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
 

Advertising

(a) Advertisements in all forms to physicians and health-related professionals

10. The wording and illustrations in advertisements to physicians and related health professionals should be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. The text should be fully legible.

11. Some countries require that advertisements should contain full product information, as defined by the approved scientific data sheet or similar document, for a given period from the date of first promotion or for the full product life. Advertisements that make a promotional claim should at least contain summary scientific information.

12. The following list, based on the sample drug information sheet contained in the second report of the WHO Expert Committee on the Use of Essential Drugs1 and appended for ease of reference, can serve as an illustration of the type of information that such advents should usually contain, among others:

1 WHO Technical Report Series, No. 722, 1985, p.43

X the name(s) of the active ingredient(s) using either international nonproprietary names (INN) or the approved generic name of the drug;

X the brand name;

X content of active ingredients) per dosage form or regimen;

X name of other ingredients known to cause problems;

X approved therapeutic uses;

X dosage form or regimen;

X side-effects and major adverse drug reactions;

X precautions, contra-indications and warnings;

X major interactions;

X name and address of manufacturer or distributor;

X reference to scientific literature as appropriate.

13. Where advertisements are permitted without claims (reminder advertisements), they ought to include at least the brand name, the international nonproprietary name or approved generic name, the name of each active ingredient, and the name and address of the manufacturer or distributor for the purpose of receiving further information.

(b) Advertisements in all forms to the general public

14. Advertisements to the general public should help people to make rational decisions on the use of drugs determined to be legally available without a prescription. While they should take account of peoples legitimate desire for information regarding their health, they should not take undue advantage of people’s concern for their health. They should not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners, for which certain countries have established lists. To fight drug addiction and dependency, scheduled narcotic and psychotropic drugs should not be advertised to the general public. While health education aimed at children is highly desirable, drug advertisements should not be directed at children. Advertisements may claim that a drug can cure, prevent, or relieve an ailment only if this can be substantiated. They should also indicate, where applicable, appropriate limitations to the use of the drug.

15. When lay language is used, the information should be consistent with the approved scientific data sheet or other legally determined scientific basis for approval. Language which brings about fear or distress should not be used.

16. The following list serves as an illustration of the type of information advertisements to the general public should contain, taking into account the media employed:

X the name(s) of the active ingredient(s) using either international nonproprietary names (INN) or the approved generic name of the drug;

X the brand name;

X major indication(s) for use;

X major precautions, contra-indications and warnings;

X name and address of manufacturer or distributor.

Information on price to the consumer should be accurately and honestly portrayed.

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Last updated: May 3, 2013