Table Of Contents (TOC) for BELARUS

BELARUS

Authority

website

if any

REQUIREMENT FOR PRODUCT REGISTRATION

S.No.

PARTICULARS

Page #

1.

Presentation Letter in Russian

2.

Application: summary containing brief information on the following points in Russian/English

a)

Company name/country

b)

Manufacturer/country

c)

Product name

d)

INN (international non-proprietary name)

e)

Manufacturer of an active substance/country

f)

Composition (name & quantity of active ingredients as well as excipients)

g)

Note changes appeared since the date of registration*.

h)

Presentation and doses of an active ingredient (for a single-component products)

i)

Standard commercial package (primary & secondary)

j)

Mode of usage (per oral, for injections etc.)

k)

Basic indications

l)

Expiry date

m)

Storage

n)

Patentee in Belarus

o)

Product Price of the Manufacturer

3.

Registration Certificates for a country of the origin and of the other countries (original or authorized copy)

4.

GMP Certificate (authorized copy) + Free Sale Certificate (authorized copy) + Certificate of Pharmaceutical Product (original - “Importing Country: Belarus”)

5.

Manufacturing License (authorized copy)

6.

Instructions on use /for specialists (1) & patients (2), leaflet (3) /in Russian (original)

7.

Detailed composition of the product & quality control of the every component (original + translation in Russian)

8.

Layout of the technological process (manufacture) (original + translation in Russian)

9.

Normative Documentation for quality control of pharmaceutical substance & active/non-active additives (original + translation in Russian)

10.

Quality control and tests of intermediate products/derivatives

11.

Normative Documentation for quality control & certificates of the final product (3 lots) (original + translation in Russian)

12.

The sample of the Quality Certificate of the pharmaceutical substance & Quality Certificate of the final product (the same 1 lot)

13.

Reference: metrological control  of the equipment

14.

The sample of the commercial packing tagged label in Russian

15.

The protocol of the stability test - (2 or more lots) (original + translation in Russian)

16.

Protocols of the bioequivalent study

17.

The results of the investigation – not for generic medicines, if presented protocols of bioequivalent study (original + translation in Russian):

18.

Expert reports on pre-clinical and clinical study (including publications and other data) (original + translation in Russian or abstracts in Russian)

19.

Commercial Price of the Product (in Application)