6 Tips for Apostille or Document Legalization

When marketing and selling medical devices, pharmaceutical products, cosmetics or foods outside the U.S., your company will be required to have certain regulatory, quality or supporting technical documents authenticated either by apostille or by consular legalization through the embassy of the target country.

The health ministries of countries require assurances that the products entering are safe, effective and in conformance with current Good Manufacturing Practices (CGMPs). Thus, companies are required to submit for review to the ministry copies of the company’s U.S. Food and Drug Administration (FDA) approval certificates such as:

  • Certificate to Foreign Government (CFG),
  • Certificate of Exportability (COE);
  • 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.

To confirm authenticity, these certificates need document legalization, authentication or apostille within the U.S. depending on the national ministry’s requirements. To do this, one can handle it in-house or utilize the expertise of a service specializing in efficiently handling this process.

If you choose to handle it on your own, these six quick tips can help you through the document legalization process!

Preventing Document Legalization Rejection at the Embassy

In its simplest form, document legalization is “the process of authenticating or certifying a legal document so a foreign country’s legal system will recognize it as with full legal effect,” at least, so says Wikipedia.  However, the process can be far from simple.

And for those within a company who are lucky enough to be tasked with handling this process internally, the tangential feat of memorizing each country’s specific requirements can be about as simple as memorizing every bone in the human body for a high-school biology exam.

So I have decided to “throw a bone” to anyone who has experienced the “Unfortunately, we were unable to process your document because..” letter that accompanies a rejected document from an Embassy.  This article will reveal some, I repeat, some, unique requirements of some frequently called upon Embassies that can assuage one’s fear of rejection.

How To Deal With Government Entities To Get Your Documents Legalized:

Regulated industries, including but certainly not limited to, Pharmaceuticals, Medical Devices, Biotechnology, and Consumer Products, have a virtual obstacle course of hoops to jump through in efforts to bring their products to market. Companies that have a global footprint continue the hoop jumping in efforts to get the product onto international “shelves.” It is for those additional steps that companies sending product overseas should outsource.

Document Legalization: a process during which documents are navigated through an assembly line of notarizations, certifications, and authentications so that these documents can be used in foreign countries to transact business. It is a “hurry up and wait” game as the documents are passed around government agencies in hopes of getting their stamps of approval. Notaries, Clerks of Court, Chambers of Commerce, Secretaries of State, U.S. Department of State, and Embassies…Oh my!

It is a necessary evil, a niche administrative task that can be confusing and tedious, and it should be outsourced. Here is why:

Important Payment Change from the Embassy of Qatar

Starting tomorrow, 12/12/2014, the Embassy of Qatar will no longer accept payments via cash, check, credit card or money order.

All legalization payments for all documents both legal and commercial will have to be made to the Embassy’s bank account.  Once the payment is complete, one must remit the deposit slip accompanied with the document to the Embassy’s consulate to be processed.

We certainly understand that this is not any easy transition for those looking to legalize documents with the Embassy of Qatar.  But we are here to help so feel free to contact us if you have any questions.

In the meantime, you can learn more about the Embassy of Qatar’s legalization procedures here. 

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