Document Authentication for Product Registration/Regulatory Submissions Outside the US

Have you ever opened your email to find a message that contained something like:

"This CFG/CFS/CPP/COE^1,2,3,4 must be apostilled⁵ for Russia"?

"These ISO certs⁶ need legalization (or consularization) from the Consulate of Brazil"?

Either you are very familiar with these requirements or, particularly if your company is relatively new to foreign markets, you have no idea what these terms mean.

It's important to know that when engaged in marketing its medical devices, IVDs, pharmaceutical products, cosmetics or foods in other countries, your company will be requiredto have certain regulatory, quality or supporting technical documents authenticated either by apostille (French for "certification") or by consular legalization through the embassy of the target country.

So what does legalization, or more properly, consular legalization, or alternatively, apostille mean? More importantly, why is it essential?

Generally speaking, the health ministries of foreign countries where a company wishes to market its products require assurances that they are safe, effective and in conformance with current Good Manufacturing Practices (CGMPs). The ministries often require copies of the company's US Food and Drug Administration (FDA) approval certificates (Certificate to Foreign Government (CFG), Certificate of Exportability (COE) or Certificate of Pharmaceutical Product (CPP)) and its International Organization for Standardization (ISO) certification or Free Sale Certificate (CFS) to document that its products are free from defect, disease or harmful nature. (Note: CFG is used by FDA to describe a type of certificate referred to in other countries as a CFS.)

Further, to prove these documents are authentic, they must be certified, authenticated, legalized or apostilled depending upon the national health ministry's requirements.

Apostille or Consular Legalization?

Where document authentication is concerned, the world can be divided into two categories (see Table 1).

Many countries, as signatory nations to The Hague (Convention) Agreement of 19617 that established the apostille as a widely accepted form of international authentication, require documents be apostilled.

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This is a fairly straightforward process that requires the documents to be notarized by a notary public certified as qualified by and registered with the appropriate secretary of state. In the case of government-issued documents such as CFGs or CPPs, the apostille will be obtained from the US Department of State Authentications Division. Originals of government-issued documents must be supplied to the State Department. However, true and correct copies of other types of documents can be notarized. This typically involves having the notary sign an affidavit statement on the reverse of the document, attesting that it is a "True & Correct Copy of the Original Document."

Countries that are not signatory nations to The Hague Agreement, however, require a more complex chain of authentication, culminating in what is known as "consular legalization"(commonly referred to as "consularization") by the country's consulate or embassy.

The consularization process varies to a certain degree across different countries but generally requires the following chain of authentication:

• Notarization
• Certification of the Notary Public by the secretary of state of a US state
• Authentication of that secretary of state by the US Department of State
• Consular legalization at the embassy or consulate of the destination country

This process may be better understood by using a generic example. Once the company, ACMESTENT Inc.,⁸ has received FDA approval for its new coronary stent product, company management may be eager to begin marketing this product overseas, as well as in the US. A small part of the process involves applying to FDA to be issued the CFG, a process that takes approximately four to six weeks. (Note: In some cases, if a product is not yet cleared or approved in the US, a sponsor may obtain a COE from FDA.)

However, before this certificate can be submitted to the health ministry of Brazil, China, Mexico or another country, it must be authenticated for use in that nation. For Mexico, or any other apostille country, the proper authentication must be obtained from the US Department of State Authentications Division. The document can either be sent to that office with a request for apostille, a check for $8.00 and a self-addressed envelope, or sent to a consular service company that will request the State Department apostille in person.

For any non-apostille country such as Brazil, China or Iraq, after submission to the State Department Authentications Division, the document must to be sent to the respective embassy for consular legalization. This process can take five to seven business days or even up to a month for certain embassies. Turnaround time can vary greatly depending upon whether the company executes the process itself or uses a service company to hand-deliver the document to the embassy, pay the necessary fees, etc.

Either way, once the company has the CFG with the US State Department apostille required for Hague Convention countries, or with the addition of consular legalization stamps and seals from a non-apostille country embassy, it now can include these documents in its product registration dossier that is submitted to the health ministries of the countries where the company wishes to market its FDA-approved product.

Finally, please note that the procedures discussed here pertain only to documents originating from or pertaining to manufacturing facilities located in the US. Documents originating in other countries most often require apostille or consular legalization from the embassies in those foreign countries. This is particularly true for documents intended to be used in Brazil, Iraq, Lebanon or Algeria.

The complexity and timeline of the apostille or consular legalization process varies depending upon the specific requirements of offices and embassies regarding fees, forms of payment, turnaround times and mailing/courier requirements. As a result, even though some companies employ staff specifically trained to carry out the appropriate chain of authentication for their regulatory documents, others find it far simpler to use the expertise of a service company dedicated to this process.

References

1. Certificate of Foreign Government (CFG)-A type of export certificate issued by FDA "…for the export of human drugs and biologics, animal drugs, and devices that can be legally marketed in the United States." Guidance for Industry-FDA Export Certificates (2004). FDA website. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. Accessed 17 July 2013.
2. Certificate of Free Sale (CFS)-The CFS is "…for food, including dietary supplements, and cosmetic products that may be legally marketed in the United States." Guidance for Industry-FDA Export Certificates (2004). FDA website. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. Accessed 17 July 2013.
3. Certificate of a Pharmaceutical Product (CPP)- A type of export certificate issued by FDA. According to FDA's website, "The CPP conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when considering whether to license the product in question for sale in that country." Guidance for Industry-FDA Export Certificates (2004). FDA website. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. Accessed 17 July 2013.
4. Certificate of Exportability (COE)-The COE "is for the export of human drugs and biologics, animal drugs, and devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) or 802 of the Act and may be legally exported. (CBER, CDRH and CVM)." Guidance for Industry-FDA Export Certificates (2004). FDA website. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. Accessed 17 July 2013.
5. Apostille-"An Apostille is a certificate that authenticates the origin of a public document (e.g., a birth, marriage or death certificate, a judgment, an extract of a register or a notarial attestation). Apostilles can only be issued for documents issued in one country party to the Apostille Convention and that are to be used in another country which is also a party to the Convention." The ABCs of Apostilles. Hague Conference on Private International Law website. http://www.hcch.net/upload/abc12e.pdf. Accessed 17 July 2013.
6. ISO Certification-Certification offered by ISO is "…the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements." ISO website. http://www.iso.org/iso/home/standards/certification.htm. Accessed 17 July 2013.
7. Hague Convention of 1961-Formally known as The Hague Convention Abolishing the Requirement for Legalisation for Foreign Public Documents, and also as the Apostille Convention or Apostille Treaty. It is an international treaty drafted by The Hague Conference on Private and International Law that specified ways in which a document issued in one of the signatory countries can be certified for legal purposes in all the other signatory states. Outline Hague Apostille Convention. Hague Conference on Private International Law website. http://www.hcch.net/upload/outline12e.pdf. Accessed 17 July 2013.
8. ACMESTENT Inc. is a purely fictitious name created for example purposes only. Any similarity to any real corporate name, product, concept, copyright, trademark or venture is purely coincidental and no claims of any kind whatsoever are made to the name.