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1.
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Notifying Member: RUSSIAN FEDERATION
If applicable, name of local government
involved (Article 3.2 and 7.2):
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2.
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Agency responsible:
Eurasian Economic Commission Department for Technical Regulation and
Accreditation
Tel: +7(495)669-24-00
Fax: +7(495)669-24-15
E-mail: dept_techregulation@eurasiancommission.org
Website: www.eurasiancommission.org
Name and address (including telephone and
fax numbers, email and website addresses, if available) of agency or
authority designated to handle comments regarding the notification shall be
indicated if different from above:
Russian Scientific and Technical Center for Information on Standardization,
Metrology and Conformity Assessment (Standartinform, National enquiry point
for the TBT Agreement)
Tel: +7(495) 531-26-59
E-mail: info@gostinfo.ru
Website: www.gostinfo.ru
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3.
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Notified under Article 2.9.2 [X], 2.10.1
[ ], 5.6.2 [ ],
5.7.1 [ ], 3.2 [ ], 7.2 [ ], other:
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4.
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Products covered (HS or CCCN where applicable, otherwise national
tariff heading. ICS numbers may be provided in addition, where applicable): Medicinal
products
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5.
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Title, number of pages and language(s) of the notified document: Draft
amendments to the Rules for Investigation of Biological Medicinal Products in
the Eurasian Economic Union; (140 page(s), in Russian)
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6.
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Description of content: The
draft amendments to the Rules for Investigation of Biological Medicinal
Products in the Eurasian Economic Union provide for the elimination of
differences in the requirements for pharmaceutical development, planning and
conducting studies of the safety and quality of medicines based on human
somatic cells and medicines containing genetically modified cells by
establishing uniform, objective and transparent rules for research of these
groups of medicines.
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7.
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Objective and rationale, including the nature of urgent problems
where applicable: Protection of life and health of the end users of
medicinal products;
Protection of the interests of manufacturers of medicines based on hu
an somatic cells and medicines containing genetically modified cells,
authorized bodies (expert organizations) in the sphere of healthcare of the
Member States of the Union
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8.
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Relevant
documents:
Draft
amendments on the Rules for Investigation of Biological Medicinal Products of
the Eurasian Economic Union (140 pages in Russian)
https://docs.eaeunion.org/ria/ru-ru/0106437/ria_09022024
Decision
№ 89 of the Council of the Eurasian Economic Commission of November 3, 2016
https://docs.eaeunion.org/docs/ru-ru/01411954/chcd_21112016_89
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9.
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Proposed date of adoption: To be determined
Proposed date of entry into force: To be determined
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10.
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Final date for comments: 16
March 2024
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11.
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Texts
available from: National enquiry point [ ] or address, telephone and fax numbers and email and
website addresses, if available, of other body:
Eurasian Economic Commission
Department for Technical
Regulation and Accreditation
Tel: +
7(495)669-24-00
Fax: +
7(495)669-24-15
E-mail: dept_techregulation@eurasiancommission.org
Website: www.eurasiancommission.org
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