List of documents required for registration and re-registration of medical purpose products in Kyrgyzstan
№ п/ п
|
Document name
|
medical purpose products
|
1.
|
Application
|
+
|
2.
|
Document that confirms registration of medical purpose products in the manufacturer’s country
|
+
|
3.
|
Information on registration in other countries with number and date of manufacturing authorization
|
+
|
4.
|
Certificate of Free
|
+
|
6.
|
Document that confirms compliance of the manufacture conditions with national and/or international standards (GMP; ISO, EN)
|
+
|
7.
|
Regulatory document that shall govern medical purpose products: international, national, organizational standard, technical conditions
|
+
|
8.
|
Specifications with indication of technical characteristics, list of accessories and consumables (as per the form)
|
+
|
9.
|
Results of clinical (medical) trials
|
+
|
10.
|
Instructions for application of the medical purpose product (original copy provided by the manufacturer)
|
+
|
List of documents, required for registration of pharmaceutical products in Kyrgyzstan
№
|
Document name
|
pharmaceutical products
|
1.
|
Application for state registration in accordance to form
| |
2.
|
Certificate of Pharmaceutical product (СРР), issued in compliance with WHO recommendations (certified by a notary)
| |
3.
|
Certificate GMP with date and results of last inspection
| |
4.
|
Free sale Certificate
| |
5.
|
Information on registration in other countries with specification of number and date of manufacturing authorization
| |
6.
|
Summary of product characteristics (SPC)
| |
7.
|
Leaflet
| |
8.
|
Color model of packages and labels on printed carriers
| |
9.
|
Qualitative and quantitative composition of pharmaceutical product
| |
10.
|
Approved regulatory document regulating quality and safety of pharmaceutical product
| |
11.
|
Results of stability date
| |
12.
|
Data on bioavailability, bioequivalence
| |
13.
|
Pharmacological and toxicological documentation
| |
14.
|
Clinical documentation
| |
15.
|
Periodic safety update report (in case of reregistration)
| |
16.
|
Samples of pharmaceutical product in amount sufficient for 3-sample analysis performance
| |
17.
|
Standard samples of active substance and impurities
|
List of documents required for registration and re-registration of medical equipment
in Kyrgyzstan
№
|
Document name
|
medical equipment
|
1.
|
Application
|
+
|
2.
|
Document that confirms registration of medical purpose products in the manufacturer’s country
|
+
|
3.
|
Information on registration in other countries with number and date of manufacturing authorization
|
+
|
4.
|
Certificate of Free
|
+
|
5.
|
Document that confirms compliance of the manufacture conditions with national and/or international standards (GMP; ISO, EN)
|
+
|
6.
|
Regulatory document that shall govern medical purpose products: international, national, organizational standard, technical conditions
|
+
|
7.
|
Specifications with indication of technical characteristics, list of accessories and consumables (as per the form)
|
+
|
8.
|
Results of clinical (medical) trials
|
+
|
9.
|
Operation document for medical equipment, including instructions for application of consumables and accessories for medical equipment being medical purpose products
|
+
|
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