Cosmetic Fair Trade Council Japan

III. Laws & regulations related with the Act Against Unjustifiable Premiums and Misleading Representations

Standards for Fair Advertising Practices of Drugs, Quasi-drugs, Cosmetics and Medical Devices

PAB Notification NO.1339, Notification from the Director-General of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, October 9, 1980.

(Purpose)
This standard aims at rationalizing the advertisements of drugs, quasi-drugs, cosmetics and medical devices (hereinafter referred to as (drugs,etc.) while preventing them from becoming falsified or exaggerated.
(Duty of advertiser)
A person who puts advertisements of drugs, etc. shall make efforts to relay accurate information so that users can use the drugs, etc. concerned properly.
(Standards)
1. Those related to names
  1. The scope of expression for the names of drugs requiring approval For the drugs requiring approval pursuant to the provisions of Article 14 of the Pharmaceutical Affairs Law (hereinafter referred to as the "Law")( including cases where it applies mutatis mutandis under Article 23. Hereinafter referred to as "approval"), names other than the trade names authorized, names designated by the Japanese Pharmacopoeia or generic names shall not be used.
  2. The scope of expression for the names of the drugs requiring no approval. For the drugs requiring no approval, names other than the names designated by the Japanese Pharmacopoeia, generic names or trade names shall not be used.
    The trade names shall not be those which likely lead to understanding contrary to the fact as to the manufacturing method, effect or efficacy and safety of the drugs concerned.
  3. The scope of expression for the names of quasi-drugs, cosmetics and medical devices. For quasi-drugs, cosmetics and medical devices, names other than the names authorized or licensed pursuant to the provisions of Law Article 13, Law Article 18 (including cases where it applies mutatis mutandis under Law Article 23) or Law Article 22 shall not be used.
2. Those related to the manufacturing method
  As to the manufacturing method of drugs, etc., any expression that is different from the actual manufacturing method or any expression that is likely to lead to understanding contrary to the fact as to its superiority shall not be used.
3. Those related to the effect or efficacy, performance and safety
  1. The scope of expression of the effect or efficacy, etc. as to the drugs, etc. requiring approval. An expression as to the effect or efficacy or performance(hereinafter referred to as "effect or efficacy, etc.") of the drugs, etc. requiring approval shall not exceed the scope of the effect or efficacy, etc. authorized. As to the drugs or medical devices other than the drugs or medical devices exclusively used for specific diseases, an expression to give a misunderstanding as if they were exclusively used for specific diseases by specially stressing only a part of the effect or efficacy authorized shall not be used.
  2. The scope of effect or efficacy of the drugs and medical devices requiring no approval. The expression of the effect or efficacy of the drugs and medical devises requiring no approval shall not exceed the scope recognized medically and pharmacologically.
  3. The scope of the expression of the effect or efficacy of cosmetics requiring no approval. The expressions of the effect or efficacy of the cosmetics requiring no approval shall not exceed the scope laid down in (1-3-3) of PAB Notification No.44, February 8, 1961 from Pharmaceutical Affairs Bureau to the prefectural governors.
  4. (1) The scope of expression as to the ingredients and their quantity or essence of drugs, etc. as well as the raw material, shape, structure and size of medical devices. Advertisements that are likely to lead to understanding contrary to the facts as to the effect or efficacy or safety by using a false expression, incorrect expressions as to the quantity or essence of the ingredients and their quantity as well as raw material, shape, structure and size of medical devises shall not be put.
  5. The scope of expression as to usage and dosage
    Advertisements that are likely to lead to understanding contrary to the facts as to the effect or efficacy or safety by using an expression exceeding the scope authorized for the drugs, etc. requiring approval and an expression exceeding the scope medically and pharmacologically for the drugs, cosmetics and medical devises requiring no approval as to the usage and dosage of drugs, etc. shall not be put.
  6. Prohibition of expressions guaranteeing the effect or efficacy, etc. or safety of drugs, etc. Expressions that indicate concrete effect or efficacy or safety and guarantee it to be sure as to the effect or efficacy, etc or safety of drugs, etc. shall not be made.
  7. Prohibition of expression of the highest grade or similar expressions as to the effect or efficacy, etc. or safety. Expressions of the highest grade or similar expressions as to the effect or efficacy, etc. Or safety of drugs, etc. shall not be made.
  8. The scope of expression as to the extent of manifestation of the effect or efficacy
    Expressions as to the rapid effect, duration of effect of drugs, etc. shall not exceed the scope recognized medically and pharmacologically.
  9. Prohibition of expressions not recognized as the essential effect or efficacy, etc. Advertisements that are likely to lead to misunderstanding of the effect or efficacy, etc. by expressing the effect or efficacy etc. not recognized as the essential effect or efficacy. etc. as to the effect or efficacy of drugs, etc. shall not be put.
4. Restrictions of advertisements that are likely to make for overdose or abuse of drugs, etc. Advertisements that are likely to make for overdose or abuse of drugs, etc. shall not be put.
5. Restrictions of advertisements of ethical drugs
  1. As to the drugs which are supplied on the premise of being used by a physician or dentist himself or those which are used by the prescription or instruction of those persons, advertisements aiming at the general public other than those concerned with medicine or pharmacology shall not be put.
  2. For the medical devices that are supplied on the premise of being used by a physician or dentist himself or by the prescription or instruction of those persons, those which are likely to cause hazards in terms of health and sanitation when used by the general public shall also be handled as in (1).
6. Restriction on expressions as the effect or efficacy in advertisements for the generl public. For the diseases of which cure cannot generally be expected unless diagnosed or treated by a physician or dentist, expressions to the effect that cure can be attained without diagnosis or treatment by a physician or dentist shall not be used in the advertisements for the general public other than the persons concerned with medicine.
7. Description to be added or mentioned additionally in the advertisements of habit-forming drugs. In cases of advertising drugs designated by the Minister of Health, Labor and Welfare. Minister of pursuant to the provisions of the Law Article 50 Clause 8, a statement that the drug is habit forming shall be added or mentioned additionally.
8. Description to be added or mentioned additionally in advertisements as to the caution on use and handling. In cases of advertising drugs, for which there is need particularly to arouse caution on use and handling, such description or a statement that care should be taken about caution on use and handling shall be added or mentioned additionally. However, in cases where no mention whatsoever is made of the manufacturing method, effect or efficacy etc.in the advertisements by structures such as neon signs and signboards, this shall not apply.
9. Restrictions on the advertisements slandering products of other persons Advertisement slandering products of other persons as to the quality, effect or efficacy, etc. safety and others of drugs shall not be put.
10. Recommendation by those concerned with medicine. With respect to the persons concerned with medicine, barbers, beauticians, hospitals, clinics and effect or efficacy, etc. of drugs, advertisements that are designated, recommended, guided or managed by the public offices, schools or associations that have a considerable influence on the understanding of the general public shall not be put. However, in special cases such as where there is need to advertise the facts that they are designated by the public offices for maintaining and promoting public health or similar offices, this shall not apply.
11. Restrictions on advertisements by offering of a prize, etc.
  1. Advertisements of drugs, etc. or firms by methods inciting the speculative spirit such as offering excessive prizes, etc. shall not be put.
  2. Advertisements to the effect that drugs are given as a prize, etc. shall not be put in principle.
  3. Advertisements to the effect that drugs are given in exchange for a container, wrapper, etc. of drugs shall not be put.
12. Restrictions on expressions giving discomfort, anxiety, etc. Advertisements of drugs, etc. using expressions likely to give a feeling of discomfort or anxiety or fear shall not be put.
  
  2 of 12 Restrictions on the advertising methods giving a feeling of discomfort, annoyance, etc.
  Advertisements giving a feeling of discomfort, annoyance, etc. to the persons who have received the advertisements of drugs, etc. shall not be put.
  When putting an advertisement by an electronic mail in particular, following methods shall be observed.
  1. Places to contact such as the electronic mail address of drug dealers, etc. shall be indicated.
  2. In cases where an advertisement of drugs, etc. are sent by an electronic mail unilaterally without obtaining request or approval of a consumer, a statement to the effect that it is an advertisement shall be indicated in the case name column of the mail.
  3. In cases where a consumer does not want to make minutes receive advertisements of drugs, etc. by an electronic mail in the future, a method to indicate an intention to that effect shall be indicated, while at the same time advertisements by an electronic mail shall not be offered to the persons who showed their intention.
13. Handling of advertisements in the programs, etc of television or radio
  1. In the programs of television and radio or movies and dramas, performers shall not mention or suggest the quality, effect or efficacy, safety, etc. of specific drugs, etc.
  2. As to the advertisements in the TV and radio programs for children, care shall be taken specially not to give a wrong knowledge about drugs, etc.
14. Restrictions on expressions as to the usage of drugs as cosmetics or food and the usage of medical devices as beauty devices or health devices
  As to the cosmetics-like usage or food-like usage of drugs or beauty device-like usage or health device-like usage of medical devices, advertisements likely to make for consumers' easy-going use by stressing the beauty device-like or health device-like usage shall not be put.
15. Maintenance, etc. of the grade of drugs, etc.
  Besides the provisions of the preceding passages, in view of the essence of drugs, advertisements likely to impair the grade or stain the reputation shall not be put.



	index(English) > III. Laws & regulations related with the Act Against Unjustifiable Premiums and Misleading Representations III. Laws & regulations related with the Act Against Unjustifiable Premiums and Misleading Representations Standards for Fair Advertising Practices of Drugs, Quasi-drugs, Cosmetics and Medical Devices PAB Notification NO.1339, Notification from the Director-General of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, October 9, 1980. (Purpose) This standard aims at rationalizing the advertisements of drugs, quasi-drugs, cosmetics and medical devices (hereinafter referred to as (drugs,etc.) while preventing them from becoming falsified or exaggerated. (Duty of advertiser) A person who puts advertisements of drugs, etc. shall make efforts to relay accurate information so that users can use the drugs, etc. concerned properly. (Standards) Those related to names The scope of expression for the names of drugs requiring approval For the drugs requiring approval pursuant to the provisions of Article 14 of the Pharmaceutical Affairs Law (hereinafter referred to as the "Law")( including cases where it applies mutatis mutandis under Article 23. Hereinafter referred to as "approval"), names other than the trade names authorized, names designated by the Japanese Pharmacopoeia or generic names shall not be used. The scope of expression for the names of the drugs requiring no approval. For the drugs requiring no approval, names other than the names designated by the Japanese Pharmacopoeia, generic names or trade names shall not be used. The trade names shall not be those which likely lead to understanding contrary to the fact as to the manufacturing method, effect or efficacy and safety of the drugs concerned. The scope of expression for the names of quasi-drugs, cosmetics and medical devices. For quasi-drugs, cosmetics and medical devices, names other than the names authorized or licensed pursuant to the provisions of Law Article 13, Law Article 18 (including cases where it applies mutatis mutandis under Law Article 23) or Law Article 22 shall not be used. Those related to the manufacturing method As to the manufacturing method of drugs, etc., any expression that is different from the actual manufacturing method or any expression that is likely to lead to understanding contrary to the fact as to its superiority shall not be used. Those related to the effect or efficacy, performance and safety The scope of expression of the effect or efficacy, etc. as to the drugs, etc. requiring approval. An expression as to the effect or efficacy or performance(hereinafter referred to as "effect or efficacy, etc.") of the drugs, etc. requiring approval shall not exceed the scope of the effect or efficacy, etc. authorized. As to the drugs or medical devices other than the drugs or medical devices exclusively used for specific diseases, an expression to give a misunderstanding as if they were exclusively used for specific diseases by specially stressing only a part of the effect or efficacy authorized shall not be used. The scope of effect or efficacy of the drugs and medical devices requiring no approval. The expression of the effect or efficacy of the drugs and medical devises requiring no approval shall not exceed the scope recognized medically and pharmacologically. The scope of the expression of the effect or efficacy of cosmetics requiring no approval. The expressions of the effect or efficacy of the cosmetics requiring no approval shall not exceed the scope laid down in (1-3-3) of PAB Notification No.44, February 8, 1961 from Pharmaceutical Affairs Bureau to the prefectural governors. (1) The scope of expression as to the ingredients and their quantity or essence of drugs, etc. as well as the raw material, shape, structure and size of medical devices. Advertisements that are likely to lead to understanding contrary to the facts as to the effect or efficacy or safety by using a false expression, incorrect expressions as to the quantity or essence of the ingredients and their quantity as well as raw material, shape, structure and size of medical devises shall not be put. The scope of expression as to usage and dosage Advertisements that are likely to lead to understanding contrary to the facts as to the effect or efficacy or safety by using an expression exceeding the scope authorized for the drugs, etc. requiring approval and an expression exceeding the scope medically and pharmacologically for the drugs, cosmetics and medical devises requiring no approval as to the usage and dosage of drugs, etc. shall not be put. Prohibition of expressions guaranteeing the effect or efficacy, etc. or safety of drugs, etc. Expressions that indicate concrete effect or efficacy or safety and guarantee it to be sure as to the effect or efficacy, etc or safety of drugs, etc. shall not be made. Prohibition of expression of the highest grade or similar expressions as to the effect or efficacy, etc. or safety. Expressions of the highest grade or similar expressions as to the effect or efficacy, etc. Or safety of drugs, etc. shall not be made. The scope of expression as to the extent of manifestation of the effect or efficacy Expressions as to the rapid effect, duration of effect of drugs, etc. shall not exceed the scope recognized medically and pharmacologically. Prohibition of expressions not recognized as the essential effect or efficacy, etc. Advertisements that are likely to lead to misunderstanding of the effect or efficacy, etc. by expressing the effect or efficacy etc. not recognized as the essential effect or efficacy. etc. as to the effect or efficacy of drugs, etc. shall not be put. Restrictions of advertisements that are likely to make for overdose or abuse of drugs, etc. Advertisements that are likely to make for overdose or abuse of drugs, etc. shall not be put. Restrictions of advertisements of ethical drugs As to the drugs which are supplied on the premise of being used by a physician or dentist himself or those which are used by the prescription or instruction of those persons, advertisements aiming at the general public other than those concerned with medicine or pharmacology shall not be put. For the medical devices that are supplied on the premise of being used by a physician or dentist himself or by the prescription or instruction of those persons, those which are likely to cause hazards in terms of health and sanitation when used by the general public shall also be handled as in (1). Restriction on expressions as the effect or efficacy in advertisements for the generl public. For the diseases of which cure cannot generally be expected unless diagnosed or treated by a physician or dentist, expressions to the effect that cure can be attained without diagnosis or treatment by a physician or dentist shall not be used in the advertisements for the general public other than the persons concerned with medicine. Description to be added or mentioned additionally in the advertisements of habit-forming drugs. In cases of advertising drugs designated by the Minister of Health, Labor and Welfare. Minister of pursuant to the provisions of the Law Article 50 Clause 8, a statement that the drug is habit forming shall be added or mentioned additionally. Description to be added or mentioned additionally in advertisements as to the caution on use and handling. In cases of advertising drugs, for which there is need particularly to arouse caution on use and handling, such description or a statement that care should be taken about caution on use and handling shall be added or mentioned additionally. However, in cases where no mention whatsoever is made of the manufacturing method, effect or efficacy etc.in the advertisements by structures such as neon signs and signboards, this shall not apply. Restrictions on the advertisements slandering products of other persons Advertisement slandering products of other persons as to the quality, effect or efficacy, etc. safety and others of drugs shall not be put. Recommendation by those concerned with medicine. With respect to the persons concerned with medicine, barbers, beauticians, hospitals, clinics and effect or efficacy, etc. of drugs, advertisements that are designated, recommended, guided or managed by the public offices, schools or associations that have a considerable influence on the understanding of the general public shall not be put. However, in special cases such as where there is need to advertise the facts that they are designated by the public offices for maintaining and promoting public health or similar offices, this shall not apply. Restrictions on advertisements by offering of a prize, etc. Advertisements of drugs, etc. or firms by methods inciting the speculative spirit such as offering excessive prizes, etc. shall not be put. Advertisements to the effect that drugs are given as a prize, etc. shall not be put in principle. Advertisements to the effect that drugs are given in exchange for a container, wrapper, etc. of drugs shall not be put. Restrictions on expressions giving discomfort, anxiety, etc. Advertisements of drugs, etc. using expressions likely to give a feeling of discomfort or anxiety or fear shall not be put. 2 of 12 Restrictions on the advertising methods giving a feeling of discomfort, annoyance, etc. Advertisements giving a feeling of discomfort, annoyance, etc. to the persons who have received the advertisements of drugs, etc. shall not be put. When putting an advertisement by an electronic mail in particular, following methods shall be observed. Places to contact such as the electronic mail address of drug dealers, etc. shall be indicated. In cases where an advertisement of drugs, etc. are sent by an electronic mail unilaterally without obtaining request or approval of a consumer, a statement to the effect that it is an advertisement shall be indicated in the case name column of the mail. In cases where a consumer does not want to make minutes receive advertisements of drugs, etc. by an electronic mail in the future, a method to indicate an intention to that effect shall be indicated, while at the same time advertisements by an electronic mail shall not be offered to the persons who showed their intention. Handling of advertisements in the programs, etc of television or radio In the programs of television and radio or movies and dramas, performers shall not mention or suggest the quality, effect or efficacy, safety, etc. of specific drugs, etc. As to the advertisements in the TV and radio programs for children, care shall be taken specially not to give a wrong knowledge about drugs, etc. Restrictions on expressions as to the usage of drugs as cosmetics or food and the usage of medical devices as beauty devices or health devices As to the cosmetics-like usage or food-like usage of drugs or beauty device-like usage or health device-like usage of medical devices, advertisements likely to make for consumers' easy-going use by stressing the beauty device-like or health device-like usage shall not be put. Maintenance, etc. of the grade of drugs, etc. Besides the provisions of the preceding passages, in view of the essence of drugs, advertisements likely to impair the grade or stain the reputation shall not be put. \| Back \| Index \| Next \|