WHO Certificates of Pharmaceutical Products (CPP) Issued by BfArM

Purpose and Legal Basis

The WHO Certificate of Pharmaceutical Product (CPP), also known as the WHO Certification Scheme certificate, is an official document issued by BfArM for medicinal products authorised in Germany. It attests that the product is authorised for marketing in Germany, complies with German and EU quality, safety, and efficacy standards, and that the manufacturing site adheres to Good Manufacturing Practice (GMP) requirements equivalent to WHO GMP guidelines. This certificate facilitates regulatory approval and import in importing countries that are not part of the EU or have not adopted mutual recognition agreements. Information on WHO Certificates - BfArM

Eligibility and Scope

• CPPs are issued only for medicinal products (including generics and biosimilars) that hold a valid marketing authorisation in Germany.
• Certificates cover nationally authorised, decentralised, mutual recognition, and centralised products (where BfArM is involved or can confirm GMP compliance).
• BfArM issues certificates in the WHO-recommended format, including details on product name, dosage form, strength, marketing authorisation holder, manufacturing site(s), and GMP status.

Application Process

• Applications must be submitted electronically via the BfArM portal using the official form.
• Required documents include proof of marketing authorisation, GMP certificates for manufacturing sites, and payment of the applicable fee.
• Processing time is typically several weeks; urgent requests may be considered with justification.
• BfArM verifies information against its records and may request additional details if needed.

Key Information Included in the CPP

• Confirmation of marketing authorisation status and date.
• Product composition and pharmaceutical form.
• Name and address of the authorisation holder and manufacturer.
• Statement on GMP compliance of the manufacturing site(s).
• Indication whether the product is identical to the one marketed in Germany.

Practical Notes for Exporters

• The CPP is valid as long as the underlying marketing authorisation and GMP certification remain current.
• Multiple manufacturing sites or formulations require separate certificates.
• BfArM does not issue statements on batch release or specific batch quality; separate batch certificates may be requested if required by the importing country.
• Applicants should check importing country requirements, as some accept EU GMP certificates directly or require additional attestations.

WHO CPPs issued by BfArM remain an essential tool for German pharmaceutical companies exporting to global markets, ensuring trust in the product's regulatory status and manufacturing quality. Information on WHO Certificates - BfArM