1. Application on variations in a form established by a competent federal executive authority;

2. Variations to the specified documents;

3. Documents proving the necessity of variations;

4. Document proving payment of state fee for variations to the prescribing information of a medicinal product for human use;

5. Document proving payment of state fee for variations to the composition of a medicinal product for human use;

Documents must contain enough information for proving the necessity of variations!

Expert evaluation of a drug quality and/or assessment of expected risk/benefit ratio of a medicinal product for human use is conducted in case the variations concern:

- the following sections of the prescribing information:

d) therapeutic indications;
e) contraindications;f) posology, method of administration and, if necessary, time of administration, duration of treatment (including in children below and over one year of age);
g) special precautions for use;
h) symptoms and treatment of overdose;
i) if necessary, peculiarities of action of the product following the first administration or discontinuation;
j) if necessary, actions to be taken by physicians (nurses), veterinary specialists, patients, or animal’s owners in case one or several doses are missed;
k) adverse reactions that may occur following administration of the drug product;l) interactions with other medicinal products and/or food;
m) use of the product in pregnant or breastfeeding women, children and adults with chronic diseases;
n) effects of the product on the ability to drive and use machines;
o) shelf-life and a warning that the product should not be used after the expiry date;
t) dispensing conditions;

- composition of a medicinal product for human use;
- manufacturing site;
- quality parameters;
- quality control methods;
- shelf-life.

Based on:

Federal Law №61-ФЗ "On drugs”, Chapter 6 State registration of drug products, Article 30. Variations to the documents contained in the registration dossier for an authorized drug product for human use

Article 333.32.1. State fees for competent federal executive authority activities related to state registration of drugs. Federal Law No. 41-ФЗ dated 05.04.2010

List of documents necessary for inclusion of a drug substance in the Russian Federation State register of medical products
List of documents for registration of drugs in Russia
List of documents necessary for approval of a clinical trial of a medicinal product