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To work abroad, you’ll need a Certificate of Current Professional Status (CCPS) – sometimes known as a ‘letter of good standing’. We can provide this to the regulating body you’re registering with. This’ll confirm you have met our registration criteria and provide information about your registration with us.
CPPs In The U.S. In the U.S., CPPs fall within a subset of the FDA’s Export Certification Program. Export certificates include all products subject to the. Federal Food, Drug, and Cosmetic (FD&C) Act and other statutes that the FDA administers, with the exception of tobacco. Therefore, export certificates are issued by five FDA centers.
- Export Guidance and Additional Information
- CPP Information
- CGMP Declarations Information
- CDER Electronic Certificate Application and Tracking System
CPPs provide information about the drug’s U.S. marketing status and the manufacturer’s compliance with quality manufacturing requirements. Companies request CPPs to help qualify their product for importation into a foreign market or to receive approval, licensing or registration of the drug abroad. CPP applications may be submitted using our online...
FDA issues letters, called CGMP declarations, to foreign regulators to convey the CGMP compliance status of manufacturing facilities located in the U.S. The status is based on FDA’s most recent inspection. These letters help streamline other regulatory authorities’ need to reinspect facilities in the U.S. Foreign regulators can also find the inspec...
CDER has an electronic system called CDER export certification and tracking system (CDEReCATS) which allows users to request a CPP or CGMP declaration online. See the application guidefor step-by-step instructions on how to use CDEReCATS to request an export certificate.
May 10, 2024 · A CPP may be required when a pharmaceutical product is under consideration for a product licence/marketing authorisation or when administrative action is required to renew, extend or vary such a licence.
A1: Yes. There are different types of CPPs depending on the approval status1, manufacturing and export status of the product. The following CPPs can be issued: Drug product manufacturing, primary and secondary packaging must all take place in the US. The drug product must be exported from the US to the CPP requesting country.
Jul 28, 2021 · Students also commented that handling logistics of certification exam registration and addressing individual student issues took valuable class time as well. Discussion The purpose of this innovative pilot was to investigate whether qualified U.S. undergraduate medical students could prepare for and complete the CPPS™ certification exam in 8 weeks or less.
People also ask
Can a CPP be issued if a product is not marketed in the US?
Are CPPs FDA certified?
What is a pharmaceutical export certificate (CPP)?
When will ECPPS be issued?
Sep 30, 2021 · The Certificate of Pharmaceutical Product (CPP) is a document issued by a country’s regulatory authority at the request of a product owner to support the registration process of a pharmaceutical product of another regulatory authority in a different country. The certificate has been introduced as a tool to accelerate the availability of new ...
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