One document delays more international submissions to Ghana's FDA than almost any other single item in the dossier: the Certificate of Pharmaceutical Product, usually shortened to CPP. It is not complicated in concept — but the timing mistake companies make with it is one of the most avoidable causes of a stalled registration.
What a CPP actually is
A CPP is issued by the medicines regulatory authority in your product's country of origin, following the format set out under the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce — a long name for a widely used, standard instrument. Ghana FDA's registration guidelines require a valid CPP issued in the name of Ghana, or with Ghana included among the listed importing countries, as part of the dossier for any product manufactured outside Ghana. Where a country issues a Free Sale Certificate instead of a CPP, Ghana FDA's biological products guidelines note that this should be accompanied by a separate GMP certificate.
In short: the CPP is the exporting country's official confirmation that your product is legitimately approved and manufactured where it says it is. Ghana's FDA relies on it as external verification it cannot generate itself.
The timing problem
CPPs are issued by a separate regulatory authority — not Ghana FDA, and not your own regulatory team. Depending on the issuing country, obtaining one can take anywhere from a few weeks to several months, and that timeline sits entirely outside your control once the application is filed.
The mistake we see repeatedly: companies build a complete CTD dossier, prepare labelling, finalise stability data — and only then request the CPP, treating it as a final formality. It isn't. Sequenced last, it becomes the single item holding an otherwise-ready submission back by weeks or months.
What else the CPP interacts with
The CPP is one piece of a document set that has to be internally consistent — manufacturing site details on the CPP need to match what's declared elsewhere in the dossier, and GMP evidence for that site needs to be current. A CPP that references an outdated manufacturing address, or a GMP certificate that has since expired, creates a query even when the CPP itself is technically valid. Reviewing the full document set together, rather than each item in isolation, is what catches this before submission.
Planning a submission that needs a CPP?
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