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.
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
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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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The pharmaceutical sector of any nation is responsible for providing society with quality medicines and other pharmaceutical services. According to the World Health Organization (WHO), Pharmaceuticals may constitute as much as 40% of the national health budget in developing countries, yet portions o
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f the population may lack access to the most essential medicines; while the limited funds available for health are spent on unnecessary, ineffective and even dangerous medications.
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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
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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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Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
Rwanda Guidelines for variation to registered pharmaceutical products.
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Therapeutics Information and Pharmacovigilance Centre | TIPC