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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!

1. Plan Ahead

We understand that often a regulatory professional handling this process is responding to a request with a quick turnaround. But to the extent you can, plan ahead and give yourself some time to understand the process as document legalization requirements are constantly changing depending on the country.

2. Determine Country Status

The legalization requirements for your document are largely dictated by the destination country and whether or not this country is a signatory to The Hague (Convention) Agreement of 1961 that established the apostille as a widely accepted form of international authentication. You can visit our site to determine if your country is an apostille or non-apostille country.

3. Research Country Requirements

Apostille countries have the same process for document legalization. Non-apostille countries often have different guidelines, which are unique to each country.

4. Identify Fee and Form of Payment

The type of document is also critical to what authentication process it follows for a particular country. Generally speaking, there are three categories of documents:

  • Government-issued documents – documents issued by a federal, state or local government entity
  • General documents – documents that are NOT issued by a federal, state or local government entity, the largest catch-all category
  • Commercial/Shipping documents – documents required for shipping a product out

Make sure to identify the correct fee based on the destination country and document type. Note that certain embassies only take specific forms of payment such as money orders or cashier’s checks.

5. Prepare Document for Submission

Though the process can be fairly straightforward, requirements and fees for embassies can change frequently and often, drastically. Be sure to stay up-to-date on this information and check on specific requirements before submitting your documents including those around copies, originals, etc. It can be incredibly frustrating and time-consuming to have your documents rejected for overlooking a small requirement like failing to provide enough copies.

6. Ship Documents

As mentioned above, because things are always changing around embassy fees and requirements, don’t be deterred if you have to resubmit or adjust to the needs of the Embassy. 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. Pat yourself on the back for making it through or you are always welcome to drop us a line if you need help!

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