Serialization: is the business ready?

Serialization: vision of national track&trace system operator By September 2019: more than 24 thousand participants are registered *, the number of registrations in the system is constantly growing 26 million packages serialized * 5,9 K Drugs are serialized The transition from experiment to mandatory drug serialization will be seamless * Contrary to the market expectations, there will be no postponement * The Industrial Development Fund issued 35 loans of 1.3 billion rubles* in total for the purchase of specialized equipment (1% per annum for up to 2 years) *По данным ЦРПТ

Serialization: vision of the Business Producer The first withdrawal registering device was tested in Moscow only in August 2019. Producer Medical Institutions Withdrawal registration procedure takes 1-3 min Low readiness despite of the pilot project with high-cost nosologies Wholesaler Finished product code downloading to the scan system may slow down the production % of packaging defects increase Pharmacies Serialization of products sold in primary packaging an issue still Slowing down of the orders processing Weak Internet coverage Most manufacturers are reporting the readiness by January 1, 2020 Reverse acceptance as a necessary temporary measure Slow down of orders reception from the wholesaler High readiness level declared by the majority of TOP 5 distributors Lack of sufficient information from the operator and authorized regional bodies.

Serialization: Bosnalijek experience The need to put a code on manufactured products as early as 2019, without registering them in the system (Decree of the Government of the Russian Federation of December 14, 2018 No. 1557) “... drug circulation entities that are manufacturers of drugs ... ensure the application of drug identification means on the primary packaging of the drug (if secondary packaging is not provided) and on the secondary (consumer) packaging of the drug from October 1, 2019 ” Reduction of the crypto part from 88 to 44 characters by Decree No. 1118 of August 30, 2019 does not allow to complete software setup and printing equipment by October 01, 2019 An increase in the packaging size of one of Bosnalijek key products was required for high-quality serialization, which entailed additional regulatory and marketing costs and COG increase

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