Matters relating to the system for the sale of OTC medicines.

■*OTC medicines* classification.

In Japan, OTC pharmaceuticals, also known as 'OTC pharmaceuticals' or 'OTC drugs', are drugs that can be purchased at pharmacies and drugstores without a prescription and are classified according to the Pharmaceutical Affairs Law as follows.

１．What is a medicinal product requiring special instructions?

Deleterious substances and medicines within ３ years of being converted from prescription drugs to OTC medicines.

２．What is a Class 1 medicinal product?

Medicinal products containing ingredients that require special attention from a safety point of view, such as lack of experience in their use as OTC medicinal products.

３．What is a Class ２ medicinal product

Medicinal products containing ingredients that may cause health problems.
*Medicines that require special attention are designated as Category 2 medicines.

４．What is a Class ３ medicinal product?

Medicines that have a relatively low risk of side effects and may cause physical alterations and disorders, although not to the extent that they interfere with daily life.

■ *About risk classifications

OTC medicines have obligatory and effort-based requirements for information providers and consultation services, depending on the risk category, and the corresponding specialist.

１．Medicines requiring special instructions.

Provision of information　　： obligatory
Consultation service　　　　： obligatory
Specialist to be consulted　　： pharmacist (face-to-face only)

２．Class 1 medicines.

Provision of information　　： obligatory
Consultation　　　　　　　： obligatory
Specialisation supported by　： pharmacist support

３．Class ２ medicines.

Provision of information　　：obligation to make efforts
Consultation　　　　　　　： obligatory.
Specialist support　　　　　：pharmacist or registered sales person.

４．Class ３ medicines.

Information provided　　　： not required
Consultation　　　　　　　： obligatory.
Specialist support　　　　　： pharmacist or registered sales person.