Consolidated version from 20/01/2016
The order was published: TAR 02-01-2015, i. k. 2015-00006
ORDER OF THE DIRECTOR OF THE LITHUANIAN BIOETHICS COMMITTEE
ON DOCUMENTS TO BE SUBMITTED BY THE CUSTOMER OF A CLINICAL MEDICINAL PRODUCT OR OTHER BIOMEDICAL INVESTIGATION
AUTHORIZED REPRESENTATIVE OR MAIN INVESTIGATOR FOR CONSENT TO OBTAIN A CLINICAL TRIAL OF A MEDICINAL PRODUCT
APPROVAL OF THE PROCEDURE FOR SUBMISSION OF A CERTIFICATE OR PERMIT FOR PERFORMANCE OF A BIOMEDICAL INVESTIGATION TO THE LITHUANIAN BIOETHICAL COMMITTEE
2014 31 December No. V-24 ​​Vilnius
1. T he documents to be provided by a clinical trial or other biomedical application of a medicinal product
the sponsor of the study, his authorized representative or the principal investigator for approval of the clinical trial
examination of a medicinal product or a permit to perform a biomedical study, submission of Lithuanian bioethics
a description of the procedure to the committee (attached).
2. Withdrawal:
2.1. Chairman of the Lithuanian Bioethics Committee in 2004 December 24 order no. V-21 “On the Documents You Must
submitted by the sponsor of the biomedical study or the principal investigator for approval
biomedical research, approval of the description of the procedure for submission to the Lithuanian Bioethics Committee ”;
2.2. Chairman of the Lithuanian Bioethics Committee in 2004 June 30 order no. V-11 “On the Documents You Must
submitted to the sponsor or principal investigator of a clinical trial for approval
clinical trial, approval of the requirements for the list, form and content of the medicinal product ’.
Chief Specialist,
acting director Vilma
Lukaševičienė
APPROVED
Director of the Lithuanian Bioethics Committee in 2014 31 December by order no. V-24
DOCUMENTS TO BE SUBMITTED BY THE APPLICANT FOR A CLINICAL TRIAL OR OTHER BIOMEDICAL INVESTIGATION
AUTHORIZED REPRESENTATIVE OR MAIN INVESTIGATOR FOR CONSENT TO OBTAIN A CLINICAL TRIAL OF A MEDICINAL PRODUCT
DESCRIPTION OF THE PROCEDURE FOR SUBMITTING A CERTIFICATE OR PERMIT FOR PERFORMANCE TO A BIOMEDICAL INVESTIGATION TO THE LITHUANIAN BIOETHICAL COMMITTEE
1. The sponsor of a clinical trial or other biomedical trial (hereinafter referred to as the sponsor), his
an authorized representative or principal investigator in order to obtain the approval of the Lithuanian Bioethics Committee to conduct a clinical trial
a study certificate of the medicinal product or a permit of the Lithuanian Bioethics Committee to perform a biomedical study,
must submit documents, the lists of which are approved by the Minister of Health.
2. At the meeting of the Biomedical Research Expert Group of the Lithuanian Bioethics Committee, the documents that
received no later than twenty working days before the scheduled meeting date. Documents shall be considered at the meeting if:
the sponsor, his authorized representative, or the principal investigator provided all relevant information to the Minister of Health
the documents specified in the approved list and executed in accordance with the requirements specified in Paragraph 4 of this Description of the Procedure.
3. Information on the dates of the next meetings shall be published on the website of the Lithuanian Bioethics Committee.
The sponsor, his authorized representative or the principal investigator shall also have the right to know the information of the next of kin
dates of meetings in the Lithuanian Bioethics Committee (Vilniaus St. 16, LT-01402, Vilnius) or by phone (8 ~ 5) 212 45 65).
4. All documents submitted must be signed and copies of the documents submitted must be certified
notary or person (s) signing the application. Application for Biomedical Research and Biomedical Research Ethics
the evaluation questionnaire, as well as the ethical evaluation questionnaire of the Clinical Medicinal Product Investigation
each principal investigator individually.
5. The signatory of the application and the documents (annexes to the application) are responsible for the authenticity of the submitted documents.
the person (s) who submitted it.
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.
Item changes:
No. V-3, 15/01/2016, published in TAR 2016-01-19, i. k. 2016-01180
7. Documents shall be submitted to the Lithuanian Bioethics Committee by applying directly to the Lithuanian Bioethics Committee
(Vilniaus St. 16, LT-01402, Vilnius) at the time set by the Lithuanian Bioethics Committee, which can be found by phone (8 ~ 5)
212 45 65, electronically via the public electronic services portal (Electronic Government Gateway Internet
website www.epaslaugos.lt) or remotely (by sending an e-mail, signing a secure e-mail
signature, post or courier).
Item changes:
No. V-3, 15/01/2016, published in TAR 2016-01-19, i. k. 2016-01180
Changes:
1.
Lithuanian Bioethics Committee, Order
No. V-3, 15/01/2016, published in TAR 2016-01-19, i. k. 2016-01180
Regarding the Director of the Lithuanian Bioethics Committee in 2014. 31 December order no. V-24 ​​“On the Documents You Have
submitted by the client of a clinical trial of a medicinal product or another biomedical study, authorized by him
representative or principal investigator to obtain approval for a clinical trial of a medicinal product
a description of the procedure for submission of a certificate or permit to perform a biomedical research to the Lithuanian Bioethics Committee
approval "