Japan versus each jurisdiction — what actually differs

A prescription drug advertisement is false, lacking in fair balance, or otherwise misleading if it contains a representation or suggestion, not approved or permitted for use in the labeling, that the drug is better, more effective, useful in a broader range of conditions or patients, or safer than has been demonstrated by substantial evidence or substantial clinical experience.

No person may label, package, treat, process, sell or advertise a drug in a manner that is false, misleading or deceptive as to its character, value, quantity, composition, merit or safety.

All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics, and the advertising shall encourage the rational use of the medicinal product by presenting it objectively and without exaggerating its properties and shall not be misleading (Directive 2001/83/EC, Article 87(2) and (3)). The Directive binds Member States as to the result, and what a reviewer applies is the national implementing law. One national implementation has now been read: the German Heilmittelwerbegesetz (HWG). Section 3 HWG makes misleading advertising unlawful and treats as misleading in particular (1) attributing to a medicine a therapeutic efficacy or effects that it does not have, (2) falsely creating the impression that success can be expected with certainty, that no harmful effects occur on intended or prolonged use, or that the advertising is not carried out for competitive purposes, and (3) making untrue or deceptive statements about the composition or properties of the medicine or about the person, training, qualifications or achievements of the manufacturer or inventor. Section 3a HWG prohibits advertising for a medicine that is subject to authorisation and is not authorised, and likewise where the advertising relates to indications or pharmaceutical forms not covered by the authorisation. Section 4(1) HWG requires every advertisement for a medicine to carry the name and registered office of the pharmaceutical company, the name of the medicine, its composition, indications, contraindications, adverse effects, warnings, and for prescription-only medicines the statement 'Verschreibungspflichtig'; section 4(2) requires those particulars to agree with those prescribed for the package leaflet.

An advertisement for a medicinal product with a UK marketing authorisation must comply with the particulars listed in the summary of product characteristics, must encourage rational use by presenting the product objectively without exaggerating its properties, and must not be misleading.

Advertisements for medical services, drugs and medical devices must not contain assertions or guarantees of efficacy or safety, nor state cure rates or effectiveness rates, and the content of a drug advertisement must not be inconsistent with the package insert approved by the drug regulator.

An advertisement about therapeutic goods must be accurate, balanced and not misleading or likely to mislead, must only contain information substantiated by the advertiser before publication, and must not be inconsistent with any indication or intended purpose accepted for the goods' inclusion in the Register.

False or exaggerated advertising about the name, manufacturing method, efficacy or performance of a drug is prohibited, advertising by means of articles, photographs, designs or other implicit methods suggesting efficacy or performance is prohibited, and no advertising of the name, manufacturing method, efficacy or performance may take place before the product has received approval or variation approval or has filed the required notification.

All statements in professional advertising must be consistent with the medicinal product information last approved by Swissmedic and only indications and uses approved by Swissmedic may be advertised; the statements must be accurate, balanced, factually correct, substantiable and not misleading, and must be based on and reflect the current state of scientific knowledge, with the same consistency requirement applying to advertising to the public.

An advertisement is false, lacking in fair balance, or otherwise misleading if it contains a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience.

A therapeutic comparative claim must involve drugs sharing an authorized indication, compare them under the same conditions of use, not conflict with the compared products' terms of market authorization, be clinically relevant, rest on conclusive evidence, and identify the compared entities.

Advertising of a medicinal product to the general public must not contain any material that suggests that the effects of taking the medicine are better than, or equivalent to, those of another treatment or medicinal product (Directive 2001/83/EC, Article 90(b)), and all advertising must comply with the summary of product characteristics and must not be misleading (Article 87(2)-(3)). The text of Directive 2006/114/EC on misleading and comparative advertising has now been obtained and read. Article 1 states its purpose as protecting traders against misleading advertising and laying down the conditions under which comparative advertising is permitted, so its protective addressees are traders. Article 2(c) defines comparative advertising as any advertising which explicitly or by implication identifies a competitor or goods or services offered by a competitor. Article 4 permits comparative advertising, as far as the comparison is concerned, only where all of the following are met: (a) it is not misleading within Articles 2(b), 3 and 8(1) of that Directive or Articles 6 and 7 of Directive 2005/29/EC; (b) it compares goods or services meeting the same needs or intended for the same purpose; (c) it objectively compares one or more material, relevant, verifiable and representative features, which may include price; (d) it does not discredit or denigrate the marks, names, goods, services, activities or circumstances of a competitor; (e) for products with a designation of origin, it relates to products with the same designation; (f) it does not take unfair advantage of the reputation of a competitor's mark or name or of a competing product's designation of origin; (g) it does not present goods or services as imitations or replicas of goods or services bearing a protected trade mark or trade name; and (h) it does not create confusion among traders, between the advertiser and a competitor, or between their marks, names, distinguishing marks, goods or services. Article 7 requires Member States to empower courts or administrative authorities to require the advertiser to furnish evidence of the accuracy of factual claims, in a short period of time in the case of comparative advertising, and to consider factual claims inaccurate if that evidence is not furnished or is deemed insufficient.

In advertising to the general public, comparative claims against another named product such as 'works faster than XXX' are prohibited, although a category claim such as 'works faster than standard tablets' is permitted if supported by evidence.

Advertisements for medical services, drugs and medical devices must not contain comparisons with the efficacy or safety of other drugs or medical devices, or with other medical institutions.

An advertisement about therapeutic goods must not compare the goods with other therapeutic goods, classes of therapeutic goods or therapeutic services where the comparison suggests that the comparator goods or services are harmful or ineffectual.

In advertising a drug it is prohibited to make an advertisement that disparages another product, or that is suspected of disparaging it, irrespective of whether the content is true, and it is prohibited to advertise efficacy or performance with content such as 'this is definitely guaranteed' or with absolute expressions such as 'the best' or 'the finest'; for quasi-drugs, comparative statements about competing products must be made in accordance with the facts and exclusive absolute expressions such as 'the best' or 'the finest' may not be used.

Statements comparing a medicinal product with other medicinal products are permitted only if they are scientifically correct and are based on equivalent clinical trials or data collections meeting the requirements of Art. 5(5), and where the studies used for the comparison rest on in vitro or animal experiments (for human medicines) this must be openly disclosed.

Every prescription drug advertisement other than the listed exempt advertisements must present a true statement of information in brief summary relating to side effects, contraindications and effectiveness, and it fails that requirement if effectiveness information is presented in greater scope, depth or detail than section 502(n) requires and is not fairly balanced by a summary of true information relating to side effects and contraindications.

Risk information must be given prominence comparable to benefit in the main body copy, the advertising message must reference a safety profile consistent with the Terms of Market Authorization, and special warnings, precautions, clinically significant serious adverse events and use limitations must appear in the body copy.

Advertising to persons qualified to prescribe or supply must include essential information compatible with the summary of product characteristics and the supply classification of the product, and all information contained in promotional documentation must be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product.

An advertisement directed at persons qualified to prescribe or supply must include the entries, or a succinct statement of the entries, in the summary of product characteristics relating to adverse reactions, precautions, contra-indications, dosage and method of administration.

A drug advertisement must prominently state the contraindications and the adverse reactions.

An advertisement about therapeutic goods must not contain any statement, pictorial representation or design that expressly or by implication represents the goods to be safe or without harm or side-effects, effective in all cases or a guaranteed cure, or infallible, unfailing, magical or miraculous.

For a drug that has adverse reactions, no advertisement may use expressions that deny those adverse reactions or that unduly emphasise safety; matters prescribed by the Commissioner of the Ministry of Food and Drug Safety must be displayed so that the drug is not misused or abused; and advertisements may not display the symptoms of a disease related to the efficacy, or scenes of surgery, in a threatening manner, nor display or suggest the indication in threatening terms.

Every advertisement must contain at least a summary of the restrictions on use, the undesirable effects and the interactions, alongside the brand name, the active substances under their short designation (INN), the name and address of the marketing authorisation holder, at least one indication or use together with the dosage and route of administration, the dispensing category and a reference telling the reader that detailed information is in the published medicinal product information.

For prescription drug advertisements for human use presented directly to consumers in television or radio format, the major statement of major side effects and contraindications must be presented in a clear, conspicuous and neutral manner, and in television format it must be presented concurrently using both audio and text.

If a person advertises a prescription drug to the general public, the person may not make any representation other than the brand name, proper name, common name, price and quantity of the drug.

Member States must prohibit advertising to the general public of medicinal products that are available on medical prescription only or that contain substances defined as psychotropic or narcotic by international convention, while medicinal products that by virtue of their composition and purpose are intended and designed for use without the intervention of a medical practitioner may be advertised to the general public.

A person may not publish an advertisement that is likely to lead to the use of a prescription only medicine.

Narcotic, psychotropic, medically toxic and radioactive drugs and other special drugs, drug precursor chemicals and detoxification products may not be advertised at all, and other prescription drugs may only be advertised in medical and pharmaceutical professional publications jointly designated by the State Council health administration and the State Council drug regulator.

It is an offence to advertise therapeutic goods where the advertisement refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 of the current Poisons Standard but not in Appendix H, other than a reference authorised or required by an Australian government authority.

It is prohibited to advertise prescription drugs, over-the-counter drugs having the same dosage form, route of administration and main ingredient content per unit dosage form as a prescription drug, and active pharmaceutical ingredients.

Advertising to the public is prohibited for medicinal products that may be dispensed only on medical prescription, that contain narcotics or psychotropic substances, that by their composition and intended purpose cannot be used without medical intervention for the corresponding diagnosis, prescription or treatment, or that are frequently misused or can lead to habituation and dependence; the ordinance permits advertising to the public only for medicines in dispensing categories C, D and E and for cantonally authorised medicines.

Advertisements subject to section 502(n) of the Act include advertisements in published journals, magazines, other periodicals and newspapers and advertisements broadcast through media such as radio, television and telephone communication systems, so journal advertising directed at prescribers is subject to the brief summary and fair balance requirements of 21 CFR 202.1(e).

In materials directed to health professionals the product information or a link to it must be presented within the main message, the brand name, non-proprietary name and federal drug schedule must appear in juxtaposition at least once, and the proposed layout must be submitted to PAAB for preclearance.

Any advertising to persons qualified to prescribe or supply must include essential information compatible with the summary of product characteristics and the supply classification, documentation transmitted as part of promotion must state the date on which it was drawn up or last revised, and quotations, tables and other illustrative matter taken from medical journals or other scientific works must be faithfully reproduced with the precise sources indicated.

An advertisement wholly or mainly directed at persons qualified to prescribe or supply must contain the particulars in paragraphs 1 to 8 of Schedule 30, namely the marketing authorisation number, the holder's name and address, the legal classification, the product name, the active ingredients by common name, indications consistent with the authorisation, the relevant SmPC entries and the cost excluding VAT.

A prescription drug advertisement must prominently bear the statement 'this advertisement is for reading by medical and pharmaceutical professionals only' (Advertising Law article 16(3) and article 5(2) of the Interim Measures for the Administration of the Review of Advertisements for Drugs, Medical Devices, Health Foods and Formula Foods for Special Medical Purposes). Article 22 of the Interim Measures provides that, apart from the products for which advertising is prohibited outright by article 21, advertisements for prescription drugs may be published only in the medical and pharmaceutical professional publications jointly designated by the health administration department and the drug regulatory department of the State Council; it also forbids using the name of a prescription drug to title or sponsor activities, and forbids using a trade mark or company trade name identical to a prescription drug name in media other than those professional publications as a disguised form of advertising. Article 2(2) forbids publishing such advertisements without review; article 9 requires the advertisement approval number to be prominently shown; article 16 requires the review to be completed within ten working days of acceptance; and article 20 requires publication exactly as approved, without editing, splicing or modification. Article 11(2) prohibits using the name or image of research institutions, academic bodies, trade associations, or of experts, scholars, physicians, pharmacists, clinical dietitians or patients, as a recommendation or proof. Article 21 prohibits advertising altogether for narcotic drugs, psychotropic drugs, medicinal toxic drugs, radiopharmaceuticals, precursor chemicals, drugs and devices for treating drug dependence, drugs for special military needs and preparations compounded by military medical institutions, and preparations compounded by medical institutions. Under article 29, a breach of article 11(1), article 21 or article 22 is punished in accordance with article 57 of the Advertising Law.

Part 5-1 of the Therapeutic Goods Act 1989 does not apply to advertisements directed exclusively to health practitioners and the other listed categories such as wholesalers and hospital purchasing officers (section 42AA), and the statutory Advertising Code likewise does not apply. What actually governs promotion of prescription medicines to health professionals beyond that exclusion is the industry's own self-regulatory instrument, the Medicines Australia Code of Conduct (Edition 20, adopted 30 October 2024, effective 30 March 2025). Its Scope section states that the Constitution of Medicines Australia binds member companies to the Code, and that 'the Therapeutic Goods Administration states that, as a condition of registration, prescription medicines must be promoted in accordance with this Medicines Australia Code of Conduct, whether the Company is a member or non-member'. Part B section 1 permits promotion of prescription products to health professionals so long as all information, claims and graphical representations are current, accurate, balanced, consistent with the approved product information and do not mislead directly, by implication or by omission; companies are responsible for referencing all promotional claims and for ensuring the cited references provide the appropriate level of evidence, reflect the body of evidence and allow health professionals to evaluate the validity of the results independently. Qualifying statements must be linked to the claim by a readily identifiable symbol, placed directly below or adjacent to it and be prominent; claims based on animal or laboratory data must be appropriately qualified; claims for clinical benefit must be of a magnitude generally accepted as clinically meaningful; and the statistical significance of comparative claims must be clearly indicated. Overarching Principle 8 in Part A requires all promotional claims, including claims about competitor products, to be consistent with the Australian Product Information. Sanctions are set out in Part F section 15.6: cessation of conduct and withdrawal of the promotional activity, corrective action including corrective letters and advertising approved by the Code Committee before release, and monetary fines with a schedule of maximums (minor A$100,000; moderate A$150,000; severe A$200,000; a severe breach where the activity was completed and there is no opportunity for corrective action, and a repeat of a previous breach, A$250,000; failure to complete corrective action within 30 calendar days A$50,000; failure to pay a fine within 30 days A$50,000), fines being imposable individually or cumulatively up to a maximum of A$300,000 per complaint.

The prohibition on advertising prescription drugs does not apply to advertising in professional pharmaceutical media aimed at medical and pharmaceutical experts, or to advertising using media or means of an academic character aimed at such experts.

The addressees of professional advertising are limited, within the scope of their entitlement to prescribe, dispense or use medicinal products, to physicians, dentists, veterinarians and chiropractors, pharmacists, druggists, the further persons referred to in Art. 24 and 25 HMG and the persons referred to in Art. 52(2) of the Medicinal Products Ordinance, and such advertising must carry all the mandatory particulars listed in Art. 6 AWV (Art. 3, 4 and 6 AWV). As to gifts and hospitality, former Art. 11 AWV was transferred with effect from 1 January 2020 to the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH, SR 812.214.31, of 10 April 2019), and that ordinance has now been read. Art. 3(1) VITH permits, as benefits of modest value under Art. 55(2)(a) HMG, benefits to professionals of a total value of at most 300 francs per professional per year that are relevant to medical or pharmaceutical practice; Art. 3(2) defines relevance as a direct connection with the professional's practice of their profession or a direct benefit to the professional's clientele. Art. 3(3) allows prizes in competitions only where they consist of a benefit of modest value relevant to practice, where the competition is addressed exclusively to the addressees of professional advertising under Art. 3 AWV, and where participation is not tied to the purchase of prescription-only medicines. Art. 4 requires support contributions for research, teaching and infrastructure to be given to the employing organisation rather than to the professional, to rest on a written agreement stating the intended purpose, to be used exclusively for that purpose, not to be tied to conditions concerning the prescription, dispensing, use or purchase of particular prescription-only medicines, to be paid into a dedicated account of the organisation to which professionals have no sole access, and to be shown in the organisation's accounts. Art. 5 applies the same requirements to support for the further or continuing education of professionals and requires the organisation to decide independently on the type and selection of the education and on the participants. Art. 6 requires written agreement for support of attendance at educational events and an own contribution (Selbstkostenbeitrag) from the attending professional or the employing organisation of at least one third of the costs for a continuing-education event (Fortbildung) and at least one fifth for a specialist-training event (Weiterbildung), calculated on participation fees, outward and return travel, accommodation and meals, and any ancillary programme of clearly subordinate importance; it prohibits refunding the own contribution in whole or in part, covering indirect costs such as loss of working time or income, covering the costs of an ancillary programme that is not clearly subordinate to the professional part of the event, and covering travel, accommodation, meals or ancillary-programme costs of accompanying persons, even where those persons are themselves professionals. Art. 7 requires remuneration for equivalent consideration to rest on a written agreement stating the nature and extent of the consideration and the remuneration and to be proportionate, with meal costs of up to 100 francs in the context of a professional discussion exempted from the written-agreement requirement.

An applicant must submit specimens of promotional labeling and advertising at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement, accompanied by Form FDA-2253 and a copy of the product's current professional labeling, and for drug products being considered for accelerated approval all promotional materials intended for dissemination or publication within 120 days following approval must be submitted during the preapproval review period, with later materials submitted at least 30 days prior to intended initial dissemination.

Preclearance of advertising for marketed health products is administered through an independent, self-regulatory and voluntary system, with PAAB reviewing material directed to health professionals and Advertising Standards Canada and MIJO reviewing non-prescription drug and natural health product material directed to consumers.

Member States must ensure that there are adequate and effective methods to monitor the advertising of medicinal products, and such methods may be based on a system of prior vetting (Directive 2001/83/EC, Article 97(1)); the marketing authorisation holder must keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising a sample of all advertisements emanating from its undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination (Article 98(2)). Because prior vetting is an option and not an obligation, whether it applies depends on national law, and examples in both directions have now been checked in national sources. France operates prior vetting: the ANSM states that for all medicines, whether or not subject to medical prescription, the whole body of promotional documents intended for health professionals and for the public is subject to a contrôle a priori by the ANSM, that is, before any dissemination, and that where the criteria are met the application results in a prior authorisation called a visa de publicité, while failure to meet them leads to refusal. By contrast the German Heilmittelwerbegesetz contains no prior-vetting provision at all; control under that Act operates after the fact through the criminal penalty in section 14, the administrative fine in section 15 and competition-law remedies.

The MHRA has statutory powers to require companies to submit advertising material for pre-publication vetting, has committed as a matter of policy to vet initial advertising for all new active substances, and applies vetting for a period that is normally one to three months and normally no longer than six months.

Advertisements for medical services, drugs and medical devices must be reviewed as to content by the advertising review authority before publication, and may not be published without such review.

Use of a restricted representation, that is one referring to a serious form of a disease, condition, ailment or defect, requires prior approval by the Secretary, who must approve it if satisfied the representation is accurate, balanced and not misleading, and who is taken to have approved it if no written notice is given within 60 days of the application.

A manufacturer, marketing authorisation holder or importer that intends to advertise a drug through newspapers, internet newspapers, periodicals, television or radio broadcasting, the internet, or media designated by the MFDS Commissioner must obtain prior review by the delegated advertising review body.

Switzerland has no across-the-board pre-vetting scheme: prior authorisation by Swissmedic is required only for advertising to the public under Art. 15(a) and (c) for analgesics, sleeping aids, sedatives, laxatives and anorectics where the medicinal product information mentions a potential for abuse or dependence, and, in addition, Swissmedic may require a marketing authorisation holder that has seriously or repeatedly infringed the advertising provisions to submit all planned advertising for review and approval before publication for an appropriate period.

For digital media the binding rule is 21 CFR 202.1. Paragraph (l)(1) states only that 'advertisements subject to section 502(n) of the act include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems'; the full text of section 202.1 in the 2024 CFR (title 21, volume 4) does not contain the words internet, website or social media anywhere. Paragraph (l)(2) determines that brochures, mailing pieces, detailing pieces, reprints and similar matter are labeling as defined in section 201(m). The only recent binding medium-specific provision is (e)(1)(ii), which requires the major statement in direct-to-consumer television or radio advertisements to be presented in a clear, conspicuous and neutral manner; it does not reach the internet. The only FDA document addressing internet and social media platforms with character space limitations remains the June 2014 draft guidance, which recommends incorporating risk information within the same character-space-limited communication and providing a mechanism such as a hyperlink within each communication to a more complete discussion of risk; those are nonbinding recommendations.

The PAAB Code applies to all digital formats and media, including internet, electronic and social media advertising systems, and applies equally to websites and other online activities within the sponsor's control or influence where the intended audience is Canadians.

Directive 2001/83/EC defines advertising of medicinal products in Article 86(1) as any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products, without limitation as to medium, and Articles 86 to 100 contain no provision specific to digital or social media.

The prohibition on advertising prescription only medicines to the public applies to social networks such as Facebook and Twitter in the same way as to traditional media, and prescription medicines must not be named in posts linked to the services being provided.

It is prohibited to publish prescription drug advertisements via the internet, unless laws or administrative regulations provide otherwise.

An advertisement that directly facilitates the purchase or supply of a medicine that cannot be physically inspected before supply, which the Code's note says includes advertisements on a website, social media or a software application through which a transaction may be conducted, must also include the dosage form name, the quantity, each active ingredient, and either a list of, or a link to, any applicable health warnings.

The internet and computer communications are listed in the ordinance as media for advertising drugs, and drug advertising via internet newspapers and via the internet is subject to mandatory prior review.

Professional advertising may not be made publicly accessible on the internet; it must be furnished with a suitable technical, password-protected access restriction and may be made available only to the persons listed in Art. 3 AWV (Art. 5a AWV). The AWV itself contains no provision specific to social media, influencers or search advertising, but Swissmedic states its practice on this in a published FAQ ('Internetrichtlinie - Social Media'). According to that FAQ, advertising of medicinal products means all measures of information, market development and the creation of incentives that aim to promote the prescription, dispensing, sale, consumption or use of medicinal products (Art. 2(a) AWV); the advertising provisions of the HMG and the AWV apply to all advertising tools, and therefore also to advertising of medicinal products on social media. Because the scope of public advertising is broadly defined, not only the pharmaceutical industry but all actors who advertise particular medicines to the general public - the FAQ names influencers and media professionals as examples - can be addressees of the advertising provisions. Accordingly, internet advertising for prescription-only medicines must carry a suitable technical, password-protected access restriction and be made accessible only to the professionals under Art. 3 AWV. Medicines must also be unambiguously identifiable as medicines in the advertising, by carrying the mandatory notice and the other compulsory particulars including the marketing authorisation holder in accordance with Art. 16(3), Art. 16(5) and Art. 17 AWV, so that the viewer is made aware immediately and unmistakably that this is a medicine and not a food supplement, cosmetic or foodstuff, even without following any further links. The FAQ further states that, because public advertising may not raise the expectation that the effect of the medicine corresponds to or is superior to another treatment or another medicine (Art. 22(c) AWV) and may not mention or refer to testimonials or recommendations of medical or pharmaceutical laypersons (Art. 22(g) AWV), advertising of medicinal products on social media is inadmissible where the like, share and comment functions are activated for the post, so that the medicine can be rated, furnished with experience reports and recommendations, and disseminated.

The opening words of 21 U.S.C. 352 provide that a drug or device 'shall be deemed to be misbranded' in the listed cases. Section 352(n) provides that a prescription drug is misbranded unless the manufacturer, packer or distributor includes in all advertisements and other descriptive printed matter it issues with respect to that drug a true statement of (1) the established name, printed prominently and in type at least half as large as any trade or brand name, (2) the quantitative formula, and (3) such other information in brief summary relating to side effects, contraindications and effectiveness as the Secretary requires by regulation. Section 331 prohibits (a) the introduction or delivery for introduction into interstate commerce of a misbranded drug, (b) misbranding in interstate commerce, and (c) the receipt in interstate commerce of a misbranded drug and its delivery for pay or otherwise. The chain 'advertising violation to misbranding to prohibited act' therefore holds on the face of the statute. Under 21 U.S.C. 333(a)(1) a violation of section 331 carries up to one year of imprisonment or a fine of up to $1,000 or both, and under 333(a)(2) a violation after a conviction under that section has become final, or one committed with intent to defraud or mislead, carries up to three years or a fine of up to $10,000 or both. However, 18 U.S.C. 3571(e) preserves a lower statutory fine only where the law setting forth the offence 'by specific reference' exempts the offence, and the text of 333(a) contains no such reference. Consequently, under 18 U.S.C. 3559(a) the 333(a)(1) offence is a Class A misdemeanour and the 333(a)(2) offence a Class E felony, and under 18 U.S.C. 3571(b)(3) and (b)(5) and 3571(c)(3) and (c)(5) an individual may be fined up to $250,000 for the felony and up to $100,000 for the Class A misdemeanour not resulting in death, and an organisation up to $500,000 and $200,000 respectively. Section 3571(d) additionally permits a fine of up to twice the gross gain or twice the gross loss.

The general $500/$5,000 scheme in section 31 applies only 'subject to sections 31.1, 31.2 and 31.4', so for medicines those special provisions govern. Under the section 2 definitions, a 'therapeutic product' means a drug or device or any combination of them, and 'drug' includes any substance manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of disease. Section 31.2(1) provides that, subject to section 31.4, every person who contravenes any provision of the Act or the regulations as it relates to a therapeutic product is guilty of an offence and liable on conviction by indictment to a fine not exceeding $5,000,000 or imprisonment not exceeding two years or both, and on summary conviction to a fine not exceeding $250,000 or six months' imprisonment or both for a first offence and $500,000 or 18 months for a subsequent offence. Section 31.4(1) provides that a person who contravenes section 21.6, or who knowingly or recklessly causes a serious risk of injury to human health in contravening another provision as it relates to a therapeutic product, is liable on indictment to a fine in the discretion of the court or to imprisonment not exceeding five years or both, and on summary conviction to $500,000 or 18 months for a first offence and $1,000,000 or two years for a subsequent offence. Section 31.3 makes due diligence a defence except for a section 31.4 offence, and section 31.5 requires a court sentencing under section 31.2 or 31.4 to take into account the harm or risk of harm caused and the vulnerability of consumers of the therapeutic product.

Member States must confer upon the courts or administrative authorities powers to order the cessation of misleading advertising, or to order the prohibition of its publication where publication is imminent, even without proof of actual loss or damage or of intention or negligence on the part of the advertiser, and must determine the penalties for infringement of the national provisions adopted in execution of Title VIII (Directive 2001/83/EC, Articles 97(2)-(4) and 99). Equivalent powers appear in Article 5 of Directive 2006/114/EC: paragraph 1 requires adequate and effective means to combat misleading advertising and to enforce compliance with the provisions on comparative advertising, including legal provisions under which persons or organisations with a legitimate interest may take legal action or bring the advertising before a competent administrative authority; paragraph 3 requires powers to order cessation or prohibition even without proof of loss, intention or negligence, under an accelerated procedure with interim or definitive effect; paragraph 4 permits powers to require publication of the decision in whole or in part and of a corrective statement; and paragraph 6 requires reasons always to be given where the powers are exercised exclusively by an administrative authority, together with provision for judicial review. The level of penalties is set by each Member State, not by EU law. One national implementation has now been read: under the German Heilmittelwerbegesetz, section 14 punishes a breach of the prohibition on misleading advertising in section 3 with imprisonment of up to one year or a fine; section 15(1) makes breaches of sections 3a, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 regulatory offences; section 15(2) makes a negligent breach of section 3 a regulatory offence; and section 15(3) sets the administrative fine at up to 50,000 euro for a section 15(1) offence and up to 20,000 euro for a section 15(2) offence. Section 16 permits confiscation of the advertising material concerned.

A person guilty of an offence under the advertising provisions is liable on summary conviction to a fine not exceeding the statutory maximum, or on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

Publishing a medical, drug or medical device advertisement in breach of article 16 attracts an order to stop publication and eliminate the effects, a fine of one to three times the advertising cost (or 100,000 to 200,000 yuan where the cost cannot be calculated), and in serious cases three to five times the cost (or 200,000 to 1,000,000 yuan), possible revocation of the business licence, revocation of the advertising approval document and refusal to accept further advertising review applications for one year.

Advertising therapeutic goods in a way that does not comply with the Advertising Code carries a criminal penalty of up to five years' imprisonment or 4,000 penalty units where harm or injury results or is likely, up to 12 months or 1,000 penalty units otherwise, a strict liability offence of 100 penalty units, and a maximum civil penalty of 5,000 penalty units for an individual and 50,000 for a body corporate.

A person who violates article 68 of the Pharmaceutical Affairs Act (prohibition of exaggerated advertising) is punishable under article 95(1) item 10 by imprisonment for up to one year or a fine of up to 10 million won, and article 95(2) allows imprisonment and the fine to be imposed together. Under the dual-liability provision in article 97, where a representative or employee of a corporation commits an article 95 offence in connection with the business, the corporation or individual is also fined under that article, unless it did not neglect due care and supervision. As to administrative sanctions, article 76(1) provides that where a manufacturer of drugs, a holder of an item authorisation, a registrant of an active ingredient, an importer, a holder of clinical trial plan approval, a pharmacy founder, a drug seller or a drug sales-promotion operator falls under any of the listed grounds - which include item 3, 'where this Act or an order under this Act has been violated' - the Minister of Food and Drug Safety, or the mayor or head of the county or district, may revoke the authorisation, approval or registration, revoke acceptance of a notification, order closure of the consigned manufacturing and marketing site or the manufacturing site, order closure of the business office, prohibit the manufacture or import of the item, or order suspension of all or part of the business for up to one year. Article 68-2 further provides that a drug manufacturer, holder of an item authorisation or importer who intends to advertise a drug it has manufactured or imported must undergo review by the Minister of Food and Drug Safety as prescribed by Prime Ministerial Decree, and that the Minister may entrust that review to a corporation established under article 67.

Swissmedic may seize, officially impound or destroy unlawful advertising material, prohibit its use and publish that prohibition at the expense of those responsible, and in the event of a serious or repeated infringement of the advertising provisions may prohibit advertising for a particular therapeutic product temporarily or permanently and publish that prohibition likewise at their expense; intentional infringement of the provisions on medicinal product advertising is punishable by a fine of up to CHF 50,000, by a monetary penalty where the offender acts commercially, and by a fine of up to CHF 20,000 where the offender acts negligently.