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!

Bolivia Document Legalization Procedure Update

The Embassy of Bolivia has just announced a change in procedure for document legalization. All non-government-issued documents, or “General Documents,” must be notarized and certified locally by the Secretary of State of their issue. This procedure is the same for government-issued documents. Examples of General Documents include:

Corporate documents such as:
  • Powers of Attorney
  • Corporate Formation Documents
  • Distributorship Agreements
  • Company bylaws
  • Good standing certificates
  • Minutes of board meetings
  • Affidavits
​Academic documents such as:
  • Accreditation letters
  • Authorization letters to obtain academic records
  • Bar certificates
  • Degrees
  • Diplomas
  • Official transcripts
  • Practice licenses for nurses and physicians
  • Statements of study major
  • Teaching certification
  • Verification letters from the registrar’s office

For more information on document legalization for Bolivia, visit the Bolivia country page on our website.

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.

Embassy closings for the upcoming Eid holidays

A number of Embassies in DC will be closing in observance of the Eid-al-Adha holidays which could affect the document authentication process in terms of turnaround times.

Below is a working list of the Embassy closings.  We shall update it as we receive this information from the Embassies.

BAHRAIN

  • Friday and Monday

BANGLADESH

  • Friday and Monday

EGYPT 

  • Monday

IRAQ

  • ALL of next week – 10/6 – 10/10

KUWAIT

  • Monday, Tuesday and Wednesday

MALAYSIA

  • Monday

NIGERIA

  • Monday and Tuesday

QATAR

  • Monday

SAUDI ARABIA

  • Monday, Tuesday and Wednesday

UNITED ARAB EMIRATES

  • Friday

——-

NATIONAL US-ARAB CHAMBER OF COMMERCE

  •  Friday

And Eid Mubarak for all those celebrating!

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