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!

COVID-19 UPDATES

July 8th Update

The State of Maryland has announced a Phase II plan, and we are working diligently in the office to serve you!

Thanks to the selfless service of Healthcare workers and Marylanders for staying home and practicing social distancing. The State of Maryland is slowly on its road to recovery.

WCS is observing the Maryland State guidelines to ensure a safe work environment for our staff and for our community.

The US Department of State is currently prioritizing all life and death matters with respect to document processing; hence the authentication process for corporate documents has been significantly delayed. The Maryland Secretary of State has developed reliable procedures that give us reasonable turnaround times, yet are not as efficient as pre-COVID-19. More Embassies have opened for public service, but with limited staff and operational hours.  Even with these challenges, WCS is processing your documents most effectively. We are trying our best to keep the pressure on our leading partners to reduce backlogs and delays.

Processing times will return to normal as soon as the Federal, State agencies, and Embassies resume its operations in full strength. Nevertheless, please continue to send your documents for authentication and we suggest not to hold them back for later.

We highly appreciate our customers for their trust, patience, and consideration during the pandemic. Thank you for your incredible support!

We are in this together; please be safe and healthy!

WCS TEAM

May 18th Update

Dear Valued Customers,

Thank you for your tremendous patience and understanding during these unprecedented times. WCS is ever grateful to all our customers for trusting us to steer your legalization ship.

The  Maryland State has relaxed its “stay at home orders” for certain counties, hence WCS is working with reduced capacity in office and the remaining staff is assisting customers remotely.

Government agencies like the Department of State and Embassies in DC are still in Stay at home orders with limited hours of operation. Even so we have found out ways to work around this fluid situation with a delayed turnaround.

WCS is taking all safety measures to ensure your documents are safe for processors to handle. FedEx, UPS & USPS packages are delivered to our office, with no contact delivery. All received packages are disinfected, as per the CDC’s guidelines before it can be handled by our team. We are aware that the Government Departments and Embassies are also practicing social distancing and safe document handling.

We are anticipating delays in the legalization process due to safety measures, limited staff hours at the Government and Embassies. Despite all these restrictions in place, WCS will continue to assist you with all your authentication needs, kindly continue to send your documents to WCS as usual.

WCS is committed to serving its clients throughout these challenging times.

Thank you and stay safe.

WCS TEAM

April 2nd Update

To our valued and prospective clients:

WCS office is closed under the order from the Governor of the State of Maryland, requiring only essential businesses to stay open. We have made arrangements with FedEx, UPS, and USPS to continue delivering documents to our office. Please know that your documents will be safe in our office. Meanwhile, WCS staff will be working remotely to accept and process electronic documents as applicable within the time frames and restrictions in the current market. We will respond to email and voicemail queries promptly.

We are taking this step as we are good corporate citizens and want to ensure the health of our employees and the community. We are continuing to monitor the situation and will update everyone as soon as we have any relevant information.

Thank you for your cooperation and patience in this crisis. We look forward to working with you as soon as possible.

WCS Team

March 17 Update – WCS has learned that the Embassies of Egypt and Saudi Arabia will remain closed until March 24, 2020 and the Embassy of Qatar until April 1, 2020. Please expect delays in document processing through these Embassies. We’re working diligently to accommodate your requests.

Please expect delays in document processing through these Embassies. We’re working diligently to accommodate your requests at this time.

COVID-19 Resources

Read prevention measures from the Centers for Disease Control and Prevention here and review the following household checklist from the CDC to see their recommendations on how to plan and make decisions now that will protect you and your family during a COVID-19 outbreak.

COVID 19’s Impact on the Global Health Industry

In the wake of COVID-19, the global health industry has been put to the test. Age-old protocols were threatened as social distancing and illness threatened to wreak havoc on companies. While nearly all industries have had to work to adapt to the rapidly-spreading illness, the global health field has had their work cut out for them. Currently, many of those companies are experiencing or anticipating work stoppages due to COVID-19.

1. RA & Quality Control: Document Authentication Backlog

Document authentication is an often overlooked component of regulatory affairs in the global trade life cycle. In mid-March, embassies began to close, or run on minimal staffing. Now, this created an immense problem for regulated goods headed to Non-Hague countries, as embassy legalization is necessary to export and sell in those destinations. While finalized products face this issue, products on an earlier bend of the quality control cycle risk developmental delays. With social distancing in place and many employees now remote, review cycles and timelines for products have been impacted.

2. FDA Overriding Supply Chain Security Requirements

With the intent of combatting COVID-19 and related illnesses, the FDA issued guidance detailing exclusions and exemptions to certain requirements under the Drug Supply Chain Security Act, due to the urgency of COVID-19 by the end of April.

To keep things moving forward, the FDA has been doing all it can to ensure Med/BioTech companies are able to respond to the rapidly evolving battle against COVID. The FDA published a nine page guidelines document on COVID, and explained their exemptions under the DSCSA. Download the full guidelines from FDA here.

“Under the DSCSA, specific activities are automatically excluded from certain DSCSA requirements upon the declaration of a public health emergency.”

FDA

3. EU MDR Postponed to May 2021

The most massive impact on the industry has been the postponement of the EU’s Medical Device Regulations, introduced in 2017 and originally set to launch in May of 2020. With Notified Bodies already overwhelmed, the delays brought on by COVID forced a delay into 2021.Read our EU MDR updates here.

Europe’s New Medical Devices Regulations 2017/745(MDR) deadline is finally here!

European Union Medical Device Regulation 2017/745 deadline approaches on May 26, 2020. Medical device companies must comply with the new regulations to maintain market access and mitigate risk.

Medical devices and implantable objects have not faced the high level of regulation the public might expect. This is beginning to change. The European Commission has deemed regulations passed in the 1990s insufficient, and with the desire to strengthen legislation for public safety, the new European Union (EU) Medical Device Regulation (MDR) 2017/745 was born. The EU MDR, which takes into consideration technological and scientific progress made in the last 20 years, will increase the amount of data required to put medical devices on the market. This includes items that serve cosmetic purposes, which were previously out of scope.

What is EU MDR?

The EU MDR was first proposed in September 2012, and accompanied by a separate, complementary regulation targeting in-vitro devices. These regulations were developed to increase the safety of medical devices for the general public, as well as improve traceability and legal certainty. Regulators devised the EU MDR because the existing regulation, the EU Medical Device Directive (MDD), was outdated and provided insufficient standards for maintaining safe and properly-functioning medical devices. The regulation entered into force on May 25, 2017, with a transition period for manufacturers that will continue until May 26, 2020.

Currently, there are 500,000 existing, registered medical devices. The majority — 314,000 — will need to be re-certified under the EU MDR in order to maintain market access.

EU MDR NEW RULES HIGHLIGHTS FOR MEDICAL DEVICE MANUFACTURER’S
  • Manufacturers will be able to register a device once at the EU level, instead of having to go through multiple registration procedures.
  • Clinical trials taking place in more than one EU member state will be subject to a single coordinated assessment instead of multiple national assessments.
  • The European database will expand to contain extensive information on medical devices, with most made publicly available.
  • Implant cards will include more information for patients
  • There will be a financial plan for patient compensation in cases where people have been harmed by medical devices.

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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