Authenticating & Legalizing a Canadian Certificate of Pharmaceutical Product
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Certificate of Pharmaceutical Product Authentication in Canada
To successfully use a certificate of the pharmaceutical product outside of Canada, it must first be authenticated by Global Affairs Canada and then legalized by the Embassy of the country in which you intend to use the certificate.
Each foreign country has its own practices when it comes to recognizing documents issued by other countries. Some may ask for a certificate of pharmaceutical product apostille, while others may ask for a certificate of pharmaceutical product attestation. In Canada, this process is called authentication and legalization.
This guide provides information on how you can prepare a Canada certificate of pharmaceutical products for use abroad.
What is a Certificate of Pharmaceutical Product (CPP)?
A Certificate of Pharmaceutical Product is a certificate issued by the Canadian Health Product Compliance Directorate. It establishes the “status of the pharmaceutical, biological, radiopharmaceutical or veterinary product listed and the good manufacturing practice status of the fabricator of the product. The certificates are issued as a service to the pharmaceutical industry when required by an importing country. While the certificate is in the format recommended by the World Health Organization (and the World Health Assembly), many foreign entities still ask for legalization.
Here’s how you can prepare your certificate of pharmaceutical product for use abroad:
Certificate of Pharmaceutical Product Authentication Canada: The Process
Authenticating a Certificate of Pharmaceutical Product is a three-step process:
- Document Preparation
Let’s go into each of these in more detail:
1- How to prepare a Canadian Certificate of Pharmaceutical Product for Authentication at Global Affairs Canada
If you still do not have a certificate of pharmaceutical product in hand, this official guide contains information on how to apply, the application requirements, conditions that may lead to certificate refusal, as well as related fees. You can also find more information about the application process in the Q&A section of this guide.
You should check with the receiving foreign entity of your document if they require authentication and legalization. They may ask you for an attestation or apostille, however, the Canadian alternative for these processes is called authentication and legalization.
When you order your certificate of pharmaceutical product from Health Canada, you can choose to send the certificate directly to our team at Document Authentication Canada, saving you time and effort.
Global Affairs Canada does not require notarization of Health Canada certificates, provided these have an original signature or seal. If your certificate does not have either of these, then it must be notarized before it’s submitted for authentication and legalization.
You can request a notarization from any Canadian notary whose signature is recognized by Global Affairs Canada. The notary will sign and seal your document. When signing your document, the notary must have a valid certificate of appointment and sign the document with ink (digital signatures don’t count).
They must also stamp it or apply a seal that shows their full name as it is stated on their certificate of appointment and the Canadian province or territory in which they have been appointed.
Once you’ve ordered and prepared your document, the next step is to submit it to Global Affairs Canada.
2- How to submit a Certificate of a Pharmaceutical Product for Canada authentication
The next step is authentication at Global Affairs Canada Ottawa. As a rule, Global Affairs Canada will not authenticate a document that:
- Does not have an original signature or seal (for example, plain photocopies)
- Has a seal or signature that Global Affairs Canada cannot verify (this should not be the case with an original certificate of a pharmaceutical product issued by Health Canada)
- Is glued or laminated
- Is covered by any substance that makes it difficult to stamp.
Once you have your document ready, you can submit it to Global Affairs Canada. Global Affairs Canada does not offer an in-person service. You can send your documents by mail instead, and include:
- The authentication request form
- The document you need to be authenticated
- A self-addressed stamped envelope or a prepaid courier shipping label
- Send your documents to the Global Affairs Canada address:
Global Affairs Canada
Authentication Services Section (JLAC)
125 Sussex Drive
Ottawa, ON K1A 0G2
In case of any questions, you can also call the Global Affairs Canada authentication services phone number: 1-833-928-1551
3- How to request legalization of a Certificate of a Pharmaceutical Product Canada
The final step in this process is to obtain a legalization stamp from the Embassy or Consulate of the country where you will be using your certificate. So, for example, if you need to submit the certificate of pharmaceutical product in Spain, you must get in touch with the Spanish embassy to legalize your document, before you can use it successfully in Spain.
A number of embassies ask for supporting documents to process your request. These may include a cover letter, an application form, a copy of your ID or passport, and, in some cases, also a translation.
While completing Step 2 (Authentication) you have the option to ask Global Affairs Canada to forward your documents to an Embassy or consulate in Ottawa on your behalf, for them to complete the legalization step. To do this:
- Select “Forward to an embassy/consulate” in the “Shipping Details” section of the mail-in form
- Provide the embassy or consulate’s full mailing address
- Include a separate, sealed envelope with documents for the embassy
If you choose this option, get in touch with the Embassy or Consulate before you mail your documents to Global Affairs Canada. Failure to follow Global Affairs Canada’s or the Embassy’s instructions may result in your documents being returned to you without having been legalized.
To expedite the process (and as already noted), you can order a certificate of pharmaceutical product and have it sent directly to us at Document Authentication Canada. We can then complete the entire authentication and legalization process for you, saving you time and money.
Our simple 4-step process helps you authenticate and legalize your Canadian documents in a fast & easy manner.
Start by calling us at 1-855-700-5840 or requesting a quote online. We’ll get back to you in 1 hour.
Not sure if your documents meet the requirements for authentication and legalisation? 👇
Reach out to our experts and receive a Free Document Evaluation.
Once you receive a quote and select a time frame that works best for you. We'll provide you with a final price and help you prepare your documents. When your ready ship your documents to our office in Ottawa: 1103-467 Laurier West, Avenue Ottawa, Ontario, Canada, K1R 5C7.
We recommend that you use a secure, prepaid and tracked courier service for sending your documents.
Have any questions? Feel free to call us at 1-855-700-5840
After receiving your documents we will take care of the rest. We will make sure your documents get authenticated and legalized within your requested time frame.
Want to stay updated throughout the whole process?
Check out Document Authentication Canada's Document Tracking System.
…and that’s it! After completing the document authentication and legalization process, we will send your documents using the shipping method of your choice.
Remember: With Document Authentication Canada you only pay at the end, once your documents have been completely authenticated and legalized.
Common Questions about Certificate of Pharmaceutical Product Authentication and Legalization
What does it mean to authenticate a document?
Authenticating a document means preparing it to be recognized abroad. Authentication and legalization prove that the signature and the seal on your document are genuine.
Since it’s difficult for countries to prove that a document issued in a foreign country is genuine, there is a process that involves both the country that issued the document and the country where the document will be used.
In Canada, this process is called authentication and legalization and it also applies to pharmaceutical product certificates.
What is CPP in the pharmaceutical industry?
CPP stands for certificate of the pharmaceutical product. The World Health Organization requires that this certificate is issued by the exporting country to establish the status of the pharmaceutical product and its applicant. A CCP is issued for a single product, because manufacturing arrangements and approved information vary from one product to another, as does the approved information for different strengths.
The importing country requires a CPP when registering or renewing the registration of the said product for distribution in the country.
How do I get a certificate of pharmaceutical product?
To apply for a certificate of pharmaceutical product in Canada you must follow these steps:
- Fill out the Application Form for a Certificate of a Pharmaceutical Product – one form for each product is required. One application form must be filled out for each country – this means that if the product is intended for export to two countries, you must fill in two separate forms.
- Fill out the Fee Form for a Certificate of a Pharmaceutical Product. You can find relative fees in this guide. The fee increases by 2% on April 1st of every year.
- If you need supplemental copies of the same certificate, you must request them at the same time as the request for the original. There is a fee attached to each supplemental copy, but you can fill in one Fee Form for all.
- Payment in Canadian funds must accompany the form. You can do this by cheque or money order made payable to the Receiver General for Canada, or via a company account, Visa, MasterCard or Amex Card. No refunds are issued for refused applications.
- There are other steps you must follow if the documents relating to the product on the requested certificate need to be stamped by Health Canada. You can find more detailed information here
- Once you have everything ready, send your request to:
Drug Establishment Licensing Unit
Health Product Compliance Directorate – Regulatory Operations and Enforcement Branch
Jeanne Mance Building, 13th floor
200 Eglantine Driveway
Address Locator #1913B
The average turnaround time is 10 business days. A seal is affixed on each page, and includes the year of issuance. A fluorescent mark provides an additional security feature.
How long is a GMP certificate valid for?
Do you need to notarize a certificate of pharmaceutical product?
How do I authenticate a certificate of pharmaceutical product?
How do I legalize a Canada CPP?
Legalization is the final step in a three-step process that includes preparing your document, getting it authenticated by Global Affairs Canada, and then legalization at the Embassy of the country where you will submit your certificate.
Each Embassy has specific legalization rules. You can check our Embassy pages to learn more.
How do I get a certificate of pharmaceutical product attestation?
What is needed for a Canada Certificate of Pharmaceutical Product apostille?
Strictly speaking, you cannot obtain an apostille in Canada. This is because Canada did not sign the Hague Apostille Convention. Instead, you can request authentication and legalization and this is an accepted equivalent. You can find detailed information about each step in the process in the guide above.
How long does it take to legalize a certificate of pharmaceutical product?
Global Affairs Canada’s current processing time is 40 business days, but this excludes mailing time, and the time it takes for the Embassy or consulate to complete the legalization step. The whole process can easily take from 8 to 10 weeks, more if you do not submit the correct documents.
This excludes the time it takes to obtain the CPP. Provided all is in order, the average turnaround time at Health Canada is 10 business days.
If you’d prefer to speed up the authentication and legalization part of the process, you can choose to outsource it to experts who can navigate these steps accurately and efficiently. At Document Authentication Canada, we can get a certificate of pharmaceutical products authenticated, legalized, and ready for use abroad quickly. Get in touch with us for a free quote!
How much does it cost to authenticate my Canadian certificate of pharmaceutical product?
Quick Canada Certificate of Pharmaceutical Product Authentication
This guide has provided all you should know about applying for a certificate of pharmaceutical product in Canada and then getting it authenticated and legalized, ready for use abroad.
Preparing your certificate of pharmaceutical product and then submitting it to Global Affairs Canada and the Embassy or consulate concerned can be a complicated and lengthy process. There are multiple entities involved, as well as specific procedures to follow.
At Document Authentication Canada, we help facilitate the legalization of pharmaceutical product certificates and other documents in Canada. We navigate through the bureaucracy on your behalf so that you avoid unnecessary delays. Get in touch with our expert team at 1-855-700-5840 to request a quote and a free document evaluation.
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