complies with all the requirements of production and manufacturing
quality control of drugs, issued by the competent authority in the country of
manufacturer

3) The draft regulatory document or legal instrument for drug
preparation or instruction relevant pharmacopoeial monograph;
4) The scheme of technological process of production of the drug, its description and
(Or) the scheme of the technological process of the pharmaceutical substance, its description;
5) The document, translated into Russian, confirming that the manufacturer
of the pharmaceutical substance complies with the rules of organization and control of the Quality of Medicines issued by the competent authority of pharmaceutical substance’s country of origin, which shall contain:
a) name of the pharmaceutical substance (or nonproprietary
chemical and trade names);
b) the name and address of the manufacturer of pharmaceutical substance;
c) the shelf life of pharmaceutical substance;
6) a document containing information regarding the quality of pharmaceutical substances
used in the manufacture of drugs;
7) The regulatory documents or regulations on pharmaceutical substance,
any indication of the relevant pharmacopoeial monograph;
8) information on the conditions of storage, transportation and other drug
information;
9) report on the results of preclinical studies of the drug’s
medical use, containing a description of the results and statistical analysis
results of preclinical studies;
10) report of the results of preclinical studies of drug and
Clinical trials of medicines for veterinary use;
11) the draft protocol of the clinical trials of medicines for
medical use;
12) Investigator's Brochure;
13) patient information leaflet;
14) information about payments and compensation to patients (healthy volunteers, healthy patients)
(Hereinafter - the patients), attracted to conducting clinical trials of medicinal
the drug for medical use, bioequivalence studies and (or)
therapeutic equivalence;
15) report on the results of international multicenter clinical trials of
the drug for medical use, some of which were held in
Russian Federation;
16) draft instructions for using a drug that contains the following
Information:
a) name of drug (or nonproprietary
chemical and trade names);
b) The dosage form of the name and the quantity of
(Activity) of pharmaceutical substances and excipients;
c) Pharmacological drug group;
d) indications for use;
e) contraindications for use;
e) the dosage, route of administration, if necessary, while taking medication
drug, duration of treatment (including the children before and after one year);
g) safety precautions when using;
h) symptoms of overdose, measures to assist in overdose;
and) an indication, if necessary, the features of the drug in
first call or when its abolition;
a) A description, if necessary, actions, medical (medical assistant), a specialist in the field
veterinary medicine, the patient, the owner of the animal you missed taking one or more doses
drug;
l) the possible side effects when using the drug;
m) interaction with other drugs and (or) food;