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07:01:162025-06-25

Computer Application of Marketing of Blood Products

HEADQUARTERS AEMPS > Procedures > Medicinal products for human use > Computer Application of Marketing of Blood Products
Access to the app
Target persons

Instructions for filling out the Market Entry Form for Blood Products

Instruction 1st

All batches of human blood products may not be placed on the market without authorisation, according to the following procedure.

Instruction 2nd

This provision does not apply to plasma derivatives that act as an excipient or as a reagent in the production of other medicines or medical devices.

It also does not cover foreign medicines, nor products in the phase of clinical trials.

3rd Instruction

Before placing the medicinal product on the market, an application for placing on the market shall be sent to the Division of Biological Products, Advanced Therapies and Biotechnology (DPB) of the Spanish Agency for Medicinal Products and Health Products (AEMPS).

For this purpose, the telematic support developed by the AEMPS to process the requests is enabled and in operation. It is accessed through the Agency’s website https://www.aemps.gob.es.
The address to which they must connect is as follows: https://hemoyvacunas.aemps.es.

4th Instruction

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 IIB).
  • European Union Release Certificate for the corresponding plasma mixture (Annex IID).
  • Marketing Information Sheet (Annex IV Marketing Information Form).
  • Declaration of compliance with Circular 1/98 of the General Directorate of Pharmacy, or failing it, document stating the country of origin of the plasma

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 marketing. The computer system will enable the requesting laboratory 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 e-mail (hemoderivados@aemps.es), or another alternative procedure.

6th Instruction

In the event that the batch of the blood-derived medicinal product in question does not have a European Union Batch Release Certificate, an application for placing on the market, including a declaration that the batch has not been sent to another Official Medicines Control Laboratory (OMCL) for release, will be sent to the DPB before placing the medicinal product on the market.

In addition, it will be accompanied by the following documentation:

  • Marketing Information Sheet (Annex IV).
  • The following samples will be sent:
    • 4 containers of 1.5 ml of the plasma mixture from which the medicinal product is derived, to be sent in accordance with the relevant procedures, or otherwise certified by an OMCL for the release of the plasma mixture corresponding to the medicinal product in question.

If in the period of 60 days after the shipment there is no communication that notifies the existence of problems in the documentation and samples sent, the batches can be released on the market.

Request for access

The access request is not necessary.

Manuals of use
Characteristics of the client equipment

What authentication methods will be needed?

  • Digital certificate
  • Electronic DNI
  • Cl@ve PIN
  • In some cases it will not be necessary to have any method of authentication

What characteristics do the client teams have to have?

  • Next generation browser: Edge, Chrome, Firefox, Safari or similar.
  • The use of Internet Explorer is not recommended.
  • Any PDF document viewer. You can download the Adobe Acrobat Reader at the address http://www.adobe.com/.
  • User authorization and password of RPS.
  • Application security: activate the Java Script option in the browser if it is not active (this option comes by default).

Since it is a Web application, there are no operating system or memory or disk requirements beyond those necessary for the operating system, browser and PDF viewer chosen.

What are the security elements that the applications incorporate?

  • 128-bit SSL communications encryption.
  • User authentication using USER and password.
  • Autenticación de usuario de segundo nivel, mediante TOKEN UNICO por solicitud que el usuario debe introducir para el envío de las mismas.
  • Each external user can only access the data of the entity it represents.
  • Log of accesses and audit of modifications (it is known who modifies and what).
  • Time out of connection.
Answers to frequently asked questions (FAQs)
  • Communications concerning the placing on the market of blood products may be made by:
  • To reduce the number of files to be sent, you can include in the “Declaration of compliance with Circular 1/98” the declaration of “not sent to another EUOMCL”.
  • When the product has more than one plasma pool and you must send more than one certificate, in the list of documents to send, you will have to add the different plasma pool certificates by choosing the option‘other documents’.

A problem has been detectedwhich sometimes occurs due to an Internet Explorer security issue and because the library provided by Microsoft for digital signature is unsigned, which prevents applications from being digitally signed. To avoid this problem, the steps that should be followed are:

  • Open your Internet Explorer browser and tap Internet Tools/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 buttonDefault 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 buttonDefault 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 safe for scripts.
    • Apply the changes.
    • Close the browser and try to authenticate again.
Notification of errors

For data quality errors, as mentioned in the presentation please send it toThis email address.

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

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