AEMPS Certificate Legalisation for Iran: Spanish CLV, CEX and CPP Guide

Ginkgo Advisory · AEMPS export document review and legalisation coordination

Using an AEMPS certificate in Iran: the key points

When using an AEMPS certificate for product registration, import documentation or commercial checks in Iran, first establish whether the recipient needs a CLV, CEX or CPP and whether diplomatic or consular legalisation is required. As at 30 October 2026, Iran was not listed as a contracting party to the Apostille Convention, so a Spanish apostille alone should not be assumed sufficient. Ginkgo Advisory can verify the documents and coordinate the applicable authentication steps.

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 Iran?

Official regulatory enquiries: Food and Drug Administration, Iran. WHO\’s official directory of contacts for its pharmaceutical certification scheme lists Iran\’s FDA. The local applicant must confirm the current receiving checklist for the particular product.

1. WHO\’s pharmaceutical certification scheme contact directory lists Iran\’s FDA and can help establish the identity of the relevant medicines authority. The directory itself is not an Iranian import registration or authentication checklist.
2. Obtain written confirmation of Iran\’s current receiving requirements for the particular product from the relevant department or local applicant. Get that checklist before arranging authentication and delivery of a CPP, CLV or other certificate.
3. In particular, list product registration evidence, commercial papers and authorisations separately. Establish which need originals, translations or consular procedures before arranging authentication that may not be required.

Scope of the sources: The WHO directory helps verify the authority\’s identity; it does not replace Iran\’s current product registration checklist. Obtain separate written confirmation of the specific document requirements.

For these local requirements, see the WHO pharmaceutical certification scheme contact directory.

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 Iran?

As at 30 October 2026, the HCCH status table did not list Iran as a contracting party to the Apostille Convention. If the recipient requires authentication, assess diplomatic and consular legalisation according to the specific Spanish document and the destination\’s requirements.

For electronic AEMPS documents that need the traditional legalisation chain, the Spanish Ministry of Health\’s guidance sets out this basic sequence:

1. Obtain signature verification from the Spanish Ministry of Health through the applicable procedure;
2. Have the document legalised by the Spanish Ministry of Foreign Affairs (MAUEC);
3. Submit it to the appropriate diplomatic mission of Iran for legalisation where required;
4. Check separately for any required translations, authentication after arrival or other destination-country submission formalities.

This sequence is not an instruction to add every step to every certificate. Handwritten originals, existing authentication, exemptions and different purposes can change the route, so review the original and the written requirements first. An existing e-Apostille also does not automatically replace consular legalisation required by a destination outside the Convention.

How do you verify electronic AEMPS documents for Iran?

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.

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 Iran, 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 Iran?

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 (Iran), 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 Iran

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

For example, if an Iranian importer verbally requests only an \’authenticated certificate\’, obtain the formal checklist and the receiving department\’s name before deciding the route for the Spanish document.

AEMPS certificates for Iran: frequently asked questions