The rise of e-commerce has transformed retail landscapes globally, and the pharmaceutical sector has not been immune. In Japan, the online sale of Over-The-Counter (OTC) pharmaceuticals, while offering convenience to consumers, is subject to a detailed and carefully constructed regulatory framework under the "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (PMD Act or Yakkiho). This framework, known as "Specific Sales" (特定販売 - tokutei hanbai), aims to balance consumer access with the imperative of ensuring medication safety and appropriate use. Understanding the definition of Specific Sales, which drugs are eligible, and the comprehensive operational and compliance requirements is essential for any business involved in or considering online pharmaceutical retail in Japan.

The Genesis of Regulated Online OTC Sales in Japan

Historically, the online sale of most OTC pharmaceuticals in Japan, particularly those in higher-risk categories (Class 1 and Class 2), faced significant restrictions. Ministry of Health, Labour and Welfare (MHLW) ordinances effectively prohibited such sales, citing concerns about patient safety and the difficulty of providing adequate professional consultation remotely.

This regulatory stance was challenged, leading to a landmark Supreme Court of Japan decision on January 11, 2013 (Saikōsai Dai-ni Shōhōtei Hanketsu, Heisei 25-nen (Gyō Hi) Dai 257-gō). The Court ruled that the MHLW ordinances broadly banning internet sales of Class 1 and Class 2 OTC drugs were illegal and void. The reasoning was that such a blanket prohibition exceeded the scope of authority delegated to the Ministry by the then-Pharmaceutical Affairs Law (the PMD Act's predecessor) and unduly restricted consumer access without sufficient justification that online sales inherently posed an unacceptable risk if properly regulated.

In response to this judicial decision and recognizing the evolving consumer landscape, the PMD Act (which came into full effect in November 2014) and its associated Enforcement Regulations were revised to establish a formal legal framework for the online sale of OTC drugs. This framework categorizes such non-face-to-face sales under the umbrella of "Specific Sales."

Defining "Specific Sales" (特定販売 - Tokutei Hanbai)

"Specific Sales" are defined in Article 1, Paragraph 2, Item 5 of the PMD Act Enforcement Regulations (薬機法施行規則 - Yakkiho Shikō Kisoku). The term refers to the sale or supply of designated pharmaceuticals (primarily general OTC drugs) through methods other than direct, face-to-face interaction between the seller and the purchaser at a physical pharmacy or licensed retail store. This primarily encompasses:

• Sales via the internet (e-commerce websites, online marketplaces).
• Sales via telephone or mail order.

The key characteristic is that communication and the transaction occur with a person who is not physically present at the licensed premises of the seller.

Products Excluded from Specific Sales:
It is crucial to note that not all pharmaceuticals can be sold via Specific Sales. The following categories must be sold through face-to-face interaction with a pharmacist and are prohibited from online or other remote sales channels:

1. Prescription Pharmaceuticals (医療用医薬品 - iryō-yō iyakuhin): These always require a physician's prescription and dispensing by a pharmacist, typically in person.
2. Guidance-Requiring Pharmaceuticals (要指導医薬品 - yōshidō iyakuhin): This category of high-caution OTC drugs (e.g., recently switched Rx-to-OTC drugs, certain direct-OTC drugs) explicitly requires face-to-face sale and guidance by a pharmacist.

Therefore, Specific Sales are permissible only for General OTC Pharmaceuticals (一般用医薬品 - ippan-yō iyakuhin), which are further divided into Class 1, Class 2, and Class 3 based on their risk profiles.

Core Requirements for Businesses Conducting Specific Sales

Entities wishing to engage in the Specific Sales of OTC drugs must adhere to a comprehensive set of requirements:

1. Licensed Physical Premise

• Requirement for a Real Store/Pharmacy: Specific Sales can only be conducted by an entity that holds a valid license to operate a physical pharmacy (薬局開設許可 - yakkyoku kaisetsu kyoka) or a store-based pharmaceutical retail business (店舗販売業の許可 - tenpo hanbai-gyō no kyoka).
• Link to Physical Operation: The online sales operation must be intrinsically linked to and managed by this licensed physical establishment. Purely virtual online pharmacies with no licensed physical storefront or operational base in Japan are not permitted. The physical store serves as the responsible entity for the sales, stock management, and professional oversight.
• Specialized Online Stores: It is permissible to establish a licensed store that specializes in Specific Sales, but it must still meet all the structural and operational requirements of a physical licensed premise, including having qualified personnel and secure drug storage.

2. Information Disclosure on the Sales Platform (Website, etc.)

Transparency is key. The online platform used for Specific Sales must clearly and conspicuously display:

• The name and physical address of the licensed pharmacy or store.
• The license number and date of issuance/expiry.
• The name(s) of the pharmacist(s) and/or registered seller(s) responsible for managing Specific Sales and providing consultation.
• Contact information (telephone number, email address) and the specific hours during which consultations are available.
• Photographs showing the appearance of the actual physical storefront and relevant areas within the store (e.g., consultation counter, areas where OTC drugs are displayed/stored).
• The opening hours of the physical pharmacy/store.
• A summary of the key sales procedures, including how information is provided and how consultations are conducted.

3. Rules for Selling Different Classes of OTC Drugs Online

The level of professional involvement and information provision required for Specific Sales varies significantly depending on the risk classification of the OTC drug being sold:

• Class 1 Pharmaceuticals (第一類医薬品 - Dai-ichirui Iyakuhin): (Highest risk among general OTCs)
  • Pharmacist Involvement Mandatory: A licensed pharmacist (yakuzaishi) must personally oversee and be directly involved in the sale of Class 1 drugs. This includes providing information and responding to consultations.
  • Proactive and Mandatory Information Provision: Before the sale is finalized, the pharmacist must actively provide the purchaser with detailed information about the Class 1 drug. This includes its proper use, potential risks, significant side effects, contraindications, and interactions. This information must be conveyed via suitable remote communication methods (e.g., telephone, email, video call, secure messaging with clear pharmacist identification).
  • Confirmation of Purchaser's Understanding: The pharmacist must take steps to confirm that the purchaser has adequately understood the information provided. This might involve asking clarifying questions, or requiring the purchaser to acknowledge receipt and understanding (e.g., via a checkbox confirmation or a return email).
  • Consultation System: A readily accessible system for purchasers to consult with the pharmacist regarding the Class 1 drug must be available and clearly indicated.
  • Record Keeping: Detailed records of the information provided, consultations conducted, and sales of Class 1 drugs must be maintained by the pharmacy/store.
• Class 2 Pharmaceuticals (第二類医薬品 - Dai-nirui Iyakuhin): (Moderate risk)
  • Pharmacist or Registered Seller Involvement: Sales and information provision can be handled by either a pharmacist or a qualified "Registered Seller" (登録販売者 - tōroku hanbaisha).
  • Information Provision (Effort Obligation): The seller (pharmacist or registered seller) must make a "best effort" to provide relevant information to the purchaser. For "Designated Class 2 Pharmaceuticals" (指定第二類医薬品 - shitei dai-nirui iyakuhin), which carry a slightly higher caution level within Class 2, this effort obligation is stronger, and proactive encouragement for consultation is expected.
  • Mandatory Response to Consultation: If a purchaser initiates a consultation regarding a Class 2 drug, the pharmacist or registered seller is obligated to respond and provide appropriate advice.
• Class 3 Pharmaceuticals (第三類医薬品 - Dai-sanrui Iyakuhin): (Lowest risk among general OTCs)
  • Pharmacist or Registered Seller Involvement: Sales can be handled by either a pharmacist or a registered seller.
  • Information Provision: Proactive, mandatory information provision is not required by law unless the purchaser specifically requests a consultation. However, providing information is considered good practice.
  • Mandatory Response to Consultation: If consulted, the pharmacist or registered seller must provide the necessary information.

4. Operational Aspects and Logistics

• Shipping and Control of Pharmaceuticals:
  • Origin of Shipment: A key principle is that pharmaceuticals sold via Specific Sales should be dispatched from the licensed physical pharmacy or store that is conducting the sale. This ensures that the licensed entity maintains control over the drug inventory and the dispensing/packaging process. Shipping directly from a separate, unlicensed warehouse not directly integrated into the licensed store's operations is generally not permitted, as it could circumvent the oversight of the qualified personnel at the licensed site.
  • Sale Occurs at the Licensed Premise: Legally, the "sale" is considered to take place at the licensed physical store, even though the order is received and communication occurs remotely.
• Delivery Locations:
  • Typically, delivery is made to the consumer's registered address.
  • Delivery to alternative locations, such as convenience stores for consumer pickup, may be permissible under certain conditions. However, the seller must ensure that all necessary information provision and confirmations (especially for Class 1 drugs) are completed before the product is dispatched to such a pickup point. The convenience store's role should be purely as a logistical handover point, not involving any pharmaceutical consultation or sales activity.
• Consultation Mechanisms:
  • Sellers must establish effective and readily accessible means for consumers to consult with pharmacists or registered sellers. This can include telephone lines, email addresses, secure web chat, or video conferencing facilities.
  • The availability hours for these consultation services must be clearly stated.
• Order Reception and Management:
  • While administrative functions like order reception (e.g., via a call center or a separate web management team) can be located remotely from the physical store, the pharmaceutical aspects—including final review of the order by qualified personnel, provision of mandatory information (especially for Class 1), handling of consultations, and the actual dispensing and dispatch of the drugs—must be managed by and from the licensed physical pharmacy or store. Qualified pharmaceutical personnel at the licensed site must have oversight.
• Record Keeping: Comprehensive records of all Specific Sales transactions, including customer orders, communications, information provided, consultations given, and details of the drugs supplied, must be maintained for a specified period as per regulatory requirements.

5. Advertising and Promotion

All advertising and promotional materials for OTC drugs sold via Specific Sales must strictly comply with:

• PMD Act Article 66: Prohibiting false or exaggerated claims regarding efficacy, effects, or safety.
• The "Proper Advertising Standards for Pharmaceuticals, etc." (医薬品等適正広告基準 - Iyakuhin-tō Tekisei Kōkoku Kijun): Detailed MHLW guidance on acceptable advertising practices.
  Specific requirements for online advertising include:
• Clear display of the drug's risk classification on product listings.
• Ensuring that claims made online are consistent with the product's approved indications and do not mislead consumers.
• Providing a balanced presentation of both benefits and potential risks or side effects.
• The website must not create the impression that prescription drugs or guidance-requiring pharmaceuticals are available for online purchase.

Ongoing Oversight and Future Trends (as of May 2025)

The MHLW and prefectural governments actively monitor online pharmaceutical sales to ensure compliance with these regulations. The convenience of online purchasing has led to increased adoption by consumers, particularly accelerated by societal changes in recent years. Technology for remote consultations, such as video calls with pharmacists, is also becoming more sophisticated and accepted.

It is important to distinguish the Specific Sales of OTC drugs from the separate, evolving framework for "online medication guidance" (オンライン服薬指導 - onrain fukuyaku shidō) which pertains to the pharmacist's role in counseling patients and dispensing prescription medications, a system that has also seen significant development and was made permanently available under certain conditions following PMD Act amendments effective in September 2020. While both involve remote interaction, the specific rules and eligible products differ significantly.

Conclusion

The "Specific Sales" framework in Japan provides a regulated pathway for the online and remote sale of general Over-The-Counter pharmaceuticals, reflecting a balance between consumer convenience and public health protection. Businesses engaging in this activity must operate from a licensed physical pharmacy or store, adhere to strict rules regarding the involvement of pharmacists or registered sellers based on drug classification, ensure robust information provision and consultation mechanisms, and maintain compliant operational procedures for order fulfillment and record-keeping. While the digital marketplace offers significant opportunities, navigating Japan's detailed regulations for online pharmaceutical sales requires meticulous attention to compliance to ensure both legality and the safety of consumers.