REGULATION NO. 2000/52
UNMIK/REG/2000/52
The Special Representative of the Secretary-General,
Pursuant to the authority given to him under United Nations Security Council resolution 1244 (1999) of 10 June 1999,
Taking into account United Nations Interim Administration Mission in Kosovo (UNMIK) Regulation No. 1999/1 of 25 July 1999, as amended, on the Authority of the Interim Administration in Kosovo and 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 regulating the import, manufacture, sale and distribution of pharmaceutical products, including narcotic drugs and psychotropic substances, in Kosovo,
Hereby promulgates the following:
Section 1
For the purposes of the present regulation:
(a) “Pharmaceutical Products” shall mean any substance or mixture of substances that is manufactured, sold, offered for sale or represented:
(i) For use in the treatment, mitigation, prevention, or diagnosis of disease, an abnormal physical state or the symptoms thereof in human or animal;
(ii)
For use in the
restoration, correction or modification of organic functions in human or animal;
and
(iii)
As labile blood
products.
(b) “Narcotic Drugs” shall mean any of the substances listed in Schedules I and II of the Single Convention on Narcotic Drugs 1961, as amended by the 1972 Protocol, whether natural or synthetic;
(c) “Psychotropic Substances” shall mean any substance, natural or synthetic listed in Schedules I, II, III or IV of the Convention on Psychotropic Substances 1971;
(d) “Raw materials” shall mean all substances active or inactive, unchanged or altered that are employed in the manufacture of drugs;
(e)
“Intermediate products” shall mean semi-finished
products and bulk products;
(f) “Manufacture of
pharmaceutical products” shall mean all operations involved in the production of
a drug, including processing, compounding, formulating, filling, packaging and
labeling;
(g)
“Manufacturer” shall mean any
licensed person or entity who manufactures products described in paragraphs (a)
to (e) above for wholesaling, freesaling or for human
trials;
(h)
“Pharmaceutical Retailer”
shall mean any licensed person or entity who dispenses products described in
paragraphs (a) to (c) above and/or makes magistral or officinal preparations;
and
(i)
“Pharmaceutical Wholesaler”
shall mean any licensed person or entity who buys and stores products described
in paragraphs (a) to (e) above in order to bulk-distribute them
unchanged.
Section 2
2.1 Any person
or entity that wishes to engage in one or more of the following activities shall
first obtain a license from the Kosovo Drug Regulatory Authority (hereinafter
“the designated authority”):
(a) Operation as a pharmaceutical wholesaler;
(b) Import of pharmaceutical products, including labile blood products and intermediate products;
(c) Import of narcotic drugs and/or psychotropic substances;
(d) Manufacture of pharmaceutical products;
(e) Import of raw materials to be used in manufacturing pharmaceutical products; and
(f) Operation as a pharmaceutical retailer.
2.2 Licenses granted under section 2.1 (a), (b), (c), (e) and (f) above shall be valid for a period of five (5) years unless revoked, suspended or otherwise terminated by the designated authority or in accordance with the present regulation.
2.3 Licenses
granted under section 2.1(d) above shall be valid, unless revoked, suspended or
otherwise terminated by the designated authority, for an indefinite period.
However, where a renovation is made to premises used for manufacturing or there
is a change in the use of the premises, the license shall be reviewed, and may
at the discretion of the designated authority be reissued.
Section 3
3.1 Any person or entity that wishes to operate as a pharmaceutical wholesaler shall make an application to the designated authority for a license providing sufficient proof of having fulfilled the following conditions:
(a) The employment of a pharmacist(s) registered with the designated authority;
(b) The applicant has registered his or her business in accordance with UNMIK Regulation No. 2000/8 of 29 February 2000 on the Provisional Registration of Businesses in Kosovo;
(c) Warehouses or stores are secure and adequate for the purpose and have sufficient space according to the activities conducted on the premises;
(d)
The floor of the warehouse is sufficiently durable to
withstand heavy traffic and loads;
(e) The warehouse is clean and fulfills normal sanitary conditions, in particular, free from dust, vermin and insects;
(f) Storage spaces are protected from direct sunlight and heat, adequately lit and properly ventilated;
(g) The humidity and temperature of the storage areas are adequately controlled to ensure proper maintenance of the shelf lives of the pharmaceutical products stored in them;
(h) The premises are sufficiently secured preventing unauthorized access;
(i)
Transactions pertaining to ordering, storing and
distribution of pharmaceutical products including transaction date, drugs
received, drugs issued and the name of the recipient of the drugs shall be
accurately recorded;
(j) Narcotics and psychotropic substances shall be secured in an appropriate and secure safe and all transactions recorded according to national and international regulations using the registers and documentation approved by the designated authority;
(k) A list of pharmaceutical products that the applicant wishes to wholesale has been submitted to the designated authority;
(l)
The applicant shall sell only products approved by the
designated authority; and
(m)
Thermo-labile products shall
be stored in a refrigerator reserved for the storage of
pharmaceuticals.
3.2 Any change
in pharmacists or a relocation of the business to a
different premises shall be brought to the notice of the designated authority.
In the event that the business is moved to a different location, a new license
shall be applied for.
3.3 The license to operate as a pharmaceutical wholesaler shall at all times be visibly displayed on the premises.
Section 4
4.1 A licensed pharmaceutical wholesaler may make an application to the designated authority for a license for the import of pharmaceutical products (including intermediate products and labile blood products). The applicant shall make available to the designated authority:
(a) A list of the pharmaceutical products to be imported, each of which must be approved by the designated authority as a product allowed for import;
(b) For each pharmaceutical product on the list a certificate ensuring product quality and safety (such as, a certificate according to the World Health Organisation Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce), including proof of marketing authorization and for every product on the list which is not an intermediate product, proof of compliance with Good Manufacturing Practices (GMP) in the exporting country; and
(c) For each pharmaceutical product on the list, documents justifying the use of the product and hence the need to import it into Kosovo.
4.2 The shelf life of any imported pharmaceutical product shall be at least one (1) year from the date of delivery into Kosovo. In special cases, as determined by the designated authority, a shorter shelf life may be acceptable.
4.3 A Certificate of Analysis showing the specifications and test results of a pharmaceutical product may in appropriate circumstances be required.
Section 5
A licensed pharmaceutical wholesaler that wishes to import narcotic drugs and/or psychotropic substances shall make an application to the designated authority for a license in accordance with the requirements and procedures set forth in section 4 above, applying to pharmaceutical products.
Section 6
Any person or entity that wishes to manufacture pharmaceutical products shall make an application for a license to the designated authority in accordance with requirements that shall be set out in a regulation.
Section 7
7.1 Any person or entity that wishes to import raw materials to be used in the manufacture of pharmaceutical products shall make an application to the designated authority for a license. The applicant shall make available to the designated authority:
(a) A list of the products to be imported, each of which must be approved by the designated authority as a product approved for import;
(b) For each product on the list, a certificate ensuring product quality and safety (such as, a certificate according to the World Health Organisation Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce);
(c) For each active pharmaceutical substance, a document issued by the appropriate authority of the exporting country, certifying the use of the active substance in the manufacture of drugs and confirming that it is a substance authorized for export; and
(d) For each raw material, a document justifying the need to import the material into Kosovo, specifying its use as well as authorizing its use in the manufacture of drugs in Kosovo.
7.2 The shelf life of any imported raw material shall be at least one (1) year from the date of delivery into Kosovo. In special cases, as determined by the designated authority, a shorter shelf life may be acceptable.
7.3 A Certificate of Analysis showing the specifications and test results shall accompany each batch of raw materials to be imported.
Section 8
8.1 Any person or entity that wishes to operate as a pharmaceutical retailer shall make an application to the designated authority for a license providing sufficient proof of having fulfilled the following conditions:
(a) The employment of a pharmacist(s) registered with the designated authority with at least one (1) year of relevant experience;
(b) The pharmacy employs at least one (1) pharmacy assistant;
(c) The applicant has registered his or her business in accordance with UNMIK Regulation No. 2000/8 of 29 February 2000 on the Provisional Registration of Businesses in Kosovo;
(d)
The premises are secure and adequate for use as a
pharmacy;
(e) The premises have sufficient office and storage space according to the activities conducted on the premises. Additional space is required for toilets, washing rooms and wardrobes and, if the pharmacy is to prepare galenical products, a laboratory with sufficient space according to the activities conducted in the laboratory;
(f) The pharmacy possesses adequate literature on relevant
subjects;
(g) The premises are clean and fulfill normal sanitary conditions, in particular, free from dust, vermin and insects;
(h) Storage spaces are protected from direct sunlight and heat, adequately lit and properly ventilated;
(i) The humidity and temperature of the storage areas are adequately controlled to ensure proper maintenance of the shelf lives of the pharmaceutical products stored in them;
(j) The premises are sufficiently secured to prevent unauthorized access;
(k) The applicant shall sell only products approved by the designated authority;
(l)
Transactions pertaining to the ordering, storing and
distribution of pharmaceutical products including purchase, sale and
prescriptions shall be accurately recorded;
(m)
Narcotics and psychotropic substances shall be secured
in an appropriate and secure safe and all
transactions recorded according to national and international regulations using the
registers and documentation approved by the designated authority;
and
(n)
Thermo-labile products shall
be stored in a refrigerator reserved for the storage of
pharmaceuticals.
8.2 Any change
in pharmacy managers or a relocation of the business
to a different premise shall be brought to the notice of the designated
authority. In the event that the business is moved to a different location, a
new license shall be applied for.
8.3 The license to operate the premises as a pharmacy shall at all times be visibly displayed on the premises.
Section 9
A Pharmacist, for the purposes of section 3.1(a) and section 8.1(a) above shall be a person who, in the opinion of the designated authority, possesses:
(a) Knowledge of the activities to be carried out and of the procedures to be performed under the license; and
(b) Experience in those activities and procedures, which is adequate for those purposes.
Section 10
10.1 Products listed in the “Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments”, published by the United Nations, as revised from time to time, are banned from import.
10.2 Drug Donations will only be accepted after prior approval by the designated authority and upon proof that the goods to be donated comply with the “Interagency Guidelines for Drug Donations”, as revised from time to time.
Section 11
Pharmaceutical importers, manufacturers, wholesalers and
retailers, when promoting their products shall comply with the criteria and
procedures established in Resolution of the World Health Assembly, WHA41.17 on
the “Ethical Criteria for Medicinal Drug Promotion”, as revised from time
to time, as it applies to their particular
circumstance.
Section 12
12.1 It shall be an offence for any person to engage or be involved in any of the activities specified in section 2.1 above without first obtaining a license from the designated authority, or to continue to so engage or be involved, pending the suspension, revocation, or termination of any such license, in accordance with the present regulation.
12.2 The designated authority may confiscate, without compensation, pharmaceutical products including narcotic drugs and psychotropic substances held or used without a license or in any way not in compliance with the terms of any license issued under this regulation. Where the holder breaches a material provision of the license, the designated authority may suspend or revoke the license.
12.3 Any person committing an offence under the provisions of section 12.1 above shall be liable to applicable penalties that shall be set out in a regulation.
Section 13
13.1
The Pharmaceutics Appeals Board (hereinafter "the Board") shall hear and
decide on appeals by any applicant against a refusal of the designated authority
to issue a license or a decision to suspend, revoke or otherwise terminate a
license. The Board may uphold, modify or rescind any decision of the designated
authority to refuse, suspend, revoke or terminate a license. The Board shall
state the reasons for its decision.
13.2
Appeal against a decision of the designated authority shall be made
within fifteen (15) days of the issuance of such decision. The appeal shall be
made in writing and may be accompanied by such documentation or other evidence
as the appellant wishes to present.
13.3
The Board shall be composed of two (2) international members and three
(3) local members who shall be recommended by the Deputy Special Representative
of the Secretary-General for Civil Administration. The Special Representative of
the Secretary-General shall appoint the members of the Board and shall designate
one international member as the President of the Board.
13.4
The Board shall determine its own rules of procedure, which shall
guarantee fair and impartial proceedings in accordance with internationally
recognized human rights standards. In particular, such rules shall include
provisions on reconsideration of decisions of the Board. The said rules of
procedure shall be adopted prior to the first hearings of appeals by the
Board.
13.5 Nothing in this section shall preclude an applicant from seeking redress against any decision of the Board from a competent court in Kosovo.
Section 14
14.1 The designated authority shall levy fees for licenses issued under the present regulation in amounts and under conditions which shall be set forth in an administrative direction.
14.2 Revenue derived from license fees shall be deposited in the Kosovo Consolidated Budget.
Section 15
Existing importers, manufacturers, wholesalers and retailers shall apply for the licenses provided for in section 2.1 no later than thirty (30) days after the entry into force of the present regulation.
Section 16
The Special Representative of the Secretary-General may issue administrative directions in connection with the implementation of the present regulation.
Section 17
The present regulation shall supersede any provision in the applicable law which is inconsistent with it.
Section 18
The present regulation shall enter into force on 2 September 2000.
Bernard
Kouchner
Special
Representative of the
Secretary-General