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What is OTC (Over the Counter) as defined by the US (FDA)?
OTC (Over the Counter) refers to drugs that are safe, effective, and used in the human body, that is, over-the-counter drugs that can be purchased without a doctor's prescription. OTC Drugs include sunscreens, BB creams, whitening or wrinkle improvement creams (if SPF is included), toothpaste, and quasi-drugs that can be purchased at pharmacies, such as trauma treatment ointments.
• Over the Counter (OTC) Registration Requirements
If there is an active ingredient designated by the FDA, it is registered as an Approved drug
If there is no active ingredient designated by the FDA, it is registered as an Unapproved drug by determining whether it is possible
• Advantages of OTC
• TC validity period
• OTC registration process
Drug Facility Registration: Manufacturing facility registration _ FDA2656 (*Renewal of facility registration required every year)
OTC Drug Registration: Registration of drug product ingredients and composition _ FDA2657 & Form2658
Peer review with FDA reviewers
What is Drug Facility Registration required by the US (FDA)?
A related facility that manufactures, prepares, synthesizes, or processes OTC pharmaceuticals must register the facility within 5 days of business opening and renew the facility registration for that facility annually.
Information required for registration of manufacturing facilities: US Agent's name, address, contact information / Importer's business name, address, contact information in the US / Manufacturer's name, contact information, etc.
For registration of manufacturing facilities, a Data Universal Numbering System (D-U-NS®) number corresponding to overseas business registration must be obtained and submitted together before application.
• Drug Facility Registration
Pharmaceutical Manufacturers
Packer
Foreign manufacturer
•Drug Facility Registration Checklist
Prior to facility registration, a labeler code must be obtained for the use of NDC (National Drug Codes).
All companies engaged in manufacturing processes, such as manufacturing, preparation, packaging, and labeling, must register with the FDA.
Submission of form for registration of facilities
When changes occur after facility registration, submit a revised facility registration plan출
What is OTC Drug Registration as defined by the US (FDA)?
All manufacturers who intend to sell over-the-counter (OTC) drugs in the United States must provide all information required by FDA-related laws to register the ingredients and composition of their products through the SPL format.
Information necessary for product ingredient and composition registration: related manufacturer information and process, inactive ingredients, product-related information, OTC monograph number, packaging information, etc.
After inputting the necessary information for product registration through the SPL format, receive a CPIS registration number from the FDA and activate it
• For OTC Drug Registration
OTC drug manufacturer (Manufacturer)
Distributor
Foreign OTC drug manufacturer
• OTC Drug Registration Checklist
Submission of Form for OTC Drug Product Registration (FDA 2657)
For distributors, manufacturers must register their products on the register (FDA2658)
Submit amendments twice annually (June or December) using Form 2658 FDA
US (FDA) Latest Notice
Announcement of new regulations for quasi-drugs (OTC) products in 2018
http://consultingwithus.com/board/news/2558