Essence of the Law:
The law introduces significant changes to the regulation of registration and circulation of medicines in Ukraine. The main innovations concern simplifying the registration procedure for drugs purchased by the state, creating a National Catalog of Medicine Prices, and establishing restrictions on monopolization of the pharmaceutical market.
Structure and Main Provisions:
1. The state registration procedure for drugs purchased by the state is changing – registration of medicines registered in countries with strict regulation is being simplified.
2. A National Catalog of Medicine Prices with a reference pricing mechanism is being created.
3. Restrictions on concentration in the pharmaceutical market are being introduced – a manufacturer/importer cannot sell more than 20% of annual volume to one buyer.
4. New requirements for pharmacy networks and their marketing activities are being established.
Most Important Provisions for Use:
1. A unified State Register of Medicines is being introduced as an information and communication system.
2. Margin limits for medicines are being set – wholesale up to 8% and retail according to the Cabinet of Ministers resolution.
3. Pharmacies are obliged to have medicines with the lowest prices from the National Catalog in stock.
4. Electronic prescriptions must contain information about the cheapest analog of the prescribed medicine.
5. Restrictions on advertising and marketing services in pharmacies are being introduced.
