What are Class 1 drugs that require guidance?

Update date: March 2, 2023

Over-the-counter drugs that can be purchased at pharmacies and drugstores are classified into drugs requiring guidance and over-the-counter drugs (Class 1 drugs, Class 2 drugs, and Class 3 drugs) depending on the degree of risk.

Risk classification of over-the-counter drugs

The risk classification of over-the-counter medicines is clearly indicated on the outer box (package).
When purchasing over-the-counter medicines, check the risk classification and precautions for use, and proactively consult with a pharmacist or other specialist to receive information and use the medicines appropriately.
In order to enable purchasers to use over-the-counter medicines appropriately, rules have been established regarding sales methods at pharmacies and drugstores, and the specialists involved, as shown in the table below.

Drugs requiring guidance Class 1 pharmaceuticals Class 2 drugs Class 3 drugs
definition This drug contains ingredients that will be sold for the first time as an over-the-counter drug and is currently being evaluated for risks such as side effects, so it must be handled with care.
Drugs designated as poisonous or powerful drugs
Medications that require special attention because their side effects may interfere with daily life. Drugs that in rare cases may interfere with daily life due to side effects, etc.

(Designated class 2 drug)
Drugs that require special attention among Class 2 drugs (drugs that have a risk of interaction, drugs that increase the risk of side effects depending on the user, etc.)
Drugs that do not interfere with daily life due to side effects, etc., but may cause physical changes or discomfort
From ethical drugs (note 1)
Medicines that have recently been replaced with over-the-counter medicines
List of drugs requiring guidance
(Ministry of Health, Labor and Welfare website)
some stomach medicines
Some hair medications, etc.
Main cold medicine
antipyretic analgesic
Gastrointestinal medicine etc.
vitamin supplements
Intestinal medicine etc.
pharmacist pharmacist pharmacist
Registered seller
Registered seller
sales and
Information provision
Flow of
Face-to-face from the purchaser (user himself/herself),
Check information such as symptoms, age, and medication history,
Using paper or tablet devices,
After providing explanations (pharmaceutical guidance) for appropriate use according to the condition and situation of the purchaser,
Only one package will be sold per person.

At the pharmacist's discretion, you may be advised to switch to an over-the-counter drug or recommend seeing a medical institution.
Based on the user's information (symptoms, age, medication history, etc.),
Using paper or tablet devices,
Products will be sold after providing explanations deemed necessary for the user to use them properly.

At the pharmacist's discretion, you may be advised to see a medical institution.
We will endeavor to provide instructions for proper use.
If there is a consultation, we will sell the product after explaining how to use it properly.

(Class 2 designation only)
We encourage purchasers to check the precautions for use and consult with experts through voice calls and pop-up displays.
If there is a consultation, we will sell the product after explaining how to use it properly.
Record the date and time of sale, product name, quantity, name of the expert who sold it, etc.
As a security measure, we may verify the buyer's contact information.
For security purposes, we may check the contact information of the purchaser and record it along with the date and time of sale, product name, quantity, and name of the specialist who sold it.
Specific sales (note 2)
(Sales via the internet, etc.)
Impossible Possible Possible Possible
  • (Note 1) Medical drugs: Medications that are prescribed by a doctor according to the patient's illness, symptoms, constitution, etc., and then dispensed by a pharmacist based on that prescription.
  • (Note 2) Specified sales: Selling pharmaceuticals via the Internet, telephone, catalogs, etc.
  • When selling over-the-counter drugs, the name of the store where the drug was sold, contact information, and the name of the specialist will be communicated to the purchaser by calling out to them or using a name tag.


  • Medicines that may be abused, etc.

For medicines that contain ingredients that pose a risk of abuse (dependency or habit-forming), regardless of risk classification,
We will sell the item after confirming the following items 1 to 4.

  1. If the purchaser is a young person such as a junior high school or high school student, name and age
  2. Purchasing status of pharmaceuticals at other stores
  3. If you are attempting to purchase more than the quantity deemed necessary (in principle, one per person), the reason.
  4. Other information necessary to confirm that the purchase is for proper use.

Relief for health damage caused by pharmaceuticals

Counter (Germany) Pharmaceuticals and Medical Devices Agency
Contact information: 0120-149-931 (toll-free)
Reception hours: Monday to Friday (excluding holidays and New Year's holidays) 9:00 a.m. to 5:00 p.m.
home page http://www.pmda.go.jp/kenkouhigai.html