ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of January 23, 2013 No. 71

About approval of the Regulations on the organization and functioning, structure and limiting manpower ceiling of the Agency on drugs and medical products

Based on the Law No. 102/2017 on medical products (The official monitor of the Republic of Moldova, 2017, Art. No. 244-251, 389), with subsequent changes, the Law on pharmaceutical activities No. 1456-XII of May 25, 1993 (repeated publication: The official monitor of the Republic of Moldova, 2005, Art. No. 59-61, 200), with subsequent changes and amendments, the Law on drugs No. 1409-XIII for December 17, 1997. (The official monitor of the Republic of Moldova, 1998, Art. No. 52-53, 368), with subsequent changes and amendments, DECIDES: the Government

1. Reorganize by the Agency transformation on drugs into the Agency on drugs and medical products which is administrative authority in subordination of the Government.

2. Approve:

Regulations on the organization and functioning of the Agency on drugs and medical products according to appendix No. 1;

structure of the Agency on drugs and medical products according to appendix No. 2;

to organigramm of the Agency on drugs and medical products according to appendix No. 2-1;

changes which are made to the separate orders of the Government, according to appendix No. 3;

The list of the orders of the Government which are recognized invalid, according to appendix No. 4.

3. Establish the extreme number of staff of the Agency on drugs and medical products in number of 110 units.

4. Release of personnel is performed according to provisions of the current legislation.

5. And liabilities, fixed assets and other material values to perform transfer of assets based on the delivery-acceptance certificates which are drawn up according to the Regulations on procedure for transfer of the state companies, the organizations, organizations, their divisions, buildings, constructions, fixed assets and other assets approved by the Order of the Government No. 688 of October 9, 1995 (The official monitor of the Republic of Moldova, 1996, No. 10, the Art. 45), with subsequent changes and amendments.

6. To the Ministry of Health:

bring the regulations into accord with this resolution;

provide functionality of the Agency on drugs and medical products.

Appendix No. 1

to the Order of the Government of the Republic of Moldova of January 23, 2013 No. 71

Regulations on the organization and activities of the Agency for drugs and medical products

Chapter I General provisions

Scope

1. The regulations on the organization and activities of the Agency for drugs and medical products (further - the Provision) regulate the purposes, the main functions, obligations and the rights of the Agency on drugs and medical products, and also the organization of activities of the last.

Legal position of the Agency on drugs and medical products

2. The agency on drugs and medical products (further - the Agency) is administrative authority, in subordination of the Government, with the location to the address: mun. Chisinau, ul Korolenko, 2/1, given authority on regulation and supervision in the field of drugs, pharmaceutical activities and medical products.

3. The agency has the status of the legal entity given the public law, has seal with the image of the State Emblem of the Republic of Moldova, own balance, treasurer accounts, financial and the appliances, other attributes necessary for normal activities.

4. In the field of the activities the Agency is the competent authority making decisions and cooperates with bodies of the central public management and others to authorities.

Activities regulatory framework

5. The agency performs the activities according to the Constitution of the Republic of Moldova, the laws and resolutions of Parliament, presidential decrees of the Republic of Moldova, ordinances, resolutions and orders of the Government, international agreements which party the Republic of Moldova is regulating documents of the Ministry of Health, and also requirements of this provision.

Chapter II Mission, main functions, obligations and rights of the Agency

Mission of the Agency

6. The mission of the Agency consists in implementation of state policy in the field of drugs, pharmaceutical activities, turnover of narcotic, psychotropic substances and precursors and medical products for the purpose of promotion and protection of public health by means of providing with high-quality, safe, effective and available drugs and medical products.

Functions of the Agency

7. For realization of the mission the Agency performs the following functions:

1) authorization (examination, approval and registration) of drugs;

1-1) authorizations of import of the unregistered drugs for the purpose of registration;

2) supervision and control of quality of medicines;

3) supervision and control of pharmaceutical activities except for the control provided in part (3/1) of article 16 of the Law No. 1456-XH 25 of May, 1993 about pharmaceutical activities;

4) application of procedures of supervision of the market according to the provisions established by the legislation in the field of medical products;

5) No. 1128 is excluded according to the Order of the Government of the Republic of Moldova of 10.10.2016

6) it is excluded;

7) promotion and monitoring of rational use of drugs;

8) application and development of system of pharmakonadzor;

9) authorization of supervision of carrying out clinical testing and approval of their results;

10) monitoring of process of supply and equipping with medical products, in particular public medical and sanitary organizations;

11) implementation and development of information technologies in the field of pharmaceutics;

12) maintaining the State register of the drugs authorized in the Republic of Moldova;

13) creation and maintaining the State register of medical products according to the Law on registers No. 71-XV of March 22, 2007;

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