Ministry of Health proposes regulations for blood establishments in Colombia

Jaime Alberto Cabal Sanclemente, President
Jaime Alberto Cabal Sanclemente, President
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The Ministry of Health and Social Protection announced on Apr. 7 the release of a draft decree aimed at regulating establishments involved in the extraction, processing, conservation, and distribution of blood and its components, as well as medicinal products derived from plasma and serum.

The proposed regulation seeks to standardize various stages in the transfusion chain to ensure a safe supply of blood and related products. It also aims to establish the National Blood Network, define its functions, classify blood banks, set procedures for opening new banks and collection centers, and outline certification requirements for good practices.

According to the draft decree, human blood and its components may only be collected and used without profit motives for preventive, therapeutic, or diagnostic purposes in humans. The use is also permitted for producing medicinal products from plasma or serum or conducting scientific research.

Only authorized establishments will be allowed to carry out activities such as promoting donation, selecting donors, extracting blood, processing it, storing it, distributing it, using it therapeutically or transfusionally, or fractionating it. These activities must comply with both this decree’s provisions and other relevant health regulations.

The initiative emphasizes voluntary donation by promoting awareness about the importance of donating blood altruistically. The Ministry invites stakeholders to submit comments on the proposal by April 9.



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