This Certificate Controls Global Drug Trade—Do You Know It?

Pharmacy
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The Certificate of Pharmaceutical Product (COPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product, about the quality of pharmaceutical products moving in the international market.

The CPP supports the review in countries without sufficient capability to conduct a full review themselves. Ideally, a CPP should not be required in countries that have the capabilities to conduct full reviews.

It was first developed in 1975; since then, it has been revised in 1988, 1992, & in 1997.

The COPP is the legal document that declares a certain manufacturing company is legally allowed to sell its pharmaceutical product in the country they are producing.

A COPP demonstrates in question that the imported medicine is of the appropriate standard of quality, safety & efficacy to allow marketing in their market, having undergone rigorous quality testing by Regulatory Authorities in the exporting country.

Need & Importance of COPP

To obtain global marketing approval for any pharmaceutical product (whether intended for animal/human use), one of the key documents required red is a COPP, which has been recommended by the WHO.

A COPP is issued by the authorized body of the exporting country.

So what do you guys think can a pharmaceutical product enter the global market without a COPP?

MBH/PS

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Thanks a lot for sharing an important information like this. This certificate will give an advantage to the company as it will provide the certification for the quality of the product which is already in the market, it will help the company reputation to grow and also the trust of the people will increase eventually towards the product.

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COPP isn’t just paperwork it’s a trust bridge between regulators, ensuring medicines crossing borders don’t compromise patient safety.

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