Competent authorities

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

 

Last modified 15 Jan 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

Therapeutic Goods Administration

Australian Health Practitioner Regulation Agency

Competent authority/authorities enforcing the above code(s) of conduct Medicines Australia
Competent authorities enforcing any other provisions indicated above Not applicable

Last modified 15 Jan 2021

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.

Last modified 15 Jan 2021

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

Last modified 15 Jan 2021

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.

Last modified 15 Jan 2021

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 Over-The-Counter Medicines Industry – ABIMIP

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

 

Last modified 15 Jan 2021

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

Last modified 15 Jan 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

Institute of Public Health

Competent authority/authorities enforcing the above code(s) of conduct Ethics Tribunal of the Chilean Chamber of Pharmaceutical Innovation ("CIF")
Competent authorities enforcing any other provisions indicated above Not applicable

Last modified 15 Jan 2021

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Competent authority/authorities enforcing the above statutory law(s)

The National Health Commission of PRC 

The National Medical Products Administration of PRC

The Supreme and Local Procuratorates

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

 

Last modified 15 Jan 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

For Law 1751 from 2015: The Superintendence of Health and The Ministry of Health and Social Protection. 

For Law 1474 from 2011: The Superintendence of Health. 

For Resolution 2881 from 2018: The Superintendence of Health and The Ministry of Health and Social Protection.

Competent authority/authorities enforcing the above code(s) of conduct

AFIDRO'S Code of Ethics stablished a control organ called:

  • AFIRDRO’S External Tribunal.

ANDI's Code of Ethics and Transparency creates several control groups and committees inside the Chamber of the Pharmaceutical Industry. However, sanctions are defined and imposed mainly by:

  • The External Ethics Committee.
  • Technical Secretariat.
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 said that, since all companies are members of a guild, there is a little more collective accountability.

Last modified 15 Jan 2021

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.

Last modified 15 Jan 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

State Institute for Drug Control (Státní ústav pro kontrolu léčiv)

Ministry of Health

Criminal law enforcement authorities (Police)

Competent authority/authorities enforcing the above code(s) of conduct Ethics Committee of AIFP (Etická komise AIFP)
Competent authorities enforcing any other provisions indicated above Not applicable

Please also see European Union.

Last modified 23 Mar 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

Lægemiddelstyrrelsen (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.

Last modified 12 Jan 2021

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

Last modified 23 Mar 2021

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.

Last modified 15 Jan 2021

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.

Last modified 22 Jan 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

National Organization for Medicines

Competent authority/authorities enforcing the above code(s) of conduct Hellenic Association of Pharmaceutical Companies
Competent authorities enforcing any other provisions indicated above Not applicable

Please also see European Union.

Last modified 26 Mar 2021

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. (see "Approving authority" as defined under section 1 of the Notice)

Last modified 21 Jan 2021

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.

Last modified 15 Jan 2021

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

Competent authorities enforcing any other provisions indicated above Not applicable

Please also see European Union.

Last modified 9 Apr 2021

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.

Last modified 15 Jan 2021

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

Last modified 2 Feb 2021

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.

Last modified 15 Jan 2021

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

Last modified 15 Jan 2021

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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)
Competent authorities enforcing any other provisions indicated above Not applicable

Please also see European Union.

Last modified 15 Jan 2021

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

Other health professions have particular regulators (not listed here).

Competent authorities enforcing any other provisions indicated above Not applicable

Last modified 10 Jun 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

The Norwegian Medicines Agency

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

Last modified 16 Feb 2021

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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.

Last modified 15 Jan 2021

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)
Competent authorities enforcing any other provisions indicated above Not applicable

Please also see European Union.

Last modified 5 Jan 2021

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

Last modified 15 Jan 2021

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.

Last modified 15 Jan 2021

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

Last modified 15 Jan 2021

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

Last modified 15 Jan 2021

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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.

Last modified 15 Jan 2021

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.

Last modified 15 Jan 2021

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

The Ethics Monitoring Unit (Unidad de Supervisión Deontológica)

The Ethics Commission of the Pharmaceutical Industry established in Spain (Comisión Deontológica de la Industria Farmacéutica implantada en España)

The Jury of AUTOCONTROL.

Competent authorities enforcing any other provisions indicated above Not applicable

Please also see European Union.

Last modified 15 Jan 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

Not applicable

Competent authority/authorities enforcing the above code(s) of conduct 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.

Last modified 15 Jan 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

MOHAP, the local public health authority and the Public Prosecutor.

Competent authority/authorities enforcing the above code(s) of conduct MOHAP
Competent authorities enforcing any other provisions indicated above Not applicable

Last modified 15 Jan 2021

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")

Competent authority/authorities enforcing the above code(s) of conduct

ABPI is enforced by the Association of the British Pharmaceutical Industry and also the Prescription Medicines Code of Practice Authority.

PAGB is enforced by the Proprietary Association of Great Britain.

The Blue Guide is enforced by the MHRA.

GMC is enforced by the General Medical Council.

Competent authorities enforcing any other provisions indicated above Not applicable.

Last modified 15 Jan 2021

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

Federal Authorities

Department of Justice

Department of Health and Human Services, Office of Inspector General

Centers for Medicare and Medicaid Services 

State Authorities

Medicaid Fraud Control Units

State Attorneys General

Other State Regulatory Agencies and Boards

Competent authority/authorities enforcing the above code(s) of conduct

PhRMA Code

PhRMA 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 Code

AdvaMed 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 states

Certain 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.

Last modified 15 Jan 2021

Argentina

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

Last modified 15 Jan 2021

Argentina

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

 

Last modified 15 Jan 2021

Argentina

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).

Last modified 15 Jan 2021

Argentina

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.

Last modified 15 Jan 2021

Argentina

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.).

Last modified 15 Jan 2021

Argentina

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

Last modified 15 Jan 2021

Argentina

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

Last modified 15 Jan 2021

Argentina

Argentina

Topic Details
Rules applicable to family members travelling together with HCPs to the event location. No specific rules

Last modified 15 Jan 2021

Argentina

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

Last modified 15 Jan 2021

Argentina

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

Last modified 15 Jan 2021