PHARMA SERVICES FAQ
Can you get documents legalised in another country?
Yes, we can handle apostille and/or embassy legalisation for documents in over 30+ countries. We collaborate with a network of trusted international agencies and operate our own office in the UK, the USA and the Netherlands.
If a scanned copy of your document is provided, we can confirm which country the document should be legalised in, outline the process involved, and advise on the specific requirements for that document.
What is the timeframe for apostille in Ireland?
The timeframe for a document to be apostilled in Ireland is typically 3–5 working days. The document will be shipped or emailed to Ireland, who will arrange the apostille through the DFA (Department of Foreign Affairs). Once the process is complete, the document will be returned to our office for quality control checks, scanned and shipped to the destination with the tracking details.
What is the typical processing time for a document to be apostilled?
Our goal is to finalise every apostille request within 3-5 working days, ensuing a promote and reliable service from start to finish. We prioritise efficacy at each stage of the process so that your documents are handled quickly, accuracy and with the highest level of care.
What is the approximate timeframe for embassy legalisation?
Because each embassy follows its own processing timelines, the duration can vary significantly from one embassy to another. Once we know which country your document is to be process for, we will provide you with a clear indication of the expected timeframe for completion.
Do you offer an end-to-end service?
Yes. We offer a fully managed, end to end legalisation service for pharmaceutical documents. Clients can provide a document or certificate directly, alternatively our submission team can handle the application process to obtain a certificate for you. We then handle the full legalisation process from start to finish, this includes obtaining the apostille and completing embassy legalisation where necessary, ensuring it is fully compliant with the requirements of the relevant country.
What types of documents do you provide services for?
Our expertise extends to the legalisation of corporate ancillary and pharmaceutical-related documentation, ensuring full compliance with regulatory requirements of the destination country. Where required, our submission team can apply for certificates on behalf of clients. They work directly with over 10 recognised health authorities, managing the application process from start to finish to ensure accuracy, efficiency and adherence to all relevant procedural standards.
What are common reasons for rejection or delay for a CPP?
Common reasons for rejection of a Certificate of Pharmaceutical Product (CPP) include incomplete or incorrect application forms, missing or inconsistent manufacturer information, and failure to meet notarization or legalization requirements. A CPP may also be rejected if the product is not authorized or marketed in the issuing country or if the supporting product dossier lacks essential information such as composition, stability data, or manufacturing details.
Delays typically occur due to requests from the Health Authority for clarification when supporting documents are missing or unclear. Legalization steps such as notarization or apostille can also extend processing times, and seasonal workload fluctuations within regulatory authorities may further slowdown issuance.
Can an issued CPP be modified, or must a new one be requested?
A CPP cannot be amended after it has been issued because it is treated as a finalized, authenticated regulatory document. If any information on the certificate is incorrect or needs updating, the issuing authority will not modify the original; instead, the applicant must submit a new request so a fresh CPP can be issued with the corrected details, a new date, and a new certificate number. This approach preserves the document’s integrity, ensures traceability, and maintains its credibility for international regulatory use.
How long is a CPP valid for?
The validity of a CPP varies depending on the issuing Health Authority and their internal regulation regarding expiry dates. The validity period can be readily checked either on the relevant Health Authority website or by direct contact for further information.
Some Health Authorities (e.g. ANSM in France and CIBG in the Netherlands) state an official validity period. These Health Authorities differ in how they communicate this information, with some listing this directly in the CPP and others releasing official communication including this information for easy reference.
Other Health Authorities (e.g. EMA and HPRA) state that the validity period is dependent on details of the marketing authorisation remaining the same as they are on the date the CPP is issued. If there are changes to any registered information the validity of the CPP is voided as it no longer reflects the marketing authorisation.
Can an agent/consultant apply for a CPP on my behalf?
Yes. In most cases, an agent/consultant can apply and manage the CPP application on behalf of the Marketing Authorisation Holder (MAH), depending on the requirements of the relevant Health Authority.
In most cases, the Health Authority will require formal authorisation from the MAH to allow the agent/consultant on their behalf. This is typically provided via a Power of Attorney (POA) or through the authorities’ online system.
CDN can support and manage the full end-to-end process for submitting CPP applications to the many Health Authorities around the world.
How can I track my request?
At CDN, we have created a dedicated system called the Client Interaction Portal (CIP), which is used for submitting requests, managing communication, and tracking the progress in real time.
Once your request has been submitted, you can log into CIP at any time to view the current status, updates, and any actions required. The portal provides full visibility throughout the process and allows you to manage all your requests in one centralised system.
What information is required to make a CPP application?
Product specific information must be provided to the Health Authority such as the relevant marketing authorisation number/s of the drug product, manufacturing site/s and activities. The Health Authority will check the provided details against the registered details in the marketing authorisation to ensure there are no conflicts.
The application package required to be submitted to the Health Authority can vary as some will require separate annexes to be provided, such as the Summary of Product Characteristics or composition of the drug product. Other Health Authorities keep these annexes on file and do not request them to be provided with each application.
If a 3rd party (e.g. agent or consultant) is making CPP applications on behalf of the marketing authorisation holder, official permission will usually have to be granted to ensure CPPs are being issued to the correct authorised persons.