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Reference Documents

 

Documents available :

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Theme 1: Knowledge and Perfect Command of the Multi-source Medicines Market from the "Manufacturing Sources" and "Quality" Point of View

Documents from the Because Health Platform

Recent revision of the Belgian pharmaceutical law - Text published in the Belgian "Moniteur" of 22/12/2006 - Royal Decree concerning the medicines for human and veterinarian usage (202 pages, FR & NL)

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Extracts from the Belgian pharmaceutical law concerning export of medicines (3 pages, FR)

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Text of the Charter signed by the members of the Because Health Platform concerning "quality assurance of medicines, vaccines, diagnostics and small medical supplies" (3 pages, FR)

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Documents attached to the Because Health Charter providing the signatories with a model of technical checklist for evaluation of the manufacturer and the product dossiers for qualification of the medicines, vaccines, diagnostics and small medical supplies (5 pages, FR)

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Access to Quality Medicines in Resource-Poor Countries: New findings, new challenges - Background document prepared by Raffaella Ravinetto, Institute of Tropical Medicine, Antwerp, for the Be-Cause Health Seminar "Drugs: Cure or Curse?". Egmont Palace, Brussels, December 3rd, 2007 (12 pages, ENG)

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Medicines in Developing Countries : Documented cases of quality problems - Because Health Internal Fact Sheet on reported quality problems, Raffaella Ravinetto, version updated on 20th July 2010 (20 pages, ENG)

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Substandard medicines in resource-poor settings: a problem that can no longer be ignored -complete text of an article published in the "Tropical Medicine and International Health (volume 13, numéro 8, pp. 1062-1072, August 2008)" by J.M. Caudron, N. Ford, M. Henkens, C. Macé, R. Kiddle-Monroe and J. Pinel (mixed redaction team from MSF International and the AEDES Foundation) (11 pages, ENG)

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Documents on the WHO Model Quality Assurance System (MQAS)

Information mails concerning the publication of the WHO MQAS (Interagency Guidelines: A model quality assurance system for procurement agencies - Référence WHO/PSM/PAR/2007.3), in the "WHO Technical Report No. 937" (3 pages, ENG)

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Model Quality Assurance System for Procurement Agencies: Recommendations about the quality assurance systems based on manufacturers and products prequalification, purchases, storage and distribution of pharmaceutical products (WHO Guidelines) - Original English version edition of the "MQAS" (140 pages, ENG)

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Model Quality Assurance System for Procurement Agencies: Recommendations about the quality assurance systems based on manufacturers and products prequalification, purchases, storage and distribution of pharmaceutical products (WHO Guidelines) - French translation of the "MQAS" (149 pages, FR)

 
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Theme 2: Supply Chain (Procurement and Distribution)

Documents from the WHO EMP Department ("Essential Medicines Programme")

Various useful links proposed to and by the WHO EMP Department (1 page, FR) :
- Link to the WHO Essential Medicines and Pharmaceutical Policies Department, from which all documents on essential medicines published by WHO can be found
- Direct link to the WHO publication (internal and external to WHO), sorted by country
- Mapping of the essential medicines procurement and distribution systems in African countries

 
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Theme 3: Pharmaceutical Sector Regulation

Documents on National Pharmaceutical Regulatory Authorities' Support initiatives

Registering new drugs: The African Context - New tools for new times - Report published in January 2010 by DNDi (Drugs for Neglected Diseases Institute) and The George Institute for International Health (38 pages, ENG)

Documents on harmonisation of pharmaceutical policies, procedures and regulations at sub-regional level in Africa

CEMAC Common Pharmaceutical Policy Document: Institutional and juridical framework, Human Resources, Quality Assurance, Access to Medicines - published in August 2007 (20 pages, FR)

Various documents published by CEMAC as attachments to the main text defining the harmonisation framework of pharmacovigilance policies: (i) Glossary, (ii) Model of a Notification sheet of undesirable side effects likely to be due to medicines for human usage, (iii) Algorithm of imputability used by the CEMAC pharmacovigilance structures, (iv) Organogram of the Pharmacovigilance system in CEMAC area (12 pages, FR)

Documents on Pharmacovigilance

Specification sheet of a quality default of a pharmaceutical product, AFSSAPS (2 pages, FR)

Declaration sheet of an undesirable side effect likely to be due to a pharmaceutical product, AFSSAPS (2 pages, FR)

Notification sheet of undesirable side effects of medicines, vaccines and health products, Pharmacovigilance National Centre, Togo, 2009 (1 page, FR)

Various documents published by CEMAC as attachments to the main text defining the harmonisation framework of pharmacovigilance policies: (i) Glossary, (ii) Model of a Notification sheet of undesirable side effects likely to be due to medicines for human usage, (iii) Algorithm of imputability used by the CEMAC pharmacovigilance structures, (iv) Organogram of the Pharmacovigilance system in CEMAC area (12 pages, FR)

 
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Product Development

Documents

Investigational pharmaceutical products for clinical trials in humans - Annex 7, WHO Technical Report Series 863, 1996 :

See Document or Website
Website

DNDi (Drugs for Neglected Diseases initiative) (initiative pour la recherche et le développement de solutions adaptées pour les maladies négligées) :

http://www.dndi.org/

NEPAD (New Partnership for Africa's Development) (partenariat panafricain pour le développement - Programme de l'Union Africaine) :

http://www.nepad.org

EDCTP (European and Development Countries Clinical Trial Partnership) (partenariat Nord-Sud relatif aux essais cliniques) :

http://www.edctp.org/

COHRED (Council on Health Research for Health) (aide au développement des systèmes nationaux de recherché en santé poiur les pays à faibles et moyens revenus) :

http://www.cohred.org/

Nuffield Council on Bioethics (questions éthiques en biologie et en médicine) :

http://www.nuffieldbioethics.org/

Pharmaceutical Production- Active Pharmaceutical Ingredient (API)

Documents

GMP for Active pharmaceutical ingredients (bulk drug substances) - Annex 1, § 18 (pp. 72-79) to the WHO Technical Report Series 823, 1992 :

See Document or Website

Pharmaceutical excipients - Annex 5, WHO Technical Report Series 885, 1999 :

See Document or Website

Good manufacturing practices: Requirement for the sampling of starting materials (amendment) - Annex 2 (pp. 38-39) to the WHO Technical Report Series 929, 2005 :

See Document or Website

WHO Technical Report Series 957, 2010 (Quality Control, Quality Assurance, Prequalification, revised GMP, revised GDP, miscellaneous...) :

See Document or Website
Website

WHO publications on pharmaceutical production (active pharmaceutical ingredients and other) - GMP, risk analysis, training documents on the topic, etc.:

http://www.who.int

Web site of the ARTEPAL Project:

http://www.artepal.org/

MMV (Medicines for Malaria Venture) (network for fighting against malaria):

http://www.mmv.org/

"CEP Search Page" (Certification European Pharmacopoeia) for Active Pharmaceutical Ingredients in the EDQM Web site:

http://extranet.pheur.org

"DMF Search Page" (Drug Master File) for Active Pharmaceutical Ingredients in the US-FDA Web site:

http://www.betterchem.com

Chemical Information Service :

http://www.chemicalinfo.com/

Pharmaceutical Production - Manufactured Pharmaceutical Product

Documents

Good Manufacturing Practices for Pharmaceutical Products: Main Principles - Annex 4 (pp. 36-89) to the WHO Technical Report Series 908, 2003 :

See Document or Website

Sterile pharmaceutical products - Annex 6 (pp. 76-93) to the WHO Technical Report Series 902, 2002 :

See Document or Website
Website

WHO Prequalification Programme Web site:

http://mednet3.who.int/prequal/

Page on the US-FDA Web site presenting the list of products approved by US-FDA for supply to international aid programmes in Africa and Asia:

http://www.fda.gov

Pricing and Marketing

International Drug Price Indicator Guide (published by Management Sciences or Health, last update 2009) :

See Document or Website

Untangling the Web of Antiretroviral price reductions (MSF Access Campaign)...

  • 11th edition (FR), Juily 2008 :
See Document or Website
  • 11th edition (ENG), July 2008 :
See Document or Website
  • 11th edition, Update 1 (ENG), January 2009 :
See Document or Website
  • 12th edition prepublication price analysis (ENG), July 2009 :
See Document or Website

Procurement and Distribution channels

List of documents published by WHO relating the essential medicines supply systems:

See Document or Website

Model Quality Assurance System for Procurement Agencies (MQAS) - WHO Guidelines, 2006 :

See Document or Website

Malaria Control Booster Program, Procurement and Supply Management, Tool kit, 2006 :

See Document or Website

Guide on the Global Fund policy on medicines procurement, storage and distribution management, November 2009:

See Document or Website

Good Distribution Practices (WHO) - edition 2005 (annex 5 to 44th report of the WHO Expert Committee on specifications for pharmaceutical preparations, WHO Technical Report Series 937, 2006) :

See Document or Website

WHO Technical Report Series 957, 2010 (Quality Control, Quality Assurance, Prequalification, revised GMP, revised GDP, miscellaneous...) :

See Document or Website

Medicines Prescription and Dispensing to Patients

Documents

MSF Reference Books (Medical References, updated 26th May 2010):

  • Essential Medicines (2010) - FR-ENG-ES versions
  • Clinical Guidelines (2010) - FR-ENG-ES versions
  • Refugee Health (1997) - ENG version
  • Management of epidemic meningococcal meningitis (2008) - FR-ENG versions
  • Rapid health assessment of refugee or displaced populations (2006) - FR-ENG versions
  • Obstetrics in remote settings (2007) - FR-ENG versions
  • Tuberculosis (March 2010) - FR-ENG versions
See Document or Website

Martindale Pharmacopoeia, 36th edition, Oct. 2009 :

See Document or Website

WHO Model Formulary, edition 2008 (in English):

See Document or Website

WHO Model Formulary for Children, edition 2010 (in English):

See Document or Website
Website

Thériaque (French database on medicines) (developed by the "CNHIM") :

http://www.theriaque.org/

CNHIM (Centre National Hospitalier d'Information sur le Médicament - Hospital National Centre for Information on Medicines):

http://www.cnhim.org/

eMC (electronic Medicines Compendium) (British database on medicines) :

http://www.medicines.org.uk/

BNF (British National Formulary) :

http://www.bnf.org/bnf/

WHO publications on Essential Medicines Lists, Model Formularies and access to the WHO Library on essential medicines:

http://www.who.int/selection

WHO Essential Medicines Lists (for adults and children):

http://www.who.int/medicines

WHO Publication - "WHO Drug Info":

http://www.who.int/druginformation/

Pharmaceutical Regulation

Documents

Free Marketing Authorisation of medicines for human usage, including those with multi-source origin (generics) - Guidelines for the Pharmaceutical Regulatory Authorities, Pharmaceutical Regulation Series, No. 13 (« Blue Book » in FR version):

See Document or Website

List of WHO-published documents on pharmaceutical inspection and quality systems (GMP and other references...):

See Document or Website

Norms for stability studies - WHO Technical Report Series on Specifications for Pharmaceuticals Preparations No. 953 (43e rapport technique), Annex 2 (pp. 87-130):

See Document or Website

Guidelines for multi-source generic medicines registration to establish interchangeability - WHO Technical Report Series on Specifications for Pharmaceuticals Preparations No. 937 (40th Technical Report), Annex 7 (pp. 347-390):

See Document or Website

List of WHO-published documents on regulation standards applicable in quality systems (stability, interchangeability and other references...):

See Document or Website

List of WHO Technical Reports relating to pharmaceutical products specifications (Specifications for Pharmaceutical Preparations): Technical Reports No. 32 to 44 (GMP and other quality-related standards):

See Document or Website
Website

AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé - French Pharmaceutical Regulatory Agency):

http://www.afssaps.fr/

AFMPS (Agence Fédérale belge des Médicaments et des Produits de Santé- Belgian Pharmaceutical Regulatory Agency):

http://www.fagg-afmps.be/fr/

EMA (European Medicines Agency):

http://www.ema.europa.eu/

Pharmacopoeias

International Pharmacopoeia, last edition (current edition = 4th edition, 2008, including the first addendum) (WHO Publication, English version):

See Document or Website

British Pharmacopoeia, last edition (current edition = 2010; the new 2011 edition is also available online):

See Document or Website

European Pharmacopoeia / Pharmacopée Européenne, last edition available (current edition = 6th edition) (EDQM publication in French and English versions):

See Document or Website

US Pharmacopoeia, official site::

See Document or Website

US Pharmacopoeia online (only for subscribers):

See Document or Website