Economic and Legal Frameworks for Non-Prescription Medicines 2004 studied by AESGP 3. PATIENT INFORMATION The specifications for consumer information through labelling (labels and package inserts) are laid down in a couple of the PAL articles, some of which read as follows: On the immediate container or wrapper of a medicine, the following particulars shall be indicated:   (1) The name and address of the manufacturer (or importer); (2) The name (For a medicine recognised by Japanese Pharmacopoeia (JP), the name given therein; for any of the other medicines, the generic name, if applicable); (3) The manufacturing number or code; (4) The quantity of the contents in terms of weight, volume, number, and the like (5) For a medicine recognised by JP, both the letters, "Japanese Pharmacopoeia," and the matters specified by JP to be entered on the immediate container or wrapper; (6) For a medicine for which the standards are specified under Article 42, Paragraph 1, storage, expiry date and other matters required by the standards to be indicated on the immediate container or wrapper. (7) For a medicine not recognised by JP, the name (the generic name, if applicable) and quantity of each active ingredient (for a medicine containing unknown active ingredient, its nature and an outline of its manufacturing process); (8) For a medicine designated as a habit-forming medicine by the Minister of Health, Labour and Welfare, the letters, "Caution: Habit forming"; (9) For a drug designated by the Minister pursuant to the provisions of Article 49, Paragraph 1, the term "Caution: Use under prescription by a physician, etc."; (10) The expiry date for a medicine designated by the Minister of Health, Labour and Welfare. (11) Matters specified by the MHLW Ministerial Ordinance supplementary to those specified in the preceding items. If the immediate container or wrapper of a medicine is packaged for retail and if the preceding details are not easily legible through the outer container or wrapper, the same details should also be indicated on the outer container or wrapper. On the insert enclosed with a medicine (package insert) or on the container or wrapper of a medicine, the following matters should be indicated:   (1) Directions, dosage, and other necessary precautions for use and handling; (2) For a medicine recognised by JP or standards placed by the Minister according to Article 42, the matters specified by JP or the standards to be indicated on the package insert, or container or wrapper; (3) Matters specified by the MHLW Ministerial Ordinance supplementary to those specified in the preceding items. On the other hand, there are certain "Details not allowed to be indicated" on the package insert, or container or wrapper (including the inner package) of a medicine:   False or misleading claims concerning the medicine; Indications or effects which are not approved; Directions, dosage or during of use which are dangerous to health and hygiene; In line with a report published by the "Working Group for the Improvement of Package Inserts" as part of the Welfare Science Study programme, the Director-General of Pharmaceutical Affairs Bureau, MHW on 12 August 1999 issued two Notices:   Notice by the Director-General, Iyakuhatsu No. 983 "Guidelines for Precautions for Use of Non-prescription Medicines" and Notice by the Director-General, Iyakuhatsu No. 984 "Guidelines for Package Inserts for Non-prescription Medicines. These guidelines aimed to ensure that the use of user-friendly terms easily understood by the general public, the ordered placement of the important instructions and warnings for the correct use of the drugs are included after the product's brand name on the Package Inserts, and the clear inscription of the following data on the outer container or wrapper:     Information on persons who should not take/use the drug Information on areas on which the drug should not be applied/used Information on a person's capability to operate machinery and/or drive a motor vehicle after taking the drug. The MHLW had urged the revision of the labelling and package inserts by the end of March 2002. As of February 2002, almost all manufacturers had revised their Precautions for Use.