Michael Metzger is head of Track & Trace for the pharmaceutical industry and responsible for international projects. With his long experience in business he answers questions about the Delegated Regulation 2016/161/EU.
Mr. Metzger, from your point of view, what do you think has changed for companies since the release of the Delegated Regulation 2016/161/EU?
Finally, companies have a basis for reliable planning. The Directive 2001/83/EC itself was already known by the affected companies. By supplementing this Directive with the Delegated Regulation 2016/161/EU there is a date they can go for. At least now there is a need for action.
What would you think needs to be approached first at organizations?
First of all, what usually happens is a review of the company´s situation:
Now the decisions are made which investments seems to suit best for which lines, sites, or locations
Are there recurring pitfalls you are facing again and again? What do you think should be focused on?
If it is about the manufacturing and development of pharmaceuticals, we are well within the core competencies of pharmaceutical companies. What´s new is the challenge of managing different disciplines over different locations, even beyond national borders. This essential task of project management is underestimated too often, in particular concerning the demand for resources. To fulfill this, special skills are required. Those skills are not always available in-house and need to be either developed or sourced from third parties. This needs to be planned in time so you do not fall into a shortage. In addition, the integration of CMO’s can be a challenge.
Could you explain a bit further, what you see challenging with the CMO’s?
Especially for the CMO‘s it can become difficult – different clients do have various expectations in terms of data formatting and data exchange management. Just serving two or three clients can lead to a serious increase in complexity. At the same time, pharmaceutical manufacturers expect domain knowledge within the CMO organizations in order to continue to see them as competent partners.
What do you think about the development of regulations within the different markets?
Within Europe, regulations are clear. I don´t expect any short-term changes of serialization regulations. On the other hand, it remains exciting if we look at other markets – we all experienced short-term modifications as well as delays like in Brazil. In a couple countries there will be surprises. We will see if in Europe aggregation will be required or if OTC-products will be serialized. As I said, from my point of view looking at the near future, companies will stick to the already ambitious plan.
Mr Metzger, you could gain standing experiences. What is your recommendation for companies introducing serialization projects?
First of all, time is tight even though 3 years seem to be a long time. My recommendation is to set up the project now to secure future delivery capacity. If a company has already taken the first steps, they should consider delivering serialized products as soon as possible. That might help to gain a higher consumer acceptance on the market. Keep in mind, beside multi-nationals, or even global players, now everybody is out on the market and approaching hardware-suppliers, consultants, and implementation resources. It is easy to fall into shortage.
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