Single sourcing of raw materials (including “molecules”) and/or lack of alternative raw material suppliers

Panic buying or stockpiling by patients or pharmacies

Lack of redundancy in production capacity

Geographic concentration of suppliers

Long lead times

Inability of manufacturers to react swiftly to changes in demand and demand forecasts

Inability of parallel traders to react quickly to shortages

Competition for raw materials with other industries, especially the food industry

Consolidation of manufacturers and/or lack of alternative suppliers

Lack of facilities, knowledge, and expertise to reshore raw material production

Lack of transparency about inventory levels and import /export volumes among manufacturers and between manufacturers and wholesalers

Lack of transparency and control of (conditions at) raw material supplier

Lack of transparency and control of supply and demand volumes due to parallel trade

Lack of good systems to monitor drug availability and automated ordering processes between manufacturer and wholesaler

Lack of information transparency between pharmacy and manufacturer/wholesaler about prices, volumes, and source of raw materials

Frequently renewed tenders

Complex and expensive procedures regarding the use of “shared pack” boxes and multilingual boxes/leaflets

Frequent price law recalibrations

Complex, un-harmonized, and expensive registration processes among EU member states for new and existing drugs

Differences in legal (quality) requirements for the same ingredients by the over-the-counter (OTC) board, European Medicines Agency (EMA) board, and food industry

High costs of (complying with) complex legal policies

Long external quality and safety testing procedures

Requirement to have multiple quality tests of the same production batch for different shipments

Inflexibility in demand due to medical reasons and bureaucracy

Contamination and quality risks

Operational complexity of the drug production process