**Docket No. 2003N-0361**

Comments from Mr. Magnar Loken, Kezzler AS

Private, Device Industry

1\.

The greatest advantage with using unit packaging is that this makes it
easier to apply anti-counterfeit technologies and security to the drug
product. If the packaging for the drug is consistent and not changed
after production and shipping it is possible to pass crucial information
about the drug to relevant parties when necessary at any time. Unit
packaging makes it possible to record and manage data and crucial
information about the drug since it can be traced back as part of a
batch/shipment.

3\. Tamper evident packaging is a very effective way to protect both the
content integrity and the authenticity of a drug. Tamper evident
technologies are very useful for enhancing the security capabilities
provided by online Product Authentication (oPA) and Track-and-Trace
(TaT) systems.

5\. An optimum number of solutions seem to be at least three. Combined
these should cover these three basic security aspects:

-   Tamper evidence

-   Unambiguous product authentication

-   Product traceability, documentation and information about the
    affected drug

Kezzler believes it is important to use anti-counterfeit measures on all
individual drug units for all available drugs. Reasons for this
approach:

Security consistent and predictable within the industry

All-for-one approach economically sound

The user accustomed to checking drugs will be frustrated trying to
authenticate a drug being unaware of that it might not protected at all.

The lack of or inconsistency of anti-counterfeiting measures on a drug
unit hence may even lead to wrong conclusions and confusion by the user.

6\.

There should at least always be one overt technology. This ensures rapid
and uncomplicated authentication. Normally these are available to all
users and makes it easier to check the highest possible number of drug
products. Secondly there should possibly be a covert technology that
supports the initial conclusions and findings by the overt solution. The
covert technology makes it easy to check suspected products with even
higher reliability and scrutiny when needed.

7\.

No, but there are technologies such as delivered by Kezzler that targets
and protects that targeted information is accessible only to the
indented receiver group, typically consumer, manufacturer, doctors,
pharmacies, governments, etc.

8\. See comment for A1.

10\.

The manufacturers and the industry itself must take this decision as
they are expected to have the experience and knowledge to determine
different technologies practical applicability and efficiency for
different given conditions.

12\.

Kezzler would like to comment that barcodes and RFID are not
track-and-trace technologies! They are merely data carriers, and only
constitute a fraction of what is considered to be a complete and working
track-and-trace system. A track-and-trace system most of all is the
computer system managing vital information about the product to prevent
counterfeit and diversion, product information and supply chain
analysis.

Advantages:

The consumer can authenticate the drug product without effort and
without any special knowledge and tools. This makes the public more
aware of their safety and they are contributing to uphold it.

Governments can access information about any drug and drug individual
drug unit that is in the market at any time without having to consult
any other party (such as the manufacturer)

Crucial updated targeted information about the drug on an individual
basis or batch basis might be given concerning recalls, prescriptions,
warnings, intended market, ect.

Another distinqtive advantage with oPA and TaT is the fact that is works
independent of the structure of the supply chain, hence there is no need
to change the supply chain to solve this particular problem.

Disadvantages:

Using RFID as a data carrier is very expensive and complex, systems are
immature and it will definitely leave out the consumer and a large
portion of the supply chain.

13\.

The cost of the for instance Kezzler system is very low for both the
manufacturers, governments, distributors and consumers since the only
needed infrastructure is Internet or phone access.

14\.

Kezzler is of the opinion that these data is the property of the
manufacturer (brand owner) and is created under their supervision and
legal control. It must also be the manufacturers responsibility that
their system is safe and secure at all times. The manufacturer
determines the access to the data.

15.See A12.

18\.

Yes. The counterfeiter will only move to the next easy target and
therefore drug security must be based on the security principle that
counterfeiting attacks are expected, taking a pro-active approach
instead of a re-active approach with safety.