Q&A

Befintliga reklamationsrapporteringskanaler kommer att användas som en första lösning när kommunikation behövs mellan apotek/distributör och läkemedelsföretag kring e-verifikation. En reklamationsrapporteringskanal är tex Reklameraläkemedel.se. Övriga reklamationsrapporteringskanaler som är överenskomna mellan apotek/distributör och läkemedelsföretag kan också komma att användas.

När ett larm initieras skickas också en signal direkt till ansvarigt läkemedelsföretag via systemet.

LIF som ansvarar för Reklameraläkemedel kommer att den 9 feb 2019 öppna ett nytt rapporteringsformulär på Reklameraläkemedel.se: “Återförsäljare rapportering e-verifikation”.
Instruktioner hur formuläret ska användas finns här till höger (Reklameralakemedel_se instruktioner).
Övriga reklamationsrapporteringskanaler bör anpassas på liknande sätt.

Det finns många olika felmeddelanden som kan genereras från e-verifikationssystemet. Dokumenten här till höger “SMVS System responses -alert” (larm) och här SMVS System Responses – no alert” (inga larm) beskriver några av de viktigaste fallen (på engelska). Dessa dokument kan komma att uppdateras – aktuell version kommer att finnas publicerade här.

– Säkerställa att möjliga förfalskningar utreds så snabbt som möjligt så att förfalskade läkemedel inte kan komma in i den legala försörjningskedjan.
– I tidig användning av systemet kan det förekomma larm pga fel i process eller teknik, dvs det är ett falskt larm och förpackningen kan ändå användas då det konstaterats att larmet var felaktigt. Detta måste ske så fort som möjligt så att situationer där felfria förpackningar inte lämnas ut kan undvikas.
– Apotek/distributörer ska hantera och kommunicera larm på samma sätt.
– Lokala ombud i Sverige (läkemedelsföretag) snabbt ska få vetskap om problem med förpackningar, agera och återkoppla kring larm.
– Undvika olika tolkningar som leder till oklarheter, extra administration och långa ledtider.

The content of the 2D code will be different for all individual physical packs.

European Commission answered this in Q&A article 2.21. https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_safetyfeature_v9.pdf/a>

See Q&A from the European Commission article 2.10

Each company is responsible for creating and managing its own unique identifiers for e-verification. Please see Article 4 of the Regulation for information on how to design the unique identifier. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

The company prefix is provided by GS1. Companies choose to use the company prefix in different ways. You should therefore check internally to see if there is already a company prefix that should be used, and how the GTIN structure is to be built up in Sweden.

Each company is responsible for handling of their own GTIN. A GTIN contains of:

company prefix + article number + check digit

Delete the leading zero in a GTIN-14 to obtain a GTIN-13

There is no difference between an EAN 13 and a 12-digit UPC. It is the same barcode.

LiiV has a field called Barcode. Fill in the NTIN/GTIN in this field.

Yes, it is possible to manage multiple GTINs simultaneously. The difference between NPL (National Product Database for Medications) and LiiV is that LiiV displays both the current barcode and the previous barcode for users. Multiple historical barcodes are not all displayed, but are saved just as previously in the underlying field (though they are not visible to users).

Under evaluation

The 2D code includes the following elements:
• Product code (GTIN or unique NTIN)
• Unique identifier (randomiszed) for each individual pack
• Batch number
• Expiryation date
Read more in the European Commission’s Delegated Regulation and at VnrWiki.

Yes, it is very important to upload the information in the EU Hub so that the system does not generate many false alarms. False alarms would undermine confidence in the system and would mean that pharmaceutical companies could not sell their medicines.

Retrospective uploading must occur when MAHs distribute drugs with safety features before the verification system in a destination country is ready and online. If data are uploaded to the European Hub, the data will then be sent back to the company and the company must upload the data to the European Hub once again when the system is ready.

Yes, the market(s) in which each individual pack will be sold must be specified.

Yes, it should be uploaded centrally; not more than one (1) upload channel per company where information is gathered from the company’s manufacturing divisions/contract manufacturers. This is important from a security perspective. The process of gaining access to the EU Hub is rigorous and includes formal steps: submitting a request, a background check to ensure that the company is legitimate, signing a contract and technical testing and connection. More information EMVO home page. .

Each company with marketing authorisation must appoint an “On-Boarding Partner” (OBP) who communicates and signs contracts with the EMVO. In typical cases, all uploading to the EU Hub is then carried out via an integrated interface between the company’s system and the European Hub. There will only be one (1) such connection per company; i.e., data from all manufacturing facilities and contract manufacturers will be collected and uploaded to the EU Hub through this interface.
Contract manufacturers cannot upload products via the integrated interface, only via the EMVO Gateway, see below.
There will also be an option to manually upload data using the web-based EMVO Gateway. This will be a potential second connection for a company. This gateway allows companies to upload data before they have developed the automatic interface. The OBP can also create an account here for one or more contract manufacturers so that they can take care of uploading the information. The account can be limited with respect to which activities may be performed, as well as to specific packs (stock keeping unit – SKU). This solution may be appropriate for small companies with limited quantities of data.

Nothing, the EU Hub knows that the information has already been entered and there is no duplication. If you upload the information a second time for a product that is only intended for one country, you will get an error message stating that it has already been uploaded. If during the transition period through February 2019 information is uploaded for a multimarket product and not all the national systems concerned are running, only the information for the market that has a functioning national system will be accepted. For the other markets, the information must be uploaded again through retrospective uploading when the national systems are running; in other words, the same information can be uploaded multiple times. This is not a problem for the EU Hub.
There will also be an option to manually upload data using the web-based EMVO Gateway. This will be a potential second connection for a company. This gateway allows companies to upload data before they have developed the automatic interface. The OBP can also create an account here for one or more contract manufacturers so that they can take care of uploading the information. The account can be limited with respect to which activities may be performed, as well as to specific packs (stock keeping unit – SKU). This solution may be appropriate for small companies with limited quantities of data.

No. Packs that will be used as free samples or samples for authorities must have safety features and be uploaded to the database. Before they are given to the recipient they must be the decommissioned by the product owner (through the EU Hub). There will be status categories for Free Samples and Sample (NCA) = National Competent Authority that must be entered upon decommissioning. If samples are taken from a commercial batch they must be decommissioned (status as above) and the packages must be marked according to the regular procedures for free samples.

Products that are under development and are not authorised are exempt. If the investigational medicinal product is an approved product, it must be decommissioned when dispensed.

The total cost of the Swedish system will be divided among Marketing Authorisation Holders or those who are responsible in some legal form for products on the Swedish market. This has been decided in September 2018.

A company may have several MAHs (x). In such cases the company will pay x times the annual fee. Marketing Authorisation Holders include MAHs, but also others – we usually say that whoever is responsible for placing the product on the Swedish market will pay Sweden’s organisation, e-VIS (e-Verifikation i Sverige); e-VIS will sign agreements with all payers in 2018.

The fee is 100.000 SEK/year/MAH. This fee will be charged from 2019.

The system will gradually be built up in 2016–2018 and thereby cost money. The costs for 2016–2018 have been paid for by loans from LIF, FGL and the Swedish Association of Pharma Traders and will be repaid over three years (2019–2021). The fee in 4.1 includes this repayment. Invoices covering 2019 was sent out in December 2018.

Yes, a one-time fee for joining the EU Hub has been decided (see the EMVO webpage)

When the decision was made to introduce barcodes in the Nordic region, there were strong forces that wanted the item number to be part of the barcode. In the 1980s the need arose for machine-scannable information (barcodes) on drug medicines packaging. It was decided that the leading format for barcodes, EAN, would be used. The barcode represents an ID concept (GTIN, Global Trade Item Number) for a pack. GTIN is a global standard for item numbering that is administered by GS1. The ID concept consists of 13 characters (GTIN-13).

Format (GTIN): Company prefix + item reference + check digit

Since the item number was central in the 1980s, many people wanted to include the item number in the barcode. In order to do so, it was decided to modify the ID concept (GTIN) in the barcode for pharmaceuticals in the Nordic region.

The Nordic format is called NTIN (Nordic/National Trade Item Number) and has the same format as the GTIN, 13 digits, but with a fixed prefix and an item number instead of a reference number for an item.

Format (NTIN): Nordic prefix (704626) + item number + check digit

Det nordiska formatet kallas NTIN (Nordic/National Trade Item Number) och har samma format som GTIN, 13 tecken, men med ett fast prefix och ett varunummer istället för ett referensnummer till en artikel.

Format (NTIN): Nordiskt prefix (704626) + varunummer + kontrollsiffra

No, item numbers and the NTIN worked well at first, but conditions have changed. An item can thus have several different packs with the same Vnr.

e-verification will require unique NTINs/GTINs. In other words, you may continue to use unique NTINs, but they must follow the guidelines for the GTIN (http://https://www.gs1.org/1/gtinrules/index.php?lang=english) and therefore be changed, for example, when changing the external dimensions of the pack by more than 20 percent.

e-verification requires unique NTINs/GTINs. See 5.3 Note that in order to be able to distinguish among the different packs of an item, a unique identity at the pack level (GTIN/unique NTIN) is always required. The reason is that there will be not be any link between the different packs of an item and the unique identifier. The unique identifier alone is therefore not sufficient to identify the different packs of an item.

LIF recommends that companies should take stock of the NTIN/GTIN situation and explore the implications of the transition from the NTIN to the GTIN, and then decide when to make the transition. It is up to each company to decide when to transition from the NTIN to the GTIN. However, it may be advantageous to carry out the transition at an early stage. Implementation of e-verification will entail major changes and a considerable amount of work. The barcode has to be replaced with a 2D Data Matrix, and the production process needs to be changed so that a Data Matrix with a random unique identifier can be printed per pack. Production and, in many cases, even the layout of the packages will be affected.

Because basic conditions differ from company to company, what a company needs to do to prepare for a transition from the NTIN to the GTIN also varies.

Many companies already use the GTIN in markets outside the Nordic region. The GTIN is also used in the Nordic region today (Sweden 10 percent, Finland 10 percent, Denmark 5 percent, Norway 4 percent).

In cases where a company already uses the GTIN, such as in other markets, it is important to check with the regional office/headquarters to determine how the GTIN should be managed and administered in Sweden.

Since the packages are completely identical and contain the same package insert they may be sold in the countries concerned. They can therefore have the same item number/NTIN and the same GTIN. When choosing to switch to the GTIN, however, the change must be coordinated with the organisation in each country, and synchronised in the different countries.

Since the packages contain different package inserts in the countries concerned, they are not unique and they must therefore have different product codes. If you choose to use different GTINs for different countries, the common item number can be retained.

A Nordic item number can be approved that covers one, several or all Nordic countries.

Six basic criteria are mandatory and must be consistent in all countries if the item number is to be used in more than one country.

•Trade name
•Marketing authorisation holder (MAH)
•Pharmaceutical dosage form
•Strength
•Pack size
•Type of package

If the six criteria above are met, but the text on the packaging and/or appearance of the packaging and/or package insert are different in the different Nordic countries, an unlocked common item number can still be approved. In this case, however, the packs with the same item number must be distinguished by different GTINs.

Yes, switching from an NTIN to a GTIN in current barcodes on a pack that is only sold in Sweden is not a problem. The NTIN and the GTIN have the same format.

Yes, if the packs are identical and contain the same package insert, the NTIN can be switched to a common GTIN, but the switch must be coordinated with the organisation in each country and synchronised in the different countries.

No, the systems in Sweden can handle multiple NTINs/GTINs linked to an NPL pack ID.

Yes, the pack is allowed to have both the “old” barcode (EAN) and the new 2D code, provided that they contain the same information, i.e. the same GTIN/NTIN.

Medicines are approved through the central procedure.
A parallel trade company wants to parallel-distribute the drug in the Swedish market.
An application is submitted to the EMA specifying the countries from which the drugs will be purchased.
The EMA approves the application and assigns one (1) EMA number for the Swedish parallel-distributed drug (regardless of the country from which it was purchased).

This means that the actual medicine (e.g. tablet) is always the same (in contrast to parallel-imported products that can be distinguished in e.g. the excipients in a tablet). It is sufficient to have one (1) GTIN per NPL pack ID. (NPL= National Product register for Medicines)

In some cases, when changing the carton, the GS1’s regulations come into force and the new carton may deviate by +/- 20%. If the same company has parallel distributed medicines with the same NPL pack ID but in cartons of different sizes (more than +/- 20 %) more GTINs are needed.

It will not always be required, especially with the model that Sweden uses for distribution of prescription drugs. If the MAH wants the pharmaceutical distributor to verify receipt, naturally this can be arranged as an extra service.

a) The following applies for the “Pilot”: Manufacturers (MAHs) who participate must be connected to the European Hub through their OBP (On-boarding Partner). Pharmacies and wholesalers that will be participating must have entered into agreements/contracts with e-VIS. Participating Swedish MAHs that have products on the Swedish market will not need to have contracts with e-VIS for the pilot.

b) Before February 9, 2019. All manufacturers (MAHs) who participate must be connected to the European Hub through their OBP (On-boarding Partner).
All pharmacies and wholesalers must have entered into agreements/contracts with e-VIS. All MAHs (responsible for marketing the product in Sweden) must have agreements/contracts with e-VIS since they will be billed for the fees for the system.

Pharmacies/wholesalers – The first template is valid to 8 february 2019. Terms and conditions for operational phase (from 9 February 2019) will be drafted during fall 2018).
MAHs – template is ready and the first contracts sent out to MAH/Representatives. e-VIS is handling many contracts. If you haven´t been in contact with e-VIS please contact info@e-vis.se

The “Pilot” refers to the first controlled use of the system end-to-end that will be conducted during a qualifying period for the Swedish verification system and its environment, “end-to-end,” i.e. including connection to the EU Hub and end-user systems. It also means that the Pilot includes not only technical aspects, but also the surrounding procedures that make up the total system.

Pharmaceutical companies, wholesalers and pharmacies

Yes, genuine items will be used, and all transactions will be secured as concerns functioning and that developed instructions are adequate. Falsified items will be simulated without using real packages.

In preparation for the Pilot, participants must have modified relevant systems to be able to connect to SMVS and thereby participate. Briefly, this means that the following steps must be carried out:
• Development and testing of the new functionality in their own systems.
• Development/modification of the internal procedures that must be adapted because of the new working methods required by the directive, which will be tested in the Pilot
• Connection to SMVS according to the procedure for “on-boarding”, tab “Onboarding)
• Connection to the production environment following e-VIS approval

Pilot part 1 is completed.

For Pilot Part 2 there is no limit to the number of MAH or serialised products on the Swedish market.

The Pilot will be carried out in two parts; the first part has been carried out with an extremely limited number of participants and only a few packs.
The second part of the Pilot seeks to have more users onboarded and especially pharmacies and is not strictly limited in time.

The pharmacies and wholesalers participating in the Pilot will continue to use their improved systems and SMVS. We will start the “ramp-up” phase and all users covered by the Delegated Regulation will have the opportunity to connect to the SMVS according to the “On-boarding” SOP that qualified during the Pilot.

e-VIS will regularly publish additional information as the project progresses.

No, the regulations do not apply to any OTC products other than those included in Annex II to the Delegated Regulation (currently only omeprazole capsules 20 and 40 mg)

Whether or not a product must have safety features is determined only by the classification (prescription or non-prescription medications) made by the Swedish Medical Products Agency.

A different law determines which products may be prescribed and covered by the benefits scheme and is governed by the Dental and Pharmaceutical Benefits Agency (TLV).

No, the regulations only apply to human medicines.

No, the Swedish Medical Products Agency cannot grant exemptions for individual products.

The European Commission determines which medicines will be included in Annex I and Annex II of the Delegated Regulation.

Delegerad förordningen 2016/161/EU.
“Artikel 48
Övergångsbestämmelser
Läkemedel utan säkerhetsdetaljer som har frisläppts för försäljning eller distribution i en medlemsstat innan denna förordning blir tillämplig i den medlemsstaten och som därefter inte har packats om eller märkts om får släppas ut på marknaden, distribueras och lämnas ut till allmänheten i den medlemsstaten fram till läkemedlens utgångsdatum”

The European Medicines Verification Organisation (EMVO) has taken responsibility for advancing the formation of the European Medicines Verifications System (EMVS). The EMVS is in accordance with the EU’s Falsified Medicines Directive (FMD) and Delegated Regulation (DR) and ensures the implementation of a functioning, secure, interoperable and cost effective system across Europe.

EMVO tillhandahåller ett system, Downtimes & Distruptions Information System (DDIS), med en publik portal som visar både oplanerade och planerade avbrott respektive störningar för alla länders system i hela det europeiska systemet. Den publika portalen finns här:
https://emvo-medicines.eu/ddis

Det går att sätta upp en prenumeration för att via epost få uppdateringar på planerade och oplanerade driftsstörningar. Prenumerationen kan konfigureras så att prenumeranten bara får information om de driftstörningar som är relevant för denne, t.ex. om det gäller produktion eller testmiljöerna, vilket lands system som är relevant att få information om, etc. Sidan för att sätta upp en prenumeration finns här:
https://emvo-medicines.eu/subscribe/

Välj först environment PRD och sedan system NMVS så listas alla länder och där väljs Sweden.