Marketing
What is marketing business?
The marketing business involves distribution of products manufactured at factories or imported from overseas to the market with responsibility for securing quality, efficacy, and safety of the products. To receive license permits for business, quality control standards (Good Quality Practice: GQP) and post-marketing safety management standards (Good Vigilance Practice: GVP) and other requirements must be met. In addition, it is obligatory to appoint a “general marketing director” and a board director for compliance with laws and regulations related to pharmaceutical affairs (“board director”) to perform quality control and post-marketing safety management. Authorization from the prefectural governor is required to operate a marketing business.
GQP (MHLW Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Regenerative Medicine Products)
A standard that stipulates the operations necessary for cosmetics marketing holders to ensure the quality of the products they market. The standard covers overall quality assurance, including shipment management, manufacturer management, quality assurance, and recall and disposal of products.
GVP (Ministerial Ordinance on Standards for Post-Marketing Safety Control of Pharmaceuticals, Quasi-Drugs, Cosmetics and Regenerative Medicine Products)
This is a set of standards for post-marketing safety management to be implemented by marketing holders.
The main contents are (1) organization and personnel related to safety assurance operations, (2) duties of safety control manager, and (3) duties related to collection and examination of safety management information and measures based on the results.
Board director
Marketing holders and manufacturers are legally required to appoint an officer who is responsible for regulatory affairs in order to clarify the personnel who are responsible for legal compliance. In addition, they must provide employees with guidelines for legal compliance and establish a system for legal compliance.
General marketing director
Article 17, Paragraph 1 of the PMD Act (excerpt) stipulates “A holder of marketing authorization ... for cosmetics must appoint ... a person meeting the standards specified by Ordinance of the Ministry of Health, Labor and Welfare at a holder of marketing authorization for quasi-pharmaceutical products or cosmetics ... in order to have them provide quality control and post-marketing safety control.”
