Competent authorities

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

Argentinian Ministry of Health (AMH)
Among its objectives, the AMH is responsible of supervising everything related to the production, distribution and marketing of medicinal products, biological products, drugs, dietary products, foods, insecticides, toiletries, mineral waters, medicinal herbs and medical application materials and instruments.

National Administration of Drugs, Food and Medical Technology (ANMAT)
Through its Institutional Relations and Advertising Regulation Division, ANMAT is in charge of ensuring compliance with advertising regulations by monitoring and supervising all advertising communications for products subject to health surveillance.

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

Argentine Chamber of Medical Specialties (CAEME)
CAEME is a private Chamber whose members are multinational laboratories, and the provisions of its Code of Good Practices are mandatory exclusively to them. Local laboratories are principally gathered in another chamber, CILFA, which does not have such principles.

Competent authorities enforcing any other provisions indicated above Not applicable.

 

Last modified 17 Oct 2024

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

Last modified 10 Oct 2023

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 6 Feb 2024

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

 

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)

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.

For its part, ASILFA’s Ethics Committee is in charge of leading investigations for violation of the Regulations against its board of directors, members and/or administrative workers hired by ASILFA.
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)

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

 

Last modified 15 Jan 2021

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:

  • AFIRDRO’S External Tribunal.
  • Higher Appeal Instance

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:

  • The External Ethics Committee.
  • Technical Secretariat.

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:

  • The External Decision Panel.
  • 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 that said, 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 (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.

Last modified 23 Mar 2021

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.

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 Oct 2023

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)
  • Professional association of the health professions concerned (e.g., Conseil National de l’Ordre des Médecins)
  • Regional health agencies (Agences régionales de santé)
  • French Ministry of Defense for military health professionals;DGCCRF
  • French Anti-corruption Agency (Agence française anticorruption)
  • Public prosecutor
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.

Last modified 8 Sep 2022

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)

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.

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.

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

CORU

Health and Social Care Professionals 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

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.

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

Medical Technology Association

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

(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

www.helsetilsynet.no

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

Last modified 16 Feb 2021

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.

Last modified 23 Oct 2023

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.

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

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.

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
  1. The Ethics Monitoring Unit (Unidad de Supervisión Deontológica).
  2. The Ethics Commission of the Pharmaceutical Industry established in Spain (Comisión Deontológica de la Industria Farmacéutica implantada en España).
  3. 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)

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.

Last modified 15 Jan 2021

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.

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) 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.

Last modified 23 Oct 2023

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)

Law 16,463
Prohibits any form of public advertising of products whose sale has only been authorized "under prescription." Such advertising should only be directed to HCPs.

Resolution of the Ministry of Health 627/2007
Based on the prohibition set by Law 16,643, Resolution 627/2007 establishes Good Practices for the Promotion of Prescription Drugs among HCPs.

Disposition of the National Administration of Drugs, Food and Medical Technology (ANMAT) N°6516/2015 
It establishes that the companies holding prescription-only medicines must notify ANMAT of the promotion of medicines directed at HCPs, along with the corresponding promotional material, such material to be presented in a specific format.

Industry code(s) of conduct

Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME)

This Code outlines the principles and general guidelines governing interactions between CAEME members and healthcare professionals (HCPs). CAEME is a private chamber comprised of multinational laboratories, and the provisions of this Code are mandatory solely for its members.

The Code covers various topics concerning the interactions between HCPs and laboratories, including:

  • Promotion of Medicinal Products.
  • Promotional Material.
  • Use of Reference Quotations.
  • Promotional and other Medical Utility Items.
  • Visits to Physicians and Pharmacies.
  • Scientific, Educational or Continuing Medical Education Activities.
  • Services provided by Healthcare Professionals.
  • Clinical Research.
  • Market Research.

Local laboratories are primarily organized under a different chamber, CILFA, which does not impose these principles.

Other Not applicable.

Last modified 17 Oct 2024

Argentina

Argentina

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

Argentinian Ministry of Health (AMH)
Among its objectives, the AMH is responsible of supervising everything related to the production, distribution and marketing of medicinal products, biological products, drugs, dietary products, foods, insecticides, toiletries, mineral waters, medicinal herbs and medical application materials and instruments.

National Administration of Drugs, Food and Medical Technology (ANMAT)
Through its Institutional Relations and Advertising Regulation Division, ANMAT is in charge of ensuring compliance with advertising regulations by monitoring and supervising all advertising communications for products subject to health surveillance.

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

Argentine Chamber of Medical Specialties (CAEME)
CAEME is a private Chamber whose members are multinational laboratories, and the provisions of its Code of Good Practices are mandatory exclusively to them. Local laboratories are principally gathered in another chamber, CILFA, which does not have such principles.

Competent authorities enforcing any other provisions indicated above Not applicable.

 

Last modified 17 Oct 2024

Argentina

Argentina

Topic Detail
Restrictions on event locations (e.g., events abroad, touristic locations, mountain or beach locations during winter/summer season, etc)

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Event Location:

Companies that are members of CAEME cannot organize or sponsor events outside Argentina (international events) unless this makes more sense from a logistics and/or security viewpoint, such as that the majority of invited participants are foreigners and/or multiple countries participate or that a relevant resource or expertise that is the main purpose of the event is located abroad. If international events are organized or sponsored, in addition to the CAEME Code, member companies must also observe the specific provisions of the Codes of Practice of the country in which the event is held.

Last modified 17 Oct 2024

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)  

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Event Venue:

All events should be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the event or meeting. Companies that are members of CAEME should avoid using luxurious venues. Hospitality must not include the sponsorship or organization of entertainment or leisure activities (such as sports events, music events or other).

When companies that are members of CAEME organize or participate in events, this fact must be disclosed in all documents regarding the invitation as well as in any published paper, speech or document related to such event. Companies that are members of CAEME must duly document, pursuant to their internal procedures, any transfer of value, they directly or indirectly make to the healthcare system stakeholders. This includes, among other, fees paid for services provided, collaboration given for the organization of scientific and professional events, expenses for hospitality offered due to an event, comprising travel, registration, accommodation and meals expenses, and the provision of scientific or medical publications.

Last modified 17 Oct 2024

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.)

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Accomodation:

Accomodation expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held. Accomodation cannot be extended beyond a reasonable period after the Event.

Companies that are members of CAEME should avoid providing luxurious accomodations. Hospitality must not include the sponsorship or organization of entertainment or leisure activities (such as sports events, music events or other).

Last modified 17 Oct 2024

Argentina

Argentina

Topic Detail
Restrictions on air travel (e.g. economy class only; minimum flight duration for business class)

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to travel expenses:

Payment of reasonable fees and reimbursement of out-of-pocket expenses related to the Events, including travel for speakers and moderators at meetings, conferences, symposia and similar scientific or professional events, is acceptable. Travel expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held. There are no specific rules or restrictions on air travel.

Restriction on train transportation (class; duration; etc.)

The principles related to air travel also apply to train transportation. There are no specific rules or restrictions on train transportation.

Other restrictions regarding travel Not applicable.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Limitation on providing meals (e.g. only refreshment for events lasting for half a day or more)

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to meal expenses:

Payment of reasonable fees and reimbursement of out-of-pocket expenses related to the Events, including meals for speakers and moderators at meetings, conferences, symposia and similar scientific or professional events, is acceptable. Meal expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held.

Maximum value for meals (e.g., EUR 60) – please specify by meal (breakfast, lunch, dinner) where applicable The principles related to meal expenses described in the first box, also apply to this point.
Restrictions on where meals can be provided? (e.g. no Michelin-starred restaurant) The principles related to meal expenses described in the first box, also apply to this point.
Other restriction (e.g. no alcohol may be offered) The principles related to meal expenses described in the first box, also apply to this point.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Rules applicable to family members travelling together with HCPs to the event location.

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to family members:

Hospitality offered by companies that are members of CAEME should not be extended to persons other than HCPs.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Rules originally designed for traditional events (described in previous points) but applicable also to online conferences

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines related to traditional Events, which are also applicable to online conferences:

When member companies organize or participate in events (including online Events), this fact must be disclosed in all documents regarding the invitation as well as in any published paper, speech or document related to such event. This includes any documents, papers or speeches published in the website platform running the Event.

Additional rules applicable specifically to online conferences (incl. communication / advertising rules in relation to events attended by multinational audience) No specific rules.

Last modified 17 Oct 2024

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

Events are neither legislated nor regulated by local authorities. The Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) described in previous points (incl. event location, venue, accommodation, transport, meals, family members, online conferences), apply also to Promotional Events.

No medicinal product or therapeutic indication may be promoted prior to approval by the competent regulatory authority, ANMAT.

At Promotional Events, any material and/or information related to medicinal products and their uses, sponsored by a company, should clearly indicate that it has been sponsored by such company.

Whenever a member company finances, ensures, or directly or indirectly organizes the publication of promotional material related to Promotional Events, it should be expressly stated that such material and/or information is not presented as an independent editorial topic, and the sponsoring company should be included in a visible place.

Information on medicinal products should be accurate and not misleading, precise, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. Information should be based on an adequate evaluation of scientific evidence and clearly reflect that evidence; and it should not mislead by distortion, undue emphasis, omission or in any other way.

Promotion should be supported by scientific studies and the qualities of the medicinal product and not by the weaknesses of competitors. Comparison will be acceptable provided it is objective, true and does not contain statements affecting the reputation of third parties. Comparisons must be drawn on analogous or comparable products and should have scientific backing in a publication.

No gifts, bonuses, benefits in cash or in kind, or incentives may be given, offered or promised to healthcare professionals to induce prescription, recommendation, dispensation, supply, sale, administration or consumption of medicinal products.

Gifts for the personal benefit of HCPs (including, but not limited to, entertainment CDs and/or DVDs, sports or entertainment tickets, electronic items, cultural items, among other) should not be offered to HCPs.

Promotional items offered at events must be related to scientific and/or educational activities attended by HCPs such as items serving as containers of scientific information and/or that may be used by the HCP at the event. Moreover, promotional aids that can be delivered in the course of medical visits may also be offered at events.

Last modified 17 Oct 2024

Argentina

Argentina

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to medical devices that can be offered or delivered to HCPs at Events:

Companies that are members of CAEME may offer or deliver medical utility items or devices provided they have a modest value, they are not items that the HCP should provide for itself or should be provided by the institution in which it exercises its regular professional activity and are beneficial to the improvement of the provision of medical services or patient care. These items may not be offered more than two times per year per HCP. Medical utility items may include the name or logo of the member company but not the name of the product, unless the name of the product is essential for the correct use of the item by the patient.

Companies that are members of CAEME may provide information or educational items to healthcare professionals for their education or for the education of patients on diseases and their treatments, provided such items are mainly intended for educational purposes. Information or educational items may include the name or logo of the member company but not of a product, unless the name of the product is essential for the correct use of the item by the patient.

Last modified 17 Oct 2024