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

Ginkgo Advisory · AEMPS export document review and legalisation coordination

Using an AEMPS certificate in Tanzania: the key points

When using an AEMPS certificate for product registration, import documentation or commercial checks in Tanzania, first establish whether the recipient needs a CLV, CEX or CPP and whether diplomatic or consular legalisation is required. As at 30 October 2026, Tanzania 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 Tanzania?

Official regulatory enquiries: Tanzania Medicines and Medical Devices Authority (TMDA). TMDA establishes registration and notification procedures for medical devices and in-vitro diagnostic products.

1. TMDA distinguishes device registration from notification routes for certain low-risk products. Before preparing an AEMPS CLV, ask the applicant to confirm the risk class and applicable procedure, rather than using a checklist for another device category.
2. TMDA\’s published materials distinguish product approval from premises registration. The Spanish manufacturer\’s certificate should align with the importer\’s local eligibility, product application and consignment documents. It is not a local establishment licence.
3. If the delivery or place of use is in Zanzibar, separately confirm the actual receiving authority and regulatory arrangements. This page uses TMDA\’s published procedures as its starting point; it does not assume every Tanzanian region or authority follows the same submission process.

For these local requirements, see TMDA\’s device and IVD marketing authorisation procedures, TMDA\’s notification procedure and Tanzania\’s official trade portal: medical device premises 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 Tanzania?

As at 30 October 2026, the HCCH status table did not list Tanzania 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 Tanzania 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 Tanzania?

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 Tanzania, 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 Tanzania?

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 (Tanzania), 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 Tanzania

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

For example, a Dar es Salaam distributor submitting a low-risk device can first establish whether notification is available, then decide the treatment of the CLV, annexes and translations according to that procedure.

AEMPS certificates for Tanzania: frequently asked questions