Economic and Legal Frameworks for Non-Prescription Medicines 2004 studied by AESGP 7. DISTRIBUTION Non-prescription medicines are sold at the following five licensed retail outlets:   (1) Yakkyoku (Pharmacy) Only Yakkyoku can fill prescriptions and dispense pharmaceuticals. A pharmacist must supervise the Yakkyoku, which has to contain a dispensary. (2) Ippan-hanbai-gyo (Drugstore with a pharmacist) This is subject to the licensing standards applicable to Yakkyoku, but is not permitted to fill prescriptions or dispense prescription-only pharmaceuticals. Other than that, Ippan-hanbai-gyo can deal with any and every medicine handled by Yakkyoku. It should be supervised by a pharmacist. (3) Yakushusho-hanbai-gyo (Drugstore without a pharmacist) This premise has to be managed by a qualified person who has passed the Yakushusho Qualification Test administered by prefectural governments. This type of store is not permitted to dispense and there are some medicines (designated by the MHLW) which Yakushusho-hanbai-gyo is not permitted to sell. (4) Tokurei-hanabi-gyo (Special limited licence) This licence mostly applies to remote areas where there are no pharmacies or drugstores available. For such a situation, prefectural governors can issue the licence, on an exceptional basis, to a lay individual who is neither a pharmacist nor Yakushusho. The licence is very specific and restrictive in terms of kinds of medicines handled. (5) Haichi-hanbai-gyo (Household distribution). The licence applies to the household distribution of medicines. It is very specific and restrictive in terms of kinds of medicines handled and of business areas covered. The medicines handled are specified by prefectural governors. Products not considered as medicines can be freely sold in any retail outlets. Non-prescription medicines are, in principle, sold over-the-counter and face-to-face through a pharmacist, but recently an increase has been observed in the number of stores of types (1), (2) and (3) practising self-service / self-selection. In the latest round of deregulation taking effect in mid 2004, the Japanese regulatory authorities changed the classification of a total of 371 OTC products to quasi-drug status, allowing their sale in 24-hour convenience stores, supermarkets and many other general type outlets. Categories included certain stomach or gastrointestinal remedies, some laxative products, vitamin tonics, calcium products, external application nasal decongestants, products for chafed skin and sore throat sprays, among others. Not all items within a category are necessarily included in the shift. Manufacturers and importers planning to make the OTC-to-quasi-drug switch were given 12 months to comply with the labelling requirements concerning precautions for use, warnings, directions, etc. for the outer containers or wrappers of the reclassified quasi-drug products. The measure was expected to result in wider access to the general public. Other important factors were the considerably easier rules for the advertising, communication and promotion of quasi-drugs. While the items shifted represented only a small portion of the consumer healthcare market in Japan, the move can be seen as a continuation of a similar reclassification in 1999. There are no restrictions on the minimum distance between pharmacies or on the opening of a new pharmacy. Articles of PAL, however, stipulate the requirements on the structure or facilities of a pharmacy for conformity with the rules laid down by MHLW ordinance. There are no regulations on pharmacy opening hours. The number of retail outlets as of March 2004 was as follows:   Yakkyoku (Pharmacy) 49 956 Ippan-hanbai-gyo (Drugstore with a pharmacist) 12 080 Yakushusho-hanbai-gyo (Drugstore without a pharmacist) 14 393 Tokurei-hanabi-gyo (Special limited licence) 9 405 Haichi-hanbai-gyo (Household distribution) 11 075 Total 96 909 Also as of March 2004, there were 143 wholesalers enrolled in the Japan Pharmaceutical Wholesalers Association. The number of licensed premises for wholesalers was 10 896.