Do Exports to Poland Need an AEMPS Certificate? CLV, CEX, CPP and Authentication

Ginkgo Advisory · AEMPS export document review and legalisation coordination

Using an AEMPS certificate in Poland: the key points

Selling Spanish medical devices in Poland does not automatically require an AEMPS export certificate or an apostille. AEMPS states that export certificates are generally unnecessary for medical devices sold within the EU; the applicable product conformity and market requirements come first. If a business partner in Poland requests an AEMPS document for a particular transaction, Ginkgo Advisory can review its purpose, the certificate version and whether authentication is needed.

AEMPS stands for Agencia Española de Medicamentos y Productos Sanitarios. Document authentication concerns the signature, the capacity in which the signatory acted and the origin of the seal or stamp. Product quality, registration, import licensing and market access remain subject to the relevant regulatory procedures.

Which local requirements should you check before exporting to Poland?

Official regulatory enquiries: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), Poland. URPL provides product and device registration information. Other matters, such as pharmaceutical distribution supervision, may also involve GIF.

1. Poland is an EU member, so Spanish devices entering Poland generally do not require an export CLV. List EU product conformity, operator registration and any additional AEMPS certificate request as separate matters.
2. URPL provides separate registration guidance for devices, distributors and relevant operators. Establish the Polish recipient\’s supply-chain role rather than describing every buyer as an \’importer\’ and applying one checklist to all.
3. Polish application or procurement names may differ from the commercial names on the Spanish certificate. Create a cross-reference of names, models, UDIs and manufacturers for confirmation by the applicant. A translation cannot expand the certificate\’s coverage.

For these local requirements, see the EMA directory of EEA human-medicines authorities, AEMPS medical device export/free-sale certificates, URPL device registration and URPL distributor registration.

Choose the right certificate: CLV, CEX and CPP serve different purposes

For the different document categories, see the AEMPS guidance on medical device certificates, cosmetics CLV guidance and scope of the CPP procedure. Similar certificate names do not mean they certify the same facts.

Since February 2025, AEMPS has provided automatic apostilles for the CLV/CEX certificates covered by its announcement. When you receive a certificate, inspect the files actually downloaded before assuming that a further paid authentication procedure is needed.

CPP system status: As at 30 October 2026, the public AEMPS CPP system page displayed a notice that its apostille function was temporarily suspended, with no definite date for resumption. For pharmaceutical applications, check the system status when submitting and establish the next steps separately for any certificate issued without an apostille.

Which authentication route applies to AEMPS certificates for Poland?

Start by checking whether the document request applies. The AEMPS medical device guidance states that export certificates are not needed for sales within the EU. Only assess authentication further if the particular receiving procedure genuinely calls for additional documents. CE marking and obligations under other applicable legislation must still be addressed separately.

According to the HCCH Convention status table checked on 30 October 2026, the Apostille Convention applies between Poland and Spain. Whether authentication is needed, whether the document falls within the Convention and whether its contents meet the recipient\’s requirements are separate questions.

1. The certificate already has a valid e-Apostille: Check that the apostille relates to the correct certificate and keep the complete files and verification details. Where the Convention applies, additional consular legalisation is generally unnecessary.
2. The electronic AEMPS document has no apostille: Consider the Spanish justice authorities\’ electronic apostille procedure. Use the route appropriate to AEMPS documents and follow the competent authority\’s requirements.
3. Older certificates, documents with handwritten signatures or unusual documents: Assess reissue, renewal or another appropriate procedure according to the signature format and the recipient\’s checklist. An ordinary scan is not automatically an original that can be authenticated directly.

The Spanish Ministry of Health\’s guidance on electronic AEMPS documents distinguishes documents that already have an e-Apostille from those still awaiting authentication. Documents eligible for the direct electronic procedure do not need a separate, repeated Ministry of Health signature-verification step simply to obtain an apostille.

How do you verify electronic AEMPS documents for Poland?

1. Keep the original PDF issued or downloaded from AEMPS, together with every annex, signature and verification-code detail.
2. Use the official AEMPS document verification service, entering the localizador or CSV shown on the certificate and following the system instructions. Do not alter the code or certificate contents.
3. Compare the certificate number, issue date, company details and products with the official record. Record verification of the AEMPS document separately from verification of its apostille.
4. If an apostille is already attached, separately check its issuing authority, number and corresponding document, and retain the complete verifiable authentication file.
5. Give the recipient the correct original files and an explanation of what they contain. Confirm upload, translation or paper-delivery formats before preparing supporting versions.

Under the HCCH guidance on e-Apostilles, where the Convention applies, a valid e-Apostille cannot be rejected solely because it is electronic. Upload procedures, translations, certificate contents and product eligibility are separate requirements that must still be met.

Preparing paper copies, translations and supporting documents

Electronic AEMPS documents can be printed and checked using their verification codes, but an ordinary printout does not create a new paper apostille. If the recipient says that paper documents are required, establish whether they mean a printout for filing, a certified copy, a paper original or another specified format.

For translations for Poland, first confirm the required language, whether the authentication pages and annexes must also be translated, and any requirements for the translator or sworn translation. An existing Spanish or English version may not suit every procedure, but further translation is not automatically necessary either. Agency authorisations, manufacturers\’ declarations, GMP certificates and quality-system documents must each be assessed according to the origin of their signatures.

How can Ginkgo Advisory help with your project in Poland?

We begin with a solicitor-led document review, helping exporters, manufacturers, distributors and registration advisers check their certificates and coordinate the appropriate Spanish authentication and delivery steps. Depending on the documents, our work can include:

• Identifying CLV, CEX, CPP and other AEMPS documents and checking their version, destination and attachments;
• Verifying electronic files and checking that any existing apostille covers the complete certificate;
• Coordinating an appropriate Spanish electronic or paper authentication route to meet the recipient\’s requirements;
• Coordinating signature verification, diplomatic legalisation and destination-country consular legalisation where required;
• Reviewing submission requirements for paper versions, translations and separate supporting documents, and arranging delivery.

Fees and timescales depend on the document types and quantities, existing authentication, the authorities involved, translations and courier arrangements. Once we have the complete information, we explain the procedure, estimated timescale and breakdown of costs.

What to send for an assessment

• The complete AEMPS certificate PDF, all product annexes and any existing authentication documents;
• The place of use (Poland), the receiving organisation\’s name and the purpose of this submission;
• The recipient\’s document checklist, request for further information or written requirements;
• The product category, number of documents and any relevant authorisations or supporting certificates;
• Paper-copy and translation requirements, your preferred completion date and the delivery address.

A document-handling example for Poland

The following hypothetical example illustrates how the documents can be assessed.

Suppose a Polish procurement list uses local trade names while the AEMPS annex uses English model identifiers. Establish a verifiable one-to-one correspondence before preparing the authenticated version requested by the recipient.

AEMPS certificates for Poland: frequently asked questions