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1. SoHO entities shall apply a Single European Code to SoHO distributed for human application. In cases where SoHO are transferred for further processing in another SoHO entity or released for manufacture of products regulated by other Union legislation, as referred to in Article 2(6), or exported to third countries, SoHO entities shall, at least, apply the elements of the Single European Code that allow for the identification of the donation. The Single European Code shall also appear on the primary packaging of the SoHO concerned or on a label attached thereto, or on the documents referring to that SoHO where it can be ensured that such documents accompany the SoHO concerned.

2. Paragraph 1 of this Article shall not apply to:

(a) reproductive SoHO for within-relationship use;

(b) blood or blood components for transfusion or for the manufacture of medicinal products;

(c) SoHO applied to a SoHO recipient without being stored;

(d) SoHO imported into the Union by way of derogation and authorised directly by SoHO competent authorities pursuant to Article 26(6);

(e) SoHO that are imported to or collected in the same SoHO entity where they are applied.

3. The Commission shall adopt implementing acts concerning the format of the Single European Code and the requirements related to its application to SoHO entities and to SoHO at the point of distribution. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).