FAQ

We summarised information from our most frequently asked questions here for your convenience. If you have a question that isn’t answered here, please contact us
helpdesk@emvo-medicines.eu

Documents Overview

To support our recipients (On-boarding Partner, OBP Connection Provider, National Medicines Verification Organisations) during her On-boarding Process, we release the latest versions of our On-boarding Guides, as well as additional information, here.

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FAQ

  • 1. General

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    • 1.01 Do you have a glossary of all the abbreviations?
        To get in touch with all the used abbreviations, please use the following table.

         
        Glossary
        Abbreviation Value
        3PL Third Party Logistics
        AR Authorised Representative
        CAP centrally Authorised Medicinal Products
        CEO Chief Executive Officer
        CER Certificate
        CFO Chief Financial Officer
        CIO Chief Information Officer
        CMO Contract Manufacturing Organisation
        CSR Certificate Signing Request
        DR Delegated Regulation
        EAEPC European Association of Euro-Pharmaceutical Companies
        EDQM European Directorate for the Quality of Medicines (Our auditor)
        EFPIA European Federation of Pharmaceutical Industries and Associations
        EMA European Medicines Agency
        EMVO European Medicines Verification Organisation
        EMVS European Medicines Verification System
        EU Hub European Hub
        EVI European Medicines Verification System Information
        FMD Falsified Medicines Directive
        GIRP European Healthcare Distribution Association
        IQE Integrated Quality Environment
        ITE Integrated Test Environment
        MAH Marketing Authorisation Holder
        NDA Non-Disclosure Agreement
        NIST National Institute of Standards and Technology
        NMVO National Medicines Verification Organisation
        NMVS National Medicines Verification System
        OBP On-boarding Partner
        OBP Portal On-boarding Partner Portal
        PA Participation Agreement
        PD Parallel Distributor
        PGEU Pharmaceutical Group of the European Union
        PRD Production Environment
        RR Registration Requester
        SDK Software Development Kit
        SPOC Single Point of Contact
        UI/UID Unique Identifier
         

        The EMVO Glossary is also available in our Documents Overview section.

    • 1.02 What are the penalties for failure to comply with the deadline of February 9th 2019?
        The European Medicines Verification Organisation is neither authorised nor in the position to state or determine the consequences and penalties for failure to comply with the deadline of February 9th 2019, whether fines will be applied or not is regulated in each state national legislation. Please contact the European Commission for further information.

    • 1.03 Does EMVO fulfill the quality requirements to facilitate the medicines verification process?
        We understand the need of OBP’s to obtain a level of certainty that EMVO fulfils the quality requirements to facilitate the medicines verification process.

        EMVO asked EDQM to act as their external auditor to ensure that the European Hub is designed, managed and operated in accordance with the standards as described in the “Commission delegated regulation (EU) 2016/161” supplementing the Directive 2001/81/EC and other relevant state of the art standards. Together with EDQM, we agreed on a strategic audit plan which will allow the EMVO organisation to meet the quality expectations by February 2019. The first audit has already been executed on January 19th 2017 and during the last week of April 2017. Further audits are planned for end of 2017, and in 2018.

        We would also like to inform you that the Belgian NCA is part of the audit team as they will supervise the EU hub. Also on European level, a sub-group within the EC Expert Group was formed to develop an Aide Memoire for National Competent Authorities as a guidance document to supervise national medicines verification organisations (NMVOs) and their systems (NMVS). We decided to extend the audit team with an observer to represent this workgroup. With regards to security, EMVO also ensures a yearly external security audit on the EU Hub. This audit is managed by an external independent company.

        As EMVO strives to full transparency on its EU Hub system and processes, we will therefore provide you as OBP the full Audit Report, as currently available, after a check of your legitimacy. To get the report, please request it from the EMVO Helpdesk.

        The Directive and the  Delegated regulation are also available in our Documents overview.  

    • 1.04 What is the definition for “in-house”?
        Essentially used in the context (from the larger query set), this means made by you internally within your own organisation. Where you have your product made is for you, the legal and contractual responsibility for the data produced and uploaded remains 100% with you as the contracting party.  We do not support the connection or third parties directly to the European Hub to act on behalf of another party.

    • 1.05 Where do I have to on-board as a wholesaler?
        Wholesalers have to on-board at national level, to the National Medicines Verification Organisation(s) of the countries they have wholesale license(s) in. Further information for wholesalers is available on the Supply Chain and Medicines Verification: website here.

  • 2. Contractual On-boarding

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    • 2.01 What is a Parallel Distributor?
        The Parallel Distributor does not hold a marketing authorisation in the terms of Community law. Instead, the parallel distributor/importer is a holder of either specific product authorisations issued by national competent authorities in an abbreviated procedure or the holder of an EMA distribution notice.

        The national authorisations may be regarded under the respective national rules as « marketing authorisations » and the holder of such authorisations, for example in Germany, is a pharmaceutical entrepreneur comparable in legal status to any pharmaceutical manufacturer. In the case of centrally approved products, the product can by definition circulate in the entirety of the EEA market; when it is commercialized by a parallel distributor, the EMA only issues a so called « distribution notice » to this distributor.

        In addition, parallel distributors must repackage the product which they handle in order to comply with the labelling and other regulatory and trademark requirements of the destination market, and repackaging is a manufacturing activity regulated by GMP. The FMD correspondingly speaks of "Manufacturing Authorisation Holders" when it means on the one hand marketing authorisation holders and on the other parallel distributors. For these reasons, parallel distributors connect to the hub, comparable to other (normal) manufacturers.

    • 2.02 What is an OBP? What is an MAH?
        The concept of On-boarding Partner (OBP) has been defined in order to facilitate the On-boarding process for corporations to the EMVO. The OBP company represents the companies holding marketing authorization among its corporation. The Marketing Authorisation Holders the OBP represents and will upload data for in the EU Hub have to be the OBP’s affiliates. A corporation can decide which legal entity will act as its OBP.



        1. - Definition of On-boarding Partner (OBP): The OBP is the contracting partner of EMVO and concludes the Participation Agreement.


        2. - The OBP is legally authorized to sign on behalf of a MAH / a group of MAHs.


        3. - The OBP has to be affiliated to a MAH / a group of MAHs.“Affiliate means, in relation to a Party, any other entity Controlling, Controlled or under common Control with the Party. "Control" and its derivatives mean either the holding, directly or indirectly, of 50 % or more than 50% ownership interest or the statutory or de facto authority to exercise a decisive influence on the appointment of the majority of directors or managers or the orientation of policy provided it is, at EMVO’s own absolute discretion, sufficiently proven”.


        4. - OBP Affiliate(s) agree(s) in writing to be bound, jointly and severally with the OBP, by and to observe all terms, limitations and conditions applying to the OBP as set forth in the Participation Agreement.


        5. - The group of MAHs represented by the OBP either consists of Original Pack Manufacturers or Parallel Distributors.


    • 2.03 For whom can the OBP upload product data?
        The OBP can upload data only for its affiliated MAHs. “Affiliate means, in relation to a Party, any other entity Controlling, Controlled or under common Control with the Party. "Control" and its derivatives mean either the holding, directly or indirectly, of 50 % or more than 50% ownership interest or the statutory or de facto authority to exercise a decisive influence on the appointment of the majority of directors or managers or the orientation of policy provided it is, at EMVO’s own absolute discretion, sufficiently proven”.  

    • 2.04 Who is the OBP in the situation of “co-marketing”?
        There is the situation of “co-marketing”, where two companies (A and B) sell what is the same product but under two brands:

        1. - Company A produces as CMO for B but also sells themselves.


        2. - Company B has no own production.
        In conclusion, A would be the obvious OBP, also because only they have the repository system. But A and B are completely seperate legal entities, not parts of the same group (though they have a commercial agreement in place).

        Could A (who will need to On-board as OBP for their own products) also be acting on behalf of B? Even though A is actually the CMO, not the brand owner for the products of B.

        No. Company A can’t act on behalf of Company B, because they are not affiliated to each other.

    • 2.05 What is the difference between Original Pack Manufacturer and Parallel Distributor?
        The Original Pack Manufacturer is a pharmaceutical company holding a marketing authorisation (MA) and is placing medicines on a given market. In the context of batch release the company uploads product codes and pack data into the EU Hub.

        The Parallel Distributor or Parallel Import company is an independent company purchasing medicines in one market and – after repackaging - placing these medicines on a different market (the market of destination) under a license obtained under its name from the National Commitment Authority (NCA) of the destination market (parallel import license) or of comparable permits issued by European Medicines Agency (EMA) for centrally approved medicines (EMA parallel distribution notice).

        Parallel distributors must repackage the product which they handle in order to comply with the labelling and other regulatory and trademark requirements of the destination market; this constitutes (partial) manufacturing and is subject to a manufacturing authorisation.

    • 2.06 Marketing vs. Manufacturing Authorisation Holder?
        When EMVO uses the abbreviation MAH, we ONLY use it in relation to Marketing Authorisation Holders.

        Marketing Authorisation Holder (MAH) A Marketing Authorisation Holder is the organisation which owns the serialisation data and which is accountable for uploading the data to the EU Hub (e.g. XYZ Sales Company in EU member country). Possibly an affiliate of the OBP; for smaller companies the MAH and OBP could be the same.

        Manufacturing Authorisation Holder Both the manufacturing of pharmaceuticals according to the requirements of its marketing authorization and the repackaging of finished goods (which is the activity of parallel distribution) are subject to GMP rules and require a manufacturing authorisation. Both types of company are thus connected to the EU Hub but using different interfaces.

        The FMD correspondingly speaks of "manufacturing authorisation holders" when it means on the one hand marketing authorisation holders and on the other parallel distributors. Parallel distributors connect to the EU Hub, comparable to the other original pack manufacturers as they place “new” repackaged medicinal products on the market.

    • 2.07 Is the Participation Agreement confidential?
        No, the Participation Agreement (PA) is not confidential.

    • 2.08 Should an On-boarding Partner (OBP) sign a dedicated Participation Agreement (PA) for each Marketing Authorization Holder (MAH) or could the OBP sign one PA at group level that covers all MAHs?
        One PA per Corporation/Group signed by the OBP who represents the MAH’s of the corporation is sufficient.

    • 2.09 When is the On-boarding Partner (OBP) required to sign the Participation Agreement?
        The Participation Agreement will be signed after the company information is filled in and the Authorised Representative is appointed.

    • 2.10 Is there a declaration or an official position that endorse the statement “NO CONTRACT NEGOTIATION”?
        The Participation Agreement is only negotiable if there it is contradicting national law.

    • 2.11 What is a Copy of Proof?
        A copy of proof consists of an objective document attesting that the Authorised Representative has the authorisation to sign on behalf of the company and therefore to legally bind it. For example, it can consist of an excerpt of the Trade Register, an excerpt of the Bulletin of Act or of the status of the company, in order to certify the position of that person in the management board or in a senior position. It is needed in order to enable us to approve the Participation Agreement you would be required to send us as well as to further pursue the legitimacy check.

        Please find the list of national registers for obtaining the Copy of Proof in the Document overview, under the heading OBP.

    • 2.12 Which information on the Invoicing Information Form is obligatory vs. optional?
        Please have a 2nd look on the Invoicing Information Form from Step 2.5/5.6.1 of the OBP Portal. The obligatory fields are marked by an asterisk (Legal entity name, Address, E-Mail Address, Number of MAHs, VAT Number). All the other details are optional. You can find it in this link Invoicing Information Form, and in the Document overview.

    • 2.13 What are National Customer Number and Customer Number?
        The National Customer Number is a customer code that the local commercial entity belonging to the OBP has with a local organisation from which they have to obtain specific product references. Therefore, the OBP will be asked to provide that number only if it also acts as an MAH. Such numbers are IFA in Germany, or CIP in France, for example. It may also be that some countries don’t have such number, or that the OBP do not act as an MAH and therefore the OBP don’t have to fill that part in.

    • 2.14 What is a Company Registration Number?
        A company registration number (CRN) is a unique combination of numbers, at times of numbers and letters. It is used to identify a company and verify its legal existence as an incorporated entity. A unique Company Registration Number is assigned as the company is registered on a certain register. The issuing entity differs from country to country. In Germany the public register and issuing entity is the Handelsregister. In the UK it is the Companies House. The CRN can be found on the Certificate of Incorporation, on all official documentation received from the issuing entity or on the excerpts of the register. A company registration number is also referred to as ‘company number’.

    • 2.15 How to fill in MAH and Product Information as Parallel Distributor?
        The parallel importer, or distributor, does not hold a marketing authorisation in the terms of the Community law. Instead, the parallel importer is the holder of specific product authorisations issued by national competent authorities in an abbreviated procedure.

        These national authorisations may be regarded under the respective national rules as « marketing authorisations » and the holder of such authorisations is, for example in Germany, a pharmaceutical entrepreneur comparable in legal status to any brand manufacturer. In the case of centrally approved products, the product can by definition circulate in the entirety of the EEA market; when it enters parallel distribution, the EMA only issues a so called « distribution notice ».

        Therefore EMVO kindly asks you to fill in your legal entity with a minimum of one and a maximum of three relating licenses in step 3.8 of the OBP On-boarding Portal. A full list of all the relating licenses will be requested when entering the technical on-boarding.

    • 2.16 Where can I find the payment terms (besides the Appendix 2)?
        The terms are not further detailed. After the Participation Agreement is signed the On-boarding Fee can be paid. EMVO must received the On-boarding fee before getting connected to the Hub's test environment.

    • 2.17 What is included in the On-boarding Fee?
        The On-boarding Fee is a one-time fee which covers the administrative costs related to the On-boarding process, the costs attached to the legitimacy check and the technical costs of connecting the On-boarding Partners (OBP) with all its MAHs to the EU Hub.

        The On-Boarding fee is fixed independently from the countries in which the MAHs are active and/or registered. The fees are fixed for all OBPs as displayed below.      

    • 2.18 Will EMVO charge additional fees after on-boarding?
        No, not from EMVO's side. The National Medicines Verification Organizations will ask the OBP's for a yearly Flat Fee, the NMVO fee

    • 2.19 Who is the Authorised Representative?
        The Authorised Representative (AR) is appointed by the OBP. The AR should be a senior officer who is authorised to sign on behalf of the company, the person holding the position of CEO, CFO, CIO or a member of the management board. Only the named AR is able to sign the Participation Agreement in name and on behalf of the OBP company. The AR will confirm that the SPOC is a legitimate person who has the authority to manage the project in name and on behalf of the OBP.

        The OBP has to ensure that:

        1. - The named Authorised Representative is entitled to sign on behalf of the company


        2. - The copy of proof attached confirms the entitlement of the Authorised Representative to sign on behalf of the company


        3. - The person named in step 1.2 is the person that signed, in fact, the Participation Agreement


        4. - The full name of the AR is provided, without translation nor abbreviation, as it appears in the national register.

    • 2.20 What is a SPOC and SPOC Assistant?
        The Single Point of Contact (SPOC) is the key contact person for EMVO and is authorised by the Authorised Representative to be in charge of the correspondence between the On-boarding Partner (OBP) and EMVO. The SPOC is responsible for providing the requested information for the OBP on the OBP Portal in order to establish a connection with the EU Hub.

        The SPOC can appoint a SPOC Assistant as a back-up. This is optional. It may take several hours till the SPOC receives the credentials via e-mail after the Participation Agreement has been approved.

        Please do also note the following.

        Due to quality reasons and communication purposes, it shall be avoided that the entered/appointed SPOC, SPOC Assistant or new persons assigned to the same role, share the same e-mail address. The successful user creation, user permission and access of the SPOC and SPOC assistant is based on the uniqueness of the e-mail address. Therefore, it is of upmost importance to take this point into consideration while entering and maintaining the SPOC and SPOC Assistant.

        In case an OBP would like to increase the number of recipients receiving communication from EMVO besides the SPOC & SPOC Assistant (if applicable), EMVO recommends to use a dedicated mailing list/inbox e.g. “serialisation@emvo.eu”, as the e-mail address of the SPOC Assistant account. However please note that the e-mail address needs to be linked to a registration of a contact person (forename & last name).

    • 2.21 What is the difference between Parallel Distribution and Parallel Importation?
        Centrally authorised medicinal products (“CAPs”) put on the market of one Member State can be marketed in any other Member State by a distributor, independently of the original marketing-authorisation holder; in this case we speak of “parallel distribution”. The parallel distribution (PD) pertains to all centrally authorised products, and the European Medicines Agency (EMA) issues a "distribution notice" to the parallel distributor.

        The parallel import on the other hand concerns only nationally approved products and is authorised by the national competent authority of the Member State of import based on two conditions: that the medicine in question has a marketing authorization in the country of import as well as in the country of source, and that the medicine to be imported is therapeutically similar to the product distributed in the Member State of destination by the marketing-authorisation holder.

        For simplicity, we use for both activities the term "Parallel Distribution".

    • 2.22 What is the difference between the connection of an Original Pack Manufacturer to the Hub and the connection of a Parallel Distributor/Importer to the HUB?
        The Connection of an Original Pack Manufacturer allows to upload original pack data to the EU Hub.

        The Parallel Distributor (PD) acquires already batch released products, which are then repackaged and subject to a subsequent batch release under his authority; prior to repackaging the PD must verify and decommission the serial numbers. In addition, and according to DR Art. 36 (n) the parallel distributor has to establish a link between inbound and outbound batches, which is another reason why the interface to the EMVS is different for parallel distributors compared to other manufacturers.

        The FMD correspondingly speaks of "Manufacturing Authorisation Holders" when it means on the one hand marketing authorisation holders and on the other parallel distributors.

    • 2.23 How to on-board (a) MAH(s) separately though having a registered OBP, which on-boards MAH/s?
        It is possible to on-board (a) MAH(s) separately though there is already a registered OBP. A MAH or MAHs can on-board separately, registering and on-boarding as or under a separate OBP. However, EMVO will apply the on-boarding fee depending on the amount of MAHs per OBP. Moreover, please note that in general one MAH can only be associated to one OBP. Only in the case of a hybrid company (one entity with both company types), a double application of an MAH to two separate OBPs is possible.  

        Please note that regarding the company type a separate on-boarding of MAHs under a separate OBP also might be necessary as an OBP can either only represent Original Pack Manufacturers or only Parallel Distributors.

    • 2.24 Why it is important and how to fill in the Company Type?
        As the connection of the Original Pack Manufacturer and Parallel Distributer differs (please see FAQ 2.05), and therefore an OBP can either only on-board Original Pack Manufacturer or only Parallel Distributers, your company is requested to provide EMVO with the information about your company type in Step 1.1 ‘Company Information’ in the OBP Portal.

        This information is of paramount importance as it determines the type of connection your company will be using in the European Hub.

        Consequently, there are 4 on-boarding cases:

        a) If the MAH(s) are original pack manufacturer(s) only, the original pack manufacturers can choose one common OBP to represent/onboard them.

        b) If the MAH(s) are parallel distributor(s) only, parallel distributors can choose one common OBP to represent/onboard them.

        c) If some MAH(s) are original pack manufacturers and some are parallel distributors, the parallel distributors choose one common OBP to represent/onboard them AND the original pack manufacturers choose another common OBP to represent/onboard them.

        d) If there is only one MAH/entity which will on-board, but it has both company types so it is an original pack manufacturer and parallel distributor (Hybrid company), please contact the helpdesk for further guidance.  

    • 2.25 How to set up the coding for the different countries?
        The product codes to be uploaded in the EU Hub have to follow the coding requirements of each country where the product is marketed. The list of coding requirements per country can be consulted from the EMVO website, in this link.  

    • 2.26 How to fill in the Product Master Data and Product Batch/Pack Data in the EU Hub? Which information to include?
        Please consult the Master Data Guide, also available on EMVO website. The key data fields have to be filled-in according to this guide (Product Code and Coding Scheme (in EMVS), Data Carrier Identifier (in SPOR) which is equivalent to the Product Code in EMVS, ISO Country Identifier for each market of intended sale).

        In the Market Specific Master Data section, for each market within a multi-market pack the given table should be completed. For single market packs only one completed table is required.  

    • 2.27 We have already signed the original Participation Agreement (PA), do we need to sign the PA published in November 2018?
        Yes. As mentioned in the related Letter of Announcement, the new Participation Agreement governs the Operational Phase of the EMVS, meaning the full-scale operational mode of the repositories system. The previous Agreement covers only the period until the 9th February 2019, meaning the Implementation Phase, and expires on that day. Therefore, all OBPs need to sign the new Participation Agreement. However, this time no hardcopy of the Agreement will have to be sent by you to EMVO. You will only be requested to upload the signed Agreement via your account on the Portal and EMVO will exchange in the same way its countersigned scanned copy.

    • 2.28 Where can we find the new Participation Agreement?
        The new Participation Agreement template is now available on the OBP Portal: If you have already signed the previous Participation Agreement (for the Implementation Phase), then the new template is available on Step 5 (“Maintenance”). If you have not signed the previous Participation Agreement (for the Implementation Phase), then the new template is available on Step 2 (“Detailed Information and Participation Agreement”).

    • 2.29 We are the OBP and the MAH, do we need to sign a Letter of Adhesion?
        The purpose of the Letter of Adhesion is for the MAH to adhere to the Participation Agreement between EMVO and the OBP it uploads data for on the EU Hub. If your organisation is an OBP and MAH at the same time, then you are already bound by the Agreement as EMVO's counterparty and no further action is required, except, of course, for signing the new Participation Agreement and uploading a scanned copy thereof on the Portal.

  • 3. Legitimacy Check

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    • 3.01 What does the “Legitimacy Check” include? How this is done? What are the requirements to be met by OBP?
        In order to keep the Legitimacy Check as effective and secure as possible EMVO does not publish the procedure. The check will be based on the information EMVO receives from the On-boarding Partner during the on boarding process. As soon as the process starts, EMVO will request all relevant information via the EMVO On-boarding Portal.

    • 3.02 Will the given access rights be checked by EMVO / SolidSoft Reply?
        Access will be given to the production environment of the EU Hub by EMVO (not by Solidsoft) and only to legitimate On-boarding Partners. The details of participation are stipulated in the Participation Agreement.

    • 3.03 When shall I provide EMVO with a complete list of the MAH for which I will upload data?
        The On-boarding Partner will be asked to provide EMVO with a list of MAH on the OBP Portal. For the purpose of the legitimacy check, the OBP is asked to provide, in step 2.7 the information of a minimum of one MAH, maximum of three, and a minimum of one product, maximum of three of each MAH. In step 5 – Maintenance, the OBP is requested to fill-in the full list of MAHs for which it is willing to upload date in the EU Hub. Please note that no further information on products are required in step 5 as it is only needed for the legitimacy check purposes. The number of MAHs listed has also to be reflected in the Invoicing Information Form accordingly and adapted in Step 5 if necessary.

    • 3.04 Shall I go through the Legitimacy Check even if I already signed the contracts with EMVO before the portal was released?
        The Legitimacy Check is an inevitable step in the on-boarding of the On-boarding Partner. Without notified successful findings of the Legitimacy Check, no access will be granted to the Technical On-boarding. The OBPs that already signed contracts with EMVO are also asked to go through the portal. However, they will have the possibility to upload the contracts they already signed directly in the portal.

  • 4. Technical On-boarding

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  • 5. Maintenance

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    • 5.01 What is the Maintenance mode? Who can proceed to the modifications in that step?
        The Step 5. “Maintenance” has to be used by the SPOC and the SPOC Assistant to keep updated all relevant information filled-in during the Contractual On-Boarding (company information, SPOC and SPOC Assistant contact details, MAH information, etc.)

    • 5.02 Would I be able to modify all information of the Contractual On-Boarding Part?
        1: The OBP can maintain MAH information already provided in Step 2.7. For the purpose of the Legitimacy Check, the OBP was required to provide MAH and products information in step 2.7. However, in Step 5 – “Maintenance”, information on products is no longer required. Still, the OBP is requested to provide EMVO with the full list of the MAHs it will be willing to upload data for in the EU Hub. This list has to be complete and updated according to any change.

        2: All detailed company information, except the company type, can be updated.

        3: The OBP can also modify the SPOC and the SPOC assistant contact details.

        4: The OBP can view and/or download the latest Participation Agreement applicable. Whenever an updated Participation Agreement will be made available, the OBP will be requested to sign the new version of the contract and follow the procedure accordingly.

        5: The Invoicing Information Form can be viewed or downloaded. In case more MAHs are registered in the OBP Portal than mentioned on the already approved Invoicing Information Form, the Invoicing Form will be rejected in order for you to restart the invoicing process.

    • 5.03 Is another Legitimacy check going to be performed on the newly provided information?
        No. Once the Legitimacy check is passed in Step 3 the modification of information in Step 5. Maintenance will not trigger a new Legitimacy check.  Still, all information will be randomly checked in the aftermath in order to ensure that the MAH listed in Step 5 are all affiliated to the OBP company.

    • 5.04 How can I add more recipients to receive the EMVO communication?
        In case an OBP would like to increase the number of recipients receiving communication from EMVO besides the SPOC & SPOC Assistant (if applicable), EMVO recommends to use a dedicated mailing list/inbox e.g. “serialisation@emvo.eu”, as the e-mail address of the SPOC Assistant account. However please note that the e-mail address needs to be linked to a registration of a contact person (forename & last name). Furthermore, to receive the information with regards to all known problems within the EMVS, EMVO strongly recommends subscribing to the EVI (European Medicines Verification System Information) Alerts for the specific systems of interest.

    • 5.05 What is Product Code (PC) ownership transfer and what is the underlying process?
        Once uploaded to the EU Hub, PCs are technically linked to the OBP which initially uploaded the PC. This can lead to:

        1. Technical blockage for the legitimate owner of a PC in case of an incorrectly uploaded PC by another party.

        2. A technical blockage for the new owner of a PC in case of Divestitures and Acquisitions (D&A) activities, such as Mergers, Acquisitions or MAH transfers.

        Consequently, a PC ownership change can be performed. However, EMVO reserves the right to apply and invoice the resulting costs which include a basic charge (€1,000.00) and service charge per PC ownership change (€100.00).

        A limit of max. 100 PC per PC ownership change request is defined, to assure feasibility in a timely manner. PC ownership change requests exceeding 100 PCs are subject to arrangement.

        The PC ownership change fee model shall be effective as of 1st October 2019.

        For additional information, please contact the EMVO Helpdesk.

    • 5.06 What should I do in case my OBP/MAH is facing MAH transfer or D&A/M&A activities?
        Please notify EMVO in good time as soon as your OBP, Company or MAH(s) face(s) one of the following scenarios. 1. MA transfers 2. MAH transfers 3. D&A / M&A activities Please do so by contacting the EMVO Helpdesk (helpdesk@emvo-medicines.eu), providing the following information (if applicable).

        - Which scenario do you face?
        - How many entities are involved and which?
        - Who is the Acquirer/New Owner & who is the Transferor/Old Owner?
        - How many OBPs are involved and which?
        - What is the planned timeframe? / When is the action taking place?
        - How many SKUs/Product Codes (PC) are affected?
        - Was data uploaded for the affected SKUs/Product Codes (PC)?
        1. If yes, for which SKUs/PC?
        2. If yes, Product Master Data (PMD) and Product Pack Data (PPD)?
        - Who will be the responsible contact person(s)/representative(s) of both parties?

  • 6. Data Upload

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    • 6.01 Do you provide the EMVS Master Data Guide as download?

    • 6.02 How codes will be uploaded when multi-market packs are destined for two markets – one of which does not yet have an operational Repository?
        A use case for a product destined for Belgium and Germany (Germany is active, Belgium is inactive):

        1. - Product Master Data with Market Data uploaded for Germany only
        2. - Product Master data and Pack data sent to German Repository
        3. - Belgium comes online
        4. - Product Master Data is updated to include Belgium
        5. - Product Master Data pushed to EU Hub
        6. - EU Hub loads Product Master Data to Belgium and updates Germany
        7. - Pack data resent, loaded to both markets
          The Master Data Guide, is available in our Documents Overview. The Questions and Answers Document, published by the European Commission, also gives a helpful answer to this topic.

        Regarding this, we would like to refer to question 1.12 (Would it be possible to place a unique identifier on the packaging of a medicinal product during the 3 years period between the publication of Regulation (EU) No 2016/161 and its application?) of this FAQ from the European Commission.

    • 6.03 Is it possible to deliver a serialized product from country A to country B when this product is not registered in country B?
        If products are sold by exceptions in countries where the products are not registered, the EMVS will allow for a verification process though with very slow performance. Therefore we strongly recommend to use the multimarket pack approach which means you’ll need to upload the Product master data in the NMVSs of country A and country B. The Master Data Guide, is available in our Documents Overview.

    • 6.04 How is the EMVS testing the randomness of Serial Numbers (UID)?
        The EMVS, consisting of the European Hub and the National Systems, implemented a level of testing to check the level of randomisation of serial numbers supplied by each OBP. The Delegated Regulation (Article 4) clearly states that the serial number has to be random and places some definitions about how random the values should be for a given product code.

        To provide a sense-check, the EU Hub implemented some tests on the randomisation of serial numbers for every file of Product Pack Data (PPD) which is uploaded to the EU Hub. This might trigger a warning which is sent to the OBP, informing them that the numbers may not be sufficiently randomised.

        At this moment, EMVO plans to adapt the randomisation test algorithm in the next release of the EU Hub and have randomisation tests implemented in the National Systems. This should result in less warnings to OBP’s. When the tests are implemented by the National Systems, all serial numbers ever uploaded for a specific product, can be taken into account.

        At all times, OBP’s should be aware that it is not a warranty that the generation method used is sufficiently robust when no error message has been received. The testing undertaken by the EMVS only ‘weeds out’ those that fall well below the standard required.

        EMVO is not an authority of the use and construction of suitable algorithms to produce serial numbers of a sufficient random nature. OBP should research the recommendations of NIST (National Institute of Standards and Technology).

    • 6.05 What is to be done if the original batch number is longer than 20 characters?
        An inbound product suitably coded for the European market under the terms of the FMD Delegated regulation cannot have a batch ID greater than 20 characters – the coding schemes simply do not support this.

    • 6.06 Does the strength and pharmaceutical form need to be added to the Registered Product Name to form the Name of the Medicinal Product?
        This question is related to one of the common data elements in the EMVS Master Data Guide (Appendix 1), Name of Medicinal Product.

        Does the strength and pharmaceutical form need to be added to the Registered Product Name to form the Name of Medicinal Product, if this Registered Trade Name not includes the strength and pharmaceutical form?

        This Registered Trade Name is more appropriate for the ‘common-name’ entry and not for the ‘name’ field. According to our investigations, the name should be followed by the strength and form information as indicated in the guidance document by reference to SmPC rev.

        Ultimately however this is only guidance – you should seek detailed clarification from the regulator responsible for the market(s) on which your product is sold as EMVO is not a regulatory authority and this data is not used within the EMVS (currently) for any other purpose than report content/decoration.

        The majority of the master data elements were imposed on the system by the Delegated Regulation (Art. 33(2)) and EMVO does not have the history to know why the master data in that article is so rich in content. Your regulatory authorities should be able to provide the background and guidance. The Master Data Guide, is available in our Documents Overview.

    • 6.07 Why not all countries are listed in appendix 4 of the Master Data Guide?
        Appendix 4 of the Master Data Guide does not cover countries who made the decision of including the reimbursement number into the datamatrix code.

    • 6.08 Who is a Designated Wholesaler?
        ‘Designated Wholesalers’ are wholesalers who are designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf. Likewise, the parallel importer / parallel distributor may designate a wholesaler, by means of a written contract, to store and distribute on his behalf the products covered by the parallel import authorisations/parallel distribution notices respectively. A detailed presentation related to designated wholesaler is available in our Documents Overview.

    • 6.09 Is a designated wholesaler obliged to verify the authenticity of the unique identifier of medicinal products?
        No, the designated wholesaler is not obliged to verify the authenticity of the unique identifier of medicinal products. The Delegated Regulation sets out in which cases a wholesaler is obliged to verify the authenticity of the unique identifier of medicinal products. Consequently, wholesalers are not obliged to verify the authenticity of the unique identifier of products that they have received from the manufacturer or the MAH or a wholesaler properly designated under Article 20(b) Delegated Regulation ("designated wholesaler"). A detailed presentation related to designated wholesaler is available in our EMVO Master Data Guidance – Designated Wholesalers.

    • 6.10 What is a Sales Affiliate of a MAH?
        A Sales Affiliate of a MAH is a company focussing on sales which is controlled by the MAH or which is a subject to control by the same legal entity as the MAH. Affiliates should be considered as proxies of the MAH and should not be listed as ‘Designated Wholesaler’. ‘Affiliate’ means a company or legal entity that is effectively controlled by another or associated with others under common ownership or control. A detailed presentation related to Sales Affiliate of MAH is available in our EMVO Master Data Guidance – Designated Wholesalers.

    • 6.11 What is a Co-Marketer?
        A Co-Marketer is a company commercializing a product under a different trademark. As co-marketers commercialise the product under a different trademark, they have their own marketing authorisation, different from that of the MAH. Therefore, Co-marketers are considered as MAH in their own right and should not be listed as ‘Designated Wholesaler’. A detailed presentation related to Co-Marketer is available in our EMVO Master Data Guidance – Designated Wholesalers.

    • 6.12 How is the [Strength] field as a common master data element defined?
        In addition to the information from section 4 "Common Master Data Elements" of the EMVS Master Data Guide, please be informed that, when uploading data, there is a character limit on the [Strength] field of 30 characters. As a result, the EU Hub will reject any upload of data when this field is populated with more than 30 characters. The correct population of the [Strength] field as per above sits with is the OBP's exclusive responsibility.

  • 7. CMO and 3PL Connection

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