Introduction:
When it comes to exporting pharmaceutical products from the European Union (EU), obtaining a Certificate of Pharmaceutical Product (CPP) is a critical step for companies seeking to venture into international markets. This certificate serves as a validation of the pharmaceutical product’s quality, conforming to both EU and global standards, and enables its acceptance outside the EU. In this section, we will explore the guidelines for acquiring a CPP, including the procedural steps, necessary documentation, and strategic considerations that pharmaceutical companies should keep in mind.
The Importance of the CPP:
The CPP is an official document that provides evidence that a medicine, authorized for sale in an EU member state, complies with the Good Manufacturing Practice (GMP) standards specified by the EU. It also adheres to the format outlined by the World Health Organization (WHO) for such certifications. The CPP assures the importing country that the pharmaceutical product has undergone evaluation and approval by an EU regulatory authority, granting authorization for marketing within the EU.
Guidelines for Acquiring a CPP:
Determine Eligibility:
Ensure that the pharmaceutical product holds a valid marketing authorization in any EU member state. The CPP can only be issued for products that are legally permitted for sale within the EU.
Application through the National Competent Authority (NCA):
Submit the CPP application to the national competent authority (NCA) of the country where the product is manufactured or where the marketing authorization holder is located. Each NCA may have its own application form and submission process.
Provide Comprehensive Product Information:
The application should include detailed information about the product, such as:
· Trade name and generic name.
· Dosage form and strength.
· Composition details.
· Marketing authorization number and date of issue.
· Information on the product’s GMP status.
· Any conditions or restrictions imposed by the regulatory authority.
Compliance with GMP Requirements:
Before a CPP is issued, the manufacturing facility undergoes an inspection by the EU authority to ensure compliance with GMP standards. Typically, a current EU GMP certificate is required.
Submit the Required Documentation:
The documentation typically includes:
· Copy of the marketing authorization.
· GMP certificate for the manufacturing site.
· Details of any suspensions or revocations of the product’s marketing authorization.
· Authorization for releasing the CPP to a third party, if applicable.
Payment of Applicable Fees:
Most NCAs require a fee for issuing a CPP. Ensure that the fee is paid in accordance with the NCA’s guidelines before the certificate can be issued.
Assessment and Issue Process:
After the submission of the application, the NCA will assess it. If all the criteria are met, the CPP will be issued. The timeline for issuance may vary, so it is advisable to apply well in advance of the intended export date.
Validate the CPP:
In certain cases, the importing country may require the CPP to be legalized or apostilled to confirm its authenticity. This involves additional steps, such as verification by the foreign ministry or embassy of the importing country.
Conclusion:
Obtaining a Certificate of Pharmaceutical Product is a crucial step for EU-based pharmaceutical companies involved in export activities. This certificate serves as a testament to the quality and regulatory compliance of the product, recognized worldwide. By meticulously following the guidelines and procedures for acquiring a CPP, companies can ensure a smooth entry into non-EU markets, expanding their global presence while upholding the stringent quality and safety standards of the European Union.
Author: Pooyan Ghamari, Swiss Economist & Visionary
