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Reglamentación de las investigaciones (Documentos de la reglamentación)
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 Egypt Pharmaceutical Country Profile-2011
This Pharmaceutical Country Profile provides data on existing socio-economic and health-related conditions, resources, regulatory structures, processes and outcomes relating to the pharmaceutical sector of Egypt. The aim of this document is to compile all relevant, existing information on the pharmaceutical sector and make it available to the public in a user-friendly format. In 2010, the country profiles project was piloted in 13 countries (http://www.who.int/medicines/areas/coordination/coordination_assessment/en/in dex.html). During 2011, the World Health Organization has supported all WHO Member States to develop similar comprehensive pharmaceutical country profiles. The information is categorized in 9 sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines Trade and Production (5) Medicines Regulation, (6) Medicines Financing, (7) Pharmaceutical procurement and distribution, (8) Selection and rational use, and (9) Household data/access. The indicators have been divided into two categories, namely "core" (most important) and "supplementary" (useful if available). This narrative profile is based on data derived from both the core and supplementary indicators. The tables in the annexes also present all data collected for each of the indicators in the original survey form. For each piece of information, the year and source of the data are indicated; these have been used to build the references in the profile and are also indicated in the tables. If key national documents are available on-line, links have been provided to the source documents so that users can easily access these documents. The selection of indicators for the profiles has involved all technical units working in the Essential Medicines Department of the World Health Organization (WHO), as well as experts from WHO Regional and Country Offices, Harvard Medical School, Oswaldo Cruz Foundation (known as Fiocruz), University of Utrecht, the Austrian Federal Institute for Health Care and representatives from 13 pilot countries. Data collection in all 193 member states has been conducted using a userfriendly electronic questionnaire that included a comprehensive instruction manual and glossary. Countries were requested not to conduct any additional surveys, but only to enter the results from previous surveys and to provide centrally available information. To facilitate the work of national counterparts, the questionnaires were pre-filled at WHO HQ using all publicly-available data and before being sent out to each country by the WHO Regional Office. A coordinator was nominated for each of the member states. The coordinator for Egypt was Mahmoud Elmahdawy, Pharm D. The completed questionnaires were then used to generate individual country profiles. In order to do this in a structured and efficient manner, a text template was developed. Experts from member states took part in the development of the profile and, once the final document was ready, an officer from the Ministry of Health certified the quality of the information and gave formal permission to publish the profile on the WHO web site.  - (pdf, 1500.9 Kb)
 Egyptian ministriel decrees for Medicines
Minister Decree No. 26/2009: Fees of Services provided by CAPA Minister Decree No. 380/2009: Specifications of Pharmacies and Stores Minister Decree 350/2009 for Regulation of Tramadol Minister Decree No. 296/2009: Registration of Human Drugs Minister Decree No. 297/2009: Registration of Biologicals Arabic Version Minister Decree No. 435/2006: GMP of Biologicals Minister Decree No. 539/2007: Egyptian GMP Minister Decree No. 540/2007: Withdrawal and prohibition of pharmaceutical products do not comply with specifications. Minister Decree No. 25/2009: Regulations of Wholesale Stores Minister Decree No. 174/1999 Minister Decree No. 487/1985: Regulations for Controlled Drugs and Substances Minister Decree No. 76/2000: Organizing of registration and advertising of medicines and pharmaceutical products and dietary supplements Minister Decree No. 172/2011 Presidential Decree No. 113/1962 Pricing Ministerial Decree No. 499/2012 Ministerial Decree No. 575/2012  
 First Modification of the Law of Suppression Deception And Fraud
First Modification of the Law of Suppression Deception And Fraud  - (pdf, 95.8 Kb)
 Law of Suppression Deception And Fraud.
Law of Suppression Deception And Fraud.  - (pdf, 402.42 Kb)
 National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey
Egypt regulations are in page 87 of the document  - (pdf, 1285.65 Kb)
 Pharmacy law in Egypt
Pharmacy law in Egypt  - (pdf, 713.91 Kb)
 Second Modification of the Law of Suppression Deception And Fraud
Second Modification of the Law of Suppression Deception And Fraud  - (pdf, 123.31 Kb)
 The World Medicines Situation
The World Medicines Situation  - (pdf, 1051.9 Kb)

 

 

 

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