Computer Application of Placing on the Market of Blood Products

Instructions for filling out the Placing on the Market of Blood Products

Instruction 1st

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

Instruction two

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

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

3rd Instruction

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 Health Products (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.

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 of 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 otherwise, 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 its marketing. 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.

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 the batch on the market, including a declaration that the batch has not been sent to another Official Medicines Control Laboratory (OMCL) for release, shall 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, you can proceed to the release of the lots on the market.