Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook
Call Us Now:
+44 2080667260 sales@omcmedical.com

Food Supplement Registration in Tanzania

Home
Food Supplement Registration in Tanzania

Regulatory Authority

Tanzania Medicines and Medical Devices

Regulatory Website

–https://www.tmda.go.tz/

License Validity

5 Years

Registration Fee

TZS800,000

Classification of Food Supplement Registration in Tanzania

  • Traditional Medicine

Herbs, minerals, or animal parts with therapeutic qualities used in traditional medicines are called raw traditional medicinal products. The items are either in their native states or have gone through basic processing including crushing, grinding, drying, or cutting.

These items can be divided into two primary categories: those pre-packaged for sale and those sold loose or in bulk. The packing materials for the former should include information on the product name, brand name, ingredients, indications, dosages, and/or usage instructions.

  • Adapted Conventional Pharmaceuticals

These are locally made goods altered by adding pharmaceutical aids, anti-microbials, suspending agents, preservatives, surfactants, emollients, or other excipients.

These medications are prepared using more sophisticated techniques and come in a variety of dose forms, including tablets, capsules, syrups, ointments, creams, lotions, and solutions.

Food Supplement Registration in Tanzania

Every product—that is, those with the same contents but manufactured to a different specification—needs its own application. (in terms of dosage form, active ingredient amount, strength, etc).

Applications must be submitted using an application that is completely completed and submitted with the following documents:

(i) A CD with an application that has been fully completed in soft copy in word or text format.

(ii) A copy of the business’s certificate of incorporation or, if relevant, the registration of any additional ownership structures in Tanzania.

(iii) A traditional health practitioner’s registration certificate from Tanzania’s Traditional and Alternative Health Practice Council.

(iv) Five identified samples of the smallest commercial pack, along with a patient information booklet that is enclosed.

(v) A fifty thousand/= non-refundable application fee for each product.

(iv) A suitable and comprehensive index or list of the submission’s various sections and documents.

Processing of Application

Complete applications are the only ones that will be processed. The information provided in the dossier will serve as the basis for the Authority’s final judgment. Nonetheless, the Authority may ask questions to obtain more information while evaluating the goods. Processing must stop once a question is presented and continue only once it has been addressed. 

The answers to any multiple queries must be sent in a single transaction. The application will immediately expire and be considered withdrawn by the applicant if it is not filed within ninety days of the query letter date.

Enquiry Now

    This will close in 0 seconds