Posted in Press Release
East African Community Headquarters, Arusha, 22nd December 2017:
The East African Community Secretariat is facilitating a four-day benchmarking visit for Burundi Parliamentarians to the Tanzania Food and Drug Authority (TFDA) and Ministries responsible for Health, Agriculture, and Trade in the United Republic of Tanzania, as part of the support to Burundi government to enable it fast-track the enactment and implementation of the Burundi National Pharmaceuticals Regulation Law that is currently before the Parliament of Burundi.
The benchmarking visit, which begun on Wednesday 20th December, is also part of the EAC Secretariat’s efforts to enable the Government of Burundi to establish and fully operationalize the Autorite’ Burundaise de Regulation des Medicaments et des Aliments (ABREMA) as public autonomous or semiautonomous body and legally designated to oversee effective regulation of food and medicinal products in the country in accordance to the regional and international best practices.
The study tour was recommended by the Participants who attended a one-day high level National Multi-Stakeholders Advocacy and Sensitization Workshop on strengthening of national pharmaceutical laws and establishment of “autorite nationale de la regulation des medicaments et des aliments (ABREMA)” in the Republic of Burundi, that was held on 7th December 2017 at the Panoramique Hotel in Bujumbura, Burundi.
Participants recommended and requested the EAC Secretariat to organize and facilitate the study tour to enable the Members of the respective Committees in Parliament and technocrats to get find hand experience on the operations of TFDA and the concerned Ministries in regard to enactment and implementation of National Pharmaceutical and Regulation Law.
The 22-Member delegation, is being led by Hon. Felix Niragira, MP and Burundi’s President of Justice and Human Rights Commission, and consists of Members of the Committee on Agriculture, Livestock, Environment and Community Development; Committee on Accounts, Finances, Economic Affairs and Planning; Committee on Justice and Human Rights; Committee on Social Affairs, Repatriation of Refugees, Equality and Fight against AIDS. Others include Technical Experts from the Ministries responsible for Health, Agriculture, Trade/Commerce and the Burundi National Bureau of Standards (BBN).
Addressing the delegation this morning Friday 22nd December, at the Ministry of Health offices in Dodoma, the Deputy Minister of Trade, Industry and Investment, Hon. Eng. Stella Manyanya commended the commitment of the Legislators in the benchmarking visit having driven a long distance from Dar es Salaam and reaching Dodoma past midnight.
She said the implementation of the EAC Council decision by Burundi on the establishment of National Authority responsible for food and drugs will lay an equal play ground for the EAC Partner States in monitoring regulations harmonization, an initiative that the Partner states had worked on for so long.
She said establishment of National Authorities helps to minimize non-tariff barriers (NTBs). “The commitment of the Republic of Burundi to implement the Council decision is a step forward to resolve some of the unnecessary NTBs in the region”, affirmed the Hon. Eng. Stella Manyanya.
At the same occasion, Hon. Felix Niragira, MP and Burundi’s President of Justice and Human Rights Commission, applauded the EAC Secretariat for organizing and facilitating the benchmarking visit and said the visit was very fruitful; and will enable the Burundi Parliamentarians to make informed decision on enacting National Pharmaceuticals Regulation Law that is before Assembly. He said Tanzania was chosen for the benchmarking visit because of it (Tanzania) was a sister Partner State and TFDA was well established with long experience.
At the same function, officials from the Ministries responsible for Health, Agriculture, and Trade shared with the Burundi delegations their various mandates and how they build synergies with TFDA.
The Burundi Parliamentarians could not meet their counterparts because the Tanzania National Parliament was on Christmas and New Year holidays recess.
On Thursday 21st December, the delegation visited the Tanzania Food and Drug Authority Headquarters in Dar es Salaam, where the Ag. Director General, Dr. Danstan Hipolite shared with them the roles and responsibilities of TFDA, its Policies, Legal Framework and Governance Structure, as an Executive Government Agency under the Ministry responsible for Health mandated to control safety, quality and effectiveness food, medicines, cosmetics and medical devices including vitro diagnostics in Tanzania.
The Ag. Director General underscored the milestones of TFDa, that include, among others, being ISO 9001:2008 certified since June 2009 and ISO 9001:2015 (August 2017); putting in place key regulatory systems, processes and procedures; and setting up a WHO Prequalified medicines testing lab since Jan, 2011. TFDA’s Food and Microbiology laboratories were accredited to ISO/IEC 17025:2005 since September 2012 and its HR capacity has increased from 52 in 2003 to the current 293 with seven (7) operational zone/branch offices and inspectors in 10 major ports of entry are some of the milestones.
TFDA’s Legal Counsel, Iskari C. Fute took the Burundi delegation step by step on Tanzania Food, Drugs and Cosmetics Act, Cap 219 including the Preliminary and Administrative/General Provisions; Provisions regarding Food; Provisions regarding Drugs; Cosmetics; Packaging and Labeling; Promotion; Enforcement and Legal Proceedings; among others.
Earlier, members of the delegation visited Shellys Pharmaceutical Company and were received by the General Manager, Mr. Yajas Ulla, who briefed them on how the Company was operating under the Tanzania Law on Food and Drugs.
Notes to Editor
The Republic of Burundi is the only Partner State in the Community that has not enacted and implemented strong National Pharmaceutical Laws through the National Parliament and has not established semi-autonomous National Medicines Regulatory Authorities (NMRAs) in order to promote public health and safety as well as facilitate cross-border trade in medicines, health technologies and other medical products, including enhancing local pharmaceutical manufacturing under the EAC Common Market Protocol.
The Republic of Burundi is still lagging behind hence denying the country the benefits of the harmonized EAC Regional Guidelines and Standards for Medicines Evaluation and Registration, Good Manufacturing Practices, Quality Management Systems and Information Management Systems as well the Mutual Reciprocal Recognition and Technical Cooperation with other Partner States and the International Medicines Regulatory Bodies and Agencies.
-ENDS-
For more information, please contact:
Mr Owora Richard Othieno
Head, Corporate Communications and Public Affairs Department
EAC Secretariat
Arusha, Tanzania
Tel: +255 784 835021
Email: OOthieno [at] eachq.org
About the East African Community Secretariat:
The East African Community (EAC) is a regional intergovernmental organisation of five Partner States, comprising Burundi, Kenya, Rwanda, Tanzania and Uganda, with its headquarters in Arusha, Tanzania.
The EAC Secretariat is ISO 2008:9001 Certified
Posted in Press Release
East African Legislative Assembly, Arusha, Tanzania: December 20, 2017:
The Assembly has elected Members to the EALA Commission. The House approved by secret ballot the names of two Commissioners each, from the Republics of Kenya, Uganda, Rwanda, South Sudan and the United Republic of Tanzania in line with the provisions of Section (3)(2) of the Administration of the Assembly Act, 2011 and Rule 83 (1), (2) and (3) of the Rules of Procedure of the EAC. The Motion to constitute the Assembly was moved by Hon Chris Opoka-Okumu. The following were elected and will sit in the EALA Commission for two and a half years.
Republic of Kenya
Hon Muhia Wanjiku – 35 votes.
Hon Dr Oburu Oginga – 33 votes.
Republic of Rwanda
Hon Dr Kalinda Xavier Kalinda – 35 votes.
Hon Gasinzigwa Oda – 35 votes.
Republic of South Sudan
Hon Dr Itto Leonardo Ann -34 votes.
Hon Gabriel Garang Aher Arol – 35 votes.
United Republic of Tanzania
Hon Nkuhi Fancy Haji – 35 votes.
Hon Yahya Mariam Ussi – 35 votes.
Republic of Uganda
Hon Nakawuki Susan - 35 votes.
Hon Mukasa Mbidde – 35 votes.
The nominees of the Republic of Burundi withdrew in writing to the Clerk. The Chair of the EALA Chapter from the United Republic of Tanzania had similarly written to the Clerk requesting to withdraw the names. However, in absence of the withdrawal by the nominees per se, the Speaker therefore ruled that the names be maintained in the list. The election which took place at the EALA Chambers was presided over by the Clerk to the Assembly, Mr Kenneth Madete. There were no spoilt votes.
The EALA Commission is a creation of the Administration of the Assembly Act 2011. The mandate of the Commission is to manage the business and the programmes of the Assembly, to nominate Members of Standing and other Committees and to recommend to the Council the appointment of the Clerk and other Officers of the Assembly. The Commission further causes to be prepared in each Financial Year, estimates of revenue expenditure for the Assembly for the next Financial Year and to perform other functions as may be necessary for the well-being of the Members and staff of the Assembly so as to ensure the effective and efficient functioning of the Assembly.
Prior to dispensing with the activity, the Assembly moved a motion under Rule 30(d) and the corresponding Rule 84(1) on suspension of a rule and in this particular case that on Rule 12 on quorum of the House. The motion was moved by Hon Susan Nakawuki and seconded by Hon Abdikadir Aden. Hon Aden said the motion was well intended as it would allow the House to carry out the important work. Others rising in support were Hon Kennedy Kalonzo, Hon Fatuma Ali and Hon Chris Opoka while Hon Dr Ngwaru Jumanne opposed the motion.
The House meanwhile adjourned sine die (without resumption date).
- ENDS -
For more information, please contact:
Bobi Odiko
Senior Public Relations Officer
East African Legislative Assembly
Arusha, Tanzania
Tel: +255-27-2508240
Fax: +255-27-2503103
Cell: +255-787-870945, +254-733-718036
Email: BOdiko [at] eachq.org
Web: www.eala.org
About the East African Legislative Assembly:
The East African Legislative Assembly (EALA) is the Legislative Organ of the Community and has a cardinal function to further EAC objectives, through its Legislative, Representative and Oversight mandate. It was established under Article 9 of the Treaty for the Establishment of the East African Community.
