ADMINISTRATIVE DIRECTION NO. 2000/12

UNMIK/DIR/2000/12

19 May 2000

 

 

IMPLEMENTING UNMIK REGULATION NO.  2000/10 ON THE ESTABLISHMENT OF THE ADMINISTRATIVE DEPARTMENT OF HEALTH AND SOCIAL WELFARE

 

 

The Special Representative of the Secretary-General,

 

Pursuant to the authority given to him under section 5 of United Nations Interim Administration Mission in Kosovo (UNMIK) Regulation No. 2000/10 of 3 March 2000 on the Establishment of the Administrative Department of Health and Social Welfare,

 

For the purpose of establishing the Kosovo Drug Regulatory Authority,

 

Hereby gives the following Administrative Direction:

 

 

Section 1

KOSOVO DRUG REGULATORY AUTHORITY

 

1.1         The Kosovo Drug Regulatory Authority (hereinafter “the Authority”) is hereby established.

 

1.2         The Authority, acting under the authority of the Administrative Department of Health and Social Welfare (hereinafter “the Department”), shall be responsible for matters relating to the import, manufacture, sales and distribution of pharmaceutical products, including narcotic drugs, psychotropic substances and raw materials (hereinafter “pharmaceutical products”), in Kosovo.

 

 

Section 2

FUNCTIONS

 

2.1         The Authority may make recommendations through the Co-Heads of the Department to the Deputy Special Representative of the Secretary-General for Civil Administration concerning, inter alia:

 

(a)    Formulation of the strategy for import, manufacture, sales and distribution of pharmaceutical products in Kosovo; and

 

(b)   Development of a regulatory framework for import, manufacture, sales and distribution of the pharmaceutical products, including the setting of standards to be maintained.

 

2.2         The Authority shall:

 

(a)    Provide technical support to the Department in the management and supervision of matters relating to the import, manufacture, sales and distribution of pharmaceutical products;

 

(b)   Implement, under the direction of Co-Heads of the Department, regulations and administrative directions relating to the import, manufacture, sales and distribution of the pharmaceutical products;

 

(c)    Receive, process and record applications and issue licenses for the import, manufacture and/or sales of pharmaceutical products in accordance with procedure and requirements to be established in a regulation;

 

(d)   Maintain a register of entities licensed to operate as importers, manufacturers, wholesalers or retailers of pharmaceutical products, including premises where such entities operate;

 

(e)    Inspect relevant premises for the purpose of ensuring their compliance with the licenses;

 

(f)     Maintain a register of persons acting as pharmacy managers;

 

(g)    Provide technical advice to customs officials with regard to the import of pharmaceutical products, including the criteria and procedures to be applied for examining pharmaceutical products for compliance with import licenses;

 

(h)    Maintain a list of the pharmaceutical products allowed for import;

 

(i)     Inspect, in coordination with the Customs Services, imported goods and import documents for the purpose of establishing compliance with the provisions of the applicable license; and

 

(j)     Publish, with the prior approval of the Department, procedures and forms for the implementation of the functions set out above in this section.

 

 

Section 3

STAFFING, ORGANIZATION AND ADMINISTRATION OF THE AUTHORITY

 

The Head of the Authority shall be appointed and the Authority shall be staffed, organized and administered in accordance with sections 3 and 4 of UNMIK Regulation No. 2000/10.

 

 

Section 4

ENTRY INTO FORCE

 

The present administrative direction shall enter into force on 19 May 2000.

 

 

 

 

 

                                                                                                                     Bernard Kouchner

               Special Representative of the Secretary-General