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The Big Serialisation Survey
1.
There is currently a debate about who should fund the data repository associated with Falsified Medicines Directive (FMD) compliance. Where do you think responsibility should lie?
Marketing Authorisation Holder
Manufacturing Authorisation Holder
Other (please specify)
2.
Do you think that counterfeiting is as much of a problem for generic pharmaceuticals as it is for research based pharmaceuticals?
Yes
No
3.
What level of impact do you think that serialisation will have on Overall Equipment Effectiveness (OEE) levels in manufacturing?
Positive impact
Negative impact
No impact
4.
If you think serialisation will NEGATIVELY impact OEE levels in manufacturing, what do you expect the impact to be?
Below 5%
5-10%
10-20%
Above 20%
5.
If you think serialisation will POSITIVELY impact OEE levels in manufacturing, what do you expect the impact to be?
Below 5%
5-10%
10-20%
Above 20%
6.
The European Stakeholder Model suggests that it takes between four and five years to properly implement a serialisation scheme into an average sized manufacturer. In your opinion this is...
Not long enough
Correct
Too long
7.
Even though aggregation is not part of the requirements for FMD, do you believe an anti-falsified medicines solution could work without it?
Yes
No
Comments (please specify)
8.
In your opinion what is the greatest challenge facing manufacturers in implementing serialisation?
9.
If you have any further comments or insights on the topic of serialisation under EU FMD please provide them here.
10.
If you would like your comments attributed to you please provide your name, title and organisation below. If not comments will be treated as strictly anonymous.
Name
Role
Organisation