In the field of pharmaceutical exports from the European Union (EU), the acquisition of a Certificate of Pharmaceutical Product (CPP) holds great significance for companies aspiring to expand into international markets. This certification serves as an endorsement of the pharmaceutical product's quality, in alignment with both EU and global standards, thereby facilitating its acceptance beyond EU borders. This section provides an in-depth exploration of the procedures, documentation requirements, and strategic considerations involved in obtaining a CPP, allowing pharmaceutical companies to navigate this process effectively while avoiding plagiarism.
The Importance of the CPP:
A CPP serves as official evidence that a medicine, authorized for sale in an EU member state, complies with the Good Manufacturing Practice (GMP) standards mandated by the EU. Moreover, it adheres to the World Health Organization's (WHO) format for such certifications. By acquiring a CPP, pharmaceutical exporters assure importing countries that their products have undergone evaluation and approval by an EU regulatory authority, granting authorization for marketing within the EU.
Guidelines for Obtaining a CPP:
It is essential to ensure that the pharmaceutical product possesses a valid marketing authorization in any EU member state. A CPP can only be issued for products that are legally permitted for sale within the EU.
Apply through the National Competent Authority (NCA):
Submit the CPP application to the NCA of the country where the product is manufactured or where the holder of the marketing authorization is located. Each NCA may have specific application forms and submission processes.
Provide Comprehensive Product Information:
The application must include comprehensive product information, encompassing details such as:
- The product's trade name and generic name.
- Dosage form and strength.
- Composition specifics.
- Marketing authorization number and date of issuance.
- Information regarding the product's GMP status.
- Any conditions or restrictions imposed by the regulatory authority.
Comply with GMP Requirements:
Before a CPP is issued, the manufacturing facility undergoes an inspection by the EU authority to assess compliance with GMP standards. Typically, a current EU GMP certificate is required.
Submit the Required Documentation:
The documentation generally includes:
- A copy of the marketing authorization.
- A GMP certificate for the manufacturing site.
- Details of any suspensions or revocations of the product's marketing authorization.
- Authorization to release the CPP to a third party, if applicable.
Pay the Applicable Fees:
Most NCAs impose fees for CPP issuance. These fees must be paid according to the NCA's guidelines before the certificate can be granted.
Await Assessment and Issuance:
Upon submission, the NCA assesses the CPP application. If all criteria are met, the certificate is 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 process involves additional steps, such as verification by the country's foreign ministry or embassy.
The acquisition of a Certificate of Pharmaceutical Product holds immense importance for EU-based pharmaceutical companies engaged in export activities. This certificate acts as a seal of quality and regulatory compliance acknowledged globally. By diligently following the CPP acquisition procedures and guidelines, companies can ensure a smooth entry into non-EU markets while upholding the rigorous quality and safety standards of the European Union.
Author: Pooyan Ghamari, Swiss Economist & Visionary