Economic and Legal Frameworks for Non-Prescription Medicines 2004 studied by AESGP 11. MARKET DATA No data on the total pharmaceutical market representing the sales at the consumer price level are available. The data below represent manufacturers' sales, based on the annual report "Statistics on Trends in Medicine Production" compiled by Health Policy Bureau of the MHLW. In Japan, non-prescription medicines are synonymous with self-medication, therefore the total non-prescription market is equal to the total self-medication market. In JPY billions at MSP level 2001 2002 2003 Total pharmaceutical market 9402.6 9588.3 8612.1 Self-medication market 1335.2 1342.4   In euro billions at MSP level 2001 2002 2003 Total pharmaceutical market 86.5 81.2 65.8 Self-medication market 12.3 11.4 7.7 Percentage change over previous year 2001 2002 2003 Total pharmaceutical market +5.2% -6.1% -18.9% Self-medication market -3.0% -2.3% -1.7% Percentage of total pharmaceutical market 2001 2002 2003 Self-medication market 14.2% 14.0%   Main self-medication product groups In JPY billions at MSP level 2001 2001 2003 Cough and cold 107.6 114.2 103.1 Analgesics 30.2 34.4 33.0 Digestives and intestinal remedies 85.1 81.5 77.4 Skin treatment 119.4 109.8 117.1 Vitamins and minerals 240.5 236.7 228.1 In euro billions at MSP level 2001 2001 2003 Cough and cold 990.0 967.3 787.2 Analgesics 277.9 291.4 252.0 Digestives and intestinal remedies 733.0 690.3 591.0 Skin treatment 1098.6 930.0 894.1 Vitamins and minerals 2212.8 2004.9 1741.6 In JPY billions at MSP level 2001 2002 2003 Total pharmaceutical market 6504.3 6489.3   Self-medication market 921.3 905.5   In euro billions at MSP level 2001 2002 2003 Total pharmaceutical market 59.8 55.0   Self-medication market 8.5 7.7   Percentage change over previous year 2001 2002 2003 Total pharmaceutical market +5.2% -0.2%   Self-medication market -3.0% -1.7%   Percentage of total pharmaceutical market 2001 2002 2003 Self-medication market 14.2% 14.0%   Main self-medication product groups In JPY billions at MSP level 2001 2001 2003 Cough and cold 107.6 114.2   Analgesics 30.2 34.4   Digestives and intestinal remedies 85.1 81.5   Skin treatment 119.4 109.8   Vitamins and minerals 240.5 236.7   In euro billions at MSP level 2001 2001 2003 Cough and cold 990.0 967.3   Analgesics 277.9 291.4   Digestives and intestinal remedies 733.0 690.3   Skin treatment 1098.6 930.0   Vitamins and minerals 2212.8 2004.9   Michael, please explain why the 2001 and 2002 figures have been restated. This does not make for a very homogenous picture. Could you also please fill out the self-medication figure and / or percentage for 2003 12. RESTRICTIONS CONCERNING IMPORTS After the recent amendment of the Pharmaceutical Affairs Law, there is no legal difference between an importer and a distributor of pharmaceutical products. Before the amendment as explained in point 2 (Registration), it was necessary to obtain "Approval" for the manufacture or import of each item as well as a "Licence" for the manufacture or import of the "approved" item. With the amendment, the Market Approval Holder may import, manufacture or distribute the item approved under the specific Market Approval. A foreign manufacturer intending to export products to Japan may also obtain Market Approval but is obliged to appoint an official representative in Japan. Other than this restriction, there is no significant difference between a normal market approval holder and a foreign "restricted" approval holder.