DIRECTOR OF THE LITHUANIAN BIOETHICS COMMITTEE
ORDER
ON THE DIRECTOR OF THE LITHUANIAN BIOETICS COMMITTEE DECEMBER 31, 2014
D. ORDER NO. V-24 ​​"ON DOCUMENTS TO BE PROVIDED BY A CLINICAL TRIAL FOR AN INVESTIGATION OR OTHER BIOMEDICAL
THE CUSTOMER, ITS AUTHORIZED REPRESENTATIVE OR THE MAIN INVESTIGATOR, IN ORDER TO OBTAIN CONSENT TO A CLINICAL MEDICINAL PRODUCT
PROCEDURES FOR SUBMISSION TO THE LITHUANIAN BIOETETICS COMMITTEE OF A TEST CERTIFICATE OR PERMIT FOR PERFORMANCE OF A BIOMEDICAL INVESTIGATION OF A PREPARATION
DESCRIPTION OF APPROVAL ”
2016 January 15 No. V-3 Vilnius
Documentation to be provided by a clinical trial or other biomedical application
the sponsor, his authorized representative or the principal investigator in order to obtain approval to conduct a clinical trial
submission of a study certificate or a permit to perform a biomedical study to the Lithuanian Bioethics Committee
description of the procedure approved by the Director of the Lithuanian Bioethics Committee in 2014. 31 December by order no. V-24 ​​“On
Documentation to be provided by a clinical trial or other biomedical study
the sponsor, his authorized representative or the principal investigator in order to obtain approval to conduct a clinical trial
the submission of a certificate or permission to perform a biomedical study of a medicinal product in Lithuania
approval of the description of the procedure to the Bioethics Committee ":
1. I amend point 6 to read as follows:
„6. In cases where the opinion of the regional ethics committee (s) for biomedical research is required, the Lithuanian
additional sets of required documents (originals or copies) shall be submitted to the Bioethics Committee for
Regional Ethics Committee (s) for Biomedical Research and, where
the conclusion of the Service for Health Care Activities under the Ministry of Health - additional required
a set of documents (originals or copies) for State accreditation of health care activities
service under the Ministry of Health. "
2. I amend point 7 to read as follows:
„7. Documents are submitted to the Lithuanian Bioethics Committee by applying directly to the Lithuanian Bioethics Committee (Vilnius
g. 16, LT-01402, Vilnius) at the time set by the Lithuanian Bioethics Committee, which can be obtained by phone (8 ~ 5) 212 45
65, electronically via the Public Electronic Services Portal (Electronic Government Gateway website
www.epaslaugos.lt) or remotely (by sending by e-mail, signing with a secure electronic signature,
by post or courier). "
Director
Eugene Gefen