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)
Índice de contenido
Ver el documentoPREFACE
Ver el documentoI. INTRODUCTION
Abrir esta carpeta y ver su contenidoII. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
Abrir esta carpeta y ver su contenidoIII. OPERATING ACTIVITIES
Abrir esta carpeta y ver su contenidoIV. REVIEW OF APPLICATIONS FOR MARKETING AUTHORIZATION OF MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
Ver el documentoV. ISSUE OF WRITTEN MARKETING AUTHORIZATION
Ver el documentoVI. VARIATIONS
Ver el documentoVII. PERIODIC REVIEWS
Ver el documentoVIII. SUSPENSION AND REVOCATION OF MARKETING AUTHORIZATION
Ver el documentoGLOSSARY
Ver el documentoABBREVIATIONS
Ver el documentoREFERENCES
Cerrar esta carpetaANNEXES
Abrir esta carpeta y ver su contenidoAnnex 1: National drug regulatory legislation: guiding principles for small drug regulatory authorities1
Abrir esta carpeta y ver su contenidoAnnex 2: *Guidelines for Implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce1
Abrir esta carpeta y ver su contenidoAnnex 3: *Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability1
Ver el documentoAnnex 4: Model Guidelines on Conflict of Interest and Model Proforma for a Signed Statement on Conflict of Interest
Ver el documentoAnnex 5: Model Contract between a Regulatory Authority and an External Evaluator of Chemistry, Pharmaceutical and Bioavailability Data
Ver el documentoAnnex 6: Model Application Form for new Marketing Authorizations, Periodic Reviews and Variations, with Notes to the Applicant
Ver el documentoAnnex 7: Detailed Advice on Evaluation of Data by the Drug Regulatory Authority
Cerrar esta carpetaAnnex 8: Ethical criteria for medicinal drug promotion1
Ver el documentoResolution WHA41.17 adopted by the Forty-first World Health Assembly, 13 May 1988
Ver el documentoIntroduction
Ver el documentoObjective
Ver el documentoEthical criteria
Ver el documentoApplicability and implementation of criteria
Ver el documentoPromotion
Ver el documentoAdvertising
Ver el documentoMedical representatives
Ver el documentoFree samples of prescription drugs for promotional purposes
Ver el documentoFree samples of non-prescription drugs to the general pubic for promotional purposes
Ver el documentoSymposia and other scientific meetings
Ver el documentoPost-marketing scientific studies, surveillance and dissemination of information
Ver el documentoPackaging and labelling
Ver el documentoInformation for patients: package inserts, leaflets and booklets
Ver el documentoPromotion of exported drugs
Ver el documentoAppendix: Sample drug information sheet2
Ver el documentoAnnex 9: Model marketing authorization letter
Ver el documentoAnnex 10: Model List of Variations (Changes) to Pharmaceutical Aspects of Registered Products which may be made without Prior Approval
Abrir esta carpeta y ver su contenidoAnnex 11: *Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
 

Applicability and implementation of criteria

4. These criteria constitute general principles for ethical standards which could be adapted by governments to national circumstances as appropriate to their political, economic, cultural, social, educational, scientific and technical situation, laws and regulations, disease profile, therapeutic traditions and the level of development of their health system. They apply to prescription and non-prescription medicinal drugs (“over-the-counter drugs”). They also apply generally to traditional medicines as appropriate, and to any other product promoted as a medicine. The criteria could be used by people in all walks of life; by governments; the pharmaceutical industry (manufacturers and distributors); the promotion industry (advertising agencies, market research organizations and the like); health personnel involved in the prescription, dispensing, supply and distribution of drugs; universities and other teaching institutions; professional associations; patients’ and consumer groups; and the professional and general media (including; publishers and editors of medical journals and related publications). All these are encouraged to use the criteria as appropriate to their spheres of competence, activity and responsibility. They are also encouraged to take the criteria into account in developing their own sets of ethical standards in their own field relating to medicinal drug promotion.

5. The criteria do not constitute legal obligations; governments may adopt legislation or other measures based on them as they deem fit. Similarly, other groups may adopt self-regulatory measures based on them. All these bodies should monitor and enforce their standards.

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Última actualización: le 3 mayo 2013