The Need to Unify the Text of the Instruction on the Medical Use of Vaccines
https://doi.org/10.31631/2073-3046-2019-18-1-112-117
Abstract
The article analyzes the content of instructions for use of vaccines and toxoids registered in the Russian Federation. It was stated that this important document is a standard of the manufacturer, and not a standard of the Ministry of Health of Russia, and does not always correspond to other regulatory documents. It is noted that instructions for foreign immunobiological preparations often differ significantly from instructions for similar domestic preparations. Examples of foreign vaccine instructions are given, the text of which does not match Russian requirements, in addition, they contain recommendations and information contradicting the Order of the Ministry of Health of Russia dated September 21, 2016 No. 724n «On approval of the Requirement for instructions on the medical use of drugs». There were suggestions to discuss the issue of unifying the text of instructions on immunobiological preparations and assigning them the title of a legal document.
About the Author
N. A. Ozeretskovskiy
State Research Institute for Standardization and Control of Medical Biological Preparations L.A. Tarasevich; Scientific Center for Expertise of Medical Products
Russian Federation
Russian Federation
Nikolai A. Ozeretskovsky – Cand. Sci. (Med.) retiree. Head of the Laboratory for Assessing the Side Effects of Medical Immunobiological Preparations and standardization of regulatory documentation, chief specialist
+7 (916)688-59-20
References
1. Оrder of the Ministry of health of the Russian Federation of September 21, 2016 N 724n «on approval of requirements to the instruction on medical use of medicines». http://RuLaws.ru/acts/Prikaz-Minzdrava-Rossii-ot-21.09.2016-N-724n/
2. Guidelines 3.3.1.1095-02. 3.3.1. Vaccine prevention. Medical contraindications for prophylactic vaccination with the national vaccination calendar. (Approved by the Chief State Sanitary Doctor of the Russian Federation on January 9, 2002. Available at: http://legalacts.ru/doc/mu-3311095-02-331-vaktsinoprofilaktika-meditsinskie-protivopokazanija-k/
3. WHO. Global Manual of Adverse Events following Immunization. 2014 (revised March 2016). Annex 1. Frequency of vaccine Adverse Reactions of commonly used vaccines.
4. Federal Law «On circulation of medicines» dated 12 April 2010 No. 61-FZ. http://legalacts.ru/doc/federalnyi-zakon-ot-12042010-n-61-fz-ob/
Review
For citations:
Ozeretskovskiy N.A. The Need to Unify the Text of the Instruction on the Medical Use of Vaccines. Epidemiology and Vaccinal Prevention. 2019;18(1):112-117. (In Russ.) https://doi.org/10.31631/2073-3046-2019-18-1-112-117
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