Government Regulation of the Republic of Indonesia regarding Security of Pharmaceutical Preparations and Medical Equipments
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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6th edition, 2010. | Published in collaboration with World Health Organisation and Clinton Health Access Initiative.
The essential medicines are those that meet the priority needs of the healthcare of the population. While reviewing the 5th edition of the essential Medicines, special attention focused on the health sector policy. Indeed, medicines play an important role in protecting, maintaining and restoring th...e peoples’ health and credibility of health facilities. Their availability is a fundamental aspect of primary health care as defined in different declarations including Alma-Ata of 1978.
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During this work, a survey on essential medicines availability was conducted. This article was first written on this subject for sharing the poor financial availability of the essential medicines in the hospital and secondly, a call for an action to be taken in improving hospital pharmacies developm...ent in each hospital in Burkina Faso.
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On April 1, 2017, the Ukrainian government launched the Affordable Medicines National Prescription Drugs Cost Reimbursement Program providing for full or partial reimbursement of essential medicines for treatment of cardiovascular diseases, asthma and diabetes mellitus type 2 (also known as type 2 d...iabetes).
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The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priorit...y areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
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Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
First edition, November 1997 | Revised July 2002