Making amendments to the regulatory documents for the approved medicinal product

In case of making amendments to the instruction for medical application regarding the data listed in sub-paragraphs "д" - "п", «х» of paragraph 16,  part 3, Article 18 of Federal Act № 61-FA, viz.:

д) contra-indications;
е) dosage regimen, route of administration, medicinal product intake time (if necessary), length of treatment (including  treatment of early infancy and young children);
ж) precautions for medical use;
з) overdosage symptoms, relief measures in case of overdosage;
и) special warnings and special precautions when using the medicinal product for the first time and in case of its coming off (if necessary);
к) taking actions by the doctor (the veterinarian, the patient, the owner of the animal)  in case of failing/forgetting to take in one or several doses of the medicinal product;
л) possible side effects while using the medicinal product;
м) interactions with other medicinal products and other forms of interaction;
н) special warnings and special precautions for use in  pregnancy and lactation, for use by children and (or) adults having some pre-existing conditions;
о) effects on ability to drive and use machines;
п) proposed shelf-life and prohibition against using the medicinal product upon its shelf life expiration;
х) Marketing Status (pharmacy purchasing terms);

as well as in case of making amendments to the composition of the medicinal product, the expertize of the medicinal product quality control and (or) the expertize of relation of expected advantage to possible risk of the medicinal product intake (benefit-risk expertize) is to be carried out. In case of making some other amendments to the instruction for medical application, the medicinal product expertize is not carried out.

In case of making amendments to the regulatory documents for the approved medicinal products, the Applicant submits an application for making such amendments to the corresponding authorized federal body of the executive branch - Ministry of Health and Social Development of RF (Minzdravsocrazvitiya Rossii), made in due form and approved by this authorized federal body, with attached draft modifications to the regulatory documents, documents, which confirm the necessity of making these amendments, documents confirming payment of State duty for making amendments to the Information Leaflet for a human drug preparation, State duty for Making amendments to the composition of a human drug preparation. The procedure of making amendments to the regulatory documents for the approved medicinal products is carried out within the time-limit of 90 (ninety) working days and begins on the date of submitting an application for making amendments to the Ministry of Health and Social Development of RF (Minzdravsocrazvitiya Rossii).