Tuesday, 8 July 2014

List of documents required for registration and re-registration of medical purpose products in Kyrgyzstan

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 manufacturers country
+
3.
Information on registration in other countries with number and date of manufacturing authorization
+
4.
Certificate of Free Sale
+
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 manufacturers country
+
3.
Information on registration in other countries with number and date of manufacturing authorization
+
4.
Certificate of Free Sale
+
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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