Beginning on March 25, 2022, the FDA will be adding a unique quick response (QR) code to electronic Certificates of Pharmaceutical Products (eCPPs). Exports Compliance Branch is making this change for quicker and easier verification of authenticity of FDA electronic export certificates, known as eCPPs.
Understanding this FDA Safety Measure
This added security measure allows foreign governments and other entities that receive an electronic export certificate from a U.S. exporter and scan the QR code to view a copy of the FDA-issued certificate. Use of QR codes will verify FDA-issued electronic export certificates more quickly than the current system, which requires creation of an account with FDA, contacting the FDA to activate the account, and logging in to verify certificate authenticity. QR codes will also reduce the need for U.S. exporters and recipients of electronic export certificates to submit inquiries to CDER to verify certificates.
THE FDA requests that importing countries continue to honor and accept certificates issued prior to March 25 without a QR code through their expiration dates.
Resources available to FDA for Product Classification Verification
- FDA’s Orange Book, a public database with information about FDA-approved drugs such as the date of approval.
- FDA’s inspection classification database, where stakeholders can find the most recent inspection classification of an establishment.
- FDA’s letters that are issued within 90 days of an inspection to the establishment and indicate the agency’s inspection classification of the establishment.
- CPPs are printed on security paper and contain the signature of the authorized FDA official, embossed federal seal and ribbon.
FDA-approved fee amounts
FDA is authorized to charge a fee for CPPs issued within 20 days of receipt of an application, not to exceed $175.00. The fees are:
- First certificate for the same country in the same application $175.00.
- Second certificate for the same country in the same application $ 90.00.
- Third and subsequent certificates for the same country in the same application $ 40.00.
Important Aspects About Paying Fees
- Please do not send payment with the application.
- Invoices are issued quarterly.
- CPP applications may be submitted using the CDER export certification and tracking system (CDEReCATS) online portal.
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.