Safety information

In sales information provision activities a company must provide necessary safety information including adverse reactions, not efficacy alone, and must not select the information it provides arbitrarily.

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.