.