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!

International Business Map

Notified Bodies Update

Even though the EU MDR was postponed until May 2021, the dwindled-down list of Notified Bodies suggests Regulatory Affairs professionals might not want to kick the can too far down the road.

For those looking at the upcoming IVDR, the situation is even bleaker. The IVDR has not yet been postponed, still facing a May 2022 effective date.

“…with only three notified bodies designated against the IVDR so far, potential delays in further designations because of COVID-19 and social distancing could be a real problem for a diagnostics industry that has been preventing from moving towards compliance when there are so many unfinished structures and documents”

@MedtechAmanda

To search the database of designated NBs on NANDO’s website, click here.

Read our updates on EU MDR by clicking here.

Updates on the EUMDR

In response to the COVID-19 pandemic, EU regulators proposed a one-year delay on the new EU MDR, to May 2021.

The EU MDR Date of Application has officially been extended until May 2021. While most Regulatory Affairs and Quality Control professionals are rejoicing in this push-back, keep the ball rolling on meeting new MDR compliance. Those scrambling to review their products’ compliance may be able to exhale, but the race to completion is still on.

In 2017, EU came out with the new MDR, that would go into effect in 2020. Since then, medical device manufacturers have been tasked with determining which of their products need to be re-registered with participating Notified Bodies, in order to meet the new regulations for export in the EU. However, this posed a new problem for RA professionals.

The once lengthy list of Notified Bodies has now dwindled to only a handful. This poses a great problem for many manufacturers as Notified Bodies become more and more overwhelmed with products to register.

US Apostille & Embassy Consular Legalization

Critically Important, Often Overlooked: Document Requirements

Every regulatory department must manage document requirements either internally or by engaging an outside service. This article covers the process for “legalizing” documents to sell regulated products outside of the US. A US product cannot be sold overseas without proof of the legalized document.

Apostille. Consular Legalization. Certificate to Foreign Government. Certificate of Pharmaceutical Product. Certificate of Free Sale. ISO Certificates.

Ever heard of those?

These terms refer to international document legalization, a critically important, but often overlooked aspect of doing business oversea”s.

What is an “apostille?” When and why do you need it?

Once you understand apostille, how is that different from consular legalization? And, when and why do need consular legalization instead of an apostille?

Let’s dive in, shall we?

What is an apostille?

An apostille is a certificate that authenticates the origin of a public document. The word “apostille” is of French origin and is derived from the old French word “postille,” which means “annotation.” It is relevant to the regulatory profession because legalized and/or apostilled documents grant companies the authority to legally sell products in overseas markets. In other words, it is a regulatory compliance issue.

When is apostille appropriate versus consular legalization?

This is where the distinction between Hague and non-Hague signatory countries becomes relevant. Signatory countries to the 1961 Hague Convention Abolishing the Requirement of Legalization for Foreign Public Documents agree to recognize the authenticity of an apostilled document from all other signatory countries. In the document authentication business, these are the “Hague” countries.

In contrast, consular legalization is the process for authenticating documents when selling products in non-Hague countries or countries that are not signatories to the Hague Convention document protocol. Generally (with some processing quirks for certain countries), the consular legalization process involves obtaining certification and stamps from

1. a state level Secretary of State
2. the US State Department and
3. the Embassy of the destination country

The legalized document is directly tied to a specific product and includes government issued documents such as Certificate to Foreign Government (CFG), Certificate of Pharmaceutical Product (CPP) and Certificate of Free Sale (CFS).{1-3} It also can include non-government issued documents including corporate documents, letters of authorization, distributor agreements, and many other types of documents for use in non-Hague countries.

Why is it important?

The simple answer is a company cannot legally do business in certain countries without obtaining these certifications. But that begs the question: what is the purpose behind this process? The answer is the apostille and/or consular legalization process is a way for foreign governments to authenticate the quality and safety of the products to be sold in their country. Essentially, these processes are the tools foreign countries use to protect their citizens. And, they rely on the US regulatory authorities for assurance.

To protect the health and safety of their citizens, foreign Health Ministries require assurance that the products being sold and utilized in their country are safe, effective, and comply with Good Manufacturing Practices (GMPs). In the European Union (EU), Mutual Recognition Agreements (MRAs) have been signed with third country authorities to support mutual recognition of good manufacturing practices in human and veterinary medicines.{4} In the US, the  Food and Drug Administration (FDA) notes on their website:

“In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States or meet specific U.S. regulations, for example current Good Manufacturing Practice (cGMP) regulations.”{5} The document legalization process conveys US regulatory officials have certified that a product has successfully passed the review and regulatory processes in the US. Although people often complain about the regulatory burdens of US government agencies, a certification from the US FDA or other regulatory agency is the gold standard for most countries around the world.

In addition to the legal compliance aspect, efficient document legalization is important from an efficiency and cost perspective. One vice president of regulatory affairs for an international pharmaceutical company related how he emphasized the importance of document regulatory compliance with his Board of Directors. In his presentation to the Board, he said:

“We generate approximately $10 billion per year. That means we generate approximately $833,000 per month in revenue. And, that means it costs us $28,000 per day for every day we are not legally authorized to do business in a given country.”{6}

Obviously, an efficient and effective process for handling apostille and document legalization contributes to the company’s bottom line.

Apostille or Not?

Hague vs. Non-Hague Countries

It may be instructive to describe the process using a generic example. Company X has received approval from the US FDA for a new surgical stent product. This product is key component to the company’s overseas development strategy. The first step is to get FDA to issue a Certificate to Foreign Government (CFG) identifying the new product.

As noted above, the next step is to determine the “Hague” status of the destination countries. For a Hague country, such as Mexico, the process is to take the CFG for an apostille at the US State Department. The State Department accepts mail in requests or the company can engage a document services company to obtain the certification in person.

For any non-Hague country such as China, Saudi Arabia, or Iraq, the process is to obtain a certification from the US State Department and then have the document legalized by the respective Embassy. This process can take as few as six days to as many as 40 days depending on the Embassy.

After completing the Hague/Non-Hague process above, the company has obtained an apostille from the US State Department or consular legalization stamps and seals from the non-Hague country embassy. At this point, the company can now include these authenticated documents in its product registration dossier to submit to the health ministries of countries where the company wishes to market its products.

Lastly, it should be noted that the processes outlined herein is for documents originating in the US. Documents originating outside of the US generally require apostille or consular legalization in the host countries.

Click a country below to view their requirements

Hague Countries

Non-Hague Countries

Risks and Uncertainties

What could go wrong? Well, just because a process is defined does not mean changes cannot be made unilaterally and without notice. For example, a recent submission was rejected by the Embassy when the Embassy unilaterally concluded that a notary stamp on the document was too close to expiration. What is “too close” to expiration? Whatever the Embassy decides is too close. In this case, the new rule (unannounced except via the rejection of the document) was that notary stamps could not be within six months of expiration at the time the document was submitted.

Unfortunately, the client was expecting the document to be returned in time for the CEO to take the authenticated document with him on his business trip. The Embassy refused to consider any rule change even with strenuous efforts made to appeal the decision.

In addition to unforeseen changes to the rules, some countries create additional rules specific rules that fall outside the Hague vs. non-Hague paradigm. Indeed, some Hague countries still treat certain documents as if they were being used in a non-Hague country. Argentina, for example. Argentina, as a member of the Hague convention, only requires documents to be apostilled for use in Argentina, unless the documents are commercial documents. Then, they must go through legalization as if they were a non-Hague country. Does this run counter to the idea of being a member of the Hague convention for document authentication? Yes.

The complexity and ever-changing nature of the apostille or consular legalization processes present challenges to regulatory professionals. Many companies dedicate specially trained individuals to handle these requirements in-house while other companies elect to utilize the expertise of a document management service.

Authenticating Academic Documents for Use in Qatar

If you’re planning to teach overseas, or if you’ve ventured out to international job markets, you may have realized that some countries have extra requirements for document authentication. China, Qatar, and Kuwait—just to name a few.

Let’s say you need your education documents (originating in the US) legalized for use in Qatar.

Qatar Diploma / Degree Attestation

The new requirements set by the Qatar Embassy/Consulate require the following documents to be processed together as a set:

1. Original Diploma (Notarized)

2. Original Transcript (Notarized)

3. Original Verification Letter (Notarized) — verification letter must be signed with a live signature and stamped by the registrar’s office and contain the following information

  • Certificate information is accurate
  • Enrollment and attendance (full-time, part-time, distance)
  • Study and tests locations
  • Degree obtained by the student (Diploma, Bachelors, Masters, Doctorate)
  • Duration of the program
  • The actual time the student spent to get a certificate (study start date – study end date)
  • Public or private academic institution
  • *In cases where the student attended more than two institutions, this must be specified in this letter. The letter must mention that the diploma took place on campus, face to face, not online, in case students took some portion online, specify how many classes out of how many on campus-in person.

The three documents specified above will need to be bundled together as one set. The three documents will receive one seal/stamp from the US Department of State, and then will be legalized by the embassy/consulates.

The Qatar consulate will only legalize ORIGINAL documents—photocopies/scanned copies are no longer accepted. You may re-order a diploma with your university for this document legalization process. 

These are the necessary steps that need be completed by the Secretary of State, U.S. Department of State, and the relevant embassy—Qatar’s consulate, in this case.

Before you send these documents in to WCS, each document must be notarized locally by a notary public where the document was issued. Then, the bundle (all the documents together) must be certified by the local secretary of state. Only after these critical steps are completed, should you send in your document bundle to WCS.

Once you’ve sent in the documents to WCS, we’ll send you our Education Records Consent and Release Form — you must return this document to us signed and completed.

From there, WCS will handle the document legalization process. WCS will take the bundle to the US Department of State and finally to the Qatar embassy/consulate.

Better yet, handle this process step-by-step with our app, WCS Express. We’re here to answer any questions you may have throughout this process!

Submit a Request is now WCS Express -Get Started with your order now!