CONTENTS
- 1. Copyright (c) 2014 SHINSEGAE LANGUAGE SCHOOL. All Rights Reserved.
- - Difference between items
- 2. Copyright(c) SHINSEGAE CO.,LTD. All Rights Reserved.
- - Pharmacy system and item permission
- - Governing Law
- 3. Item permission | Target and Standard
- - Disputes and reporting subjects
- - Product Type Regulation Difference
- - Terms and Conditions for Overnight Stay
- 4. Item permission | Procedure
- - Application
- - Examination and Compensation Procedure
- - Terms and Conditions
- 5. Copyright (c) 2014. All Rights Reserved.
- - Application
- - CTD system and practical application
- 6. Copyright (C) 2018. All Rights Reserved.
- - Legal responsibility for the event
- - Copyright (c) 2015 DAEWOO. All Rights Reserved.
1. Copyright (c) 2014 SHINSEGAE LANGUAGE SCHOOL. All Rights Reserved.
Approx. It is an administration that allows the market distribution before manufacturing or importing the medicines, ensuring that the product's safety, Effectiveness, Quality is pre-expected by the state.
It has a strong regulatory nature in terms of practical examinations based on scientific materials. News /span>
In particular, the manufacturer must be authorized separately for each product. “Product Unit Regulations”.
This is reflected that even if it is the same manufacturer, it can be safe and effective by product. News /span>
Difference between items
the item permission and item identification are all procedures for the distribution of medicines, but there are differences in the application and examination level. News /span>
Item permission |
2. Copyright(c) SHINSEGAE CO.,LTD. All Rights Reserved.
The item permission has a structure combined with multiple sub-regulations around the pharmacy.
You need to take a look at the statute system to understand the permit procedure. News /span>
Pharmacy system and item permission
<1 The purpose of the manufacturing of the drug is to obtain the safety of the food according to the facility standard specified by the President.
2 1. The manufacturer in accordance with Paragraph 1 of the manufacture (includes manufacturing for other manufacturers). In the case of selling medicines, the manufacturer of food-related safety products (hereinafter referred to as “product permits”) shall be obtained or sold to the sale item.
>The person who wants to upgrade the import of the drug products shall be subject to the approval of the food item according to the general rule. also same as if you want to change the permissions or the notifications.
"Pharmaceuticals" Article 31 is required for manufacturing medicines and Article 42 is required for the same item authorization or declaration for imported medicines. News /span>
In particular, in the case of imported medicine, the item permission is principle, which is to apply the same level of regulation as domestic manufacturing medicine.
Now, even if it is an approved medicine from abroad, it is necessary to run a separate authorization procedure to be distributed in Korea. News /span>
(Multi Only Clinical Trial Medicine, In some exceptions such as rare medications, imports may be allowed without item permission. )
Governing Law
The actual procedure is aligned by the following subregions: News /span>
This regulation specifies the type of submission material, simplified standard, chart; GMP submission of related materials is legally required. News /span>
3. Item permission | Target and Standard
Item permit is not a system that is applied to all medicines component of the medicine, manufacturing method, experience, distance data accumulation,etc.
The drug is required for strict advance screening if there is a new ingredient or high risk of direct action in the human body, and if it is fully proven, the regulator has a mitigated structure. News /span>
Disputes and reporting subjects
Item permit target | The medicine containing a new drug or a new active ingredient is not valid for the human body because it is not enough for the effect. In this case, the applicant must submit the material that can prove safety and validity such as clinical trial data, non-toxic test data, and the certificate is based on this. News /span> In case of a standardized medicine, it may be classified to the report. If you are unable to submit a separate clinical data, we will take a look at whether it is appropriate or not. |
Product Type Regulation Difference
The drug is viewed in the same category, but it is actually applied to all kinds of medicines, medical medicines, reverse medicines and etc. News /span>
Perfect medicine is the final product that is administered directly to the patient.
Safety, Effective, Quality data is all required and the importance of clinical trial data is very large. News /span>
is a component used for the manufacturing of finished medicines, which is a key factor for the consistency of quality and manufacturing processes.
In this case, it is mainly based on quality materials and manufacturing standards. News /span>
Also, rare medicines is because there are many cases where the number of patients applied is very small and there is no alternative medicines the same level of material demand is realistic.
With this, data submission can be mitigated or conditional permission may be made. News /span>
Terms and Conditions for Overnight Stay
Item permits exist in case the law permit itself is limited to pre-registration.
Representatively "The rules regarding the safety of medicines, etc. are limited to items. News /span>
(*Yes: Vietnamese teen infection hazardous raw materials etc.
• If you use the name that you can cause obesity or confusion to the people,
in particular, the regulation related to product names may be limited if you express efficacy and effectiveness directly or using an exaggerated name. News /span>
4. Item permission | Procedure
This is an important factor to determine the possibility of permitting to understand the procedure because the screening is progressed based on the content and completion of the publication materials. News /span>
Application
< style="color:black;">This process can be repeatedly progressed in accordance with the complementary requirements The total length may vary greatly depending on the number of times and content. News /span>
Examination and Compensation Procedure
Food and Drug Administration is required to supplement if the submitted material is not short or consistent with scientific criteria.
This complementary process is There are many cases that include substantial data supplements such as additional submissions or modifications of reference materials. News /u>
Also, in the process of the screening process, compared with consistent medicines, Equipment permit cases, International standards are also considered and/nbsp;Unacceptable via comprehensive review.
Terms and Conditions
For some medicines, if competitive need is recognized, the conditional permit may be made.
This applies to medicines or alternative treatments for a great disease treatment, etc., and is licensed as a prerequisite to complement regular materials. News /u>
It is an exception system, so it is necessary to take care of additional regulations such as cancellation of permission if the following data submission obligations are not fulfilled. News /span>
5. Copyright (c) 2014. All Rights Reserved.
The actual document is documented and documented. News /span>
Application
The material required for item permission is largely divided into safety, enability, quality data.
CTD system and practical application
In the event, you will be able to submit the submission materials such as CTD(Common Technical Document) type.
CTD is an internationally commonly used pharmaceutical authoritative material standard, the composition and application of data are organized. News /span>
This system allows the judge to review the material as a consistent basis. You can also secure connection with the global permit process.
News /span>
6. Copyright (C) 2018. All Rights Reserved.
Cancel denied or canceled, The data submission related matters may lead to administrative judgments or administrative affairs, and the criminal liability may be carried out according to the fact.
A systematic law review must be made in advance from the permit phase to follow. News /span>
Legal responsibility for the event
Copyright (c) 2015 DAEWOO. All Rights Reserved.
The law firm provides advice on all stages from the review of submissions required in the course of the drug items permit.
In particular, we review the legal issues of safety and efficacy materials that are competitive in the process of screening and focus on improving the possibility of permits by cleaning the response direction to complete needs. News /span>
Also, if the permit is denied or canceled, we will review whether the disposition of the disposition of the disposition of the disposition, and proceed to the administrative trial and administration response. review the possibility of criminal measures in need. <% if (imgObj.width >= imgObj.height) { %> <% if (image rate > 5) { %> News /span>
