Navigating the complex world of international trade can be daunting, especially for businesses in highly regulated industries such as the pharmaceutical industry. Aside from the standard export documentation, companies need to be aware of the specialized documentation required for the industry they are working in. These documents ensure various aspects of product quality, manufacturing practices, and regulatory compliance within the industry.
Companies may also need additional documentation depending on their target region when expanding out of their home territory. Therefore, they must thoroughly research their target region and the rules surrounding their shipping product when expanding out of their home territory.
But how does documentation differ for those manufacturing and distributing pharmaceutical products?
Let’s take a look.
The documents you should know if you export pharmaceutical products
At Lex Documents, we’re not only dedicated to assisting businesses with immigration documentation – we also extend our expertise to companies involved in international trade. A key industry we serve is the pharmaceutical sector, which is subject to stringent documentation and compliance regulations in order to ship goods globally.
Our services cater to a wide range of businesses, particularly those engaged in exporting products and navigating the complexities of cross-border transactions. We ensure our clients possess the correct legal documentation to successfully distribute and market their products globally.
Here are the top ten essential documents we frequently encounter while collaborating with multinational pharmaceutical corporations.
1) Certificate of Pharmaceutical Product (CPP)
A CPP is an international document issued, in the format recommended by the World Health Organization (WHO), to establish the authenticity and quality of pharmaceutical products. It ensures the product meets the necessary regulatory requirements in the country of manufacture and facilitates their import and export between countries. Therefore, it is one of the most important documents for those trading within the pharmaceutical industry.
2) Good Manufacturing Practice Certificates (GMP)
Good Manufacturing Practice (GMP) certificates are awarded to manufacturers who adhere to stringent quality control standards, ensuring their products are safe, effective, and of the highest quality. GMP covers every aspect of the production process, including the raw materials, facilities, equipment, and employee training.
These certificates provide assurance to importers, distributors, and regulators. Many countries have established their own GMP requirements based on WHO GMP guidelines, while others have opted for harmonized standards, such as those in the Association of South-East Asian Nations (ASEAN), the European Union, and the Pharmaceutical Inspection Convention.
3) Export Shipping Documents
These documents are necessary for the legal exportation of goods, including the commercial invoice, packing list, and bill of lading. They provide crucial information about the product, its destination, and transportation details, facilitating smooth customs clearance.
4) Free Sale Certificates
Free sale certificates confirm that a product is approved for sale in its country of origin. Importing countries often require them as part of their own regulatory processes as it demonstrates that the product complies with the relevant regulations and standards. These certificates need a government agency, such as the US Food & Drug Administration, to confirm that the maker or product meets the rules and specific certification for the pharmaceutical product.
5) Health Products Regulatory Authority Certificates (HPRA)
The Health Products Regulatory Authority (HPRA) issues certificates for products regulated in Ireland, ensuring they meet the required safety and efficacy standards. These documents are vital for companies wishing to export to or from the Irish market.
6) Manufacturing Licenses
These licenses authorize a company to manufacture specific products, ensuring they adhere to strict quality control standards. It is a crucial regulatory requirement for producing and distributing pharmaceutical and medical products.
7) Certificates of Origin
These documents certify the country in which a product was manufactured, serving as proof of its origin. This information is essential for customs clearance and may impact the product’s eligibility for preferential trade agreements or import duties. There can also be additional country-specific certificates of origin.
8) Bureau of Indian Standards Certificates (BIS)
The Bureau of Indian Standards (BIS) issues certificates to confirm that products meet specific quality and safety standards in India. This accreditation is critical for companies exporting products to the Indian market.
9) Veterinary Medicines Directorate Certificates (VMD)
The Veterinary Medicines Directorate (VMD) protects animal health, public health, and the environment in the UK. They issue essential certificates for veterinary medicines and their manufacturing processes, ensuring they meet the UK’s appropriate safety, quality, and efficacy standards.
10) European Medicines Agency Commission Reports (EMA)
The European Medicines Agency (EMA) issues reports on the quality, safety, and efficacy of medicines in the European Union. These commission reports are crucial for companies looking to market their products within the EU, as they confirm compliance with regulatory requirements. The authorization process enables pharmaceutical firms to submit a unified marketing authorization application, allowing them to market their medicine across the European Economic Area.
Lex Documents helps with pharmaceutical trade documentation, legalization, and translation.
Lex Documents offers businesses support with the movement of goods and international trade. This includes the additional and complex requirements of pharmaceutical industry documentation.
We can offer procurement, translation, and legalization services so businesses don’t have to negotiate with multiple entities to do the job. Our experienced and knowledgeable team 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!