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It is registered

in the Ministry of Justice

Ukraine

On July 22, 1999 No. 496/3789

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE, MINISTRY OF PROTECTION OF THE SURROUNDING ENVIRONMENT AND NUCLEAR SAFETY OF UKRAINE

of March 19, 1999 No. 67/59

About approval of Rules of carrying out utilization and destruction of low-quality medicines which part drugs, psychotropic substances and precursors are

In pursuance of article 23 of the Law of Ukraine "About medicines", Item 2 of the resolution of the Cabinet of Ministers of Ukraine of January 3, 1996 N 6 "About approval of the Regulations on activities procedure in the sphere of the address of drugs, psychotropic substances and precursors", being guided by the resolution of the Cabinet of Ministers of Ukraine of June 20, 1995 N 440 "About approval of the Procedure for receipt of permission to production, storage, transportation, use, burial, destruction and utilization of toxic agents, including toxic industrial wastes, products of biotechnology and other biological agents" (Items 3, 5) and the resolution of the Cabinet of Ministers of Ukraine of February 16, 1998 N 179 "About approval of the Regulations on the State inspectorate for quality control of medicines of the Ministry of Health" (Item 4/7) of PRIKAZYVAYEM:

1. Approve Rules of carrying out utilization and destruction of low-quality medicines which part drugs, psychotropic substances and precursors are (daleepravila; are applied).

2. The tax Governed on state registration in the Ministry of Justice of Ukraine.

3. Bring Rules to permission of institutions of health care of Ukraine, Committee on the medical and microbiological industry of Ukraine, the State-owned joint stock company "Drugs of Ukraine", the Ministry of Internal Affairs of Ukraine for management in work.

4. To impose control of execution of the order on the deputy minister of health care of Ukraine Kartish A. P., deputy minister of protection of the surrounding environment and nuclear safety of Ukraine Vasilchenko V. V.

 

Minister of Health of Ukraine

R.V.Bogatyreva

Minister of protection surrounding

environment and nuclear

safety of Ukraine

 

 

V. Ya. Shevchuk

Approved by the Order of the Ministry of Health of Ukraine, the Ministry of protection of the surrounding environment and nuclear safety of Ukraine of March 19, 1999 No. 67/59

Rules of carrying out utilization and destruction of low-quality medicines which part drugs, psychotropic substances and precursors are

1. General provisions

1.1. Rules of carrying out utilization and destruction of low-quality medicines which part drugs are psychotropic substances and precursors (further - Rules) are obligatory for all those organizations, institutions, the organizations, the companies (further - organizations) irrespective of pattern of ownership and types of their activities which make medicines use and provide with them the population. These Rules extend to medicines which part those drugs, psychotropic substances and precursors which are noted in the List of the drugs, psychotropic substances, their analogs and precursors which are subject to special control according to the legislation of Ukraine, approved by the order of Committee on control of drugs under the Ministry of Health of Ukraine (further Committee) from 23.03.98 N 7 and registered in the Ministry of Justice of Ukraine 23.06.98 N 390/2830 are.

1.2. Rules extend to domestic and foreign medicines which part drugs are, psychotropic substances and precursors (ergometrine, ergotamine, ephedrine, pseudoephedrine) (further - medicines) which term of suitability ended or which cannot be applied according to the destination in connection with discrepancy to requirements of the specifications and technical documentation.

1.3. Medicines of national production which came to the market and do not meet the requirements of the specifications and technical documentation because of the producer, return to the producer. All obligations on execution of material expenses to consumers for the low-quality medicines acquired by them are assigned to the producer.

2. Preparatory work for carrying out utilization and destruction

2.1. The basis for consideration of question of utilization or destruction of low-quality medicines is the protocol of the analysis of quality of medicine. The analysis of medicine is carried out by the State inspectorate for quality control of the National agency on control of quality and safety of food, medicines and products of medical appointment or experts of the State scientific expert center of medicines of the Ministry of Health of Ukraine, or pharmacists who are responsible for obtaining and storage of medicines.

2.2. All material expenses when carrying out utilization or destruction of medicines are assigned to the producer or the owner of organization who possesses these medicines.

2.3. All works connected with utilization and destruction of low-quality medicines are performed with obligatory observance of safety regulations and use of individual protection equipment which are applied in organization during the work with drugs, psychotropic substances and precursors.

3. Procedure for utilization of low-quality medicines which part drugs, psychotropic substances and precursors are

3.1. Low-quality medicines can be utilized by use as raw materials in own organization or are transferred for utilization to other organization according to the act of acceptance transfer.

3.2. Based on the protocol of the analysis of quality the organization submits to the Ministry of protection of the surrounding environment and nuclear safety of Ukraine the statement on receipt of permission to utilization of low-quality medicines which part drugs, psychotropic substances and precursors (appendix 1) are.

Documents are enclosed to the application:

protocol of the analysis of quality of medicine;

act of acceptance transfer.

The application is signed by the head of organization and makes sure seal of organization.

3.3. The organization in which utilization of low-quality medicines shall be carried out, reports about it in local body of the Ministry of Internal Affairs of Ukraine (further - the Ministry of Internal Affairs) which presence of the representative is obligatory when carrying out utilization, and Committee which representative to utilization in number of more than 500 kilograms of low-quality medicines which part drugs, psychotropic substances and precursors are shall be present at its carrying out.

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