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перерегистрация действующего регистрационного удостоверения

English translation: re-registration of current registration certificate

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Russian term or phrase:перерегистрация действующего регистрационного удостоверения
English translation:re-registration of current registration certificate
Entered by: Oleg Lozinskiy

11:01 Mar 22, 2020
Russian to English translations [PRO]
Medical - Medical: Health Care / pharmacovigilance
Russian term or phrase: перерегистрация действующего регистрационного удостоверения
При получении Компанией регистрационного удостоверения (РУ) на новый лекарственный препарат / перерегистрации действующего РУ / обновления списка ЛП находящихся в рамках полномочий Компании, УЛФ проводит внеплановый анализ справочных баз данных для определения базы данных, содержащей максимальное количество ссылок на статьи, имеющие отношение к подлежащему мониторированию лекарственному препарату и, при необходимости, обновляет форму по Приложению 2 .
Artyom Timeyev
Russian Federation
Local time: 12:47
re-registration of current registration certificate
Explanation:
Re-Registration

The approval of registration certificate and import license of drugs are issued for specific time periods and are required to be renewed under the Drugs and Cosmetic Act 1940 & Rules 1945 as amended.

In context to Re-Registration, there is no term such as Re-Registration in the Drugs and Cosmetic Act 1940 and Rules 1945 there under. Therefore an applicant has to submit the Re-Registration application (for obtaining the Form 41) in which the Drug Master file (DMF) and Site Master File (SMF) are not required to be submitted again as they have been submitted with the parent application. The application for Re-Registration Certificate is made nine months before the expiry of the existing certificate. The current Registration Certificate shall be deemed to continue in force until orders are passed on the application.
https://cliniexperts.com/india-regulatory-services/drug/for-...

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Note added at 19 мин (2020-03-22 11:20:56 GMT)
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Вариант: reregistration of the current Certificate of Registration

TITLE 21--FOOD AND DRUGS
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION
DEPARTMENT OF JUSTICE

PART 1301 -- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

Action on Application for Registration: Revocation or Suspension of Registration
Sec. 1301.35 Certificate of registration; denial of registration.

(a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if the issuance of registration or reregistration is required under the applicable provisions of sections 303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the issuance of registration or reregistration is not required, the Administrator shall deny the application. Before denying any application, the Administrator shall issue an order to show cause pursuant to 1301.37 and, if requested by the applicant, shall hold a hearing on the application pursuant to 1301.41.

(b) If in response to a show cause order a hearing is requested by an applicant for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, notice that a hearing has been requested shall be published in the Federal Register and shall be mailed simultaneously to the applicant and to all persons to whom notice of the application was mailed. Any person entitled to file comments or objections to the issuance of the proposed registration pursuant to 1301.33(a) may participate in the hearing by filing notice of appearance in accordance with 1301.43. Such persons shall have 30 days to file a notice of appearance after the date of publication of the notice of a request for a hearing in the Federal Register.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...
Selected response from:

Oleg Lozinskiy
Russian Federation
Local time: 10:47
Grading comment
Thank you!
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2re-registration of current registration certificate
Oleg Lozinskiy


  

Answers


12 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
re-registration of current registration certificate


Explanation:
Re-Registration

The approval of registration certificate and import license of drugs are issued for specific time periods and are required to be renewed under the Drugs and Cosmetic Act 1940 & Rules 1945 as amended.

In context to Re-Registration, there is no term such as Re-Registration in the Drugs and Cosmetic Act 1940 and Rules 1945 there under. Therefore an applicant has to submit the Re-Registration application (for obtaining the Form 41) in which the Drug Master file (DMF) and Site Master File (SMF) are not required to be submitted again as they have been submitted with the parent application. The application for Re-Registration Certificate is made nine months before the expiry of the existing certificate. The current Registration Certificate shall be deemed to continue in force until orders are passed on the application.
https://cliniexperts.com/india-regulatory-services/drug/for-...

--------------------------------------------------
Note added at 19 мин (2020-03-22 11:20:56 GMT)
--------------------------------------------------

Вариант: reregistration of the current Certificate of Registration

TITLE 21--FOOD AND DRUGS
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION
DEPARTMENT OF JUSTICE

PART 1301 -- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

Action on Application for Registration: Revocation or Suspension of Registration
Sec. 1301.35 Certificate of registration; denial of registration.

(a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if the issuance of registration or reregistration is required under the applicable provisions of sections 303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the issuance of registration or reregistration is not required, the Administrator shall deny the application. Before denying any application, the Administrator shall issue an order to show cause pursuant to 1301.37 and, if requested by the applicant, shall hold a hearing on the application pursuant to 1301.41.

(b) If in response to a show cause order a hearing is requested by an applicant for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, notice that a hearing has been requested shall be published in the Federal Register and shall be mailed simultaneously to the applicant and to all persons to whom notice of the application was mailed. Any person entitled to file comments or objections to the issuance of the proposed registration pursuant to 1301.33(a) may participate in the hearing by filing notice of appearance in accordance with 1301.43. Such persons shall have 30 days to file a notice of appearance after the date of publication of the notice of a request for a hearing in the Federal Register.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...

Oleg Lozinskiy
Russian Federation
Local time: 10:47
Native speaker of: Native in RussianRussian
PRO pts in category: 64
Grading comment
Thank you!

Peer comments on this answer (and responses from the answerer)
agree  Frank Szmulowicz, Ph. D.
1 hr
  -> Thank you, Frank!
agree  Ravindra Godbole
1 hr
  -> Thank you, Ravindra!
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