The Hague at night

Uncovering the Rich History of the Hague Convention

We call it The Hague in English, Den Hag in its native Dutch, but often La Haye, using French, the traditional language of international diplomacy. 

In any language, this is the city where a historic international accord was created   in 1961, affecting to this day the flow of vital documents among countries. This accord is called The Treaty of the Hague Convention of 1961—aka The Apostille Convention.

Recently, the Hague also became home to the European Medicines Agency, producing many of the documents relative to pharmaceutical export.

In the shorthand of global document authentication, most things boil down to “Hague” and “Non-Hague.” This designates whether the origination and destination countries of any given document are signatories to the Treaty of the Hague Convention of 1961. If it was, one official stamp, issued by any member country, will authenticate a document for use in any other member country. Today, there are more than 100 signatory nations.

It was only natural in 1961 that nations of the world would turn to The Hague Convention to streamline the approval process for cross-border documents. Natural, because long before there was a United Nations or even a League of Nations, there already existed a structure for international negotiation.

A little digging reveals a rich and storied history of the Hague Convention and one with roots in the searingly relevant issues of arms control and rules of engagement for warfare. 

The first Hague Convention convened in 1899, at the behest of Russia’s Tsar Nicholas II, to restrict the damages of war. As increasingly lethal weaponry affected civilian populations and civil infrastructure in the decades following the fall of the Napoleonic Empire and during the expansion of European colonialism, leaders sought to limit rules of engagement. Almost quaint by modern standards, but deadly serious in its time, was the practice of dropping explosives from flying balloons. Another hotly debated topic was the advent of exploding bullets. Protection of civilian targets and civil infrastructure also filled the agenda at the first Hague Convention.

Results were inconclusive, unfortunately,  and a follow-up conference was scheduled for 1907 which also failed to achieve consensus. The next Hague convention, scheduled for 1915, was canceled by the First World War, by which time aircraft had replaced balloons.

Fast forward to 1961. International conflict resolution had now passed to the United Nations, formed after WWII and headquartered in New York City. But the Hague convened for a different purpose: to streamline document legalization, a process critical to international trade of all types. They came up with apostille, a French term for “little stamp.” Suddenly, miles of red tape were removed for companies and individuals to use and apply their documents. 

Pharmaceutical companies, for example, could manufacture drugs in one country, brand them in conformity with its corporate headquarters, and pursue distribution throughout the world. 

Standard documents, such as powers-of-attorney and bills of lading, were suddenly streamlined when transiting among Hague countries.

Documents for adoption, intellectual property rights, work-abroad visas, and criminal background checks were similarly impacted.

Today, countless multitudes of companies and individuals benefit from the achievement of the Treaty of the Hague Convention of 1961. A subsequent Hague Convention treaty, crafted in 1996, added legal protections for children. Affecting cross-border adoptions and the threats of human trafficking, this was broader in scope than the previous Hague Conventions which had treated this critically important topic.

Perhaps it is the Convention’s voluminous handbook that states best the lasting legacy of this obscure treaty:

The Apostille Convention is the most widely ratified and acceded to of all the Conventions adopted under the auspices of the Hague Conventions. It is in force in over 100 States from all major regions representing all major legal systems of the world, making it one of the most successful international treaties in the area of international legal and administrative cooperation. 

Even after 60 years, the work of the Hague Convention remains incomplete. Despite its wide application among more than 100 nations around the globe, numerous countries remain non-signatories, examples including Canada, China, Egypt, and others. The most recent signatories, welcomed in 2021, include Singapore and Jamaica.

A digital world in the hands of a human

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.

International flags flowing in the wind

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.

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