Flow
No. 2 - September 2015
NOMECO BUILDS
HUGE
NEW WAREHOUSE
The current three pre-wholesale warehouses will be joined in Northern Europe’s largest pre-wholesale hub
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High-tech warehouse in Køge Publisher: Nomeco HealthCare Logistics - Borgmester Christiansens Gade 40 - 1790 Copenhagen V - Phone +45 36 45 45 36 - www.nomeco.dk
SOLID investment in
Editor-in-chief: Søren Vesti Esbensen - Director, Nomeco HealthCare Logistics Editor: Casper Koch Villumsen (ckv) Layout: Christa Job Impression: 1100 copies Printing: Kandrups Bogtrykkeri A/S
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Continuously focus on quality By Søren Vesti Esbensen, Director, Nomeco HealthCare Logistics
A solid investment in the future 3
Successful eLMK sampling
With increasing demands on quality from customers, suppliers and the authorities, Nomeco will now focus further on quality like the rest of the industry with several initiatives.
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Limitations in branded goods assortment: What is hot and what is not?
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Serialisation and falsified medicines – how far are we now?
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2 new strong women on board
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PharmaGolf 2015
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Nomeco HealthCare Logistics is becoming a bigger and a more complex business. We have seen significant growth within our pre-wholesale business, clinical trial supply management and GMP services. At the same time, Nomeco HealthCare Logistics is facing increasingly stricter demands from the authorities and customers regarding quality and the interpretation on the GDP Guidelines. As a natural part of this development, we have initiated several changes preparing us for future demands and the requirements of our customers and the authorities.
the future
Three warehouses will become one in 2017 when Nomeco HealthCare Logistics opens its new headquarters and warehouse for pre-wholesale and additional pharma-related services. The new huge warehouse will be located in Køge, which will become an important bridge for overland transportation between the Nordic countries and the rest of Europe.
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t will be a building the size of three football fields, including a hightechnological warehouse with a height of 30 metres and with room for more than 50,000 pallets. This is the vision of the future for the pharma industry, which uses Nomeco HealthCare Logistics’ services. Nomeco’s owner, the PHOENIX group,
Naturally we wish to meet the increasing demands. We definitely find that quality is a very important competitive parameter, which we would like our customers to compare us by.
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Flow - No. 2 - September 2015
One of the more noticeable initiatives is the hiring of Quality Director Pia Rask Albæk, who comes with a wealth of knowledge and experience within quality and compliance from Xellia Pharmaceuticals. You can read Pia Rask Albæk’s full story on page 11 in this issue of Flow. Furthermore, a QC position has been established, which will embed quality in all the processes in the warehouses. Another very visible initiative in quality will be the construction of Nomeco HealthCare Logistics’ new headquarter and warehouse in Køge, which will be Northern Europe’s largest warehouse for pharmaceuticals. With the construction of the warehouse, Nomeco HealthCare Logistics will have a unique opportunity to embed both efficiency and quality in all processes, which are centralised and rooted in the new high-technological warehouse.
has chosen to place its so far biggest logistics investment in Denmark, where the new ultramodern facilities will be the centre for pre-wholesale solutions for Nomeco HealthCare Logistics’ customers in the Nordic countries. “Naturally, we are proud of being known as the logistics competency centre for the pharmaceutical industry in the Nordic countries. The plans have been in the pipeline for a long time. It is a huge investment of more than half a billion DKK, requiring thorough considerations by both PHOENIX and Nomeco,” emphasises Nomeco’s Managing Director, Henrik Kaastrup. He has just completed the purchase of a big site at the Scandinavian Transport Centre,
located near Køge and only 45 km south of Copenhagen. According to Henrik Kaastrup, the geography and infrastructure at the location are perfect for overland transportation. Pharmaceuticals typically arrive from the south and must be distributed further north, Continues
The Scandinavian Transport Centre, Køge
The warehouse will become part of the Scandinavian Transport Centre, which is located near Køge and is only 45 km south of Copenhagen. Skandinavisk Transport Center is one of Denmark’s biggest joined business- and transport areas. The combination of the highway, rail road, port and optimal facilities and conditions for businesses have created a dynamic transport center with a lot of big companies like Netto, Lidl and Lemvig-Müller.
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Biggest warehouse in Northern Europe
and the new headquarters is located between the new Femern Connection and the Øresundsbron to Sweden. Furthermore, the entire highway around Køge is expanding, making trafficrelated problems no obstacle for fast and efficient transportation.
we are looking forward to centralising all our activities in one place.”
Centralising
Increased efficiency
Director of Nomeco HealthCare Logistics, Søren Vesti Esbensen, is looking forward to centralising all the activities of the division: “We will move the entire Nomeco HealthCare Logistics division. This means that not only our pre-wholesale activities will be centralised, but also the handling of clinical trial products and marketed products as well as all of our additional after-sales services will occur in our new warehouse. The sales and pre-wholesale customer service functions, CTSM, eLMK, Nomeco HospitalService and part of our Quality Department will also be moving, and
FACTS
30 metres high fully automatic warehouse.
Construction is scheduled to finish by the end of 2017, after which the present warehouses in Copenhagen, Brøndby and Køge will be closed down. Søren especially emphasised the increased efficiency and high quality the new headquarters and warehouse will bring: “The flow of goods in and out will be efficient and simple, and the new fully automatic warehouse meets all the increased quality demands from the industry and the authorities – including serialisation.” He underlined that the proximity to Nomeco Wholesale Division will not be affected by Nomeco HealthCare Logistics’ physical moving of its warehouse. Nomeco Wholesale Division will remain in the headquarters in
The flow of goods in and out will be easy and simple, and the new fully automatic warehouse meets all the increased quality demands from the industry and the authorities – including serialisation. Copenhagen, and the wholesaler will maintain its branches in Copenhagen, Odense, Aarhus and Aalborg. The advantages of the same company handling the entire supply chain from pre-wholesale to pharmacy will become even bigger. The flow from the pre-wholesale warehouse to the wholesale warehouses will to a greater extent ensure that the suppliers of pharmaceuticals have fast access to the market – not least regarding back orders.
2017
The new warehouse is expected to open at the end of 2017.
The Mayor of Køge Flemming Christensen and Managing Director Henrik Kaastrup have just shaken hands on a 100,000 m2 site for the new headquarters and warehouse for all activities of Nomeco HealthCare Logistics – including a gigantic warehouse of more than 30 metres in height for pre-wholesale services. Nomeco is aiming to build the largest and most modern centre for the pharmaceutical industry in the Nordic countries. Supporting the market trends
“With our solid investment, we are supporting the market trends and the needs of the industry for the coming years. The pharmaceutical industry is experiencing huge growth – not least measured in volume – and we have noticed this in Nomeco HealthCare Logistics where we constantly have to expand. The volume of pharmaceuticals needing cold storage is increasing,
SPACE FOR MORE THAN
50,000 PALLETS
which we have taken into account when planning the new construction. We are future-proofing our business with the new warehouse. Every year, we expect to handle pharmaceuticals worth more than DKK 11 billion,” states Søren Vesti Esbensen. Furthermore, he underlines that an increasing number of companies use the common Nordic pack, which shows
the need for a large central Nordic warehouse. “We are looking forward to starting construction soon. We are almost done choosing contractors and will start the soil analysis. But after that there should not be any further obstacles. We are looking forward to welcoming everyone in the new facilities in a few years!” mwh
The buildings will hold the pre-wholesale and facilities for repackaging of marketed pharmaceuticals, handling of clinical trial medicines etc.
There is full focus on safety and quality through the use of new technology which meets all the requirements of the EU authorities regarding the handling of pharmaceuticals for example serialisation.
The warehouse will handle huge amounts of pharmaceuticals destined for the Nordic market as well as special handling of e.g. hospital medicines for emergency situations.
The large pharmaceutical warehouse will supply the Danish and the Nordic market with medicines, and every year it is expected to handle pharmaceuticals worth more than DKK 11 billion.
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Flow - No. 2 - September 2015
The warehouse will be the size of three football fields.
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SUCCESSFUL eLMK sampling Please contact Nomeco HealthCare Logistics’ Sales department
[email protected] (+45) 36 45 45 36
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fter a significant decline since the twoyear regulation was introduced, Nomeco once again experiences increasing demand for free medicines samples. The two-year regulation means that pharmaceutical samples can only be distributed for 2 years after being marketed. Louise Slotsaa, eLMK specialist in Nomeco HealthCare Logistics, explaines that the growth is mainly due to previous customers returning to the pharmaceutical sample game – but with new products. However, there are also new business partners, who have discovered the advantages of using eLMK to market their products. “Several customers have returned since new products have been gradually added to their
portfolios. Actually, we have never had as many customers using eLMK as we have today,” says Louise. It is not only pharmaceutical samples that can be distributed to doctors via the eLMK service. It is also possible to distribute medical devices. Several of Nomeco HealthCare Logistics’ customers make use of this feature, although the system is mainly used for distributing pharmaceutical samples. eLMK is very flexible and it is not a requirement to be a customer in prewholesale for Nomeco HealthCare Logistics to handle sampling via eLMK. eLMK can handle sampling to both (GP) and hospital doctors in ambient and cold chain.
Consequences of the pharmacy act
ent:
ssortm a s d o o g nded ons in bra
Limitati
WHAT IS HOT AND WHAT IS NOT? H OT • • • •
eLMK
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DIRECT • Samples including SPC are distributed directly to doctors • Nomeco HealthCare Logistics automatically handles all of the accounting, registration and administrative procedures • Easy access to distribution reports • Customers avoid a considerable amount of heavy administrative work, e.g. - Registration of distribution of samples - Control and prevention of double sampling - Contacting the supplier’s representative if a requisition is not filled out correctly • Nomeco is responsible for all logistics regarding the samples
REP • Samples including SPC are handed out to doctors by a sales representative • The supplier and the representative handle the accounting, registration and administration themselves • Nomeco HealthCare Logistics is responsible for the logistics • Samples are ordered via www.elmk.dk • Nomeco receives the representative’s requisitions after the doctor has signed them • Nomeco distributes reports - also of any double handouts
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One of the consequences of the new pharmacy act is a more detailed list of what will be allowed and forbidden to sell at the pharmacies.
- positive list
s, band-aids, Medical devices such as condom nitor blood mo to s ice pregnancy tests, and dev sugar . Tweezers, scissors, razors, etc other things ong am ing lud inc nts Suppleme and nts me ple vitamin and mineral sup ns nutritional preparatio ts for personal Hygiene products and produc luding products care for skin, hair, teeth – inc example for is for children’s care. That sun protection e, ast thp lotion, shampoo, too removing for ts duc pro oil, h products, bat floss, cotton tal cosmetics, toothbrushes, den s. wool, and sanitary napkin Board of Health, Brochures from the National patient organisations, etc. le containers Special equipment, for examp igned for des y and equipment specificall gs. dru of use storage, opening and
N OT • • • • • • • •
- negative list
chines including Kitchenware and kitchen ma for elderly or devices for opening cans etc. disabled people Clothes, towels, etc. s etc. Shoes, including health sandal cosmetic and s bag et toil ing lud Bags, inc purses Toys, including writing tools Books ts/pastils, Groceries including candy, min spices, etc. polish, mascara, Make-up/cosmetics like nail chemical hair rouge, perfume, hair colour, removal products, etc.
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itchenware, clothes, cosmetics, shoes, perfume, toys, candy and toilet bags. This is just some of the items, which will be banned from the Danish pharmacies from January 1st 2016. The health authorities have as part of the new regulations of the Danish pharmacy sector prepared two detailed lists of categories of branded goods: One list contains all the types of branded goods that can be sold in the future. The other list is of all the types of goods not allowed. The authorities emphasize that the lists are not complete – they are just examples to give an idea of how the phrase ‘products that naturally belong in a pharmacy’ must be interpreted.
The price for keeping the monopoly
The new clarification is an attempt to limit the sale of products which clearly is on the edge of the intentions behind the regulations. “There is no doubt that this specification of hot or not is meant as a clarification in order to prevent unfair competition between retailers and pharmacies,” Dorte Taunø explains. She is assortment manager in Nomeco and responsible for all the branded goods offered to the pharmacies. Dorte stresses that Nomeco will not be the judge of how the lists should be interpreted. “Despite the attempt to clarify things there is still a lot of room for individual interpretation. Are the pharmacies for example allowed to sell cough drops or is that covered by the category ‘pastilles’, which is a no go in the future? And how about compression stockings? Are they clothes and therefore forbidden, or are they medical devices and therefore allowed?” she asks. It is up to the pharmacy itself to decide how it will react if in doubt. Nomeco will not as default remove questionable types of branded goods from the assortment. “But cosmetics and some of the other categories that are not to be mistaken will probably gradually be removed from our stock by the suppliers.”
Transitional period
The new limitation of the pharmacies assortment of branded goods is still not visible in most pharmacies. You will find most of the products on the negative list on the pharmacy shelves, as they legally can be sold for the rest of 2015. The authorities have established a transitional period of 6 months, where the categories can be sold out from the pharmacies. The only requirement is that the products were bought by the pharmacy before July 1st 2015. “The lists of hot and not will therefore have effect from 2016, and in Nomeco we will work hard to develop assortment of products within the categories on the positive list,” Dorte promise. mwh
om apoteker og Source: Bekendtgørelse s driftsforhold sygehusapoteker
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Flow - No. 2 - September 2015
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Huge interest and exiting debate
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h 20 t 6 e n u J eeting on
ing M
orn M d o o G o’s m Nomec
ro
UPDATE f
Serialisation and falsified medicines - how far are we now?
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he increasing threat from counterfeit medicines is a worldwide problem, and in EU, the serialisation of all medicine packages is an important step in the fight against this serious and potential life-threatening problem. All packages of prescription medicine dispensed in Europe must have an individual identification code in the form of a 2D barcode. Manufacturers and parallel importers must send the identification codes to a central European hub when sending packages to the market. That is the main outcome of the Falsified Medicines Directive, which is expected to become effective by 2018 or 2019. At the moment, the path leading to the new system is dominated by questions and matters to be decided. Who will pay
for the system and according to which model? How will a system to verify medicines at the point of dispensing be set up? What are the technical issues and which provider should we choose? What is the transition period and is everyone aware of the future demands? Just to mention a few of the questions that were asked at the meeting.
Agreement between Danish stakeholders
Many of these decisions have to be taken on a national level, and to do so the Danish Medicine Verification Organisation has been established. “A group with all the Danish stakeholders is working to reach agreement on the principles for cooperation, the definition of technical requirements, selection of the provider, funding, and the implementation
: ntations here e s re p o tw sation See the co.dk/seriali e m o .n w w w
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Flow - No. 2 - September 2015
Nomeco invited two experts working with the Falsified Medicines Directive to explain how far in the process we are right now. And the considerable interest among the pharma industry was noticeable when you look at the number of participants who attended Nomeco’s Go’morgenmøde on June 6th 2015.
At the latest Good Morning Meeting Nomeco HealthCare Logistics invited Johan Verhaeghe from The European Generic and Biosimilar Medicines Association (EGA) to talk about the upcoming EU-directive on serialization. The turn up was impressive and the topic resulted in many interesting questions from the audience.
of the system,” Mikkel Møller Rasmussen from The Danish Association of the Pharmaceutical Industry (Lif) explained. He was one of the experts invited to talk about the process. He is a member of the Danish stakeholder group, and stated that the group had just met, had started its work and will meet again in September 2015. “We are coordinating our work with the other Nordic countries – for example, in choosing the same IT provider. And as the Nordic countries are all aligned nationally, it is much easier for us to find the principles for cooperation compared to the other European countries,” he added.
All national systems will be linked through a European hub, and our aim is to make sure that every country has just one connection to this hub. The manufacturers and parallel importers will report to this hub too, and they have to ensure that a unique serial number is placed on each pack for authentication. Agreement on the European level
The system will be managed on a European level. “And there is a lot of work to be done there,” explained Johan Verhaeghe from The European Generic and Biosimilar Medicines
date. So presumably a package can sit on a shelf for another 5 years without a serial number. It is regarded as being out on the market when the product has been released by QP and has left the factory gate,” he said. He added that the barcode will be the only one allowed on a packet.
Association (EGA), which is one of the stakeholders working to get the design for the Pan-European system and governance in place. “All national systems will be linked through a European hub, and our aim is to make sure that every country has just one connection to this hub. The manufacturers and parallel importers will report to this hub too, and they have to ensure that a unique serial number is placed on each pack for authentication. It must be possible to check a serial number at the dispensing point. The repository system must be capable of authenticating medicinal
products at the dispensing point, and the response from the repository system must be virtually instantaneous. Moreover, the repository system must guarantee the protection of commercial, confidential and personal data.”
Transition period
According to Johan Verhaeghe, the Delegated Act will be published by the end of this year and the system will be up and running no later than 2019. “There is a three-year transition period for getting ready for the system. Until January 2019, packs do not need to have an identification code and can be sold before their expiry
“And you are not allowed just to put a sticker over an old code on a packet,” he warned.
Nomeco is close to the process
“In Nomeco we are very close to the process. We participate in the Danish stakeholder group as we have both wholesale and pre-wholesale services within our company – and there are many decisions to make also for our position in the supply chain, for example regarding risk-based verification on the wholesale level and how to handle saleable packages returned from pharmacies. We are just as eager to make the system work in the best possible way as anyone else,” said Søren Vesti Esbensen. mwh
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d r a o b n o n e m o w g n o r t s w e n 2
Back in Business
Big ambitions for quality
is the new head of Nomeco Clincal Trial Supply Management (CTSM)– Nomeco HealthCare Logistics’ department for services for clinical studies and GMP services. Actually, Nomeco HealthCare Logistics is welcoming back an old acquaintance. Mai worked for Nomeco HealthCare Logistics and Site Halmtorvet from 2006 to 2009.
is Nomeco’s new Quality Director. She will be in charge of continuing the work on developing Nomeco’s quality level. Pia was previously the director of API Operations at Xellia Pharmaceuticals.
Since her last stay at Nomeco HealthCare Logistics Mai has worked with clinical trials at Lundbeck and Novo Nordisk, among other companies. On June 1st 2015, Nomeco HealthCare Logistics once again welcomed Mai back.
Together with the rest of the Quality Department she will lift Nomeco’s competencies, documentation, systems and compliance relating to quality. Her aim is that Nomeco’s quality standard is continiously at the level of a market leader.
Mai Loan Le
“My main focus will be to continue the great development CTSM has had,” Mai explaines. “We will continuously focus significantly on quality. We are in close dialogue with our customers to find the right solutions to meet their needs – both in the start-up phase and during the study. We are changing together with the customers and if there is a service we do not provide at the moment, we are very flexible and open regarding making changes in order to always offer an attractive package.” In general, there is a tendency among most companies for outsourcing aspects of clinical trials. “To me, this makes perfectly good sense, since this is a highly specialised area that requires many resources and a very high level of expertise and professionalism. CTSM has noticed an increased demand for clinical supplies and the department has in recent years grown, in both the number of new study activities and the number of employees. Today, the department has 11 dedicated and talented employees with specialist skills related to clinical trials,” says Mai. Although it is the sponsor's responsibility to ensure that the study design is optimal, CTSM’s study coordinator often takes part in the early planning stages to ask "the right questions" and to contribute to the study design such as maintaining blinding, product forecasting, package design, text approval etc. Thus, it is advantageous to involve CTSM as early as possible to benefit from its professional expertise. The growth in the department is also due to increased activity in the repackaging of marketed pharmaceuticals. The latest advance in CTSM to accommodate this development is another packing room. All processes and packaging facilities remain in full compliance with GMP, and the department is looking forward to fulfilling even more orders from existing and new customers.
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Flow - No. 2 - September 2015
Pia Rask Albæk
We are changing together with the customers and if there is a service we do not provide at the moment, we are very flexible and open regarding making changes in order to always offer an attractive package.
Private Mai graduated with a Master of Science in Pharmacy from the University of Copenhagen and she has a degree in organisation and management. Mai is 34 years old and lives with her husband and two children in Frederikssund.
One of Pia’s mantras is that incidents are best solved when and where they occur. “One of the primary prerequisites for being able to act on incidents when and where they occur is, of course, that the employees are trained and possess the right attitude for quality,” Pia says. Some of Pia’s first impressions of Nomeco are that the employees are very dedicated, motivated and proud and there is a great can-do culture. At the same time, there is a very strong customer focus, especially with regard to business and relationships. Pia’s eyes are firmly set on consolidating Nomeco as best in class for quality and compliance. “We won’t get better by chance but we will get better by change,” Pia asserts.
One of the primary prerequisites for being able to act on incidents when and where they occur is, of course, that the employees are trained and possess the right attitude for quality.
Quality runs in Pia’s veins and she talks with great enthusiasm about quality and compliance: “Quality is not an act, it is a habit. Quality to me means doing things right when no one is looking – that is the true test. You need to live and breathe quality every moment of life,” Pia says – clearly this is her lifeblood. In the longer term, Pia wants to further develop the cooperation between the Quality Department and Nomeco’s Lean Consultants. “At the moment, the two functions are working on rolling out root cause training sessions, which are an integral part of deviation handling,” says Pia who has significant experience of pharmaceutical production.
Private Pia is 41 years old and holds a degree in chemical process engineering. She has had a long career in the pharmaceutical industry with a strong focus on quality and production. Pia lives in Bagsværd with John and her two kids.
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Contact
Søren Vesti Esbensen, Director l Nomeco HealthCare Logistics
us
Phone: +45 36 14 22 54
Pia Rask Albæk, Quality Director l Quality Department Phone: +45 36 14 21 14 Jesper Lotz, Commercial Director l Nomeco HealthCare Logistics
Phone: +45 36 14 21 09
Kristine Sakstrup Haag, Business Unit Director l Hospitals & Customer Service
Phone: +45 36 14 20 86
Mai Loan le, Business Unit Director l Clinical Trial Supply Management Phone: +45 36 14 20 76 Trine Katborg Davidsen, Business Unit Director l Commercial & Legal Affairs Phone: +45 36 14 20 70
You can order extra copies of Flow by sending an email to
[email protected]. You can also find an electronic version on www.nomeco.dk.
PharmaGOLF
2015
Never deviate from tradition. It has become a longstanding tradition to play the annual PharmaGOLF tournament in the harshest of weather conditions – and this year was no different.
The overall winner of the A line-up was Nicky Antonsen from Sandoz ( 1 ). The winner of the B line-up was Peter Sauer from Lundbeck ( 2 ).
However, a little shower was not able to spoil the good mood and enthusiasm of the many contestants.
The group competition was won by the renowned Lundbeck team with the questionable name “Master of fairway destruction”. We trust that Lundbeck will safeguard the trophy in their trophy cabinet.
This year the tournament returned to familiar pastures at Simon’s Golf Club north of Copenhagen.
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Flow - No. 2 - September 2015
www.nomeco.dk
