The new regulations (after 25th Dec, 2014) can be summarized as follows.
| Article 25 of Pharmaceutical Affairs Law | |
|---|---|
| License Type | Description |
| Professionally selling drugs | Indicates selling or providing both OTC and prescription drugs in a store. |
| Selling drugs by distribution | Indicates selling or providing OTC drugs by distribution. |
| Wholesales | Indicates selling or providing drugs to a person who runs a drug store, drug manufacturer, seller, hospital, clinic, or animal clinic. |
| License Type | Description |
|---|---|
| Seller |
Allows selling or providing all drugs, which has same effect as a license for opening a drug store (pharmacy), except that prescription is not available. A druggist who runs a store should be hired. (This license was valid until 31st May, 2012, and a new license should be achieved from 1st June, 2012) |
| Seller & Whole Seller |
Usually indicates generic retailing and a person who opens a drug store, drug manufacturer, seller, hospital, clinic, or animal clinic only can sell or provide drugs. A druggist who runs a store should be hired. (This license is replaced by Wholesales license. A licensed whole seller is regarded as a person who is allowed for wholesale business during the expiry period, but when it is expired, a new license of Wholesales should be achieved. |
| professionally selling drugs (druggist) |
Indicates all activities selling or providing drugs other than those approved by MHLW. Any specified drugs including poison cannot be handled. The store should be run by druggist, who is licensed by passing the exam held by metropolitan council. (This license was valid until 31st May, 2012, and a new license should be achieved from 1st June, 2012. The existing drug merchant can keep running a business without changing a business type.) |
| professionally selling drugs by distribution |
Indicates all activities selling or providing the drugs by distribution approved by MHLW. |
| Special seller | When the number of drug stores or sellers is insufficient, or for a specific purpose, the special sellers licensed can provide or sell the drugs approved by metropolitan council. (A license of Wholesales should be achieved for selling medical gas and dental drugsfrom 1st June, 2012.) |