Article 33. State Register of Medicines

1. The state register of medicines contains the list of medicinal products which passed state registration, the list of pharmaceutical substances included in the composition of medicinal products and the following information:

1) with respect to medicinal products:

a) name of the medicinal product (international nonproprietary or chemical name of and trade name);
b) dosage form with indication of dosage rate of the medicinal product and its quantity in consumer package;
c) name of developer of the medicinal product;
d) name and addresses of the manufacturer of the medicinal product;
e) pharmacotherapeutic group of the medicinal product;
f) indications and contraindications for use of the medicinal product;
g) side effects of the medicinal product;
h) shelf life of the medicinal product;
i) storage conditions for the medicinal product;
j) dispensing conditions for the medicinal product;
k) number of pharmacopoeia monograph and, failing the latter, of normative documentation or normative document;
l) date of state registration of the medicinal product and registration number thereof and;

2) with respect to pharmaceutical substances:

a) name of the pharmaceutical substance (nonproprietary or chemical name of and trade name);
b) name and address of the manufacturer of the pharmaceutical substance;
c) shelf life of the pharmaceutical substance;
d) storage conditions for the pharmaceutical substance;
e) number of the pharmacopoeia monograph and, failing the latter, of normative documentation or normative document.

2. A pharmaceutical substance not used in the manufacturing of medicinal products may be included in the state register of medicines on the basis of the developer’s application, or manufacturer of the medicine, or a legal entity authorized by any of them, provided that the pharmaceutical substance was duly evaluated for quality as prescribed in article 34 of this Federal Law.

3. The procedure for maintenance of the state register of medicines intended for medical use and the procedure for maintenance of the state register of medicines intended for veterinary use shall be approved by the relevant authorized federal executive body.