14 Questions/Answers from the EU Falsified Medicines Directive Webinar with rfxcel serialization expert Mark Davison.
What is the role of a Wholesale Distributor in the EU Falsified Medicines Directive (FMD)? How does Falsified Medicines Directive require Wholesale Distributor to function? Do Wholesale Distributor need to integrate to HUB / National Systems?
A: Wholesalers integrate to National Medicines Verification System (NMVSs).
Only Good Manufacturing Practice (GMP) licensed parallel traders, who need to change the box and hence the code, would use the central EU Hub.
For products in Phase 3 research, when do you recommend getting ready for serialization for Falsified Medicines Directive ?
A: It is worth having the conversation with your CMO early. If CMOs have already equipped production lines, then the Marketing Authorization Holders (MAH) software part will take around six to nine months. Work backwards from planned launch date by at least a year to be safe.
Below what level of annual turnover do you think that corporations will not engage in this process and drop their Rx-bound activity?
A: We have seen some very small companies contemplate that step. Below about 50,000 annual units produced, it is hard to amortize costs – except for high value products.
What happens when MAH issues serial numbers in bulk to CMO, is it possible to track the reconciliation?
A: The rfxcel track and trace software automatically manages the issuing, reconciliation etc. between your software and the CMO, even if they ask for a buffer stock of numbers in advance.
Is decommissioning accepted at packing line level?
A: Yes. Until product data is uploaded to European Medicines Verification System (EMVO) (which must be at or before QP release of the product) any data manipulations are fine as long as they are tracked and auditable.
Is there any penalty foreseen in case a corporation or country is not ready on time?
A: Apart from reputation and embarrassment, I don’t see how a country could be penalized. For corporations, it is simple. No codes, no sales.
Where is the legislation in regards to NMVO contracting?
A: The countries of the EU are at different states of readiness. Some NMVOs are running pilots and getting people connected, others are not yet fully set up. The fee and contracts for those connecting to them are not specified in the FMD and are at the discretion of the NMVO.
How ready are pharmacies?
A: Not very, in most countries.
Does MAH Level-4 system needs to exchange the data with CMO Level-4 or Level-3?
A: In the case of rfxcel, both are possible. Typically, it would be between Level 4 systems.
For the EMVO on-boarding process:
What title/function is generally seen and/or expected as the Single Point of Contact (SPOC) within an organization?
A: Can be anyone but should be the person able to answer and deal with queries etc.
What role/function generally handles the registration/on-boarding within an organization—Regulatory, Supply Chain, Commercial? Is this is the same as the SPOC?
A: Varies by company. Someone must sign as a legal designate of the corporate entity (i.e. senior person) but the onboarding can be done by anyone.
Where can I go to get more information on the on-going/annual fees associated with MAH per country?
I’m getting management pushback backed by external counsel, that there is no legal foundation to join NMVOs. Do you have one example in national legislation of stated requirements?
A: EU Directive 2001/83/EC, Article 54a/2/e (as amended by the provisions of Directive 2011/62/EU, commonly known as the Falsified Medicines Directive) says that the cost of the repositories system shall be borne by the manufacturers. In the UK, the Falsified Medicines Directive is transposed as-is through the Human Medicines (Amendment) Regulations 2013 [SI 2013/1855] which came into force on 20 August 2013.
Will Brexit make any difference?
A: In my opinion, no – for a couple of reasons.
The immediate timing of the FMD will be before Brexit, and with the 20-month transition time that is built in, this will allow the UK to carry on with any rules which are to be enforced during that period. So, for at least 2 years after the FMD, Brexit will have no effect, by law, on FMD enforcement.
The UK is such a large manufacturing country; I would be astonished if they diverge away from the rules that apply to the rest of the EU Union.
Do you think that the FMD could be delayed, similar to the DSCSA delay by the FDA?
A: No one knows the true answer to that. However, it could be quite possible if we are nearing the 2019 deadline and a sufficient number of organizations are not ready. With that said, I would not want to be the guy who has to explain to his superiors that we chose not to prepare ourselves, as we were counting on a delay that did not occur. We now cannot sell product for 6 months and need to take that time to catch up. My suggestion would be to not bank on it.
Will everyone be ready on 2/9/19?
This is the largest IT project in recent years; nearly 30 countries and the entire pharmaceutical supply chain is involved here. The chances of absolutely everyone being ready on day 1 are nil, but we all need to make our best effort to do everything we can to help this process be the best it can. It won’t be perfect, but it will be a whole lot better than what we have today.
Listen to the full webinar here.
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