The Big Serialisation Survey Question Title * 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) Question Title * 2. Do you think that counterfeiting is as much of a problem for generic pharmaceuticals as it is for research based pharmaceuticals? Yes No Question Title * 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 Question Title * 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% Question Title * 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% Question Title * 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 Question Title * 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) Question Title * 8. In your opinion what is the greatest challenge facing manufacturers in implementing serialisation? Question Title * 9. If you have any further comments or insights on the topic of serialisation under EU FMD please provide them here. Question Title * 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 Done
