The Permanent Secretary (PS) in the Ministry of Health and Social Welfare, Dr Donan Mmbando

The Permanent Secretary (PS) in the Ministry of Health and Social Welfare, Dr Donan Mmbando

The Permanent Secretary (PS) in the Ministry of Health and Social Welfare, Dr Donan Mmbando, told journalists in Dar es Salaam that pharmacists should not sell drugs to people without prescription.

Dr Mmbando was speaking after opening a sensitisation meeting on the use of East African Community Medicines Regulatory Harmonisation (EAC-MRH) Guidelines organised by the Tanzania Food and Drugs Authority (TFDA).

He said the guidelines, which came into effect on August 1, were aimed at having a harmonised and functioning medicines regulation system within the EAC in accordance with national and international recognised policies and standards.

?I urge the domestic pharmaceutical manufacturers to implement these guidelines. TFDA will be there to provide guidance whenever required by any manufacturers,? said the PS.

Dr Mmbando pointed out that the implementation of Phase I of the EAC-MRH programme ended on December 31, 2014 and that the new guidelines were developed and approved by the 29th Ordinary meeting of EAC Council of Ministers on September 20, last year.

He said the new guidelines focus on Medicines Evaluation and Registration (MER), Good Manufacturing Practices (GMP) and Quality Management Systems (QMS), saying the EAC Council of Ministers directed the EAC partner states to domesticate and implement in phase II effectively January, this year.

TFDA Director General, Mr Hiiti Sillo, said the programme in Phase II will focus not only on evaluation but also on designing and implementation of strengthening and harmonisation of pharmacovigilance and Post Market Surveillance (PMS) systems.

He added that the guidelines will focus also on strengthening and harmonization of medical devices and diagnostics regulation and policy, legal and regulatory frameworks.

?Initial meetings and proposals writing have been done in these new areas and will be submitted to EAC Policy Organs for approval once completed,? observed the TFDA Director General.

Mr Sillo said TFDA was committed to implement the EAC-MRH programme in close collaboration with all health stakeholders, saying TFDA will guide the manufacturers during the implementation.

By LUDOVICK KAZOKA, Tanzania Daily News

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