The 17 references in paper I. Prokopov A., E. Kovaleva L., L. Mit’Kina I., A. Pichugin V., И. Прокопов А., Е. Ковалева Л., Л. Митькина И., А. Пичугин В. (2018) “Указание условий хранения лекарственных средств в нормативной документации и на макетах упаковки. Актуальные вопросы // Relevant issues of indicating drugs storage conditions in normative documentation and drug package design” / spz:neicon:vedomostincesmp:y:2016:i:3:p:26-30

1
The State Pharmacopoeia of the USSR. 10th ed. Moscow: Meditsina; 1968 (in Russian).
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2
The State Pharmacopoeia of the USSR. 11th ed. Issue 2. Moscow: Meditsina; 1989 (in Russian).
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3
The State Pharmacopoeia of the Russian Federation. 12th ed. Moscow: NCESMP; 2007 (in Russian).
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4
Guide to good storage practices for pharmaceuticals (Annex 9). WHO Expert Committee on Specifications for Pharmaceuticals Preparations. Thirty-seventh Report. Geneva: World Health Organization. Available from: http:// apps.who.int/medicinedocs/documents/s18675en/s18675en.pdf
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5
Guideline on Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances (CPMP/QWP/609/96 Rev. 2). Available from: http:// goo.gl/L76OKp.
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6
Stability Testing of New Drug Substances and Products, Q1A(R2). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Available from: http:// goo.gl/igxjya.
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7
Prokopov IA, Kovaleva EL, Mit’kina LI, Shanazarov KS. Questions stability of drugs, the relationship with the primary packaging. Razrabotka i registratsiya lekarstvennyh sredstv 2014;4(9): 198–201 (in Russian).
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8
Sakaeva IV, Bunyatyan ND, Kovaleva EL, Sakanyan EI, Mit’kina LI, Prokopov IA, Shelekhina ES, Mit’kina YuV. Basic approaches drug stability studies: domestic and international experience. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2013; (3): 8–11 (in Russian).
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9
Mironov AN, Sakaeva IV, Bunyatyan ND, Kovaleva EL, Mit’kina LI, Prokopov IA, Shelekhina ES, Mit’kina YuV. Study of stability and setting of expiration date of medicines. In: Guidelines for the examination of drugs. V. 3. Moscow: FGBU «NÑESMP»; 2014. P. 224–41 (in Russian).
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10
The State Pharmacopoeia of the Russian Federation. 13th ed. Moscow; 2015. Available from: http://femb.ru/feml (in Russian).
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11
Order of the Ministry of Health and Social Development of the Russian Federation ¹ 706n, 23.08.2010 «On approval of the rules of storage of medicines» (in Russian).
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12
European Pharmacopeia. 8th ed. Supplement 8.2.
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13
The United States Pharmacopeia. USP 38/NF 32. The USP Convention; 2016. Available from: http:// www.uspnf.com/uspnf/login.
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14
Indian Pharmacopeia. 6th ed. Ghaziabad: Indian Pharmacopoeia Commission; 2010.
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15
Conducting stability tests and setting of expiration date and control period of medicines. Guidelines. Astana; 2006 (in Russian).
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16
Note For Guidance on Maximum shelf-life for sterile products for human use after first opening or follow reconstitution (EMA CPMP/QWP/159/96 corr). Available from: http:// goo.gl/k2Vn6E.
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17
Federal Law of the Russian Federation ¹ 61-FZ, 12.04.2010 «On Circulation of Medicines» (in Russian). AUTHORS Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, Petrovsky boulevard 8, bld. 2, Moscow 127051, Russian Federation.
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