Now the list of ONLS (Provision of essential drugs) irrelevant, as formed from essential and special medical commissions of medical institutions. Now these commissions will not be needed. To provide necessary medicines to regional beneficiaries under the regional programs will also be in the volume of EDL.
moreover, to September 1, 2020, Russia will have a Federal register of beneficiaries entitled to free medicines and those, which are released on recipes of doctors with 50% discount. As explained in the Ministry of health, the register will allow to organize automatic control for preferential drug provision, to predict the needs of individuals and the funding needed for their treatment.
Another new law for the labeling of drugs. It gives the government the right to establish a special procedure for the entry into circulation of unmarked drugs made from July 1 to October 1, 2020 and authorizes up to 1 January 2021, imports of drugs without labeling, if they are issued before October 1, 2020, in addition to medications intended for patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissue, multiple sclerosis and also people who have undergone organ transplantation.
the Law excludes the requirement of state registration of medical devices manufactured for individual patient orders, or in accordance with special requirements of health workers, released in a single copy for personal use and use on the territory of the international medical cluster or innovative research and technology centres.
the Ministry of industry and trade do not see the risk of shortage of medicines in connection with the statement of participants of the pharmaceutical market on the possibility of its occurrence due to the introduction of labelling of medicines. This was stated by the Director of Department of development of pharmaceutical and medical industry of Ministry of industry and trade Alexey Alekhin. According to him, there are temporary difficulties, which are quickly eliminated, and the risk of deficit in connection with the implementation of the marking exists only for the products, which were reported in Russia over the past two years. The Ministry also do not see any serious problems with starting the system of monitoring the movement of drugs (MDLP). Speaking about the impossibility to import foreign products produced before 1 July, in Russia, Alekhine said that foreign manufacturers can bring part of the production process – packing. “We have also envisaged the possibility of applying the stickers with the codes on medicines in Russia,” – uhe has tochni.
Earlier associations uniting participants of the pharmaceutical market, has written to Prime Minister Mikhail Mishustin a letter in which he warned of a possible shortage of medicines. The reason for the July 1 order in which the drugs unlabeled to put into circulation only if the resolution of the interdepartmental Commission. Manufacturers were asked to simplify the entry procedure and also noticed that because of the demand for drugs during a pandemic they failed on many fronts to create “buffer stocks”.
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