| 1. | 通報成員：俄羅斯 |
| 2. | 負責(zé)機構(gòu)：Eurasian Economic Commission Department for technical regulation and accreditation |
| 3. |
通報依據(jù)的條款：Article 2.9.2 [X], 2.10.1 [??], 5.6.2 [??], 5.7.1 [??]
通報依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004)
ICS：[] HS：[] |
| 5. |
通報標(biāo)題：Draft amendments to Requirements for stability testing of drugs and pharmaceutical substances.頁數(shù)：2 使用語言：俄語 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡述： The draft amendments to the Requirements for stability testing of drugs and pharmaceutical substances applies to put into circulation on the territory of the Eurasian economic Union drugs and calls for the unified approach to the definition of "production date of the series" in order to exclude the possibility of automatic updates of the shelf life of the pharmaceutical substance by a simple repackaging, and the calculation of the shelf life of finished drugs, issued in circulation in the customs territory of the Eurasian economic Union for the purpose of elimination of the possibility of automatic renewal of the shelf life of the pharmaceutical substance by its simple repackaging, as well as the use in the production of substances with an expiration date not corresponding to the shelf life of finished drugs, which may lead to inconsistencies of expert reports and recognition. The draft guide has been prepared in order to: - protection of life and health of the patient (as the final consumer of medicines); - protection of the interests of the health care system as a whole (as the primary consumer of medicines) - protection of the interests of the authorized bodies (expert organizations) that perform the procedure of evaluation of the registration dossier of the drug from the position of proof of its compliance with the specified quality standard. |
| 7. | 目的和理由：Protection of human health or safety |
| 8. | 相關(guān)文件： Draft amendments to Requirements for stability?testing?of drugs and pharmaceutical substances? Decision No.69 of the Board of the Eurasian economic Commission of 10 May 2018 http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/drug_products.aspx |
| 9. |
擬批準(zhǔn)日期：
To be determined 擬生效日期： To be determined |
| 10. | 意見反饋截至日期：25 January 2020 |
| 11. |
文本可從以下機構(gòu)得到：
Eurasian Economic Commission https://docs.eaeunion.org/ria/ru-ru/0103838/ria_23122019 |
The draft amendments to the Requirements for stability testing of drugs and pharmaceutical substances applies to put into circulation on the territory of the Eurasian economic Union drugs and calls for the unified approach to the definition of "production date of the series" in order to exclude the possibility of automatic updates of the shelf life of the pharmaceutical substance by a simple repackaging, and the calculation of the shelf life of finished drugs, issued in circulation in the customs territory of the Eurasian economic Union for the purpose of elimination of the possibility of automatic renewal of the shelf life of the pharmaceutical substance by its simple repackaging, as well as the use in the production of substances with an expiration date not corresponding to the shelf life of finished drugs, which may lead to inconsistencies of expert reports and recognition.
The draft guide has been prepared in order to:
- protection of life and health of the patient (as the final consumer of medicines);
- protection of the interests of the health care system as a whole (as the primary consumer of medicines)
- protection of the interests of the authorized bodies (expert organizations) that perform the procedure of evaluation of the registration dossier of the drug from the position of proof of its compliance with the specified quality standard.
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