A.55 Medicines and Related Substances Act, 2013 | No. 8 of 2013 | An Act to provide for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
GOVERNMENT NOTICE | No. 192 Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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Statutory Instrument 150 of 1991 | S.I. 150 of 1991 | Amended by S.I.’ s 298/93, 61/94, 319/94, 199/98, 256/98, 36/99, 24/2001 and 257/2002, 105 and 222 /2004
Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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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.
PLOS ONE | https://doi.org/10.1371/journal.pone.0192765 February 23, 2018
This module should always be used together with the
mhGAP Intervention Guide for Mental, Neurological
and Substance Use Disorders in Non-specialized Health
Settings (WHO, 2010), which outlines relevant general
principles of care and management of a range of other
mental, neurological and substa...nce use disorders.
(www.who.int/mental_health/publications/mhGAP_
intervention_guide/en/index.html)
In the future, this module may be integrated with other
products in the following ways:
– This module may be integrated – in its full form –
into future iterations of the existing mhGAP Intervention
Guide.
– The module will be integrated –in a simplified structure –
into a new product, the WHO-UNHCR mhGAP Intervention
Guide for Humanitarian Settings (planned for 2014).
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Journal of Pulmonary & Respiratory Medicine 6: 326. doi:10.4172/2161-105X.1000326
Manual for use in primary care.
There is substantial evidence for the benefits of screening and brief intervention in primary health care for alcohol problems. However, there is a need for screening and brief interventions with cross-cultural relevance for substances other than alcohol or tobacco,... such as cannabis, amphetamines, cocaine and opiates.
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed for the World Health Organization (WHO) by an international group of substance abuse researchers to detect and manage substance use and related problems in primary and general medical care settings. Primary health care professionals are well-positioned to provide interventions targeted to all substances irrespective of their legal status.
The ASSIST screening test version 3.0 is available in English and in 10 other languages (Arabic, Chinese, Farsi, French, German, Hindi, Portugüse, Russian, Spanish and Ukrainian).
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Procurement and supply management activities are fundamental to consistent and reliable access to essential medicines and health products. To reduce the impact of CVD, action needs to be taken to improve prevention, diagnosis, care and management of CVD diseases. Affordable essential medicines and t...echnologies to manage CVD disease must be available where and when they are required. Medicines and technologies need to be managed appropriately to ensure that the correct medicines are selected, procured in the right quantities, distributed to facilities in a timely manner, and handled and stored in a way that maintains their quality. This needs to be backed up by policies that enable sufficient quantities to be procured in order to reduce cost inefficiencies, ensure the reliability and security of the distribution system, and encourage the appropriate use of these health products. In order to avoid stock-outs and the disruption of treatment, all related activities need to be conducted in a timely manner, with performance continually monitored, and prompt action taken in response to problems that may arise. Additionally, medication must be dispensed correctly and used rationally by the healthcare provider and patient alike. The purpose of this guide is to explain the necessary steps.
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The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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2018
9th Edition
Offering information on HIV/AIDS treatment, prevention, and research
More than 40% of the world population is 24 years old or younger, the vast majority of whom live in low- and lower middle–income countries. Globally, a quarter of disability-adjusted life years (DALYs) for mental disorders and substance abuse is borne by this age group and about 75% of mental diso...rders diagnosed in adulthood have their onset before the age of
24 years . Most children and young people in developing countries, however, do not have access to mental health care.
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The second ECDC/EFSA/EMA joint report on the integrated analysis of antimicrobial consumption (AMC) and antimicrobial resistance (AMR) in bacteria from humans and food-producing animals addressed data obtained by the Agencies’ EU-wide surveillance networks for 2013–2015. AMC in both sectors, exp...ressed in mg/kg of estimated biomass, were compared at country and European level. Substantial variations between countries were observed in both sectors. Estimated data on AMC for pigs and poultry were used for the first time. Univariate and multivariate analyses were applied to study associations between AMC and AMR. In 2014, the average AMC was higher in animals (152 mg/kg) than in humans (124 mg/kg), but the opposite applied to the median AMC (67 and 118 mg/kg, respectively). In 18 of 28 countries, AMC was lower in animals than in humans. Univariate analysis showed statistically-significant (p < 0.05) associations between AMC and AMR for fluoroquinolones and Escherichia coli in both sectors, for 3rd- and 4th-generation cephalosporins and E. coli in humans, and tetracyclines and polymyxins and E. coli in animals. In humans, there was a statistically-significant association between AMC and AMR for carbapenems and polymyxins in Klebsiella pneumoniae. Consumption of macrolides in animals was significantly associated with macrolide resistance in Campylobacter coli in animals and humans. Multivariate analyses provided a unique approach to assess the contributions of AMC in humans and animals and AMR in bacteria from animals to AMR in bacteria from humans. Multivariate analyses demonstrated that 3rd- and 4th-generation cephalosporin and fluoroquinolone resistance in E. coli from humans was associated with corresponding AMC in humans, whereas resistance to fluoroquinolones in Salmonella spp. and Campylobacter spp. from humans was related to consumption of fluoroquinolones in animals. These results suggest that from a ‘One-health’ perspective, there is potential in both sectors to further develop prudent use of antimicrobials and thereby reduce AMR.
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Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there... is a category of medicines that faces a unique challenge in terms of availability. These are the medicines governed by the international conventions on narcotic and psychotropic substances. “Controlled medicines” is the common definition for pharmaceuticals whose active principles are listed under the 1961 United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol, such as morphine and methadone; the 1971 United Nations Convention on Psychotropic Substances, such as diazepam and buprenorphine; and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, such as ergometrine and ephedrine. The conventions list substances in “Schedules” according to their different levels of potential for abuse and harm, and the commensurate severity of control measures to be applied by countries.
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Current Tropical Medicine Reports (2018) 5:247–256 https://doi.org/10.1007/s40475-018-0166-2 .Purpose of the Review Buruli ulcer (BU) is a necrotizing and disabling cutaneous disease caused by Mycobacterium ulcerans, one of the skin-related neglected tropical diseases (skin NTDs). This article aim...s to review the current knowledge of this disease and challenges ahead.
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