Siegfried Performance Improvement Award

Siegfried AG, is are pleased to announce they have officially launched their global Track and Trace program, which is intended to support and meet the worldwide directives and standards related to improving global drug safety. While the timelines and implementation strategies vary by region, and in some cases still remain fluid, we believe we are implementing a robust and integrated solution as required by authorities, which will provide compliance for your existing and future products in any region of the world.

To familiarize ourselves with the back ground to the standards, according the US Drug Supply Chain Security Act (DSCSA) enacted November 27, 2013, we must place a unique product identifier (2D matrix code) on each package and aggregated homogeneous case, beginning November 27th 2017. Likewise, according to recent EU Legislation, Council Directive 2011/62/EU of the European Parliament and of the Council, only folding boxes with an imprinted serial number (2D matrix code) along with tamper-evidence closures will be permitted to be sold and circulated beginning later in the first quarter in 2019.

The implementation strategy of our Track and Trace System is to fulfill all legal requirements for safety aspects that are in place as of this letter or anticipated to go into effect during the upcoming years. Specifically, the areas to be covered include:

A) Serialization

B) Tamper-evidence closures

C) Aggregation

D) IT-Integration

More on A) Serialization Each and every folding box will be imprinted with its own individual serial number that is to conform to the GS1 and/or EFPIA standard using a 2D data matrix code. Also, we will be capable of printing the 128C Barcode, as it is required for other markets.

More on B) Tamper-evidence closures The opening on each and every folding box will be sealed using a tamper-evidence sticker or glue on both sides to assure the integrity of the content.

More on C) Aggregation Even though it is not (yet) required in the EU, we will also include the aggregation function for the folding boxes on all levels (batches, shipping cartons, palettes). In addition, each level receives a unique serial number with a 2D data matrix code. Thus, this way, the requirements of China and the USA are also fulfilled without having to implement any further measures. More on D) IT-Integration Siegfried is expanding our current ERP-System with a serialization module in order to guarantee the required electronic receipt and transmission of the serial numbers in the most efficient manner. In order to best achieve this integration, we will utilize an interface that is based on the standardized EPCIS code.

System requirements and changeover plan

We will adjust our Track and Trace System in two phases:

1. USA – DSCSA

2. EU and Rest of World

In order to achieve this, the following steps are required from both sides:

Regarding A) Serialization As the new standard codes (GS1, EFPIA, etc.) provide a positive data structure (product number, lot number, expiration date, serial number, etc.) they therefore, will require more space on the packaging. The packaging and bundling plan, as well as the shipping carton dimensions, are slightly altered through these adjustments.

Regarding B) Tamper-evidence closures Each of the two sides of the folding box will either be taped using a transparent strip or glued, as is the case of our solid oral products coming from our plant in Malta.

Regarding C) Aggregation Siegfried will carry-out the aggregation according to the country-specific requirements. In the event that additional aggregations that deviate from these requirements are wished, we are prepared to work with you to establish them as needed.

Regarding D) IT-Integration The GS1 EPC Global Architecture Framework, EPCIS standard, will be used for data. The exchange within your company will be validated through our system (GAMP5) within the framework of the acceptance procedure.

Changeover Timetable

As you may recall, there are two specific time frames for market compliance. Thus, in light if this, we are initially focusing on the implementation strategy for US compliance needed in November 2017, (Phase A) followed closely by compliance for the EU no later than January 2019 (Phase B).

In the coming weeks, Siegfried representatives will be contacting you to begin initial discussion related to our Track and Trace initiative. In some cases, you may have already been in contact with your Siegfried representative, either providing your system requirements or inquiring about ours. If the latter is the case, we trust you are being satisfactorily taken care of. However, if you still have questions or lack clarity, please feel free to contact your representative soon, as the deadlines for compliance are rather near, and it is our desire to avoid any market interruptions or disturbances. Below, you will find two timetables to be used as a guideline for the project.

Below, you will find two timetables to be used as a guideline for the project.

Phase A (US)

Phase B (EU)

GS1: Global Standards One (commercial organization for standardizations)

EPCIS: Electronic Product Code Information Services (developed from the GS1 data standard)

EFPIA: European Federation of Pharmaceutical Industries and Associations

In closing, we would like to thank you in advance for reviewing Siegfried’s Track and Trace progress. Should you have any questions or concerns prior to one of our representatives contacting you, please feel free to contact them directly, as we wish to ensure all your questions are addressed.