IMPORTATION OF MEDICAL DRUGS AND MEDICAL DEVICES TO TANZANIA
This is a brief on how you as foreign individuals can import drugs and other related products in Tanzania, how you can obtain Pharmaceutical licence from pharmacy council Board, how you can register company, how you can register drugs which you want to import as well as applying for import permit.
- Laws and Guidelines Manuals:
In providing this opinion, we have referred the following laws and guidelines which regulate the general affairs of importation of medical drugs and medical devices to tanzania as well as registration of companies in Tanzania.
- Tanzania Food, Drugs and Cosmetics Act, 2003.
- Tanzania Food, Drugs and Cosmetics (Importation and Exportation of Food) Regulations, 2006.
- Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2005.
- Guidelines for Importation and Exportation of Pharmaceutical products and raw materials, Second Edition, of July 2011.
- Guidelines for Importation and Exportation of Food, Revision No. 3 of November, 2011.
- Guidelines for Registration of Premises and Licensing of Pharmaceutical Business, Second Edition of December, 2008.
- Guidelines on Submission of Documentation for Registration of Veterinary Medicinal Product, Second Edition of December 2016.
- The Companies Act, 2002.
importation of medical drugs and medical devices to tanzania and other related products affairs are regulated by the Tanzania Food and Drugs Authority (TFDA) an authority which was established under the Tanzania Food, Drugs and Cosmetics Act, 2003 with the mission of protecting and promoting public health by ensuring quality, safety and effectiveness of food, drugs cosmetics and medical services being imported or produced in Tanzania.
The Law requires that any person being a citizen or foreigner dealing with importation of the related products must be registered by Tanzania Food and Drugs Authority (TFDA) and the imported pharmaceutical products must also be registered and approved by the said authority. These are the fundamental requirements for authorizing importation of pharmaceutical products and other related drugs as well as raw materials into the Tanzania market.
REQUIREMENTS OF SELLING MEDICAL PRODUCTS IN TANZANIA.
- The law requires all manufacturers and distributors of pharmaceutical products to hold valid/licenses/permits.
- The registration of premises for wholesale importation of pharmaceuticals product should be done via TFDA and must comply with all requirements as prescribed in Guidelines for Importation and Exportation of Pharmaceutical Products and Raw materials in Tanzania.
- An applicant for registration of pharmaceutical products and medical devices can be made by manufacturer or by a person who orders the products to be manufactured for sell in Tanzania.
- The applicant shall be responsible for the product, information supplied in support of the application for registration and variations thereof .
- An applicant who is not resident in Tanzania shall nominate a Local Responsible Person (LRP). A certified copy of power of attorney, formal agreement or any other official authorization shall be submitted by an applicant as official proof of nomination of a LRP.
What is Local Responsible Person.
A local responsible person is natural person residing in Tanzania or cooperate body registered in Tanzania who has received a mandate from the applicant to act on his behalf with regard to matters pertaining to registration of pharmaceutical products and medical devices in Tanzania.
The Local Responsible Person shall:
(a)Monitor the device on the market and inform the Authority Immediately after the detection of any problem relating to registered products such as serious manufacturing defects which may endanger public health.
(b)Facilitate communication between the applicant and the Authority on matters relating to the product.
(c)Handle products recalls.
(d) Provide technical support and services to users of registered device and pharmaceutical products.
Requirements of importers
All pharmaceutical products or to say any imports/ importation of medical drugs and medical devices to Tanzania must be registered by TFDA unless given special approval by the Authority.
All importation of pharmaceutical products must be done by importers whose premises are dully registered by TFDA or relevant Government institution.
All importers must import pharmaceutical products through the authorized POE (Port of Entry).
No person shall import any pharmaceutical product with shelf life of more than Twenty four months whose remaining shelf life is less than 60% and a drug with Shelf life of less or equal to twenty four months whose remaining shelf life is less
Categories personnel who can be authorized to import pharmaceutical products and raw materials into the country.
- a)Government and Non-Governmental institutions.
- b)Pharmaceutical wholesalers.
- c)Pharmaceutical manufacturers.
- d)Clinical trial sponsors and Principle investigators.
- e)Recipients of donations.
Also, under some special circumstances,
- a)Persons may be authorized to import pharmaceuticals for personal use.
- b)And, hospitals may be authorized to import pharmaceuticals for hospital use.
How can a person/ institution import drugs and other related products in Tanzania:
For a person/ individuals/ institutions to do the importation of medical drugs and medical devices to tanzania, one must make an application to the Director General of the Tanzania Food and Drugs Authority (TFDA) by filling in a special application form of which we can assist you to obtain, then the application must be submitted to TFDA head quarter offices or zone offices located in Arusha, Mwanza, Mbeya and Dodoma regions.
The application form must be accompanied by one original proforma invoice, 2 copies of the original proforma invoice from the marketing authorization holder of the product(s) or authorized supplier(s), the proforma invoices shall state each pharmaceutical to be imported, with the following details;
(i) Profoma invoice number and date
(ii) Name of the supplier.
(iii) Name of the manufacturer.
(iv) Country of origin.
(v) Trade or proprietary name.
(vi) The International Non Proprietary name (generic name) of the drug and its strength.
(vii) In the case of the product containing more than one active ingredient the name and strength of each shall be stated.
(viii) The pharmacopoeial specification of the ingredient such as BP, USP.
(ix) The product registration number issued by the Tanzania Food and Drugs Authority.
(x) The quantity to be imported for each drug, its unit value, total value and acceptance currency.
(xi) Batch number for each product
(xii) Manufacturing and expiring date
(xiv) Mode of shipment (sea, air, road)
(xv) Destination port of entry
(xvi) Expected date of arrival
(xvii) Signature and stamp of the supplier.
The application form must be stamped and signed by the pharmacist or veterinary surgeon in-charge of the importing company and the applicant before being submitted to theTanzania Food and Drugs Authority (TFDA).
After submitting the application and upon receiving the application above, TFDA will determine whether all the requirements have been met and fulfilled, if they do, the applicant will be required to pay import Free on Board (FOB) fees as stipulated under the Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2005.
Importation of unregistered pharmaceuticals products:
Unregistered pharmaceuticals requested for importation will be issued an import permit only if the following criteria are complied with:-
- a)An applicant has applied for a special permit stating reasons for importing unregistered medicines.
- b)The imported pharmaceutical products have no registered therapeutic equivalent (alternative) products available in Tanzania Mainland.
- c)Pharmaceutical products come from a TFDA approved Good Manufacturing practice (GMP) facility.
- d)Pharmaceutical products has registered therapeutic equivalent but proved not to have been imported for a minimum period of 6 months as proved by TFDA.
How can you obtain Pharmaceutical licence in Tanzania:
This is done through Tanzania Investment Centre, and the following are the procedures which are done in accordance with section 20 of the Tanzania Food, Drugs and Cosmetics Act, 2003;
- You are required to submit an application for Environmental Impact Assessment (EIA) Certificate, which you must have obtained first before making your application.
- Then you will obtain EIA screening decision letter.
iii. Submit application for scoping report and TORs
- Then submit the scoping report and TORs to NEMC where by you will obtain approval.
- Then you will be required to submit application for permit and premise registration.
- You will the pay the inspection fee and permit fee, to TFDA where you will obtain a receipt.
vii. Then you will submit that receipt, and wait to obtain pharmaceutical manufacturing license and Registration Certificate from Tanzania Investment Centre (TIC).
How can you register drugs you want to import in Tanzania:
- i)The first thing to do is to write and submit a motivation letter of not more than 500 words with the product dossier indicating why the product should be registered in Tanzania. A letter should be signed by Marketing Authorization Holder.
- ii)Manufacturing and Marketing Authorization: You must also submit a Certificate of Pharmaceutical Product or an equivalent certificate issued by competent authority of the country of origin as per WHO format.
iii) Application information
– An application and all supporting documents must be in either Swahili or English.
– Application forms should be dully filled with relevant information and attachments, dated, signed and stamped appropriately.
- iv)Data presentation:
General data should be presented in the application for registration of Pharmaceutical products and compiled with the summary of product characteristics, such as;
– API: Active Pharmaceutical Ingredient.
– FP: Finished Products.
– TE: Therapeutic Equivalent Data.
– √: Required.
– ×: Not Required.
- v)Product information and labelling: you will be required to provide copies of all package inserts, labels and any other information intended for distribution with the product to the patient.
- vi)Prescribing information (Summary of the product characteristics):
All prescriptions drugs should be accompanied by SmPC. The prescribing information is should not be a promotional document. The applicant is supposed to prepare and present prescribing information in the content in a special prescribed format, but generally the summary must provide clinical particulars like; Targeted species, contradictions, special warnings, special precautions for use, adverse reactions, use during pregnancy, lactation or lay, etc.
vii) Container labelling: the drug must be labelled as per guidelines provided by the authority.
viii) Information leaflet: Every container of a pharmaceutical product must be accompanied with information leaflet. And, the applicant will provide two (2) copies of information on A4 paper and also specimens as they will appear with a special product.
- ix)Further, the applicant must evidence a Good Manufacturing Practice (GMP): For all medicines, drugs and any other related products, irrespective of the country of origin all key manufacturing processing steps in the production of active pharmaceutical ingredients must be performed in plants that comply with Tanzania Food and Drugs Authority (TFDA) GMP.
- x)Lastly, Product samples: Five samples of the smallest commercial pack(s) from one batch with total amount not less than 200 capsules/ tablets, 400ml for liquid preparations and 250 g for a cream and ointment should be submitted, otherwise additional samples shall be submitted to meet the total minimum required for the dosage form.
Therefore, if all of these requirements are met they will need to be approved by Tanzania Food and Drugs Authority (TFDA), you will be required to pay a registration fee which as provided under The Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015, and the TFDA will issue a Certificate of Registration of that particular drug to be manufactured or imported.
Once we have the info on how many drugs or devices then we can best advise on our fees.
Apply for Registration of a company:
In registering a company in Tanzania Applicants must submit a name clearance application on line, there by suggesting like 3 names to be cleared so as to check for availability or non availability of the desirable names.
Applicants are then advised if the name is available they prepare Memorandum and Articles of Association and submit the same to the Registrar for registration process.
Compliance with all requirements relating to formation of the company is declared in form no.14b which is sworn before Commissioner for oath. Particulars of directors are given through form no. 14a and notice of the situation of the registered office is also given through the same form no. 14a, where physical locations and postal address must be provided.
Registration of companies is one of our core activities which we usually do for our clients, therefore we may assist you in this should you instruct us.
We also help our clients in protection of their brands and inventions at very affordable rates.
We are very open to a discussing and be assured that we will deliver your assignment in time. We are well connected with people at TFDA and have members of the firm that are very capable at handling the task at hand. Should you have any queries please do not hesitate to contact us.
Prepared by ABC Attorneys of Tanzania.