Dartford, UK, February 9th, 2019
Caligor Coghlan Pharma Services, a premier, global provider of pharma services, has implemented all necessary safety measures defined in the new Commission Delegated Regulation (EU) 2016/161 to fight medicine falsifications. Since the Regulation came into force on February 9, 2019, only prescription drugs for human use with the safety features of the Commission Delegated Regulation (EU) 2016/161 may be released for use. Product batches released before February 9, 2019 may still be used.
Geoff Fatzinger, Caligor Coghlan Pharma Services’ Global Vice President of Regulatory, commented: “We view the implementation of the Falsified Medicines Directive throughout the pharmaceutical supply as a great safety feature which will contribute to two things in particular: the safety of prescription drugs and the protection of patients; both of which are core values of Caligor Coghlan Pharma Services.”
The Commission Delegated Regulation (EU) 2016/161 essentially provides for the introduction of two security features.
- A unique identifier in form of a serialized number combined with a product code, batch number and expiry date make each package unique and individually identifiable.
- A so-called “anti-tampering device” protects the outer packaging against manipulation and allows verification of whether the packaging has been tampered with before the first use.
Caligor Coghlan Pharma Services has implemented a software application to verify serialised information both incoming and outgoing. This application will verify that the pack is acceptable for client use as well as ensure that the proper decommissioning status is applied to the unique identifiers of subject packs.
In addition, Caligor Coghlan Pharma Services has updated its procedures to ensure safety features of subject packs are verified and intact prior to distribution of product to clients.
For more information on Caligor Coghlan Pharma Services’ Falsified Medicines Directive (FMD) initiatives or Global Regulatory solutions, please contact firstname.lastname@example.org.
Vice President of Commercial