LAW OF UKRAINE

of May 12, 2011 No. 3323-VI

About modification of some legal acts of Ukraine of rather clinical testing of medicines

The Verkhovna Rada of Ukraine decides:

1. Make changes to the following legal acts of Ukraine:

1) part third of Article 281 of the Civil code of Ukraine (2003, NN 40-44, of the Art. 356) to add sheets of the Verkhovna Rada of Ukraine with the paragraph the second such content:

"Clinical testing of medicines are carried out according to the law";

2) in the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, N 22, the Art. 86):

in Article 7:

in the second offer of part one "specialized" to exclude the word;

in part six "specialized" to exclude the word;

in Article 8:

state part one in such edition:

"Clinical testing of medicines are carried out with the assistance of full age capable person - the patient (volunteer) in case of availability of its written consent to participation in carrying out such testing";

after part one to add with five new parts of such content:

"Clinical testing of medicines with the assistance of the juvenile or the minor can be carried out only if the corresponding medicine is intended for treatment of children's diseases or if the purpose of clinical testing is optimization of dosage or mode of use of medicine respectively for juveniles or minors.

Clinical testing of medicines with the assistance of the juvenile or the minor whose purpose is optimization of dosage or mode of use of medicine for such persons are carried out after completion of clinical testing of the corresponding medicines with the assistance of full age capable persons.

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