Directives and other rules

(including self-regulation)

on

drug advertising  

 

 

 

 

Country

Directives

International

- IFPMA, Code of Pharmaceutical Marketing Practices (2000), http://www.ifpma.org/site_docs/News/Code_English_2000.pdf

- WHO, Ethical criteria for Medicinal Drug Promotion (1988), http://www.who.int/medicines/library/dap/ethical-criteria/criteriamedicinal.pdf

- HON, Code of Conduct for medical and health Web sites,

http://www.hon.ch/HONcode/Conduct.html

United States

- Federal Food, Drug, and Cosmetic Act (FDAC), section 502 (misbranded drugs) , http://www.fda.gov/opacom/laws/fdcact/fdcact5a.htm

- 21 C.F.R. §202.

http://a257.g.akamaitech.net/7/257/2422/04nov20031500/edocket.access.gpo.gov/cfr_2001/aprqtr/pdf/21cfr202.1.pdf

- FDA, Draft Guidance, Help-Seeking and Other Disease Awareness Communications by or on behalf of Drug and Device Firms (2004)

http://www.fda.gov/cder/guidance/6019dft.pdf

- FDA, Guidance, Consumer-Directed Broadcast Advertisements, (1999)

http://www.fda.gov/cder/guidance/1804fnl.pdf , http://www.fda.gov/cder/guidance/1804q&a.htm

- FDA, Guidance, Industry-Supported Scientific and Educational Activities (1997)

http://www.fda.gov/cder/guidance/isse.pdf

- FDA, Draft Guidance, Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (1999)

http://www.fda.gov/cder/guidance/1955dft.pdf

- FDA, Draft Guidance, Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements,

http://www.fda.gov/cder/guidance/5669dft.pdf

- FDA, Draft Guidance, Accelerated Approval Products: Submission of Promotional Materials, (1999),

http://www.fda.gov/cder/guidance/2197dft.pdf

- PhRMA, Code on Interactions with Healthcare Professionals (2002)

http://www.phrma.org/publications/policy//2004-01-19.391.pdf

Canada

- Health Canada : The Distinction Between Advertising and Other Activities, POLICY From the Therapeutic Products Programme  (2000), including Appendix I, http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/advsactv_e.pdf

- Health Canada , Therapeutic Comparative Advertising: Directive and Guidance Document (2001), http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ther_comp_adv_mar-2001_e.pdf

- Health Canada , Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products, http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/advnonth_e.pdf

- Rx&D www.canadapharma.org/Industry_Publications/Code/

- PAAB, Code of Advertising Acceptance, http://www.paab.ca/code_en.pdf

- PAAB, Supplementary Guidelines for Advertising,

http://www.paab.ca/suppguide_en.html

- PAAB Procedures: http://www.paab.ca/news_en.html

- Rx&D, Code of Conduct,

http://www.canadapharma.org/Industry_Publications/Code/Code_of_Conduct_EN_June2004.pdf  

- Rx&D Procedures: http://www.canadapharma.org/Industry_Publications/Code/

European Union

- Directive 2001/83/EC (2004, consolidated)

http://pharmacos.eudra.org/F2/eudralex/vol-1/CONSOL_2004/Human%20Code.pdf

- EU Commission, Quality Criteria for Health Related Websites

http://europa.eu.int/information_society/eeurope/ehealth/quality/draft_guidelines/index_en.htm

- EFPIA European Code of Practice for the Promotion of Medicines, http://www.efpia.org/6_publ/codecon/Promomedicin_.PDF

- EFPIA, Guidelines for Internet Web Sites Available to Health Professionals, Patients and the Public in the EU

http://www.efpia.org/6_publ/Internetguidelines.pdf

Great Britain

- MHRA, Guidance Note 23, "Advertising and Promotion of Medicines in the UK"

http://medicines.mhra.gov.uk/inforesources/publications/gn23/medcont.htm

- MHRA, Guidance Note 26, Disease Awareness Campaigns Guidelines (June 2003)

http://medicines.mhra.gov.uk/inforesources/publications/gn26.pdf

- MHRA, various updates

http://medicines.mhra.gov.uk/ourwork/advertpromed/advertisingissues.htm

- ABPI, Code of Practice for the Pharmaceutical Industry (2003)

http://www.abpi.org.uk/%2Fpublications%2Fpdfs%2Fcodeofpractise03.pdf

- PAGB, Medicines Advertising Codes (Consumer and Professional Codes)

http://www.pagb.co.uk/pagb/downloads/advertisingregulations/PAGB%20Summary%20Medicines%20Advertising%20Codes.pdf

France

- Afssaps, Liste (chronologique) de recommandations pour la publicité auprès du grand public

http://agmed.sante.gouv.fr/htm/5/recopub/pubgp.htm

- Afssaps, Liste (chronologique) de recommandations pour la publicité auprès des professionnels

http://agmed.sante.gouv.fr/htm/5/recopub/pubpm.htm

- Afssaps et SNIP, Charte pour la communication sur Internet des entreprises pharmaceutiques (2002)

http://agmed.sante.gouv.fr/pdf/5/charte01.pdf

- CNIL, Recommandation sur les sites de santé destinés au public (mars 2001)

http://www.cnil.fr/index.php?id=1362

- UDA, SNPM, Information sur le médicament et publicité rédactionnelle

http://www.fnps.fr/informer/telechar/vsynd/charte2001.pdf

Pays-Bas

- Code of Conduct for Pharmaceutical Advertising

http://cgr.imanage.nl/sitedata/www.cgr.nl/uploads/misc/english/cgreng_codeofconduct.pdf

- Guidelines for Advertising and Information relating to Prescription-Only Medicines (POM) on the Internet

http://www.cgr.nl/index.cfm?pageid=4864

- Further Details regarding the Distinction between Drugs Advertising and Drugs Information

http://www.cgr.nl/index.cfm?pageid=4866

 

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Last updated: September 16, 2004