Registration Documents Needed For Pharmaceutical Substances In Russia

To register a medicinal product where the active pharmaceutical ingredient is “substance-powder”

At the initial stage, the cost of the API is of interest.

Please inform me about the cost of this substance, namely 25 kg-50 kg-100 kg-300 kg -500 kg-1000 kg?

Is it also necessary to understand the timing of the production of this substance?

The ability to provide an API sample in the amount of 1 kg, the cost of this sample?

On what conditions are we ready to provide a dossier for registration of a medicinal product, a list of necessary documents further in the text:

To register a medicinal product, please provide the following documentation for the pharmaceutical substance “Cefazolin sodium sterile”

1.Copy of production license or GMP certificate

2.Copy of the decision to include the pharmaceutical substance in the GRLS or a copy of the marketing authorization (if any)

3.DMF for a substance containing the following information

a) the name of the pharmaceutical substance, its structure, general properties;

b) the name and address of the manufacturer;

c) production technology with a description of the stages of production and control methods at all stages of production;

d) a description of the development of the production process;

e) description of control of critical stages of production and intermediate products;

f) documentary evidence (validation) of processes and their assessment;

g) properties and structure of active ingredients;

h) characterization of impurities;

i) specification for a pharmaceutical substance and its justification

j) analytical techniques used in the quality control of the pharmaceutical substance;

k) documentary confirmation (validation) of analytical procedures used in quality control of pharmaceutical substances;

l) the results of the analysis of a series of pharmaceutical substances;

m) a list of reference materials or substances used in quality control;

o) a description of the characteristics and properties of packaging materials and closures;

o) data on the stability of the pharmaceutical substance;

p) expiration date.