Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for Drug Regulatory Authorities - Regulatory Support Series No. 005
(1998; 213 pages)
Table of Contents
View the documentPREFACE
View the documentI. INTRODUCTION
Open this folder and view contentsII. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
Open this folder and view contentsIII. OPERATING ACTIVITIES
Open this folder and view contentsIV. REVIEW OF APPLICATIONS FOR MARKETING AUTHORIZATION OF MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
View the documentV. ISSUE OF WRITTEN MARKETING AUTHORIZATION
View the documentVI. VARIATIONS
View the documentVII. PERIODIC REVIEWS
View the documentVIII. SUSPENSION AND REVOCATION OF MARKETING AUTHORIZATION
View the documentGLOSSARY
View the documentABBREVIATIONS
View the documentREFERENCES
Close this folderANNEXES
Open this folder and view contentsAnnex 1: National drug regulatory legislation: guiding principles for small drug regulatory authorities1
Open this folder and view contentsAnnex 2: *Guidelines for Implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce1
Open this folder and view contentsAnnex 3: *Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability1
View the documentAnnex 4: Model Guidelines on Conflict of Interest and Model Proforma for a Signed Statement on Conflict of Interest
View the documentAnnex 5: Model Contract between a Regulatory Authority and an External Evaluator of Chemistry, Pharmaceutical and Bioavailability Data
View the documentAnnex 6: Model Application Form for new Marketing Authorizations, Periodic Reviews and Variations, with Notes to the Applicant
View the documentAnnex 7: Detailed Advice on Evaluation of Data by the Drug Regulatory Authority
Close this folderAnnex 8: Ethical criteria for medicinal drug promotion1
View the documentResolution WHA41.17 adopted by the Forty-first World Health Assembly, 13 May 1988
View the documentIntroduction
View the documentObjective
View the documentEthical criteria
View the documentApplicability and implementation of criteria
View the documentPromotion
View the documentAdvertising
View the documentMedical representatives
View the documentFree samples of prescription drugs for promotional purposes
View the documentFree samples of non-prescription drugs to the general pubic for promotional purposes
View the documentSymposia and other scientific meetings
View the documentPost-marketing scientific studies, surveillance and dissemination of information
View the documentPackaging and labelling
View the documentInformation for patients: package inserts, leaflets and booklets
View the documentPromotion of exported drugs
View the documentAppendix: Sample drug information sheet2
View the documentAnnex 9: Model marketing authorization letter
View the documentAnnex 10: Model List of Variations (Changes) to Pharmaceutical Aspects of Registered Products which may be made without Prior Approval
Open this folder and view contentsAnnex 11: *Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
 

Promotion

6. In this context, “promotion” refers to all informational and persuasive activities by manufactures and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.

7. Active promotion within a country should take place only with respect to drugs legally available in the country. Promotion should be in keeping with national health policies and in compliance with national regulations, as well as with voluntary standards where they exist. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word “safe” should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. Promotional material should not be designed so as to disguise its real nature.

8. Scientific data in the public domain should be made available to prescriber and any other person entitled to receive it, on request, as appropriate to their requirements. Promotion in the form of financial or material benefits should not be offered to or sought by health care practitioners to influence them in the prescription of drugs.

9. Scientific and educational activities should not be deliberately used for promotional purposes.

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Last updated: May 3, 2013