This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
GOVERNMENT NOTICE | No. 192 Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament
CHAPTER 15:03 | Acts 14/1969, 62/1971, 35/1974, 20/1978, 41/1978 (s. 35) 39/1979, 7/1987, 11/1988, 18/1989 (s. 27), 1/1996, 6/2000, 22/2001; R.G.N. 899/1978.
Long Acting Muscarinic Antagonists (LAMA) such as tiotropium and glycopyrronium are used in the management of COPD1. They have been shown to improve lung function, quality of life and exercise tolerance. They have also been associated with reduced COPD-related exacerbations, associated hospitalisati...ons and duration of hospital stay. Both the South African Thoracic Society (SATS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD), guidelines recommend the use of long acting anticholinergic drugs (or long acting beta agonists) in moderate to very severe disease as defined by lung function (FEV1). The most up to date guideline, utilizing the GRADE methodology (European Respiratory Society guidelines of 2017), confirms their superiority over long acting β agonists (LABA) as monotherapy for COPD in that LAMA's have demonstrated greater efficacy in terms of exacerbation reduction, with similar safety profile.2 These recommnedations are supported by published peer-reviewed
evidence including individual papers and Cochrane reviews.
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DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
This guidance should be followed if an unlicensed medicine is prepared in
a registered pharmacy. The preparation of an unlicensed medicine (for
example unlicensed methadone, or menthol in aqueous cream) in a pharmacy is called ‘extemporaneous preparation’.
The guidance should be read alon...gside the standards for registered pharmacies. These aim to create and maintain the right
environment, both organizational and physical, for the safe and effective practice of pharmacy.
By following this guidance, the pharmacy will:
• demonstrate that it meets our standards, and
• provide assurances that the health, safetyand wellbeing of patients and the public are safeguarded
Responsibility for making sure this guidance is followed lies with the pharmacy owner. If the registered pharmacy is owned by a ‘body
corporate’, the directors have responsibility.
Those responsible for the overall safe running of the pharmacy need to take into account the nature of the pharmacy and the range of services
already provided and, most importantly, the needs of patients and members of the public.
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2014-2020, Draft March 2014
Master of Science in Pharmaceutical Management Dissertation
The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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The strategic framework gives guidance to public and private health facilities and health workers on compliance with standards relating to IPC practices. To further assist health facilities to implement the IPC strategic framework, this practical implementation manual has been developed in parallel ...to accompany the document.
These implementation strategies should be read in conjunction with the National Infection Prevention and Control (IPC) Strategic Framework (2020) to support an IPC programme at health facility level towards reducing healthcare-associated infections (HAI) and antimicrobial resistance (AMR). This manual is aligned with the World Health Organization (WHO) Core Component IPC programme recommendations and highlights the essentials for developing and improving IPC at health facility level in a systematic, stepwise manner for South Africa. It supports the Framework for the Prevention and Containment of AMR in South African Hospitals (2018).
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The Kenyan Health Sector has been playing a critical role in
providing health care services in response to the population
needs in line with the Kenya Health Policy, 2014-2030’s goal
of attaining the highest possible health standards in a manner
responsive to the population needs.
WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application. This tool fac...ilitates rapid and inexpensive data collection at the facility level.
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Antibiotics 2022, 11(3), 329; https://doi.org/10.3390/antibiotics11030329.
The authors found that the most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate ...deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.
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