The manufacture, marketing authorisation, import and export, storage, distribution, advertising and promotion of pharmaceutical products, as well as their use for scientific research, are mainly regulated by the Ministry of Health and the Public Health Institute (Instituto de Salud Pública – ISP).

In this regard, the advertisement and promotion of pharmaceutical products is highly regulated by a set of legal instruments, essentially composed of:

• Supreme Decree Law 725 of the Ministry of Health, dated 11 December 1967, approving the Sanitary Code;
• Supreme Decree No 466 containing the Regulation of Pharmacies, Drugstores, Pharmaceutical Warehouses, First Aid Stations and Authorised Depots (from 1984);
• Supreme Decree No 405 containing the Regulation of Psychotropic Products (from 1983); and
• Supreme Decree No 3 containing the Regulation of the National System for the Control of Human Pharmaceutical Products (from 2010).

There are also resolutions and guidelines issues by the Public Health Institute and the Ministry of Health, such as:

• Guidelines on the contents of professional information brochures;
• Technical guide for the dispensing of medications through electronic means; and
• Guide for good prescription practices.

In Chile, self-regulatory codes apply only to members of trade associations that have enacted such codes. The pharmaceutical trade associations that have enacted self-regulatory codes to date are CIF (Pharmaceutical Innovation Chamber) and ASILFA (Industrial Association of Pharmaceutical Laboratories), and their members must comply with the ethical standard established in this codes.

In Chile, there is also a Self-Regulation and Advertising Ethics Council (CONAR), which is composed of the most important and representative institutions and companies in the advertising and communication industry in the country, through different associations. CONAR enacted the Chilean Advertising Code of Ethics, which is a self-regulation instrument derived from the private will of the advertising sector, establishing a set of ethical standards and deontological norms that should be adhered to by companies and professionals involved in advertising in Chile. Provision 25 regulates the advertisement of pharmaceutical products and cosmetics. Adherence to this code is voluntary.

Supreme Decree No 3 defines advertising as the set of procedures or activities used to make known or highlight, directly or indirectly, to the public, through any means or dissemination procedure, the specific characteristics, distribution conditions, sale and use of pharmaceutical products.

In Chile, only advertising for over-the-counter (OTC) medications (ie, those that do not require a prescription) is allowed. Moreover, advertising for OTC medications is strictly limited to that which has been authorised by the Public Health Institute.

Distinguishing between information-sharing and advertising is crucial in the regulatory context. Information-sharing typically involves the dissemination of factual and educational content without the explicit promotion of a product or brand, including disease awareness campaigns and patient support programmes, while advertising actively promotes specific products and their specific characteristics or trade marks.

Regarding disease awareness campaigns and the exchange of patient-facing information, such as patient leaflets and support programmes, the classification depends on the intent. If the primary purpose is to provide unbiased information for public health awareness, without explicitly promoting a particular medication, it aligns with information-sharing. However, if these initiatives involve specific product endorsements or promotional elements, they may be considered advertising. The key criterion is the promotional intent and whether the communication encourages the use or purchase of a particular product.

For instance, benefits offered to the final consumer, communicated through electronic means, should be conveyed in a way that informs users without incentivising specific products. In this regard, the Technical Guide for dispensing medication through electronic means allows benefits to be provided to consumers through agreements, collective agreements or similar arrangements, conveying generic price reductions without incentivising specific products. This guide establishes that electronic media can inform users about these benefits through banners or pop-ups, and that certain product categories do not need a health authorisation to offer such programmes, provided they meet the above-mentioned specified requirements.

In Chile, press releases concerning OTC medicines are permitted, subject to specific restrictions – namely, that the advertisement is authorised by the Public Health Institute. However, press releases on prescription-only medicines accessible to the general public are prohibited. Nevertheless, press releases exclusively targeting healthcare professionals are allowed, such as publications in specialised scientific magazines.

In Chile, comparative advertising is allowed for OTC medications, as long as it is truthful, sufficient, objective and substantiated. It should also be noted that there is a national policy on therapeutic bioequivalence that allows certain products to use specific graphic labelling to demonstrate to consumers that such product has the same efficacy, safety and quality characteristics as a reference or innovative product.

Comparative advertisements must also comply with specific requirements established in different regulations, such as the Consumer Protection Law and the Unfair Competition Law. In this context, the principles align with those previously mentioned. However, it is worth noting that, in Chile, engaging in unfair competition through comparative advertising is deemed to occur when illegitimate means are employed. The Supreme Court has emphasised that a comparison is considered legitimate and accurate when it contrasts comparable objects or information. It establishes that the requirements for truthfulness and demonstrability in this type of advertising are interlinked; merely proving or asserting the truthfulness of a statement is insufficient, particularly when such truthfulness is relative.

It should also be noted that CONAR’s Code defines comparative advertising as any communication claiming the superiority of a product, service, brand or industry over a competitor by explicitly or implicitly comparing their characteristics, attributes or benefits. The advertising must be ethical, truthful, objective and based on verifiable evidence, avoiding exaggerations or advertising techniques at the expense of the competition. It should compare similar goods or services, be clear and avoid generating confusion. It must not engage in unfair competition nor denigrate the image of another company.

In Chile, it is not permitted to provide information about products that have not been previously authorised. Advertising for drugs can only be done for OTC products, specifically focusing on their approved therapeutic recommendations as approved by the Public Health Institute. Any promotion beyond these approved indications is a violation of Chilean regulations.

However, some scientific information may be delivered in scientific events, provided it is not considered promotion.

The information that a professional can receive during the development of a scientific conference must not be considered promotion when that information encompasses unauthorised medicines. Therefore, information regarding unauthorised medicines must be limited to scientific information only.

The IFPMA Code of Conduct has been adopted by the main pharmaceutical trade associations and also prohibits the promotion of unauthorised pharmaceutical products. However, it establishes that this provision does not intend to hinder the right of the scientific community and the public to be fully informed about scientific and medical progress, permitting the exchange of scientific information regarding a pharmaceutical product.

In addition, any information provided must be truthful and objective, especially regarding the research or clinical study.

In Chile, it is not allowed to proactively send information to healthcare professionals about unauthorised medicines or unauthorised indications, since the legislation strictly prohibits the advertisement and promotion of unauthorised products.

This type of information must be restricted to scientific events or scientific publications, and may only provide technical information.

In Chile, it is not allowed to proactively send information to healthcare institutions about unauthorised medicines or unauthorised indications, since the legislation strictly prohibits the advertisement and promotion of unauthorised products.

This type of information must be restricted to scientific events or scientific publications, and may only provide technical information.

Early access or compassionate use programmes are regulated in Chile as Provisional Authorisations granted by the Public Health Institute. In exceptional cases, the Public Health institute may authorise the provisional use of pharmaceutical products that have not been granted a marketing authorisation for urgent medicinal use; such authorisation is personal (only for the applicant) and must be supported by a health professional authorised in Chile. This authorisation may also be granted in the case of clinical trials, in which case the holder of the special authorisation for provisional use for research purposes, and subsequently (if applicable), the holder of the market authorisation, must provide the patient with continued treatment at no cost for as long as its therapeutic utility persists, following the respective research protocol.

Regarding the publication of the availability of compassionate use programmes, there is no specific regulation other than the provision that the Public Health Institute must maintain a public record of all scientific investigations involving human subjects with pharmaceutical products or medical devices authorised to be conducted in the country.

The advertising permissible for OTC pharmaceutical products will be limited to that which has been pre-approved by the Public Health Institute. Such advertising is restricted to reproducing the exact content, whether in full or part, of patient information leaflets and labels that have received approval in the respective sanitary registration. Advertising is prohibited for products that require a prescription.

The information directed at the public is limited to reproducing the exact total or partial content of the patient information leaflets and labels approved in the sanitary registration, and it can only refer to therapeutic recommendations approved by the Public Health Institute in the respective sanitary registration; under no circumstances may it contain titles, figures, indications, effects, allusions or mentions that deviate from this. The patient information leaflet is designed to inform patients about a pharmaceutical product, including details on authorised indications, warnings, contraindications, interactions and precautions, and any other information mandated by the health authority in the registration for proper usage. For OTC pharmaceutical products, the leaflet should also include information about the typical dosage for a specific use and the approved mode of administration, as specified in the registration. It may also include the medicine's price.

Only pharmaceutical products with OTC status may be advertised in manufacturing and distribution establishments, specifying their authorised name and approved packaging, along with the producer's or distributor's logo, if applicable. In these establishments, advertising methods that may induce the purchase, use or inappropriate selection of medications – such as raffles, lotteries, donations of samples or other forms that encourage consumption, misuse or self-medication – are prohibited. Likewise, the sale of pharmaceutical products cannot be encouraged through incentives of any kind directed at pharmacy staff.

Advertising and other activities intended to inform consumers about a pharmaceutical product are only allowed for OTC medications and in accordance with the terms established in the respective.

Activities that contribute to the execution of promotion or prevention actions, such as a temporary facility for the detection of HIV or breast cancer, are allowed.

Information tailored to healthcare professionals encompasses a set of procedures and activities aimed at legally authorised professionals for prescribing or dispensing pharmaceutical products.

Promoting pharmaceutical products to healthcare professionals authorised to issue prescriptions should align with the therapeutic utility indications in the respective market authorisation. This promotion is restricted from mass media targeting the general public but may involve delivering medical samples.

The information extended to professionals must be truthful, accurate, comprehensive and verifiable, aligning precisely with the approved therapeutic use, properties and content of the professional information leaflet, as authorised in the corresponding market authorisation. It should delineate the formula, indications, interactions, contraindications, precautions, warnings, adverse reactions, side effects, dosage and toxicity risks, along with their treatment protocols.

In referencing clinical, pharmacological or other scientific studies within pharmaceutical product promotions, precision and completeness are imperative. Studies should be readily accessible to requesting professionals.

The claim of exclusive characteristics for a product shared with others is strictly forbidden. Comparative statements about similar medicines must be substantiated by supported studies. Providing scientific information that is not recognised in the market authorisation to professionals is allowed but must be explicitly stated, with the professional assuming exclusive responsibility.

In order to inform legally qualified professionals about pharmaceutical products, the professional information leaflet must reference at least the following:

• the pharmaceutical product's characteristics;
• pharmacokinetic, pharmacodynamic and toxicological aspects;
• indications;
• dosage;
• target age group;
• contraindications;
• interactions;
• precautions;
• warnings;
• adverse reactions (including those during pregnancy and breastfeeding, or in special populations); and
• overdose management measures.

The leaflet should also include information on bioavailability or demonstrated therapeutic equivalence if mandatory.

Offering incentives of any nature, such as money, goods or services, to professionals responsible for prescription or dispensing, as well as those involved in sales, is strictly prohibited if it is intended to incentivise the prescription, dispensing or sale of certain products over others.

In Chile, it is not allowed to refer to data on file or data generated from other clinical studies that are not included in the summary of product characteristics. Any modification must be communicated to the Public Health Institute

It is permitted to direct information that provides scientific information not recognised in the market authorisation to healthcare professionals, but such information must be explicitly stated, with the professional assuming exclusive responsibility. This information must conform with the information approved in the market authorisation granted by the Public Health Institute, as described in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals.

Pharmaceutical products may only be advertised or promoted for the therapeutic indication approved in the market authorisation granted by the Public Health Institute. There are no additional or specific rules for combination pharmaceutical products, so it would be necessary to modify or amend the approved market authorisation to advertise a combination with another product, including the combined therapeutic indication.

There is no special regulation for the advertising of companion diagnostic and medical devices in general. Therefore, when advertising companion diagnostics it is necessary to adhere to the general principles regarding advertising – ie, the information must be truthful, accurate, comprehensive and verifiable. Advertisements must focus on the clinical utility, benefits and intended use of the diagnostic test, avoiding misleading information.

Companies can provide journal articles related to their pharmaceutical products to healthcare professionals, as this information is considered scientific. This activity falls within the category of information provided to healthcare professionals, so there are no specific restrictions. However, it is important to note that the reprint cannot include an incentive to prescribe a particular medicine.

Medical science liaisons (MSLs) have no specific regulation in Chile. However, medical representatives play a crucial role in facilitating communication between the pharmaceutical industry and healthcare professionals. Their primary responsibility is to furnish healthcare professionals with current and pertinent scientific information concerning the company's products. While they can provide high-quality scientific information related to research studies and significant scientific advancements, it is crucial to note that both MSLs and medical representatives are only permitted to disseminate information about medicines that have received regulatory approval.

Prior authorisation from the Public Health Institute is required to publish advertisements for OTC pharmaceutical products. The advertising request must be independently submitted for evaluation to the regulatory authority by the holder of the market authorisation for each means of dissemination and each specific market authorisation. This process is subject to compliance with the regulations outlined in the Sanitary Code and Supreme Decree 3/2010 of the Ministry of Health. The advertising content presented for evaluation must precisely match the material intended for display on television, digital and audiovisual media, including relevant images and dialogue frames.

Relevant information must be provided for the authorisation request for the advertising of OTC pharmaceutical products, such as:

• the legal representative's identification and the applicant's identification or registration, if applicable;
• colour images of the graphical piece to be evaluated (if applicable);
• audio file(s) in .mp3 or similar format for evaluation (if applicable) along with a Word transcription;
• video file(s) in .mp4 or similar format for evaluation (if applicable) along with a Word transcription;
• texts of the cited bibliographic references (for “professional promotion” brochure requests); and
• any other supporting documents for the requested advertising or promotion texts.

While the existence of a standard operating procedure is not a legal requirement, pharmaceutical companies implement such procedures internally through their compliance programmes. However, it is mandatory for each pharmaceutical laboratory to designate a Technical Director responsible for representing the establishment to the health authority and ensuring compliance with relevant regulations.

Regarding advertising, as outlined in Supreme Decree No 3, the Technical Director must maintain a file containing product registration resolutions, modifications, professional information, advertising and all documentation exchanged with the Public Health Institute. They are also tasked with ensuring that pharmaceutical product advertising and information align with the provisions in the health registration and current health regulations.

It is important to note that the Technical Director must be a pharmaceutical chemist. However, for laboratories exclusively producing raw materials or biologically derived drugs through similar processes, the position may be held by a biochemist or a medical doctor with a specialisation in microbiology.

The regulations regarding the advertising of pharmaceutical products on the internet are consistent with those applicable to other forms of advertising. However, acknowledging the surge in e-commerce, the Ministry of Economy and Development introduced Decree No 6, which supports the regulation of electronic commerce. The aim was to enhance transparency and the quality of information provided to consumers on electronic commerce platforms, covering characteristics, essential features, prices and any other pertinent details to facilitate well-informed decisions for product acquisition or service contracting.

In this same context, the “Technical Guide for the Sale of Medications through Electronic Means” asserts that any mechanism involving personalised or mass distribution of brochures or advertisements to users, including through email or other means, must also comply with advertising regulations, including those applicable to social media. In addition, engaging in agreements that disclose confidential user information for advertising or promotional purposes is prohibited.

Companies must limit access to web pages containing advertising material for pharmaceutical products aimed at healthcare professionals. This precaution is necessary to avoid potential violations of regulations prohibiting advertising for specific categories of medicines requiring a medical prescription. Since the promotion and advertising of prescription medicines are restricted to healthcare professionals, any website advertising these products must implement access restrictions.

Online promotion, prevention or awareness activities targeting the general public are permitted. The only requirement is the dissemination of objective and truthful information, without encouraging consumers to purchase specific pharmaceutical products from a particular company. Violating this condition would contravene advertising regulations.

Chile does not have specific regulations governing online scientific meetings, so adherence to general principles is required. The key rule is that information provided should not be perceived as promotional, particularly when it involves unauthorised medicines. Consequently, details about unauthorised medicines must be strictly confined to scientific information.

The rules regarding the advertising of pharmaceutical products on social media are identical to those indicated for other forms of advertising.

There is no specific anti-bribery or anti-corruption legislation applicable exclusively to interactions between pharmaceutical companies and healthcare professionals or healthcare organisations in Chile. In general terms, pharmaceutical companies are subject to the same legal framework as any private legal entity, being liable to criminal responsibility under Law 20.393, which establishes criminal liability for legal entities in specified offences.

In this context, it is noteworthy that the new Economic Crimes Law has introduced a special regulatory framework to address offences committed in the business environment, with a particularly rigorous approach towards those in hierarchical positions within organisations.

The law defines four categories that determine when an offence can be considered economic. The second category impacts the pharmaceutical sector directly as it encompasses offences regulating economic activity committed in the exercise of a position within a company or seeking economic benefit or other advantages for the organisation.

Notable offences covered by the new regulations include penalisations for manufacturing or selling deteriorated or adulterated medicinal substances that pose a danger to health, with imprisonment ranging from medium to maximum and a fine of six to 50 monthly tax units. The penalty is aggravated in cases of clandestine manufacturing or sales.

Another offence affecting the industry is related to intellectual property, punishing those who maliciously manufacture, use, offer or introduce into commerce a patented invention for commercial purposes. There are also sanctions for the export, import or handling of hazardous waste without the corresponding authorisations, with a penalty of imprisonment ranging from the minimum to medium, which increases if the activity has an environmental impact.

The provision of pharmaceutical products for advertising purposes, along with any incentives encouraging the preferential use, prescription, dispensing, sale or administration of specific products, is strictly prohibited. This includes any form of payment, gift, service or economic benefit offered by pharmaceutical entities, distributors or other stakeholders with a vested interest in promoting particular products.

Incentives are defined as financial rewards or perks provided by pharmaceutical entities, and are subject to stringent regulations to prevent undue influence on healthcare professionals.

Exceptions are made for the donation of pharmaceutical products to non-profit healthcare facilities. The donation must adhere to legal regulations, ensuring that patients receive these products at no cost or with preferential pricing. Beneficiaries have the right to continue receiving these donated products under the same or improved conditions for as long as the therapeutic benefits persist.

It is crucial to note that this restriction does not hinder the application of generic price reductions or discounts offered to end consumers through agreements, welfare programmes, collective arrangements or similar initiatives, as long as these do not involve the incentives previously described.

The IFPMA Code regulates this issue in a similar way, establishing that a benefit must never constitute an incentive to prescribe, recommend, supply, sell or administer a pharmaceutical product.

Gifts may not be provided to healthcare professionals, including promotional items or services with monetary value, as this may be considered an incentive. Only materials with the company's branding but without references to products, such as pencils and/or institutional notepads, may be provided. The IFPMA Code establishes that such materials may be given to healthcare professionals as long as they are necessary for the development of activities/meetings of a specific scientific seminar and are given in small quantities and have a minimal value.

Pharmaceutical companies are allowed to provide samples of medicinal products to healthcare professionals under the terms established in the respective market authorisation, to be provided free of charge to individuals who use their services. A medical sample is defined by Chilean regulations as a unit of a pharmaceutical product that is exclusively intended for free distribution to legally authorised professionals for prescription, whose labelling is identical to the registered product, with the indication of its status as a medical sample, which may include information for the professional, and must include the wording “medical sample, not for sale” on both primary and secondary packaging, in a clear, indelible and visible manner. Companies are required to keep detailed records of the distribution of samples to healthcare professionals, since the distribution of samples is limited to professionals who are authorised to prescribe pharmaceutical products.

When requesting a marketing authorisation, the general requirements for technical information about the pharmaceutical product include a graphic labelling project for all presentations intended for public, clinical and sample distribution, in Spanish.

Psychotropics

The general rule is that the distribution and production of medical samples of psychotropic products are prohibited (those included in Lists II, III and IV of the Psychotropic Regulation). However, the distribution and production of medical samples are allowed when the product contains minimum doses of psychotropic substances, and the Public Health Institute of Chile specifically authorises the distribution of medical samples and the promotion of these medications.

Production laboratories may produce and distribute medical samples of benzodiazepines, excluding those containing lorazepam, triazolam and fluritrazepam. In this case, the Public Health Institute will determine the quantity of dosage units and other mentions that should be included in the packaging of the medical sample at the time of granting authorisation.

The distribution of these samples by the establishment to medical doctors and dentists will be formalised through a receipt provided in duplicate. The original, signed by the professional, will be kept in custody by the establishment for a period of two years from its receipt and will be available to the health authority.

Finally, every establishment that is authorised to extract, produce, manufacture, fractionate or prepare psychotropics will maintain an updated record permanently available to the health authority, which must include the quantities of authorised benzodiazepine medical samples manufactured by the establishment, production dates, names and addresses of recipients, among other details.

Companies may organise, sponsor or support scientific or professional events for the education, complement or update of healthcare professionals with the aim of enhancing their knowledge in matters related to healthcare, improving the quality of life for patients, providing healthcare services or promoting the sustainability of the system, among others, and always within the parameters established in each company's codes of good practices. The following requirements apply:

• the activities may not include direct transfers of value to healthcare professionals;
• companies must implement processes to document and communicate the scientific, educational or promotional purposes of these meetings and other activities authorised in this Code, clearly, precisely and visibly;
• healthcare professionals may not receive payment for their participation as attendees from companies;
• every event must be held in a location that is suitable for scientific or educational objectives and for the purpose of the event or meeting; and
• companies should avoid the use of excessively luxurious facilities, and meals should be of a reasonable range.

The IFPMA Code of Conduct establishes that pharmaceutical companies are not allowed to sponsor sports events or non-scientific events.

As indicated in 9.1 Gifts to Healthcare Professionals, gifts may not be provided to healthcare professionals, including promotional items or services with monetary value, as this may be considered an incentive.

Donations or grants to healthcare institutions must never constitute an incentive to prescribe, recommend, supply, sell or administer a pharmaceutical product.

Exceptions are made for the donation of pharmaceutical products to non-profit healthcare facilities. The donation must adhere to legal regulations, ensuring that patients receive these products at no cost or with preferential pricing. Beneficiaries have the right to continue receiving these donated products under the same or improved conditions for as long as the therapeutic benefits persist.

Pharmaceutical companies cannot offer discounts or reductions to healthcare professionals or healthcare institutions attending their scientific events or seminars and conferences. This could be interpreted as an incentive.

Outside of these kinds of events, laboratories may offer discounts to healthcare institutions for the purchase of medications, as long as compliance with competition protection regulations is maintained, particularly regarding discount policies and price lists.

Companies may hire healthcare professionals as consultants, researchers, speakers or advisers for their own meetings or activities, such as symposia at medical conferences or specialisation courses, both nationally and internationally.

No prior authorisation or notification is required.

Pharmaceutical companies are required to disclose the details of transfers of value made to healthcare professionals or healthcare institutions when an investigation is conducted by the Public Health Institute.

As mentioned throughout this chapter, incentives are prohibited by law. Regarding foreign companies that do not yet have products on the market, however, distinctions must be made. If they concern pharmaceutical products, prior to obtaining a health registration granted by the Public Health Institute, under no circumstances may transfers of value be made. Following the acquisition of a health registration, the donation of medications must comply with the provisions of Articles 198 and 202 of Supreme Decree No 3/10 of the Ministry of Health. This only applies to situations of a pandemic or when there is an expiration date of less than one year.

In any case, considering that this action could be construed as unauthorised promotion, prior authorisation from the Public Health Institute is always required, in addition to the transfer/donation being disclosed to the company’s crime prevention officer.

The following bodies are responsible for enforcing the rules on pharmaceutical advertising and the rules on inducement:

• the Public Health Institute;
• the Council for Self-Regulation and Advertising Ethics (CONAR); and
• the Courts of Justice.

Pharmaceutical companies are authorised to pursue legal actions against competitors for advertising infringements through three avenues.

• They can file a complaint with the Public Health Institute so that it becomes aware of the matter and initiates the corresponding sanctioning procedure against the competitor who violated advertising rules.
• They can file a complaint with CONAR, which is a non-profit private law corporation with the primary objective of self-regulating national advertising activity from an ethical perspective. It ensures that advertising aligns with the principles and standards established in the Chilean Code of Advertising Ethics.
• They can initiate legal action in the Civil Courts of Justice for unfair competition or infringement of intellectual and industrial property rights if the competitor's advertising is comparative and relies on unproven and objectively lacking facts.

In Chile, regulators or courts have the authority to impose various sanctions on pharmaceutical companies that violate medicinal product advertising rules and rules on inducements to prescribe. The specific sanctions can include:

• fines – regulators may impose monetary fines on pharmaceutical companies for non-compliance with advertising rules or inducements to prescribe regulations;
• suspension of advertising – authorities can order the suspension of specific advertisements or promotional activities that are deemed to be in violation of the rules;
• product withdrawal – in severe cases, regulators may order the withdrawal of specific medicinal products from the market if their advertising is found to be misleading, false or in violation of regulations;
• injunctions – courts may issue injunctions to prohibit a pharmaceutical company from continuing certain advertising practices or inducements to prescribe; and
• revocation of licences – in extreme cases, authorities may revoke the marketing authorisation or licence for certain products if there are repeated or serious violations.

It is important to note that the specific sanctions and their severity may vary based on the nature and extent of the violations, and the decisions are typically made based on a thorough review of the circumstances surrounding the case.

In Chile, the regulatory authority is responsible for overseeing compliance with advertising regulations, either initiated on its own or through complaints received from third parties. Once the procedure is initiated, the inspected company is allowed to present its defence, and subsequently the same authority decides whether to impose a fine on the company for non-compliance with these regulations. If the company believes that its rights were violated during the proceeding before the authority, it can appeal to the courts. At this stage, the judge reviews whether all phases of the procedure were followed, if there have been any violations of laws and regulations, and if the fine corresponds to the infringing conduct. Generally, the courts confirm the results of the Public Health Institute, given its technical nature; there is a deference to this authority.

In general, there have been no significant variations in enforcement regarding pharmaceutical advertising in Chile over the past few years, with the strict stance on the impossibility of carrying out advertising activities for pharmaceutical products subject to prescription sale being maintained. One of the interesting topics discussed until around 2019 was what precisely was understood as incentives and the regulatory changes that affected this practice.

The applicable regulations for veterinary medicines are:

• Decree No 25 of the Ministry of Agriculture; and
• Regulation No 25, of 2005, with the modifications introduced by Decrees No 24 of 2011 and No 42 of 2016, from the Ministry of Agriculture.

The regulatory framework for this type of veterinary pharmaceutical product is distinct from that of human pharmaceuticals, primarily in terms of the authority granting authorisations, which is the Agricultural and Livestock Service and its respective Divisions.

Advertising to individuals and professionals is not prohibited. However, the content of such information must replicate the authorised information for labels and accompanying leaflets, which must be previously approved in the health registration of the products.

The use for promotional purposes of terms, expressions or graphics that contradict scientific truth or lead to confusion or deception regarding the product is not allowed, nor are exaggerated expressions regarding the properties or effects of a product. The promotion of unregistered products or those authorised for experimental or special use is also prohibited.