Importance of Certificate of Pharmaceutical Product (CPP) Legalization and Translation.

The global pharmaceutical market is a behemoth, expected to reach a market volume of $1.47 billion by 2028; with this growth comes an increased demand for efficient and streamlined export processes. However, complying with export regulations across this complex supply chain can be challenging for businesses, particularly when navigating the complex documentation requirements where error can result in cargo being held back by bureaucratic hurdles and potential loss of profit.


This is where last-mile legalization expertise becomes vital, ensuring shipments reach their destination swiftly and compliantly. We’re going to discuss the key pharmaceutical documentation that businesses should be getting right and how working with a cross-border document specialist can avoid 


What is a CPP, and why is it key to pharmaceutical exports

Shipping products internationally is different from doing business domestically as important information must be conveyed to multiple parties, such as customs authorities, carriers, and foreign governments. Pharmaceutical exports, in particular, demand more than standard paperwork — specialized industry documents verify product quality, manufacturing practices, and regulatory compliance, all within a complex global trade landscape.


One of the most important documents for successful pharmaceutical exports is the Certificate of Pharmaceutical Product (CPP), a regulatory document issued in a format recommended by the World Health Organization (WHO). The CPP verifies the safety, efficacy, and regulatory compliance of a specific pharmaceutical product in the exporting country and is a valuable tool for importing countries to assess the quality and safety of incoming medications. A CPP ensures the product’s approval and guarantees fast market entry —  it also promotes global regulatory harmonization by providing different authorities with standardized information about the product.


Securing the initial CPP isn’t typically within the scope of documentation specialists, their expertise lies in expertly navigating the complexities that come in those final stages after the document has already been issued. 


Two CPP documentation considerations for a smooth import / export of pharmaceutical products

The first consideration with CPP documentation to ensure smooth trade across borders is that these documents often need official legalization (or apostille for countries that are members of the 1961 Hague Convention Treaty). This proves that the document in question, in this case a CPP, is authentic and compliant with international regulations. The legalization process can vary by country and product, adding complexity and potential delays, especially for frequent exporters or high-volume shipments. 


The second consideration for a smooth import or export of pharmaceutical products may be the translation of CPP documentation. And this does not mean simply importing the documentation into Google Translate and printing out the result. It’s important to make sure that a qualified linguist can help ensure clear communication and compliance with destination country regulations as far as translations are concerned, and that nothing is lost in translation. Understanding what documents each receiving country requires and which must be translated and authenticated can get complicated since different countries, and their trade commissions, often have different requirements.


The best way to handle this process is to work with experts that focus on international documentation and understand the complexities of paperwork and bureaucratic hurdles. Especially when it comes to the import and export of highly regulated goods like pharmaceutical products.


Lex Documents helps with pharmaceutical trade documentation, legalization, and translation.

While regulatory agencies issue the Certificate of Pharmaceutical Product (CPP) and handle its initial health pre-legalizations, Lex Documents can step in at the critical «last mile» for pharmaceutical exports. This final stage involves securing the essential apostille or consular legalization, depending on the destination country, translation, and more.


So, whether your document needs an apostille or a consular legalization, we take care of everything – navigating regional ministry interactions, apostle and consular liaising, ensuring meticulous compliance with each requirement. Once your CPP is issued, consider us your trusted partner to navigate the final leg of your pharmaceutical export journey smoothly.


Besides legalization, our experienced and knowledgeable team can also handle translation so businesses don’t have to negotiate with multiple entities to do the job. This ensures that the international pharmaceutical trade is carried out efficiently and compliantly. 


Contact us today to learn more about how we can assist you with your international import and export requirements!

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