Glossary entry

Russian term or phrase:

субъекты обращения ЛС

English translation:

subjects responsible for medicine circulation

Added to glossary by Sofia Gutkin
Jul 10, 2017 21:19
6 yrs ago
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Russian term

субъекты обращения ЛС

Russian to English Medical Medical: Pharmaceuticals
В Российской Федерации в соответствии с п. 1 ст. 41 Федерального закона от 22 июня 1998 года № 86-ФЗ «О лекарственных средствах» ***субъекты обращения ЛС*** обязаны сообщать федеральному органу исполнительной власти, в компетенцию которого входит осуществление государственного контроля и надзора в сфере здравоохранения (Федеральная служба по надзору в сфере здравоохранения и социального развития), и его территориальным органам обо всех случаях побочных действий ЛС и об особенностях взаимодействия ЛС с другими ЛС, которые не соответствуют сведениям о ЛС, содержащихся в инструкциях по их применению.

ЛС - лекарственные средства.

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Change log

Jul 14, 2017 03:01: Sofia Gutkin Created KOG entry

Discussion

Frank Szmulowicz, Ph. D. Jul 11, 2017:
Here is a very good answer from yesteryear:
Natalie
entities engaged in circulation of medications
http://www.proz.com/kudoz/russian_to_english/medical_pharmac...

I might change it to "medicinal products."
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Russian term or phrase: субъектам обращения лекарственных средств
English translation: Companies? handling the distribution of pharmaceuticals
http://www.proz.com/kudoz/russian_to_english/medical_pharmac...

Proposed translations

3 hrs
Selected

subjects responsible for drug circulation

I think this is referring to Федеральный закон от 12 апреля 2010 г. N 61-ФЗ "Об обращении лекарственных средств" (https://rg.ru/2010/04/14/lekarstva-dok.html) which can be translated as 'On the Circulation of Medicines'.
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4 KudoZ points awarded for this answer. Comment: "Thank you."
11 hrs

subjects of circulation of medicines

RF Law No. 86-FZ dated June 22, 1998 was repealed by RF Law No. 61-FZ "On Circulation of Medicines" dated March 24, 2010.
Article 4. Basic Terms Used in this Federal Law

For the purpose of this Federal Law the following basic concepts are used:

1. Medicines;
2. Pharmaceutical substances;
3. Excipients;
4. Medicinal products;
5. Dosage form;
6. List of vital and essential medicinal products;
7. Immunobiological medicinal products;
8. Narcotic medicines;
9. Psychotropic medicines;
10. Radiopharmaceutical medicines;
11. Originator medicine;
12. Generic medicine;
13. Herbal medicinal raw material;
14. Herbal medicinal product;
15. Homeopathic medicine;
16. International nonproprietary name of a medicine;
17. Trade name of a medicine;
18. General pharmacopoeia monograph;
19. Pharmacopoeia monograph;
20. Normative documentation;
21. Normative document;
22. Quality of a medicine;
23. Safety of a medicine;
24. Efficacy of a medicinal product;
25. Batch of a medicine;
26. Registration certificate of a medicinal product;
27. Registration number;
28. Сirculation of medicines;
29. Subjects of circulation of medicines;
30. Developer of a medicine;
31. Manufacturing of medicines;
32. Manufacturer of medicines;
33. Pharmaceutical activities;
34. Wholesaler of medicines;
35. Pharmacy institution;
36. Veterinary pharmacy institution;
37. Infiringing medicine;
38. Poor quality medicine;
39. Сounterfeited medicine;
40. Preclinical testing of a medicine;
41. Clinical trials of a medicinal product;
42. Multicentre clinical trial of a medicinal product for medical use;
43. International multicentre clinical trial of a medicinal product for medical use;
44. Post-registration clinical trial of a medicinal product for medical use;
45. Bioequivalence study of a medicinal product;
46. Therapeutic equivalence study of medicinal products;
47. Protocol of a clinical trial of a medicinal product;
48. Investigator's brochure;
49. Patient information sheet;
50. Side effect;
51. Serious adverse reaction;
52. Unexpected adverse reaction;
53. Medicinal product prescription;
54. Medical institution or veterinary institution order.
http://www.consultpharma.ru/index.php/en/documents/drugs/152...

Subjects of circulation of medicines are individuals, including, but not limited to individual entrepreneurs, and legal entities engaged in circulation of medicines
http://www.consultpharma.ru/index.php/en/documents/vocabular...

P.S. There could be other translations of this law into EN.

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