The Ministry of health has prepared a bill to systematize the mandatory requirements in the sphere of circulation of medicines. About it writes “the parliamentary newspaper”.
The document proposed to introduce a definition of mandatory requirements in the sphere of circulation of medicines. Under them are understood “the requirements expressed in the form of conditions, restrictions, prohibitions, which are addressed to the actions (inaction), activities, results, implementation of activities, objects, carry out activities of citizens and organizations in the sphere of circulation of medicines and assessed when conducting the state control over circulation of medicines, or for the violation of which establishes liability in accordance with the legislation of the Russian Federation,” reads the bill.
According to the draft, compulsory requirements for the treatment of medicines are established by international treaties, current Federal laws, presidential decrees and acts of the Cabinet of Ministers, in cases stipulated by international treaties.
The document also provides for the establishment of groups of mandatory requirements in the sphere of circulation of medicines:
• the logistical support (buildings, premises, equipment);
• the organization and implementation of development processes (development, testing, production, acceptance, transportation, sale, storage, application) and products;
• to staff (education, training);
• the presence and documentation.