Certificate of a Pharmaceutical Product (CPP) and legalisation

Last updated: 18 September 2024

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Anyone who has worked on licensing medicinal products in the AsiaPac, LatAm and MEA regions will quite likely have encountered the requirement to obtain a legalised Certificate Of a Pharmaceutical Product (CPP). If you haven’t already done so, then read on to find out more.

What is a Certificate of a Pharmaceutical Product (CPP)?

The WHO Certification Scheme for a Certificate of Pharmaceutical Product (CPP) is an international voluntary agreement to provide assurance to countries participating in the Scheme, about the quality of pharmaceutical products moving in international commerce.

The Scheme is an administrative instrument that requires each participating Member State, upon application by a commercially interested party, to attest to the competent authority of another participating Member State that:

• a specific product is authorized to be placed on the market within its jurisdiction or, if it is not thus authorized, the reason why that authorization has not been accorded;
• the plant in which it is produced is subject to inspections at suitable intervals to establish that the manufacturer conforms to GMP as recommended by WHO; and
• all submitted product information, including labelling, is currently authorized in the certifying country.

More information on the scheme is available here and here.

When might a CPP be required?

A CPP may be required when a pharmaceutical product is under consideration for a product licence/marketing authorisation or when administrative action is required to renew, extend or vary such a licence.

What information does a CPP contain?

A CPP contains, but is not limited to the following information:

• Confirmation of approval of Quality, Safety and Efficacy (QSE) in the issuing country,
• A snapshot of the licence (only includes information registered in the issuing country),
• Confirms product approval, licence/marketing authorisation holder and Good Manufacturing Practices (GMP) status.

Who is responsible for issuing a CPP?

CPPs:

• are normally issued by drug regulatory agencies in the WHO (World Health Organisation) recommended format
• are issued each time for a single product only, since manufacturing arrangements and approved information for different dosage forms and strengths can vary

About legalised CPPs

Legalised CPPs  are normally requested by some countries (in the AsiaPac, LatAm and MEA regions) as supporting documentation to accompany e.g. new product licence /marketing authorisation applications or renewal applications.

Legalisation (or full legalisation) is a process whereby e.g. in the UK, a CPP granted by the local drug regulatory agency, the MHRA, has to go through several authentication steps in the following sequence:

1. Notarisation– A signature/stamp from a UK notary public.
2. Apostillisation –  An Apostille Certificate is a small certificate that can be attached to a UK document to validate official signatures or seals on the document. In the UK, apostilles are issued by the Foreign and Commonwealth Office. Countries which have have signed up to the Hague convention will normally accept an ‘apostille’. Once an apostille is attached to a CPP, it is considered ‘legalised’.
3. Further authentication of a legalised CPP – Even after a CPP has been legalised, countries (where licence/marketing authorisation applications or renewals etc. are submitted) which have not signed up to the Hague convention may require further authentication of a CPP. This is essentially a signature and/or stamp from the UK Embassy of the recipient country.

In order to obtain the necessary authentication, the above steps must be followed in the sequence stated. Legalisation is a time consuming and expensive process. Whilst there is nothing to stop a pharma company attempting to apply for a CPP and have it legalised, normally this task is outsourced to third party businesses whole sole purpose it is to help pharma companies to apply for, obtain and obtain the necessary authentication.

Is it a requirement to legalise CPPs?

No, it isn’t according to a Q & A document from the WHO. The Answer to 3.Q8 in the document states:

“Legalization is not part of the WHO Scheme and this is not considered to provide additional assurance of authenticity. Approval statuses in key reference countries are currently available as public information.
Legalization should not be necessary since an official governmental authority of the certifying country signs the CPP”.

In spite of this, recipient countries continue to insist on legalisation. For pharma companies, attempting to challenge the status quo potentially means not getting a marketing authorisation or renewal granted in time or possibly ever getting it granted. This means that having to legalise CPPs is currently not an option until such time that the WHO wakes up to the situation and takes the necessary steps to address it.

A comprehensive email to the WHO asking them to address the situation did not even elicit the courtesy of a response!

Use of e-signature for Certificates using the WHO Certification Schemes

According to the World Health Organization (WHO), “some National and Regional Regulatory Authorities indicated during the COVID-19 crisis that they would no longer be in a position to issue and send paper copies of Certificates issued in the context of WHO Certification scheme on the quality of pharmaceutical products moving in international commerce.

• Instead, and in order to maintain this critical service, they opted to use a secure e-signature process.
• WHO agreed with this initiative, which does not contradict the current WHO Guideline.
• WHO recommended other regulators issuing Certificates to also consider this approach. NRAs receiving Certificates are urged by WHO to accept the electronic signature.
• This would be an example of regulatory flexibility in response to the COVID-19 pandemic”.

Online Verification of Electronic Certificates of Pharmaceutical Product

US electronic certificates of pharmaceutical product (eCPP) include a unique quick response (QR) code. This allows for quicker and easier eCPP verification of the authenticity. Anyone, including foreign governments, that receives an eCPP for human drugs exported from the U.S. may verify the authenticity of these certificates using one of the options provided. You can read more about this here on the US FDA website.

New WHO format of the Certificates of a Pharmaceutical Product (CPP)

A new format for the CPP has been detailed in TRS 1033 – 55th report (25 March 2021) of the WHO Expert Committee on Specifications for Pharmaceutical Preparations; Annex 9.

Country/Region specific information /Links to information on CPPs

Country/Region	Regulatory Agency, with link to further information	Information
Belgium	FAHMP	Click on the link for further information on how to apply for a CPP, including forms.
Canada	Health Canada	Guidance on obtaining electronic certificates of pharmaceutical product and good manufacturing practices (GUI-0024) This guidance document outlines the policies and procedure for applying for and obtaining electronic certificates for: · a pharmaceutical product · good manufacturing practices (GMP) This document covers electronic certificates issued: · for human drugs (pharmaceutical, biological and radiopharmaceutical) and for veterinary drugs (food-producing animals and non-food producing animals)known as a certificate of a pharmaceutical product (CPP) · to attest to the GMP compliance of a manufacturing site as per the drug establishment licence (DEL) known as a GMP certificate
Denmark	Danish Medicines Agency	An export certificate is a declaration from the Danish Medicines Agency based on a manufacturer’s licence for a Danish company, a marketing authorisation granted for a specific medicinal product or a requested inspection. An export certificate is completed by the company itself, and the Danish Medicines Agency then authorises the certificate. The export certificate is used to certify the medicinal product or manufacturer when exporting medicinal products.
European Union (EU)	European Medicines Agency (EMA)	As of March 2020, the EMA is only issuing certificates for human and veterinary medicines that are signed and authenticated electronically. EMA’s electronic system for issuing certificates permanently replaces the previous paper-based system, as part of EMA’s drive to digitalise procedures. The format of the certificate is based on an electronically signed PDF document using an electronic signature fully compliant with Regulation (EU) No 910/2014 on the electronic identification and trust services for electronic transactions in the internal market (eIDAS Regulation). This guarantees the unique link to the signatory and the full authenticity and integrity of the document. Further information is available in this document. An online verification system is available for health authorities outside the EU and any interested party to check the authenticity of an electronic certificate issued by EMA.
France	ANSM	It seems that ANSM uses a document called a “Certificate de Libre Vente” (CLV) or “Free Sale Certificate” in English. This document serves a similar purpose to the Certificate of a Pharmaceutical Product (CPP) used in many other countries. The Certificate de Libre Vente confirms that a medicinal product is authorized for sale in France and provides information about its regulatory status. CLVs are issued by CCIParis Ile-de-France Enterprises. Further information is available here. While the CLV is used for products already marketed in France, for products not yet marketed in France but intended for export, the ANSM can issue a document called an “Attestation d’exportation” or Export Certificate. Further information on the latter is available here.
Germany	BfArM	In accordance with Section 73a sub-section 2 AMG, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) issues a certificate corresponding to the World Health Organisation’s Certification Scheme, at the request of the pharmaceutical entrepreneur located outside the scope of the German Medicines Act (Arzneimittelgesetz, AMG) as far as the information relates to licensing issues.
Ireland	HPRA	These certificates are typically used to register or renew a product authorisation in a 3rd county (outside the EU). They might also be typically used to accompany a batch of that product as required by a foreign competent authority.  The Certificate of a Pharmaceutical Product (CPP)/ Certificate of Free Sale(CFS)/ Statement of Licensing Status of a Product are all product specific certificates, used to show the details as approved in the Irish marketing authorisation. A Price Certificate shows the cost price for the Irish market. The CPP can also be issued for a product without a Marketing Authorisation but where the dosage form is manufactured in Ireland, once the application is accompanied by a signed company declaration to state that the details are true. Please check the Useful Links section below for a draft of certificates for whichever best suits your requirements. Where a company has been inspected and found to be GMP compliant by the HPRA, certified copies of a company’s GMP certificate can be issued.
Italy	AIFA	The prrocedure for requesting Pharmaceutical Product Certificates (CPP) with AIC registered in Italy with a national, mutual recognition or decentralised procedure is available at the link shown. Marketing authorisation holders (MAHs) of medicinal products authorised via national, mutualrecognition, and decentralised procedures should note that CPP applications submitted through certified e-mail (PEC) shall be finalised with the issuance of an electronically-signed CPP. The e-signed CPP shall be sent via certified e-mail to the digital address for service indicated by the Company. Further information is available in this document.
Spain	AEMPS	Click on the link for further information on how to apply for a CPP.
Sweden	Swedish Medical Products Agency	The MPA will issue a certificate within 30 days of the arrival of the request. The certificate is issued on specific certificate paper, signed and stamped with a MPA stamp. The requesting company is responsible for the legalisation of the certificate when needed; this is not done by the Swedish Medical Products Agency.
Switzerland	Swissmedic	From 20 March 2023, Swissmedic will issue Certificates of a Pharmaceutical Product (CPP)) in the new WHO format (according to TRS 1033 – 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations; Annex 9). More information on this here.
UK	MHRA	The certificate shows details including: -the marketing authorisation holder -the active ingredients and excipients -the manufacturing, packaging and batch release sites whether or not the product is on the market in the UK
USA	Food and Drug Administration (FDA) for eCPP	Facilities exporting human drugs are often asked by foreign customers or foreign governments to provide documentation of the facility’s compliance with FDA standards. FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements.  – FDA issues electronic certificates of pharmaceutical product (eCPP) for human drugs exported from the U.S. directly to the requesting country. – FDA eCPPs conform to the World Health Organization (WHO) format and are intended for importing countries considering whether to license products for sale in that country. – Certificates expire 24 months from the date issued after which a new application must be submitted. Certificates cannot be reissued. FDA has published resources that enable stakeholders to verify whether a drug or biologic is FDA approved and to view FDA’s classifications of its inspections of foreign facilities Further information is provided here under the title Interpreting Why FDA Returned Your Electronic Certificate of Pharmaceutical Product Application.

Points to bear in mind when preparing to apply for a CPP

• When preparing a new licence/marketing authorisation application, renewal etc. for a country in the AsiaPac, LatAm and MEA regions, check the exact requirements for CPPs in the recipient country. Requirements change with time so don’t assume that what was applicable even six months ago is applicable now.
• Allow adequate time to order a CPP and to get it authenticated (if necessary). It is always a good idea to check a CPP properly once received from a local regulatory authority (prior to authentication). This is to make sure that there are no errors. Errors can be costly in terms of time and money. You might easily find yourself having to reorder a CPP and having it re-authenticated because a recipient regulatory authority has rejected it due to minor and/or major issues. This has the scope to jeopardize timelines for licence applications or renewals.

Where can you get further information?

Further information is available from IFPMA as follows:

1. Here is a link to a webinar (of 3 October 2022) entitled New procedures and policies for the electronic Certificate of Pharmaceutical Product (eCPP), a joint effort by IFPMA, EFPIA and PhRMA.
2. A link to the page entitled IFPMA CPP Network Training Toolkit on the IFPMA website. From this page you can download a very useful presentation (from September 2021) entitled Certification Scheme for a Certificate of Pharmaceutical Product (CPP).
3. Position paper – Certificate of Pharmaceutical Product (CPP) and eCPP -IFPMA, September 2021