It is registered
Ministry of Justice of Ukraine
May 18, 2015
of April 24, 2015 No. 242
About approval of Rules of utilization and destruction of medicines
According to article 23 of the Law of Ukraine "About medicines", to the paragraph to the fifth subitem 8.9 of the subitem 8 of item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467, for the purpose of enhancement of procedure for utilization and destruction of the low-quality, counterfeited and unregistered medicines including which expiration date expired, PRIKAZYVAYU:
1. Approve Rules of utilization and destruction of medicines which are attached.
2. Declare invalid the order of the Ministry of Health of Ukraine of July 8, 2004 No. 349 "About approval of Rules of carrying out utilization and destruction of low-quality medicines", No. 916/9515 registered in the Ministry of Justice of Ukraine on July 23, 2004.
3. L. Konoshevich in accordance with the established procedure to provide to the head of department of pharmaceutical activities and quality of pharmaceutical products submission of this order on state registration in the Ministry of Justice of Ukraine.
4. To impose control over the implementation of this order on the deputy minister N. Lisnevskaya.
Approved by the Order of the Ministry of health protection of Ukraine of April 24, 2015 No. 242
1. These rules are developed according to the Laws of Ukraine "About medicines", "About waste", the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467.
2. These rules determine general requirements by the treatment of medicines which are not subject to further use, for the purpose of non-admission of their further address and the prevention of negative impact on health of the person and the surrounding environment.
3. These rules are obligatory for all subjects of managing which perform the activities connected with circulation of medicines, utilization and neutralization of waste.
4. In these rules terms are used in the following values:
retirement of the medicines which are not subject to further use - urgent measures, appeals sent on non-admission low-quality, unregistered, except the cases provided by the current legislation of Ukraine, and counterfeited medicines;
medicines which are not subject to further use, - low-quality medicines, including those which expiration date expired; the unregistered medicines, except the cases provided by the current legislation of Ukraine; counterfeited medicines;
neutralization of waste of medicines - reduction or elimination of danger of waste of medicines by mechanical, physical and chemical or biological processing;
methods of quality control (further - MKK) - the regulating documentation approved in accordance with the established procedure determining techniques of quality control of medicines which establishes qualitative and quantitative indices of medicine and their admissible borders, requirements to packaging, marking, storage conditions, the transportations, expiration date approved in case of state registration (re-registration) of medicine;
low-quality medicines - medicines which quality does not conform to requirements of regulating documents, medicines which underwent to mechanical, chemical, physical, biological or other impact that makes impossible their further use, and also medicines expired;
drug circulation - the types of activity connected with production, storage, transportation, transfer, wholesale and retail sale (trade), acquisition, use, import to Ukraine and export from Ukraine, use of medicines;
state control bodies behind quality of medicines (further - state control bodies) - the central executive body realizing state policy in the sphere of quality control and safety of medicines and its territorial authorities;
waste recycling of medicines - use of waste of medicines as secondary material or energy resources;
counterfeited medicine - the medicine which is intentionally marked identically (not on) to data (to one or several of them) about medicine with the corresponding name entered in the State register of medicines of Ukraine and also the medicine which is intentionally counterfeited in a different way and which does not correspond to data (to one or several of them), including structure, about medicine with the corresponding name entered in the State register of medicines of Ukraine.
1. Availability in drug circulation, not subject to further use, is established by state control bodies and/or official (authorized) faces of subjects of managing in the sphere of drug circulation. Such medicines are withdrawn from circulation, and the fact of their availability is fixed by the act. The form of the act of availability of the medicines which are not subject to further use for subjects of managing is given in appendix 1 to these rules.
2. Prolongation of expiration date of medicines on any bases is forbidden.
3. Medicines which turnover is forbidden by orders about establishment of prohibition of drug circulation (further - the Order), issued by state control bodies, are withdrawn from circulation by the way specified on hand.
4. Low-quality medicines cannot be processed for the purpose of their reduction into compliance with requirements of MKK (except for remarkings and repackings). Implementation of transactions with remarking and repacking does not concern medicines which expiration date expired.
5. Medicines which are not subject to further use receive the status of "waste" and are transferred for utilization or neutralization to subjects of managing which have the corresponding licenses for implementation of economic activity in the sphere of the treatment of dangerous wastes directly or through suppliers if it is provided by the corresponding contractual conditions.
6. The subjects of managing having medicines which are not subject to further use submit to state control bodies in the place of implementation of activities information on transfer of such medicines on utilization or destruction. Information on transfer of the medicines which are not subject to further use for utilization or neutralization, moves in paper and electronic type in the form given in appendix 2 to these rules.
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