Madrid, May 18th 2016.- The Delegated Regulation which develops the Falsified Medicines Directive is obliged to individually identify all prescription medicine packages that are to be sold in the Spanish market from February 9th 2019. This will allow verification of its authenticity to the wholesalers and to those persons authorized to supply medicines to the public, guaranteeing patients’ safety.

Additionally, with the objective to avoid the entry of falsified medicines in the legitimate distribution chain, the Directive establishes obligations for all manufacturers, who will be forced to include safety features on the packages of all prescription medicines.

According to this legislation, the R&D based pharmaceutical industry in Spain holds itself responsible for reinforcing its commitment with the health, safety and protection of patients.

The identification and verification of medicine packages will be possible with the creation, management and accessibility to the so-called system of repositories at European and national levels, which will store the unitary package identification information.

Event held in the Ministry of Health

These new elements constitute a great challenge for all agents in the healthcare sector which will entail numerous technological and business adaptations, the need to set up a verification system at dispensing points, as well as the creation, management and accessibility of the national repository system. The narrow window of time remaining for the implementation of these measures forces stakeholders to act quickly and successfully.

This technological and logistic challenge has been analyzed in detail during the “Conference on Safety Measures: Regulatory Aspects and Set Up In Spain”, held today in the headquarters of the Spanish Ministry of Health, Social Services and Equality, organized by the Spanish Medicines and Medical Devices Agency (AEMPS).

During the meeting, representatives from the R&D based pharmaceutical industry have stated that complying with the requisites established by the Falsified Medicines Directive and the Delegated Regulation entails adapting the manufacturing process to introduce safety measures and a unique identifier on each package, which might amount to an estimated cost of 300,000 € per production line.

Furthermore, the pharmaceutical industry will cover the total cost of the set up and maintenance of the national system and the European hub, which has been estimated at between 10 and 13 million euros for its ramp-up phase in the 2016-2018 period, and between 5.5 and 8 million euros from 2019 onwards.

During the meeting, representatives from the R&D based pharmaceutical industry have stated that complying with the requisites established by the Falsified Medicines Directive and the Delegated Regulation entails adapting the manufacturing process to introduce safety measures and a unique identifier on each package, which might amount to an estimated cost of 300,000 € per production line.