EU FMD - time is running out!

13 Nov 2018

Companies that have left it too late to implement their own solution will have to rely on support from providers, whose resources are already in high demand as the deadline approaches.

With only 3 months to go until the EU FMD comes into force, what can companies do now to ensure they are compliance ready? Experts from across the industry give their advice.

EU FMD - time is running out!

Brian Daleiden, Vice President of Industry Marketing, TraceLink

"The 9 November marks the 3-month countdown to the EU Falsified Medicines Directive (FMD) compliance deadline. EU FMD applies to all countries in the European Economic Area (EEA) with the exception of Italy and Greece, who have an additional 6 years to transition from their existing serialisation regulations to those of EU FMD. The EMVO (European Medicines Verification Organisation), which operates the central EU Hub to which manufacturers will report their serialisation data, and the NMVOs (National Medicines Verification Organisations), who receive that data against which products are verified, are working to the deadline.

"Marketing Authorisation Holders (MAHs) alone are accountable for on-boarding and connecting to the EMVO, therefore their serialisation solution must also provide for data exchange with trade partners such as contract manufacturers. The EU Hub has been live for some time, with a growing number of MAHs now fully operational to transmit their serialisation data.

"Of the 30 national systems that should be in place, there are three at risk of not being ready by February. For MAHs however, lack of national system readiness does not alter their legal obligation to serialise their products and connect to the EU Hub by the deadline. Even if the national system of a country to which they ship products is not yet operational, the product data must still be uploaded to the EU Hub once the national system is live.

"MAHs that fail to serialise their packs will be in breach of the law. If a pack is released after the deadline, it must bear safety features. The legal responsibility lies on the MAH: if an audit uncovers that a pharmacist has dispensed a pack that was manufactured after February 2019 without safety features, the repercussions will fall on the MAH, not the pharmacist. The pharmacist’s accountability is to verify and decommission all packs bearing safety features.

"The ultimate financial penalty is the rejection of your stock - if wholesalers and/or pharmacists can’t verify and decommission it, by law they can’t dispense it.

"With these implications in mind and with such limited time left, it is essential that businesses prioritise the on-boarding of partners, complete the EMVO On-boarding Partner Portal (OBP Portal) process and related NMVO agreements, connect to and verify integrations with the EU Hub, and validate their end-to-end EU compliance solutions.

"The on-boarding process, internal design of all technical and operational touchpoints needed for EU compliance, and connecting IT systems to the EU Hub across multiple data transactions can all be challenging; businesses that aren’t using a pre-validated solution have a lot of work to do in a very short timeframe. Businesses that have opted for point-to-point connections with contract manufacturing organisations (CMOs) and third-party logistics providers (3PLs) have created additional layers of complexity and are at risk of failing to meet the deadline.

"As companies make decisions that will dictate their readiness for the February 2019 FMD deadline, they will have to rely on support from providers that can deliver cost-effective, turnkey solutions. A network-tenant approach where a prevalidated solution connects manufacturers with their supply chain partners and enables the data exchange required for compliance is the only viable option for any business that isn’t already well underway in implementing a solution."

Erik Haeffler, Vice President of Manufacturing Services, Recipharm

"The deadline for serialization compliance is fast approaching. Three months is a very short period of time given the scale of the changes that are required to implement a suitable solution. Ideally, contract manufacturing organizations (CMOs) will now have finished testing and validating solutions to maintain a continuous supply.

For some, however, this is not the case and those that have not completed preparations need to move very quickly to avoid a halt in production while they finalize implementation.

Companies that have been slow in their preparations will need to abandon the idea of customization and stick to standardized solutions. Partnering with companies that offer a specialized contract packaging service can also help to speed up the process; negotiations for onboarding, however, will take time and should be started immediately."

Dexter Tjoa, Director Corporate Strategy, Tjoapack

"For companies yet to install the necessary equipment and ensure suitable data storage systems are in place, there is simply not enough time left to do this alone. For companies that are unprepared, the only option to ensure compliance ahead of the deadline is to look for suitable partners to collaborate with and outsource any serialization requirements.

"However, it is important that companies do not underestimate the timeframes associated with outsourcing, the on-boarding process can take months and must be started immediately. In short, this is the last chance for companies to prepare for serialization before the EU FMD comes into force, so selecting appropriate and trustworthy partners to ensure compliance should be a priority."

Daniel Tedham, Managing Director, Wasdell Manufacturing a division of the Wasdell Group

With only 3 months left before the EU FMD deadline, the lack of readiness across the industry remains a concern. Many companies have simply left it too late to implement their own solution are now looking to outsource to experienced partners with tried and tested serialisation capabilities. Now is the time to act, as these partners’ resources are already in high demand as the deadline approaches.

For those that are further along in their preparations, they need to start working on the areas beyond the installation of new equipment and software that serialisation affects. Supply chain partners should now be on-boarded and a connection with the EMVO should be in place. Businesses should now be at the point where they are validating solutions and training teams on the new processes need to be introduced across entire businesses. Pilot schemes and any end-to-end testing should also be underway with a view to completing them well before the February deadline to ensure a seamless transition post-February 2019.

Related news

BMS and Celgene merge to create premier innovative biopharma company

BMS and Celgene merge to create premier innovative biopharma company

3 Jan 2019

Significantly expands Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential.

Read more 
An increased risk of a hard or ‘no deal Brexit?

An increased risk of a hard or ‘no deal Brexit?

24 Dec 2018

A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.

Read more 
One month on: medical cannabis is still taboo despite change in law

One month on: medical cannabis is still taboo despite change in law

11 Dec 2018

Restrictive guidelines have led many to buy CBD products online, leading to a boom in production with many products going to market without sufficient quality control.

Read more 
Proprietary nasal delivery formulation of diazepam reaches NDA

Proprietary nasal delivery formulation of diazepam reaches NDA

7 Nov 2018

The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.

Read more 
DSCSA one-month countdown!

DSCSA one-month countdown!

30 Oct 2018

With only a month to go, it really is too late to start trying to develop an in-house solution.

Read more 
Global pharma set for strong year

Global pharma set for strong year

23 Oct 2018

Eight of the top ten pharma nations reporting improving market conditions.

Read more 
Generics companies to move away from little white pills

Generics companies to move away from "little white pills"

14 Oct 2018

Accepting more complexity and risk is key for those generics companies seeking competitive differentiation by diversifying their product portfolios.

Read more 
CMOs to benefit from double digit approvals for ADCs in the next 3 years

CMOs to benefit from double digit approvals for ADCs in the next 3 years

9 Oct 2018

Therapeutic ADC market expected to reach $4 billion by 2023.

Read more 
Movement on the market reflected at CPhI Worldwide 2018

Movement on the market reflected at CPhI Worldwide 2018

3 Oct 2018

Companies new to CPhI to showcase an exciting range of products and services ranging from electroceuticals to refrigerant alternatives.

Read more 
Sanofi to refocus two global business units

Sanofi to refocus two global business units

19 Sep 2018

The new Primary Care and China & Emerging Markets global business units are expected to launch at the beginning of 2019.

Read more