Russia: Adopted requirements for the content of an instruction for a veterinary medicine

All veterinary medicines for which a registration application was submitted before 27 November 2017, the instruction must contain information set out by the adopted Order.
Any instruction for a veterinary use of a medicine must contain information on:

The name of the medicine;

Description of the medicine;

Medicinal form of the drug;

Pharmacotherapeutic group of the medicine or an indication “homeopathic medicine for veterinary use”;

Pharmacodynamic and pharmacokinetic (except homeopathic preparations) or a description of immunobiological properties;

Indications for use;


Dosage; etc.

It is not allowed to use text written in capital letters except for the heading: “INSTRUCTION FOR THE VETERINARY USE OF USE OF THE MEDICINE”, after which it is required to specify the name of the product in Russian language (and in English and Latin language, if applicable).

The text of the instruction must be printed in a font with such a size that any symbol is at least 1,4 mm high and with the space between the lines of at least 3mm.

The Instruction must be approved by the Federal Service on Veterinary and Phytosanitary Control during the process of registration of the medicine.

Law: Order No. 430 of 22 August 2017 on the Requirements for the Instruction on the Veterinary Use of a Medicine