Text of Instruction: Simple and Clear
A draft of institutional order “On approval of requirements to instruction on medical use of drugs”, prepared by the Ministry of Healthcare of the Russian Federation, is placed for public discussion.
The document specifies the requirements to the instruction for use of drug, included into the marketing authorization dossier. According to the new requirements, it should be approved by the Ministry of Health of the Russian Federation within the framework of the procedure of marketing authorization of the drug and be issued simultaneously with the marketing authorization certificate for the drug specifying the number of the certificate and the date of marketing authorization in the text of the instruction.
The text of the instruction should be brief, clear and contain no repetitions (within one section). It should be put in simple terms so that any ambiguity be avoided. In other words, having read the instruction, the patient should have full and understandable information to guide proper self-use of the drug. The instruction translated to the Russian language from other languages should be adjusted to Russian terminology.
The above requirements shall be applied to instructions for medical use of drugs, submitted for marketing authorization after the document comes into effect.
Public discussion of the document will continue to April 21, 2016.