About The National Committee For Ethics In Clinical Trial Expertise

Original Language Title: cu privire la Comitetul Naţional de Expertiză Etică a Studiului Clinic

Read the untranslated law here: http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=362783

    Pursuant to article 1. 14 of law No. 263-XVI of 27 October 2005 concerning patient rights and responsibilities (Official Gazette of the Republic of Moldova, 2005 No. 176-181, 867), with subsequent amendments and additions, art. 11 of law. 1409-XIII of 17 December 1997 regarding drugs (Official Gazette of the Republic of Moldova, 1998, no. 52-53, article 368), with subsequent amendments and additions, the Government DECIDES: 1. establish a National Committee of Ethics of the clinical trial, public nonprofit institution with financial autonomy, in which the Ministry of health has as founder.
2. Is approved: Regulation on organisation and functioning of the National Committee of Ethics of the clinical trial, according to the annex. 1;
Fees for expert examination of documents and clinical trials carried out by the approval of the National Committee of Ethics of the clinical trial, according to the annex. 2;
Changes and additions to what is operating in some decisions of the Government, according to the annex. 3.3. It establishes the Committee of 15 people. For the purpose of organizing the activity, is determined by a Committee of 3 units, consisting of: accounting, Assistant and a procrastinator/legal counsel.
4. The Committee shall apply the fees for expert examination of documents and advising of clinical trials in accordance with norms approved by this decision.
5. Financing the apparatus and members of the Committee shall be carried out at the expense of funds obtained from self-administered activities.
6. the means obtained from the provision of services and expertise of the approval of clinical trials builds on the special Committee's account and shall be used to cover related cheltuiellor in accordance with the legislation in force.
7. Ministry of health shall, within 6 months from the date of entry into force of this decision by: will ensure the conditions necessary for the proper conduct of the work of the members of the Committee;
will bring its laws into line with this decision.

Interim Prime Minister Gheorghe BREGA