The growing challenges for people in low and middle-income countries to access new medicines.
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An Act to repeal the Dangerous Medicines Act of 1973,to ensure the availability of certain drugs for exclusive medical, scientific and related purposes, while preventing their abuse; to prevent the diversion from lawful trade of controlled chemicals, controlled equipment and controlled materials for... use in the unlawful manufacture of such drugs; to render drug trafficking and related conduct as serious criminal offences and to ensure that trafficking and related conducted as serious criminal offences and to ensure that offenders or suspects are brought to justice; to render certain conduct by drug users as criminal offences, to provide for the treatment and rehabilitation of drug abusing or dependent offenders; to establish the Lesotho Narcotics Bureau; and for related matters.
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GOVERNMENT NOTICE | No. 192 Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament
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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The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and fo...rmulations on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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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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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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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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An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.
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
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.
This user guide is designed to provide national malaria control programmes with general information on glucose-6-phosphate dehydrogenase (G6PD) deficiency. Individuals with this condition may be at risk of adverse effects from medicines commonly used to cure Plasmodium vivax malaria, as well as from... other medicines and substances.
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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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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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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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