11 sectoral organisations of drug manufacturers, distributors, pharmacy and patient community, addressed to the President of the Russian Federation with a collective letter in which have stated the need to reschedule the launch of the compulsory labelling of medicines, scheduled for 1 July this year.
To address, in particular, joined the Association of Russian pharmaceutical manufacturers (ARPM), Association of international pharmaceutical manufacturers (AIPM), Association of independent pharmacies, all-Russian Union of patients.
The appeal notes that the situation with the pandemic COVID-19 demanded an unprecedented effort from the pharmaceutical manufacturers and all participants in the distribution chain – they needed to start production of essential health medicines and ensure their uninterrupted supply at health facilities.
“It is for the reasons of the global force-majeure nature of the current readiness of the system for the labelling of medicines and the entire supply chain, according to our professional estimates, now not permitting to ensure continuity of drug supply as one of the key factors of social stability in these conditions,” the letter reads.
Industry representatives also draw attention to the impossibility of setting up the equipment for marking in conditions of continuous production, restricting the availability of transportation, the inevitable increase in terms of supply of equipment for the labeling of drugs, the lack of mobility of technical professionals, the gap supply chain, workload, hospitals and pharmacies and other negative factors associated with the epidemiological situation and quarantine measures.
Also, according to them, there remain a number of unresolved questions of organizational and technological nature: not approved changes to the government’s Decree No. 1556 from 14.12.2018 year in accordance with the Federal law No. 449 and the purpose of optimization of system-critical business processes, under standard forms of contracts for the provision of services for the provision of marking codes, there remains the problem of the numerous errors in descriptions of drugs associated with a Single reference catalog of the PL have problems from IT providers and integrators serialization of data, etc.
In such a situation the launch of the labelling system within the planned timeframe will inevitably lead to increased risks of detektory BOS, the authors of the letter.
Currently, the State Duma is debating a bill to postpone the introduction of mandatory labeling on January 1, 2021, a proposal shall be considered at the meeting of the Interfactional group of the lower house of Parliament on 3 June.