| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Therapeutic Goods Administration (TGA) Australian Health Practitioner Regulation Agency (AHPRA) |
| Competent authority/authorities enforcing the above code(s) of conduct |
Medicines Australia Therapeutic Goods Administration (TGA) (where compliance with the advertising requirements in the MA Code of Conduct is a condition of marketing approval for a prescription medicine) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Federal Office for Safety in Health Care Public prosecutor |
| Competent authority/authorities enforcing the above code(s) of conduct | PHARMIG Code Adjudication and PHARMIG Code Appeal Boards according to PHARMIG Code of Conduct |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Supreme Council of Health Ministry of Health Ministry of Justice |
| Competent authority/authorities enforcing the above code(s) of conduct |
NHRA Committee of Continuing Professional Development |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Federal Agency for Medicines and Health products ("FAMHP") Mdeon |
| Competent authority/authorities enforcing the above code(s) of conduct |
FAMHP Mdeon Pharma.be |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
The Office of the Comptroller General – CGU. Criminal law enforcement authorities. Brazil health regulators (e.g., Brazil’s National Health Surveillance Agency – Anvisa). |
| Competent authority/authorities enforcing the above code(s) of conduct |
Association of the Pharmaceutical Research Industry - INTERFARMA Union of the Industry of Pharmaceutical Products - SINDUSFARMA Association of the Industry of Health Products for Selfcare – ACESSA Professional Boards, as the case may be (e.g., Professional Board of Pharmacy; Professional Board of Medicine, etc.). |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Not applicable |
| Competent authority/authorities enforcing the above code(s) of conduct | Not applicable |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Due to lack of regulation, there are no existing authorities overseeing hospitality offered by pharmaceutical companies engaging or interacting with HCPs. |
| Competent authority/authorities enforcing the above code(s) of conduct |
Violations of the provisions of the IFPMA Code of Good Practice and of CIF’s Code shall be known by the Private Regulation and Associations Resolution System of the CIF. |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
The National Health Commission The National Medical Products Administration The Supreme and Local Procuratorates The Supreme and Local Commission of Supervision The Supreme and Local Courts Administration for Market Regulation |
| Competent authority/authorities enforcing the above code(s) of conduct |
Chinese Medical Doctor Association RDPAC China AdvaMed China |
| Competent authorities enforcing any other provisions indicated above | National Medical Products Administration |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
For Law 1751 from 2015: The Superintendency of Health and the Ministry of Health and Social Protection. For Law 1474 from 2011: The Superintendency of Health. For Resolution 2881 from 2018: The Superintendency of Health and the Ministry of Health and Social Protection. For the Colombian Criminal Code: The Colombian judicial system. For Chapter XIII of the Legal Basic Circular: The Superintendency of Companies. |
| Competent authority/authorities enforcing the above code(s) of conduct |
AFIDRO'S Code of Ethics stablished two control organs called:
ANDI's Chamber of Pharmaceutical Industry Code of Ethics and Transparency creates several control groups and committees inside the Chamber. However, sanctions are defined and imposed mainly by:
ANDI’s Medical Devices and Health Supplies Code of Ethics creates several control groups and committees inside the Chamber. However, sanctions are defined and imposed mainly by:
|
| Competent authorities enforcing any other provisions indicated above | It's a goodwill pact, so the only ones responsible for its fulfillment are the companies that effectively signed it. Having that said, since all companies are members of a guild, there is a little more collective accountability. |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Pharmaceutical Inspection Office of the Croatian Health Ministry, according to Article 193 (1) of the Act. |
| Competent authority/authorities enforcing the above code(s) of conduct | Innovative Pharmaceutical Initiative, a Croatian association and the representative body of research-oriented manufacturers of medicinal products which is also member of European Federation of Pharmaceutical Industries and Associations (EFPIA) based in Brussels. |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
State Institute for Drug Control (in Czech: Státní ústav pro kontrolu léčiv) |
| Competent authority/authorities enforcing the above code(s) of conduct | Ethics committees of the respective pharmaceutical industry associations |
| Competent authorities enforcing any other provisions indicated above | State Institute for Drug Control (in Czech: Státní ústav pro kontrolu léčiv) |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Lægemiddelstyrelsen (Danish Medicines Agency) |
| Competent authority/authorities enforcing the above code(s) of conduct | ENLI (Ethical Committee for the Pharmaceutical Industry) |
| Competent authorities enforcing any other provisions indicated above | ENLI (Ethical Committee for the Pharmaceutical Industry) |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Relevant authorities in Member States |
| Competent authority/authorities enforcing the above code(s) of conduct |
The European Federation of Pharmaceutical Industries and Associations International Federation of Pharmaceutical Manufacturers & Associations |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Finnish Medicines Agency FIMEA |
| Competent authority/authorities enforcing the above code(s) of conduct | Supervisory Commission for the Marketing of Medicinal Products and the two Inspection Boards operating under the Supervisory Commission for the Marketing of Medicinal Products |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
|
| Competent authority/authorities enforcing the above code(s) of conduct |
Judge and Jury appointed according to applicable industrial Code of Ethics (e.g., Codeem) |
| Competent authorities enforcing any other provisions indicated above |
Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Criminal law enforcement authorities. Local regulatory authorities. |
| Competent authority/authorities enforcing the above code(s) of conduct | Self-regulatory organizations, e.g. the FSA and the AKG, may enforce their codes against member companies (only). |
| Competent authorities enforcing any other provisions indicated above | Non-compliance of HCPs with the applicable local professional code for physicians / dentists, e.g. as regards interactions with the pharmaceutical industry, may be sanctioned by the competent local medical / dental association. |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Ministry of Health Ministry of Digital Governance |
| Competent authority/authorities enforcing the above code(s) of conduct |
European Federation of Pharmaceutical Industries and Associations (EFPIA) Hellenic Association of Pharmaceutical Companies (SFEE) |
| Competent authorities enforcing any other provisions indicated above | Greece's National Organization for Medicines (EOF) |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
The Commissioner of the Independent Commission Against Corruption |
| Competent authority/authorities enforcing the above code(s) of conduct |
The Hong Kong Association of the Pharmaceutical Industry The Medical Council of Hong Kong The Hospital Authority |
| Competent authorities enforcing any other provisions indicated above | The Executive Council, The Chief Justice, the Director of the Chief Executive’s Office, The Commissioner of the Independent Commission Against Corruption, the Director of Audit, the Under Secretary/Political Assistant, the Chief Executive, the Financial Secretary, the Monetary Authority appointed under S. 5A of the Exchange Fund Ordinance (Cap. 66), Permanent Secretary or the Head of a Department, the Secretary for the Civil Service, Permanent Secretary of the Bureau or the Head of the Department/person holding a post of equivalent status as the Head of a Department in an organisation in which that prescribed officer is employed at the time when the advantage is offered to/solicited/accepted by the prescribed officer. |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
National Institute of Pharmacy and Nutrition (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet, OGYÉI) Competent local courts. |
| Competent authority/authorities enforcing the above code(s) of conduct | Communications Ethics Committee |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Irish Courts |
| Competent authority/authorities enforcing the above code(s) of conduct |
Health Products Regulatory Authority (HPRA) Irish Medical Council CORU Health and Social Care Professionals Council |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Italian Medicines Agency (Agenzia Italiana del Farmaco - AIFA) Public prosecutor |
| Competent authority/authorities enforcing the above code(s) of conduct | Farmindustria Audit Committee, Judge and Jury appointed according to Code of Ethics. |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Japan Fair Trade Commission Consumer Affairs Agency |
| Competent authority/authorities enforcing the above code(s) of conduct | The Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry (Kotorikyo) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Pharmacy and Medicines Division of the Health Directorate (Division de la Pharmacie et des Médicaments de la Direction de la Santé) |
| Competent authority/authorities enforcing the above code(s) of conduct | General Secretary of the Luxembourg Pharmaceutical Association (Secrétaire général de l’APL) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Health Ministry (and Local Health Authorities); COFEPRIS (Federal Comission for Protection against Sanitary Risks) (Comisión Federal para la Protección de Riesgos Sanitarios) |
| Competent authority/authorities enforcing the above code(s) of conduct | Consejo de Ética y Transparencia de la Industria Farmacéutica en México (CETIFARMA) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Inspectorate Healthcare and Youth (Inspectie Gezondheidszorg en Jeugd) |
| Competent authority/authorities enforcing the above code(s) of conduct |
Foundation Code of Conduct Pharmaceutical Advertising (Stichting Code Geneesmiddelenreclame) Inspection Board Foundation KOAG (Keuringsraad Stichting KOAG) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Individual specialist regulators for each health profession carry out regulatory and disciplinary functions under HCPA. HCPA does not apply directly to pharmaceutical companies but will affect how HCPs respond to hospitality provided by pharmaceutical companies. |
| Competent authority/authorities enforcing the above code(s) of conduct |
Medicines New Zealand Medical Council of New Zealand New Zealand Medical Association Royal Australasian college of Physicians Pharmacy Council of New Zealand Nursing Council of New Zealand Medical Technology Association Other health professions have particular regulators (not listed here). |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
The Norwegian Medicines Agency (supervising authorities with regards to the health personnel Act and the Regulation on HCPs availability to receive gifts of 29 August 2005 no. 941): Norwegian Board of Health Supervision County Governor – Statsforvalteren.no |
| Competent authority/authorities enforcing the above code(s) of conduct | The Association of the Pharmaceutical Industry (LMI) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
The Chief Pharmaceutical Inspector (Główny Inspektor Farmaceutyczny) Criminal law enforcement authorities. |
| Competent authority/authorities enforcing the above code(s) of conduct |
The Employers' Union of Innovative Pharmaceutical Companies INFARMA (Związek Pracodawców Innowacyjnych Firm Farmaceutycznych INFARMA) – representing EFPIA in Poland The Polish Association of Self Medication Industry (PASMI (Polski Związek Producentów Leków Bez Recepty)) The Polish Association of Pharmaceutical Industry Employers (Polski Związek Pracodawców Przemysłu Farmaceutycznego) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
National Authority for Medicine and Health Products (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. – INFARMED) |
| Competent authority/authorities enforcing the above code(s) of conduct |
Portuguese Association of the Pharmaceutical Industry (Associação Portuguesa da Indústria Farmacêutica – APIFARMA) Portuguese Association of Medical Devices Companies (Associação Portuguesa das Empresas de Dispositivos Médicos – APORMED) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Ministry of Public Health Ministry of Administrative Development, Labour and Social Affairs Public Prosecution |
| Competent authority/authorities enforcing the above code(s) of conduct | Entities subject to the Cabinet Decision No. 18 of 2020 |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Romanian Medicine Agency |
| Competent authority/authorities enforcing the above code(s) of conduct | Arbitration Committee (rules set out by the code) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Russian Federal Service for Surveillance in Healthcare ("Roszdravnadzor"); administrative / criminal law enforcement authorities (police and prosecutor's office). |
| Competent authority/authorities enforcing the above code(s) of conduct | Not applicable |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Saudi Food and Drug Authority Ministry of Health Ministry of Tourism Public Prosecutor |
| Competent authority/authorities enforcing the above code(s) of conduct |
Saudi Food and Drug Authority Ministry of Tourism |
| Competent authorities enforcing any other provisions indicated above | Not appliable |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
The Ministry of Health of the Slovak Republic |
| Competent authority/authorities enforcing the above code(s) of conduct |
AIFP – Association of the Innovative Pharmaceutical Industry ADL – Association of Suppliers of Drugs and Medical Devices GENAS – Association for Generic and Biosimal Drugs |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (Javna agencija Republike Slovenije za zdravila in medicinske pripomočke - JAZMP) |
| Competent authority/authorities enforcing the above code(s) of conduct | Committee of the Forum of International Research and Development Pharmaceutical Companies |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
The Spanish Agency of Medicines and Medical Devices (AEMPS). |
| Competent authority/authorities enforcing the above code(s) of conduct |
|
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Interactions with HCPs is not regulated under Swedish law. General rules on anti-bribery may apply. Matters regarding anti-bribery are tried by public prosecutors. |
| Competent authority/authorities enforcing the above code(s) of conduct | Compliance with the Ethical Rules for the Pharmaceutical Industry are tried by the self-regulatory bodies: the Compliance Officer of the Swedish Association of the Pharmaceutical Industry (LIF), the Swedish Pharmaceutical Industry's Information Examiner Committee (IGN) and the Information Practices Committee (NBL). |
| Competent authorities enforcing any other provisions indicated above | Not applicable. |
Please also see European Union.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
The Drug Department at MOHAP, its equivalent in the relevant local public health authority or the local authority itself. |
| Competent authority/authorities enforcing the above code(s) of conduct | MOHAP |
| Competent authorities enforcing any other provisions indicated above |
The Higher Committee for Drug Policies.1 |
1 The committee responsible for setting down the policies pertaining to the trading, pricing and control of Medical Products in the UAE.
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Medicines and Healthcare products Regulatory Agency (an executive agency of the UK government's Department of Health) (MHRA) in relation to the Human Medicines Regulations 2012. Law enforcement authorities such as the Serious Fraud Office, His Majesty’s Revenue & Customs and the police in relation to the Bribery Act 2010. |
| Competent authority/authorities enforcing the above code(s) of conduct |
The ABPI Code is enforced by the Association of the British Pharmaceutical Industry (ABPI), along with the Prescription Medicines Code of Practice Authority (which is a division of the ABPI, responsible for administering the ABPI's Code). The PAGB Code is enforced by the Proprietary Association of Great Britain (PAGB). The Blue Guide is enforced by the MHRA. The GMC Code is enforced by the General Medical Council (GMC). |
| Competent authorities enforcing any other provisions indicated above | Not applicable. |
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Federal AuthoritiesDepartment of Justice Department of Health and Human Services, Office of Inspector General Centers for Medicare and Medicaid Services State AuthoritiesMedicaid Fraud Control Units State Attorneys General Other State Regulatory Agencies and Boards |
| Competent authority/authorities enforcing the above code(s) of conduct |
PhRMA CodePhRMA does not have legal or regulatory enforcement authority, but if a company desires to be listed on the PhRMA website, it must annually certify compliance to the PhRMA Code. In addition, some state laws incorporate adherence to the PhRMA Code as part of their requirements. AdvaMed CodeAdvaMed does not have legal or regulatory enforcement authority, but companies that adopt the AdvaMed Code are strongly encouraged to submit an annual certification and may display the AdvaMed Code of Ethics logo upon certification. In addition, some state laws incorporate adherence to the AdvaMed Code as part of their requirements. |
| Competent authorities enforcing any other provisions indicated above |
Certain statesCertain states have incorporated the HHS-OIG Compliance Program Guidance for Pharmaceutical Manufacturers into their state requirements (e.g., California). Certain states have incorporate adherence to the PhRMA Code as part of their requirements. Certain states have incorporated adherence to the AdvaMed Code as part of their requirements. |
Argentina
| Topic | Details |
| Relevant statutory law(s) |
Resolution of the Ministry of Health 627/2007 |
| Industry code(s) of conduct |
Code of good practices of Argentine Chamber of Medical Specialties (CAEME) |
| Other | Not applicable. |
Argentina
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Argentinian Ministry of Health |
| Competent authority/authorities enforcing the above code(s) of conduct | Argentine Chamber of Medical Specialties (CAEME) |
| Competent authorities enforcing any other provisions indicated above | Not applicable. |
Argentina
| Topic | Detail |
| Restrictions on event locations (e.g., events abroad, touristic locations, mountain or beach locations during winter/summer season, etc) |
No event should take place outside the Argentine Republic, unless there are logistical or security reasons for holding it abroad (e.g. where most of the participants guests come from abroad and/or where the relevant resource or expertise is located abroad). |
Argentina
| Topic | Details |
| Restrictions or requirements regarding event venues (e.g., resorts, castles, SPAs, proximity to transport connections or centers with relevant medical expertise, etc) |
Luxurious venues should not be selected for hosting events. |
Argentina
| Topic | Details |
| Restrictions or requirements regarding accommodation provided to HCPs (e.g. five star hotels, maximum number of nights, minimum duration of events, etc.) | Accommodation may be provided to HCPs only and it should not include sponsorship or organization of entertainment or leisure activities (e.g. sporting events, musical events, etc.). |
Argentina
| Topic | Detail |
| Restrictions on air travel (e.g. economy class only; minimum flight duration for business class) | No specific rules. |
| Restriction on train transportation (class; duration; etc.) | No specific rules. |
| Other restrictions regarding travel | No specific rules. |
Argentina
| Topic | Details |
| Limitation on providing meals (e.g. only refreshment for events lasting for half a day or more) | No specific rules. |
| Maximum value for meals (e.g., EUR 60) – please specify by meal (breakfast, lunch, dinner) where applicable | No specific rules. |
| Restrictions on where meals can be provided? (e.g. no Michelin-starred restaurant) | No specific rules. |
| Other restriction (e.g. no alcohol may be offered) | No specific rules. |
Argentina
| Topic | Details |
| Rules applicable to family members travelling together with HCPs to the event location. | No specific rules. |
Argentina
| Topic | Details |
| Rules originally designed for traditional events (described in previous points) but applicable also to online conferences | No specific rules. |
| Additional rules applicable specifically to online conferences (incl. communication / advertising rules in relation to events attended by multinational audience) | No specific rules. |
Argentina
| Topic | Details |
| Specific rules applicable to promotional events organized by/on behalf of MAH in comparison to independent scientific events described in previous points (incl. event location, venue, accommodation, transport, meals, family members, online conferences | No specific rules. |
Argentina
No text yet.
Argentina
