The Law enhances the procedure of clinical testing of medicaments with the participation of infants, minors and legally incapable citizens.
Pursuant to the Law, testing of the medicaments with the participation of the minors may be conducted only when the "medicament is referred to medical treatment of minors´ diseases or when the purpose of clinic medical testing is optimization of the dosage or use regime of the medicament for minors."
Furthermore, it states that the clinical testing of medicaments with the participation of the infants shall be conducted only under the written consent of parents of a minor, the latter being provided with the full information in the accessible form; with the participation of minors after his/her written consent and the parental consent. The Law prohibits clinical testing of medicaments with the participation of infants or minors if the parents are not present.
Pursuant to the document, clinical testing of the medicaments with the participation of an individual defined by the court as legally incapable shall be conducted when the medicament is intended for the treatment of mental diseases, provided advantages of possible successful results of the testing surpass the risk of bad after-effects of the the clinical testing for the individual.
The draft was registered under Reg. No. 7054.