Certificate of Pharmaceutical Product apostille

What is a CPP apostille?

A CPP issued by the FDA is a federal public document. An apostille on a CPP confirms the FDA official's signature to the foreign drug regulatory authority receiving it. The apostille is issued by the US Department of State's Office of Authentications. It does not change or endorse the product's approval status — it authenticates the document's origin so the foreign authority can trust it without contacting the FDA directly. Many regulatory authorities in Asia, Latin America, the Middle East, and Africa require apostilled CPPs.

When you need one

You need an apostilled CPP when: registering a pharmaceutical product in a foreign country that is a WHO member and follows the CPP scheme; responding to a foreign regulator's request for authenticated US regulatory status documentation; satisfying a distribution agreement that requires the foreign distributor to submit authenticated regulatory certificates; and bidding on government pharmaceutical procurement in countries that mandate apostilled regulatory documents.

How Laurela handles it

We confirm you have the FDA-issued CPP in hand (Laurela does not apply to the FDA on your behalf). We then prepare the submission to the US Department of State for the federal apostille. For countries outside the Hague Convention — including several important pharmaceutical markets — we coordinate the additional consular legalization step. We track the process and confirm receipt at each stage.

Apostille vs. embassy legalization

Hague Convention member countries accept the apostille attached by the US Department of State. Non-member countries require additional steps: after the State Department authentication, the document must pass through the destination country's embassy or consulate in the US. This is common in pharmaceutical markets in the Middle East and parts of Asia. Laurela determines and manages the full chain.

Frequently asked questions

Do I need to obtain the CPP from the FDA before contacting Laurela?

Yes. The FDA issues CPPs directly; Laurela handles only the apostille step. Request your CPP from the FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) as applicable.

How long does it take?

Department of State processing for federal apostilles varies; expedited service may be available. We give you a current timeline estimate when you place your order.

The foreign authority wants the apostille accompanied by a certified translation. Can you help?

Yes. Laurela can coordinate certified translation of the CPP and apostille into the required language as part of the same order.

Our CPP covers multiple products. Does each product need a separate apostille?

Each FDA-issued CPP document receives its own apostille. If the FDA issued separate CPPs for each product, each will need its own authentication. If one CPP covers multiple products, one apostille covers the document.