Glossary entry (derived from question below)
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
7 viewers *
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.
Заранее благодарю
ЛС - лекарственные средства.
Заранее благодарю
Proposed translations
(English)
3 | subjects responsible for drug circulation | Sofia Gutkin |
3 | subjects of circulation of medicines | Oleg Lozinskiy |
Change log
Jul 14, 2017 03:01: Sofia Gutkin Created KOG entry
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'.
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RF Law No. 86-FZ dated June 22, 1998 was repealed by RF Law No. 61-FZ "On Circulation of Medicines" dated March 24, 2010.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.
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.
Discussion
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...