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 Legislation

LEGISLATION

The Human Medicines Regulations 2012 No. 1916

The Human Medicines (Amendment) (No.2) Regulations 2014 No. 1878

The Consumer Protection from Unfair Trading  Regulations 2008 No. 1277

Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC

Bribery Act 2010

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OTHER CODES

International

IFPMA Code of Practice (International Federation of Pharmaceutical Manufacturers and Associations)

EFPIA Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals

EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations

EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations

(European Federation of Pharmaceutical Industries and Associations – EFPIA)

WHO Ethical Criteria for Medicinal Drug Promotion, Geneva 1988 (World Health Organisation)

IPCAA Healthcare Congress Guidelines (International Pharmaceutical Congress Advisory Association)

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United Kingdom

The UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (Committee of Advertising Practice/Advertising Standards Authority)

Codes of Practice for Advertising Over-the-Counter Medicines – the PAGB Consumer Code and the PAGB Professional Code (Proprietary Association of Great Britain – PAGB)

BMA ‘Medical ethics today’ (British Medical Association)

General Medical Council ‘Good Medical Practice’

General Pharmaceutical Council ‘Standards of conduct, ethics and performance’

Nursing & Midwifery Council ‘Standards of conduct, performance and ethics for nurses and midwives’

Department of Health ‘Commercial sponsorship – Ethical standards for the NHS’

Department of Health ‘Standards of Business Conduct for NHS Staff’

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GUIDELINES

Advertising and Promotion of Medicines in the UK (2014) – The Blue Guide (Medicines and Healthcare products Regulatory Agency). It includes Disease Awareness Campaigns Guidelines and Medicines which are promoted for use during pregnancy – Guidance for the pharmaceutical industry

Best practice guidance on joint working between the NHS and the pharmaceutical industry and other relevant commercial organisations (Department of Health)

Moving beyond sponsorship: interactive toolkit for joint working between the NHS and the pharmaceutical industry (Department of Health/ABPI)

ABPI Guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 2009 (http://clinicaltrials.ifpma.org)

Joint Position on the Publication of Clinical Trial Results in the Scientific Literature 2010 (http://clinicaltrials.ifpma.org)

Guidelines on Standards in Medical Information(Pharmaceutical Information & Pharmacovigilance Association)

The Legal & Ethical Guidelines for Healthcare Market Research (British Healthcare Business Intelligence Association/ABPI)

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PMCPA GUIDANCE NOTES

Guidance about Certification (including certification of multi-company projects)

Guidance about Clause 3

Guidance about Digital Communications

Guidance on the Provision of Benefits in Connection with the Sale, Purchase or Promotion of Medicines

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