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1. This Regulation applies to:

(a) SoHO intended for human application and SoHO used to manufacture products regulated by other Union legislation, as referred to in paragraph 6, and intended for human application;

(b) SoHO donors, SoHO recipients and offspring from medically assisted reproduction;

(c) SoHO activities that have a direct impact on the quality, safety or effectiveness of SoHO, as follows:

(i) SoHO donor registration;

(ii) SoHO donor history review and medical examination;

(iii) testing of SoHO donors or of persons from whom SoHO are collected for autologous or within-relationship use;

(iv) collection;

(v) processing;

(vi) quality control;

(vii) storage; (viii) release;

(ix) distribution;

(x) import;

(xi) export;

(xii) human application; (xiii) clinical-outcome registration.

2. This Regulation does not apply to:

(a) organs intended for transplantation within the meaning of Article 3, points (h) and (q), of Directive 2010/53/EU;

(b) breast milk when used exclusively for feeding one’s own child, without any processing carried out by a SoHO entity.

3. This Regulation shall be without prejudice to national legislation which establishes rules relating to aspects of SoHO other than their quality and safety and other than the safety of SoHO donors.

4. By way of derogation from paragraph 1 of this Article, the provisions of this Regulation concerning the publication or communication of information, in particular the obligations in that respect set out in Article 4(2), Article 7, Article 19(3), Articles 29, 31, 41, 63, 64 and 67 and Article 81(3), point (b), shall not apply when such publication or communication might imply a risk to national security and defence.

5. In the case of SoHO intended for autologous use where:

(a) SoHO are processed or stored before human application, this Regulation applies;

(b) SoHO are neither processed nor stored before human application, this Regulation does not apply.

6. In the case of SoHO collected for the purposes of manufacturing medical devices, regulated by Regulation (EU) 2017/745, medicinal products, regulated by Directive 2001/83/EC, advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, or investigational medicinal products, regulated by Regulation (EU) No 536/2014, the provisions of this Regulation applicable to the SoHO activities referred to in paragraph 1, points (c)(i) to (iv) and (viii), of this Article apply. Insofar as the SoHO activities referred to in paragraph 1, points (c)(vii), (ix), (x) and (xi), of this Article are carried out on SoHO up to and including their distribution to a manufacturer regulated by other Union legislation, as referred to in this paragraph, this Regulation also applies.

7. By way of derogation from paragraph 6, where SoHO are used to manufacture products regulated by other Union legislation and those products are exclusively for therapeutic use on the person from whom the SoHO were collected, the provisions of this Regulation relating to the SoHO activities referred to in paragraph 1, points (c)(iii) and (iv), apply.

8. Where non-viable SoHO or their derivatives, within the meaning of Article 2, points (16) and (17), of Regulation (EU) 2017/745, incorporate, as an integral part, a medical device, and where the action of the non-viable SoHO or their derivatives is principal to that of the medical device, this Regulation applies to the non-viable SoHO or their derivatives and the final combination shall be subject to this Regulation. Where the action of the non-viable SoHO or their derivatives is ancillary to that of the medical device, this Regulation applies to all SoHO activities to which the non-viable SoHO or their derivatives are subjected up to and including their distribution for integration into the medical device, and the final combination shall be subject to Regulation (EU) 2017/745.