Export Certificate for Pharmaceuticals (CPP)
We handle the entire CPP application with the Swedish Medical Products Agency – from document review and power of attorney verification to delivery of your completed export certificate.
✓ Complete application handling ✓ Power of attorney verification ✓ Processing within 30 days
What is an Export Certificate (CPP)?
A Certificate of Pharmaceutical Product (CPP) is a WHO-format certificate confirming that a pharmaceutical product is approved and freely sold in Sweden/EU. It is issued by the Swedish Medical Products Agency (Läkemedelsverket) and is often required for pharmaceutical export to countries outside the EU/EEA.
Customs authorities and pharmaceutical agencies in the importing country use the CPP to verify that the product meets quality and safety requirements according to WHO standards.
The application can be made by the Marketing Authorisation Holder (MAH) or by a representative with a Letter of Authorisation (LoA). This means we can handle the entire process for you – including signing – as long as a valid LoA is included.
At DOX Visumpartner, we review your documents, verify the power of attorney, complete the application form, and submit it to the Swedish Medical Products Agency. You receive the completed certificate delivered directly to you.
Documents you need to submit:
- ✓Application form
"Request for certificate of a pharmaceutical product" – PDF form from the Swedish Medical Products Agency
- ✓Product list
Detailed list with product name, strength, dosage form, and manufacturing sites
- ✓Power of Attorney (LoA)
Letter of Authorisation from MAH to your company – signed by an authorized person
- ✓GMP certificate
Good Manufacturing Practice certificate if applicable
- ✓Additional documents
Batch information or specific information to be included in the CPP
How it works – step by step
We take care of the entire process so you can focus on your business.
Submit documents
Send application form, product list, power of attorney, and other documents via our form or email
We review
We verify that the power of attorney is valid, the form is correctly filled in, and all documents are complete
Application to the Agency
We sign and submit the application to the Swedish Medical Products Agency with all attachments
Delivery
The Agency issues the certificate on security paper. We deliver the original to you via courier
Who can apply for a CPP?
The Swedish Medical Products Agency allows two types of applicants for export certificates.
MAH (Marketing Authorisation Holder)
The marketing authorisation holder can apply directly with the Swedish Medical Products Agency.
- ✓Direct contact with the authority
- ✓No power of attorney required
- ✓Full control over the process
Requires internal capacity and knowledge of the application process.
Representative with Power of Attorney
A third party (such as DOX Visumpartner) can handle the entire application with a valid power of attorney from the MAH.
- ✓We handle all paperwork
- ✓Minimizes risk of errors
- ✓Saves time and resources
- ✓Expert review of documents
Recommended for companies without an export department or those looking to streamline the process.
Pricing for Export Certificate (CPP)
Prices include our service fee. The official fee from the Swedish Medical Products Agency is additional.
Basic
Simple CPP application
- ✓1 export certificate (CPP)
- ✓Document review
- ✓Power of attorney verification
- ✓Application to the Agency
- ✓Delivery of original
Premium
Incl. advisory + express
- ✓1 export certificate (CPP)
- ✓Advisory on destination country requirements
- ✓Expert review of all documents
- ✓Priority handling
- ✓Courier delivery
Volume agreement
For MAH with many products
- ✓Unlimited certificates
- ✓Fixed monthly price
- ✓Dedicated contact person
- ✓Bundling with COO possible
- ✓Volume discount on Agency fees
All prices excl. VAT. The Agency's fee is typically SEK 1,500–3,000 per certificate. Courier fees may apply.
When do you need an Export Certificate (CPP)?
CPP is required for pharmaceutical export to many countries. Here are the most common situations.
Pharmaceutical export outside the EU
Most countries outside the EU/EEA require a CPP to verify that the pharmaceutical product is approved and freely sold in the country of origin.
Registration in a new country
When applying for marketing authorisation in a new country, the pharmaceutical authority often requires a CPP as part of the documentation.
WHO requirements & procurement
International organizations and procurement processes (e.g., via WHO, UNICEF) often require a CPP as proof of product quality and approval.
Regions that commonly require CPP
The following regions regularly require a Certificate of Pharmaceutical Product for pharmaceutical imports.
Middle East & Africa
Asia & Latin America
Frequently asked questions about Export Certificates (CPP)
What is a Certificate of Pharmaceutical Product (CPP)?
A CPP is a WHO-format certificate issued by the Swedish Medical Products Agency confirming that a pharmaceutical product is approved and freely sold in Sweden. It is often required for pharmaceutical export to countries outside the EU/EEA.
Can you apply for a CPP on our behalf?
Yes, according to the Swedish Medical Products Agency's rules, a representative can apply for a CPP with a valid Letter of Authorisation (LoA) from the MAH. We handle the entire process – including signing the application.
How long does it take to get a CPP?
The Agency's processing time is normally within 30 days after a complete application has been submitted. We carefully review all documents before submission to avoid delays.
How much does an export certificate cost?
The price consists of the Agency's official fee (normally SEK 1,500–3,000) plus our service fee for handling, review, and delivery. Contact us for an exact quote.
What documents do I need to submit?
You need to submit the application form from the Swedish Medical Products Agency, product list, power of attorney (LoA) from the MAH, and possibly a GMP certificate or other product-specific information.
How long is a CPP valid?
A CPP has no fixed validity period but refers to the product's status at the time of issuance. Many destination countries request updated versions annually. We can help with renewals.
Related services
Certificate of Origin (COO)
Certificate of Origin via the Chamber of Commerce – often relevant for pharmaceutical export.
Apostille
International certification for documents to be used in Hague Convention countries.
Embassy legalization
Final legalization at the destination country's embassy for full validity.
Need an export certificate for pharmaceuticals?
We have experience helping pharmaceutical companies with export documentation. Contact us for a quote or order directly online.
📞 Call us: 08-40941900 | 📧 Email: info@doxvl.se