Pharmaceuticals OEM Support
OEM Support for Pharmaceuticals, Quasi-drugs, etc.
Pharmaceuticals and quasi-drugs allow for specific efficacy claims with approval from the national or prefectural government. However, the process from product design to mass production requires numerous steps based on relevant laws and regulations, often involving significant time and cost.
While these products offer many attractive advantages, their commercialization can be challenging. At Japan Pharma, we provide meticulous assistance through every step of the OEM and ODM process to ensure your vision becomes a reality.
Support for Obtaining Pharmaceutical Business Licenses
Since the amendment of the Pharmaceutical Affairs Act in 2013, all over-the-counter (OTC) drugs can now be sold online. This has opened doors for mail-order companies that previously only handled health foods or cosmetics to expand into pharmaceutical products.
However, to conduct sales, a "Pharmaceutical Retail License" from the prefectural government is required. Many companies find this process extremely complex, as it involves meeting specific requirements for facilities and human resources.
As part of our comprehensive OEM and product planning services, Japan Pharma provides full support for license acquisition. Please feel free to consult with us.
Classification of Pharmaceuticals and Sales Methods
1. Classification of Pharmaceuticals and Sales Methods
This explains the changes in sales regulations following the amendment of the Pharmaceutical Affairs Act.
Category Before Amendment After Amendment Online Sales
Ethical Pharmaceuticals Face-to-face (Ordinance) Face-to-face (Law) NO
Pharmacist-Intervention Drugs (N/A) Face-to-face NO
OTC Class 1 Face-to-face Net Sales OK YES
OTC Class 2 Face-to-face Net Sales OK YES
OTC Class 3 Net Sales OK Net Sales OK YES
Key Insight: Previously, most drugs required face-to-face sales. Now, Classes 1, 2, and 3 can all be sold online, creating a massive opportunity for e-commerce businesses.
2. Our Business Domains
A. Support for Pharmaceuticals & Electronic Commerce Business
Comprehensive consulting for entering the pharmaceutical market.
Strategic planning for online sales and distribution.
B. Functional Food Business
Development and supply of high-performance health foods (Supplements).
Bridging traditional Japanese medicine with modern nutritional science.
Pharmaceutical Advertising Regulations
In mail-order sales, advertising is the most crucial element to demonstrate who needs the product and why it is necessary.
According to the notification from the Director of the Pharmaceutical Safety Bureau, Ministry of Health and Welfare (dated September 29, 1998), an advertisement is defined by the following three essential elements:
Clear Intent to Attract Customers: There is a clear intention to stimulate the consumer's desire to purchase.
Specific Product Identification: The name of a specific pharmaceutical product or brand is clearly stated.
Public Accessibility: The information is in a state where it can be recognized by the general public.
Our Support for Compliance
At Japan Pharma, we provide comprehensive support to ensure your advertisements meet all legal standards. We guide you on what can and cannot be done under relevant laws, focusing on the specific precautions necessary for ethical and effective marketing.