3.0 REGULATORY FRAMEWORK peanut shelling machine OF DRUGS IN addition, the Authority wishes to use

1.0 INTRODUCTION a). Food and Drug Authority peanut shelling machine (TFDA) is a government agency under the Ministry of Health and Social Welfare responsible for controlling safety, quality and effectiveness of food, drugs, peanut shelling machine cosmetics and medical devices in order to protect public health. TFDA provides a wide range of control systems under the Food, Drug and Cosmetics, Chapter 219. Such systems include peanut shelling machine product registration, registration of buildings / sites to produce and sell products, laboratory investigation of samples of products including inspection and monitoring of the market. b). Through peanut shelling machine Embedded systems, TFDA has been ensuring the safety, peanut shelling machine quality and efficacy of medicines on the market. In addition, such systems also enable to identify the presence of fake and inferior products on the market and take various measures in accordance with the law. Such measures include stopping the relevant peanut shelling machine products on the market and removing them, burn them and bring suspects to law enforcement. c). It will be recalled that, on 21 September peanut shelling machine 2012, on October 4, 2012 and on October 10, 2012, the Ministry of Health and Welfare issued a public statement about the presence of fake drugs for AIDS Relief commercial titled 'TT-VIR 30 'version no. 0C.01.85 including action taken. After these reports of Ministry release, there have been various reports through the media cause confusion to the public about this issue. d). Some frustrations include how fake drug ilivyobainika, as letters

did indeed befall TFDA Tanzania Pharmaceuticals

Industries (TPI) Ltd and as the production of drugs is ongoing or not. e). To eliminate the confusion that has begun to emerge, the Authority wishes to provide further clarification about fake drugs that use it stabilizes. Similarly, TFDA would like to use this opportunity to provide clarification on the control system of medicine in the country. 2.0 INTERPRETATION ON DRUGS fake TT-VIR 30 TFDA is iliyobaini presence of counterfeit drugs form the TT-VIR 30 issue no. 0C.01.85 on the market on July 28, 2012 through its system of inspection and monitoring of products in the market. As noted in a statement issued by the Ministry of Health

and Social Welfare, TFDA emphasizes that the company TPI MSD Ltd iliiuzia counterfeits type TT-VIR 30 issue no. 0C.01.85, according to the documents available. These documents include various models presented on security for further legal action. TFDA has canceled production peanut shelling machine of ARVs drugs factory of TPI Ltd via e Ref. And. CA/C.80/222/01A/47 dated October 4, 2012 as well as the production and distribution of all drugs through a letter Ref. And. CA/C.80/222/01A/55 dated October 10, 2012. The letters were sent to 'dispatch' at Headquarters offices TPI Company Ltd which is an area of Mikocheni, Dar es Salaam and received on 04 and 10 October 2012. Information provided by the Ministry of Health and Welfare showed clearly that the TFDA is iliyositisha production of drugs in a factory TPI Ltd. Audits conducted by TFDA in a factory peanut shelling machine TPI Ltd, Arusha on 12 and 23 October 2012, has confirmed that there are no ongoing drug production in the factory concerned as required by TFDA.
3.0 REGULATORY FRAMEWORK peanut shelling machine OF DRUGS IN addition, the Authority wishes to use this opportunity to explain more about the drug regulatory system in the country as follows: a). Control of medicine is based on the Law of Food, Drugs and Cosmetics, Chapter 219, the principle laid down guidelines, peanut shelling machine based on scientific (science based) and infrastructure such as laboratories and inspection network. Control systems include the following: - i. Evaluation of scientific information regarding the quality, safety and efficacy of drugs, making inspection of manufacturing and finally register the medication. ii. Registering areas veterans, medical and pharmaceutical production and trade, including the terms of a production management experts. iii. Perform inspection of areas yanayotengeneza medicine, customs facilities and areas pamona distributing and selling drugs. & Nbs