# Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance), Article 33: Clinical trials on pregnant or breastfeeding women

Extent: E+W+S+N.I.

A clinical trial on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 28, the following conditions are met:
(a) the clinical trial has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved; or
(b) if such clinical trial has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if:
(i) a clinical trial of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding;
(ii) the clinical trial contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and
(iii) the clinical trial poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth;
(c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child; and
(d) no incentives or financial inducements are given to the subject except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/33 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-33
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.