Pharmaceutical substances for drugs manufacturing and pharmaceutical substances not used in drugs manufacturing have to be inserted in the State Register of drugs nowadays. We shall consult you about recent requirements for inscription the substance on the Register, prepare the dossier for submission, submit it to the MOH, monitor the process of expertise of pharmaceutical substance, receive the Decision of Inscription in the State Register and give it to You.
The Federal Law № 61 «About Circulation of Drugs» says that «Pharmaceutical substance is the drug in a form of active substance of biological, biotechnological, mineral or chemical nature with pharmacological properties, that intended for manufacturing, making drugs and define drugs efficiency».
Pharmaceutical substance is synonymous to the «active pharmaceutical ingredient».
The active pharmaceutical ingredient is any substance or mixture of substances intended for drugs manufacturing that become the active ingredient of this drug in the process of manufacturing. These kind of substances meant for pharmacological activity manifestation, or any other direct influence in diagnostics, treatment, relieving the symptoms, or for the prophylaxis, or for affecting the body structure or functions.