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, |
|
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. - FDA, Draft Guidance,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- FDA, Draft Guidance,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Draft Guidance, Brief Summary: Disclosing Risk Information in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Draft Guidance, Accelerated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 - Health - Health - 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 |
|
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) |
|
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 |
|
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 |
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Last updated: September 16, 2004