New packaging requirements for medicinal products to avoid falsification

On Tuesday 4 April 2017, the Danish Parliament has adopted a bill on its third reading. The bill introduces new requirements for the packaging of medicinal products in order to avoid the circulation of falsified drugs.

This will be done through the implementation of new safety requirements and a joint data storage system; making it possible to identify and verify the authenticity of medicinal products.  

The bill entails that medicinal products that are "at risk of falsification" require the placing of "safety features"; see the proposed Section 59 a(1) of the Danish Medicines Act. In general, this applies to prescription-only drugs for human use but not over-the-counter drugs. However, based on reports from member-states, the EU Commission may decide that a certain drug requires or does not require the placing of safety features due to a specific assessment of the risk of falsification. 

An EU Regulation (No 2016/161), published earlier this year, stipulates the specifically required safety features. Consequently, medicinal products comprised by the regulation require a "unique identifier" that is unique to each individual drug packaging and an anti-tampering device showing whether the packaging has been opened. 

The data storage system entails the establishment of a database; allowing manufacturers, wholesalers, and pharmacies, etc. to verify the authenticity of the individual packaging of medicinal products. 

The bill proposes: 

"In practice, the new system entails that the unique identifier and other information are uploaded to the database prior to the release of the drug for sale or distribution. At the same time, they can verify the anti-tampering device. With certain exceptions, the safety features will not be verified again until a pharmacy or a hospital pharmacy dispenses the medicinal product to the user. By scanning the unique identifier, the authenticity can be verified in the database. If the authenticity cannot be verified, the unique identifier is deactivated in the system, and consequently, the product cannot be dispensed or distributed."

The bill implements Article 54a of the Medicines Directive that was incorporated with the EU Directive on falsified medicinal products (No 2011/62/EU). The rules will not apply until 9 February 2019; however, the legislation is adopted now, allowing the companies time to prepare for the new rules. The data storage system is expected to be finalized before this date. 

Read the bill on the website of the Danish Parliament (in Danish)

Read the EU Directive on falsified medicinal products

Read the EU Commission's Regulation on the specific rules of the safety features for the packaging of medicinal products for human use.

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