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03:53:012026-11-02

Computer application of Placing on the Market of Vaccines for human use

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Computer application of Placing on the Market of Vaccines for human use
Access to the app
Target persons

INSTRUCTION ONE

All lots of vaccines for human use may not be placed on the market without being authorised, according to the following procedure.

INSTRUCTION TWO

This provision does not cover other immunological drugs such as toxins, serums and allergens, as well as individualized vaccines.
It also does not reach foreign medicines, nor products in the phase of clinical trials.

INSTRUCTION 3rd

Before placing the medicinal product in question on the market, an application for placing on the market will be sent to the Division of Biological Products, Advanced Therapies and Biotechnology (DPB) of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS).
For this purpose, the telematic support developed by the AEMPS to process applications is enabled and in operation. It is accessed through the website of the Agency https://www.aemps.gob.es.
The address you need to connect to is as follows: https://hemoyvacunas.aemps.es

INSTRUCTION 4th

This request shall be accompanied by the following documentation:
Annexes to the document “EC Administrative Procedure for Official Control Authority Batch Release”. OMCL,
Batch Release – Human Biologicals:

  • European Union batch release certificate (Annex IIA).
  • Marketing Information Sheet. (Annex IV Marketing Information Form).
  • Summary of the production and control protocols of the batch to be released, according to the administrative procedure for the Official Control Authority Batch Release and the specific guidelines of the product.
  • An image of the conditioning material (production photograph or model) of the finished product of the batch in question.

INSTRUCTION 5th

After the period of 5 working days from the shipment of the last valid documentation without negative pronouncement, and taking into account the special need of these products, it will be understood according to the lot for its marketing.
In the case of the seasonal flu vaccine the 5-day period will be reduced to 2.
The computer system will allow the laboratory making the request to be aware that the request has been made, and the AEMPS to be aware that it has sent a communication. In the event that there is a fall in the computer system, we will proceed via email (hemoderivados@aemps.es), or another alternative procedure.

Request for access

The access request is not necessary.

Manuals of use
Characteristics of the client teams

What authentication methods are needed?

What characteristics should the computer equipment have?

  • Updated web browser (Microsoft Edge, Google Chrome, Mozilla Firefox, Safari or similar).
  • Any PDF document viewer. Adobe Acrobat Reader can be downloaded at the address https://www.adobe.com/.

  • Application security: enable the JavaScript option in your browser if it is not enabled (this option is enabled by default).

    As it is a web application, there are no specific requirements for operating system, memory or storage capacity, beyond those necessary for the operation of the operating system, browser and PDF viewer used.

What are the security elements that the applications incorporate?

  • 128-bit SSL communications encryption.
  • Autenticación de usuario de segundo nivel, mediante un token único por solicitud que deberá introducirse para su envío.
  • Each external user can only access the data of the entity they represent.
  • Log of accesses and audit of modifications, which allows to identify who makes each modification and what changes have been made).
  • Connection waiting time (timeout).
Answers to frequently asked questions (FAQs)

A problem has been detectedwhich sometimes occurs due to a security problem with Internet Explorer and because the library provided by Microsoft for digital signature is not signed, which prevents applications from being digitally signed. To avoid this problem, the steps that should be followed are:

  • Open your Internet Explorer browser and click on Tools/Internet Options.
  • Select the Security tab and click on the Internet icon.
  • Follow the following steps depending on the version of your browser:

    1. For Internet Explorer 6.x

    • Click on the buttonpredetermined leveland then oncustom level.
    • In the list that is displayed, go to the fieldactiveX controls and add-onsand activate the optionInitialize and activate the script of ActiveX controls not marked as safe.
    • Apply the changes.
    • Finally close the browser and try to authenticate again.

    2. For Internet Explorer 7.x

    • Click on the buttonpredetermined leveland then oncustom level.
    • In the list that is displayed, go to the fieldactiveX controls and add-onsand enable the optionInitialize and generate scripts from unmarked activeX controls as secure for scripts.
    • Apply the changes.
    • Close the browser and try to authenticate again.
Notification of errors

For data quality errors, as mentioned in the submission please send it tothis email.

For functionality errors, communicate it in detail, if possible with the screen where it fails, tothis email.

For other topics, use the suggestion box.

Instructions for completing the Placing on the Market of Vaccines for Human Use form