Approved by the Order of the Minister of Health of the Republic of Tajikistan of November 18, 2008 No. 645

Regulations on procedure for safe destruction of the medicines inappropriate to the existing standards in the Republic of Tajikistan

1. General questions

1. This provision is developed according to article 22 of the Law of the Republic of Tajikistan "About medicines and pharmaceutical activities" and determines procedure for safe destruction of the medicines which became useless, expired, inappropriate to the operating quality standards of medicines in the Republic of Tajikistan for all organizations and the companies irrespective of pattern of ownership and departmental subordination. This provision will promote safe and economic liquidation of inventories of unsuitable pharmaceutical medicines.

2. Pharmaceutical waste can accumulate owing to discrepancy in inventory management and in distribution in view of lack of system of systematic destruction, and also inadequate practice of donation of pharmaceutical products from the international organizations.

3. This provision does not consider address questions with other waste developed by healthcare institutions (infectious waste, photographic chemicals, solvents, waste with the high content of heavy metals (for example, mercury and cadmium), waste of chemical laboratories or radioactive waste).

4. This provision is intended for competent authorities of health care, and also bodies which are going in for ecology and liquidation of waste at the republican, regional and local levels.

5. In case of destruction of unsuitable medicines it is necessary to perform the following events:

- Decision making about need of destruction of the become useless medicines;

- Coordination with the Ministry of Health of the Republic of Tajikistan for the purpose of receipt of the sanction for destruction of medicines;

- Planning concerning financing, necessary examination, personnel, costs of working hours, the areas, the equipment, material and the available options of destruction of waste;

- Forming of working crews from among health and pharmaceutical workers whose health and safety will be supported by use of the corresponding defensors (coveralls and boots, as required, gloves, masks and hats). Masks are used in case of destruction of firm dosage forms (for example, in case of inactivation). Extra care is required by work with antineoplastic medicines;

- Sorting is made for the purpose of separation of medicines into separate categories for which various methods of destruction are required. It is necessary to subdivide medicines into those which can be used and returned safely in system of medicinal supply, and those which need to be destroyed by various methods;

- Destruction options considerably differ depending on situation, and the ideal decision can be impracticable. It is necessary to choose the elementary, safest and practical alternatives.

6. For destruction of the medicines which became useless, expired, not conforming to the quality standards the working group (commission) which part the following persons are is created:

- Representatives of the Ministry of Health of the Republic of Tajikistan or governing bodies of health care on places;

- Representatives of the body authorized by the Ministry of Health of the Republic of Tajikistan on implementation of the state control of pharmaceutical activities in the Republic of Tajikistan;

- Pharmaceutical or health workers of organizations at which destruction of medicines and the responsible person of this organization is performed.

The working group (commission) is authorized to perform the activities with the assistance of at least than 80% of his members.

7. At the end of the procedure of destruction the statement of destruction of unsuitable pharmaceutical products which is certified by workgroup members (commission) is drawn up (the form of the act is applied).

8. The act shall contain the following information:

- Date and place of creation of the act;

- The name of medicines (with indication of number of series, expiration date, cost and the producer);

- Amount of the destroyed medicines;

- Owner (responsible person) of batch of medicines;

- Basis for destruction;

- Destruction method;

- Workgroup members (commissions) which were taking part in destruction of medicines (surnames, names and middle names of workgroup members (commission) with indication of their positions). The act is certified by signatures of members of the commission.

- The locus sigilli (L. S.) of the body making destruction and the signature of his head.

- The locus sigilli (L. S.) of the owner of the medicines which are liable to destruction and the signature of his head.

9. The non-governmental organizations working according to pharmaceutical programs perform the procedure of destruction of inventories of waste of medicines, unsuitable to use, according to Item 6 together with representatives of relevant organs.

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