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.

Videos

Check out the latest videos from EMVO

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
        AR Authorised Representative
        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
        EFPIA European Federation of Pharmaceutical Industries and Associations
        EMVO European Medicines Verification Organisation
        EMVS European Medicines Verification System
        EU Hub European Hub
        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
        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 Unique Identifier

         

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

         

      • 2.01 What is an OBP? What is an MAH?

        A corporation/group of companies has to decide which legal entity will act as their On-boarding Partner (OBP). All relevant data of the Marketing Authorization Holders (MAH) of the corporation/group of companies will be transferred via the OBP to the EMVO (EU Hub).   OBP and MAH   Definition of On-boarding Partner (OBP): 1. The OBP is the contracting part 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. 4. Affiliate shall mean, in relation to a Party, any other person affiliated with such Party within the meaning of Article 11[1] of the Belgian Code of Companies (it being understood, for the avoidance of doubt, that the definition set out in said Article 11 is agreed to also apply to non-Belgian persons). 5. 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. 6. The group of MAHs represented by the OBP either consists of Original Pack Manufacturers (MAH without Parallel Distribution Activities) or Parallel Distributors (MAH with Parallel Distribution Activities).  

    • 1.02 How are Delegated Regulation and the new rules on medicine verification of the European Commision implemented?

        To facilitate the implementation of the Delegated Regulation and the new rules on medicine verification, the European Commission has prepared a “Questions and Answers” document.

    • 1.03 What are the EMVO bank details?

        Bank owner: EMVO

        Bank name: ING Luxembourg

        IBAN CODE: LU54 0141 3552 8230 0000

        BIC CODE: CELLLULL

    • 1.04 What are the penalties for failure to comply with the deadline of February 9th 2019?

        The European Medicines Verification Organisation is neither authorized nor in the position to state or determine the consequences and penalties for failure to comply with the deadline of February 9th 2019.

        Please contact the European Commission for further information.

    • 1.05 Does EMVO fulfils 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 2011/62/EU and the  Delegated Regulation (EU) 2016/161 are also available in our Documents Overview.

         

  • 2. Contractual On-boarding

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    • 2.01 What is an OBP? What is an MAH?

        A corporation/group of companies has to decide which legal entity will act as their On-boarding Partner (OBP). All relevant data of the Marketing Authorization Holders (MAH) of the corporation/group of companies will be transferred via the OBP to the EMVO (EU Hub).

         

        OBP and MAH

         

        Definition of On-boarding Partner (OBP):

        1. The OBP is the contracting part 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.

        4. Affiliate shall mean, in relation to a Party, any other person affiliated with such Party within the meaning of Article 11[1] of the Belgian Code of Companies (it being understood, for the avoidance of doubt, that the definition set out in said Article 11 is agreed to also apply to non-Belgian persons).

        5. 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.

        6. The group of MAHs represented by the OBP either consists of Original Pack Manufacturers (MAH without Parallel Distribution Activities) or Parallel Distributors (MAH with Parallel Distribution Activities).

         

    • 2.02 What is the confirmation letter?

        The purpose of this confirmation letter is to approve that an OBP is authorised to act on behalf of a Marketing Authorisation Holder (MAH) / a group of MAHs and that they are affiliated with each other. As you know, EMVO has a contractual relationship to the OBP, not necessarily to the MAH which shall ensure that the information referred to in Article 33 (2) of the Delegated Regulation is uploaded to the repositories system before the medicinal product is released for sale or distribution by the manufacturer.

         

        The confirmation letter is currently in a draft stage. As soon as the work is completed the letter will be available for download in the OBP Portal.

         

        The Delegated Regulation (EU) 2016/161 is available in our Documents Overview.

    • 2.03 Can a company decide to On-board each of its MAHs to the EU Hub separately?

        No. We only allow 1 OBP per corporation. This OBP needs to be part of the corporation and will be fully responsible for uploading data into the EU Hub in name and for the account of each affiliated MAH.

    • 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:

        • Company A produces as CMO for B but also sells theselves.
        • 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 actiong 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 (MAH without Parallel Distribution Activities) and Parallel Distributor (MAH with Parallel Distribution Activities)?

        The Original Pack Manufacturer (MAH without Parallel Distribution Activities) is the classical pharmaceutical company that holds marketing authorisations and operates its own manufacturing facility (in a wholly owned entity or sometimes by using a third-party manufacturer). On a technical point of view, this allows you to upload original pack data not sourced from a repacking operation to the EU Hub.

        The Parallel Distributor (MAH with Parallel Distribution Activities) is the parallel distributor that is, by virtue of the FMD, a "manufacturing authorisation holder" for the necessary repackaging operations. On a technical point of view, this allows both the decommissioning of already uploaded pack data from a source market and the subsequent upload of new products into the market.

    • 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 date to the EU Hub (e.a. XYZ Sales Company in EU member country). Possibly an affliate of the OBP; for smaller companies the MAH and OBP could be the same.

         

        Manufacturing Authorisation Holder

        The producing company, also responsible for the release of a certain batch is a Manufacturing Authorisation Holder. Possibly an affiliate of the pharmaceutical company (e.a. XYZ Manufacturing Company); for smaller companies the Manufacturing Authorisation Holder and MFR could be the same.

    • 2.07 What is a Parallel Distributor?

        Parallel distributors are not marketing authorisation holders in the letter of EU law, they functionally take a comparable role. The parallel importer, or distributor, does not hold a marketing authorisation in the terms of the Community law. Instead, the parallel importer is holder of specific product authorisations issued by national competent authorities in an abbreviated procedure.

        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.

    • 2.08 What is a SPOC and SPOC assistant?

        The SPOC is the key contact person for EMVO and is authorised by the Authorised Representative to be in charge of the correspondence between the OBP and EMVO. The SPOC is responsible for providing the requested information for the OBP on the On-Boarding Partner 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.

    • 2.11 Is the Participation Agreement confidential?

        No, the Participation Agreement (PA) is not confidential.

    • 2.12 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.

    • 2.13 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.

    • 2.14 Is there a declaration or an official position that endorse the statement “NO CONTRACT NEGOTIATION”?

        The Participation Agreement is NON-NEGOTIABLE, only in case of contradicting national law.

    • 2.15 What is a Copy of Proof?

        A copy of proof consists in 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 in 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 here the list of National Registers for obtaining the Copy of Proof.

    • 2.16 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:

        • The named Authorised Representative is entitled to sign on behalf of the company
        • The copy of proof attached confirms the entitlement of the Authorised Representative to sign on behalf of the company
        • The person named in step 1.2 is the person that signed, in fact, the Participation Agreement
        • The full name of the AR is provided, without translation nor abbreviation, as it appears in the national register.
    • 2.21 Which information on the invoicing form is obligatory vs. optional?

        Please have a 2nd look on the invoicing form from step 2.5 in 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.

    • 2.22 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.

    • 2.23 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’.

    • 2.24 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 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 he 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 which 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.

    • 2.31 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. Latest before getting connected to the HUB test environment the fee has to be paid.

    • 2.32 What’s the amount of the On-boarding Fee?

        To cover administrative connection costs, including the cost of the legitimacy check, EMVO charges a one-time On-boarding fee.

        The applicable On-boarding Fee will be determined on the basis of the following elements:

        • The number of MAHs in Europe (European Economic Area and Switzerland) the OBP represents
        • the timing when the OBP shares its valid Participation Agreement with EMVO via the OBP Portal

         

        The Agreement will be considered valid provided all the following conditions are satisfied:

        • All pages of the Agreement have been shared with EMVO using the respective platform as per above
        • No amendments, changes or other edits have been made to the Agreement
        • The individual(s) signing the Agreement is (are) the individual(s) duly authorised to sign on behalf of the OBP and provide(s) evidence to that respect as per the requirements EMVO has set and communicated to the OBP

         

        Therefore, due to the fees adjustment over time, an application of 50% rise in the amount to be invoiced to the OBPs will be applicable from the 15th of January 2018. An additional 50% rise will apply from the 15th of June 2018.

         

    • 2.33 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. To consult the latest applicable On-boarding fees, please check the FAQ 232, or contact our Helpdesk.

         

      • 2.32 What’s the amount of the On-boarding Fee?

        To cover administrative connection costs, including the cost of the legitimacy check, EMVO charges a one-time On-boarding fee. The applicable On-boarding Fee will be determined on the basis of the following elements:

        • The number of MAHs in Europe (European Economic Area and Switzerland) the OBP represents
        • the timing when the OBP shares its valid Participation Agreement with EMVO via the OBP Portal
          The Agreement will be considered valid provided all the following conditions are satisfied:
        • All pages of the Agreement have been shared with EMVO using the respective platform as per above
        • No amendments, changes or other edits have been made to the Agreement
        • The individual(s) signing the Agreement is (are) the individual(s) duly authorised to sign on behalf of the OBP and provide(s) evidence to that respect as per the requirements EMVO has set and communicated to the OBP
          Therefore, due to the fees adjustment over time, an application of 50% rise in the amount to be invoiced to the OBPs will be applicable from the 15th of January 2018. An additional 50% rise will apply from the 15th of June 2018.  

    • 2.34 Will the operational phase be followed by additional costs/yearly maintenance?

        No, not from EMVO side. The National Medicines Verification Organizations will ask for the yearly Flat Fee.

  • 3. Legitimacy Check

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    • 3.01 What does the “Legitimacy Check” includes? 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?

        • 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.
        • All detailed company information, except the company type, can be updated.
        • The OBP can also modify the SPOC and the SPOC assistant contact details.
        • 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.
        • 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.

  • 6. Data Upload

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

    • 6.03 Is aggregation upload possible? Is there a chance to benefit from a more detailed data set by sending aggregation?

        No. Not possible and thus no potential benefit.

    • 6.04 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 EMVS 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.

    • 6.05 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 EMVS Master Data Guide is available in our Documents Overview.

    • 6.06 How is the EMVS testing the randomness of Serial Numbers (UID)?

        The EMVS, consisting of the European Hub and the National Systems, implements a level of testing to assure the random nature 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 EMVS implements some tests on all series of serial numbers loaded to the system and when numbers are loaded that do not meet the criteria set, currently a warning is returned to the OBP informing them that the numbers are not sufficiently randomised. When the system is in full operation after February 2019, this warning may be changed to an error resulting in pack uploads being rejected.

         

        The creation of numbers that are sufficiently random is not hugely difficult however the topic is massively misunderstood. EMVO have chosen the globally recognised standards for random and pseudo-random numbers defined and explained by NIST (National Institute of Standards and Technology). The EMVS however does not implement the entire suite of tests for randomness. The EMVS only implements the monobit and runs tests. As such, OBP’s should be aware that submitting number streams to the EMVS that do not give a warning is not a warranty that the generation method used is sufficiently robust. The testing undertaken by the EMVS only ‘weeds out’ those that fall well below the standard required. As such, a full review of the test suite described by NIST is highly recommended.

         

        Currently the use of static prefix and suffix numbers within the serial number will (as might be expected) cause testing failures. Try wherever possible to minimise or eradicate static sections of the number lists.

         

        EMVO is not an authority of the use and construction of suitable algorithms to produce serial numbers of a sufficient random nature. OBP suppliers should be tasked to prove their capabilities or OBP’s themselves should research the recommendations of NIST.

    • 6.07 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.

    • 6.08 How is the process to connect the batch data (section 5.1) with the article master data (section 3), if someone has to upload the batch data and the pack data more frequent (different batch numbers to the same article number).

        This Question relates to the EMVS Master Data Guide.

        The batch data is associated with the master data by means of the product code. Each batch (which includes the pack) data upload will contain the product code (article number), batch ID, Expiry date and list of serial numbers (plus of course the MFR details). Thus, the product code is used as the common field between master data and batch data. The EMVS always uses the product code as the key field and the Hub makes the connection for you.

        Parallel Distributors do also have to load the old product code and batch information so that the Hub can discharge its requirements under Article 35(4) in the DR. They can also upload new outbound batches (all different if needed) to the Hub and so long as they specify the original product code and original batch ID, the Hub will allow multiple batches up to the limit imposed by the original decommissioning.

    • 6.09 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 EMVS Master Data Guide is available in our Documents Overview.

  • 7. CMO and 3PL Connection

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Documents Overview

General

pdf
24.10.2017

Delegated Regulation (EU) 2016/161

Download the Delegated Regulation (EU) 2016/161 in English. Download the document from the EU server in other languages here.
pdf
24.10.2017

Directive 2011/62/EU

Download the Directive 2011/62/EU (FMD) in English. Download the document from the EU server in other languages here.
pdf
05.12.2017

EMVO Glossary

pdf
13.02.2018

Questions and Answers

Download the Questions and Answers V9.0 document on safety features for medicinal products for human use in English. This document was published by the European Commission.

On-boarding Partner (OBP)

pdf
20.03.2018

Coding Requirements

Coding Requirements (03-2018)
pdf
05.12.2017

Connecting Systems to the EMVS

Connecting Systems to the EMVS Version 1.0
pdf
05.12.2017

EMVS Master Data Guide

pdf
05.12.2017

Invoicing Information Form (SAMPLE)

pdf
05.12.2017

National Registers for obtaining the Copy of Proof

pdf
05.12.2017

OBP Checklist for Contractual On-boarding

pdf
11.04.2018

OBP On-boarding Guideline

OBP On-boarding Guideline Version 6.0
pdf
11.04.2018

OBP On-boarding Presentation

OBP On-boarding Presentation Version 8.0
pdf
05.12.2017

OBP Participation Agreement (SAMPLE)

pdf
05.12.2017

Web Gateway Overview

OBP IT Connection Provider (OBP CP)

pdf
05.12.2017

OBP Connection Provider License Agreement (SAMPLE)

National Medicines Verification Organisation (NMVO)

pdf
11.04.2018

2018/04/06 | Slovenian NMVS connected to the EU Hub!

pdf
11.04.2018

2018/04/10 | Irish NMVS connected to the EU Hub!

pdf
11.04.2018

2018/04/10 | Swedish NMVS connected to the EU Hub!

pdf
11.04.2018

2018/04/11 | Danish NMVS connected to the EU Hub!

pdf
18.04.2018

2018/04/18 | Bulgarian NMVS connected to the EU Hub!

pdf
20.04.2018

2018/04/20 | Lithuanian NMVS connected to the EU Hub!

pdf
05.12.2017

EMVS URS Lite

pdf
05.12.2017

National Memorandum of Understanding (template)

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05.12.2017

NMVO On-boarding Guideline

NMVO On-boarding Guideline Version 2.0
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05.12.2017

NMVO On-boarding Presentation

NMVO On-boarding Presentation Version 3.0
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05.12.2017

Roadmap to NMVO and NMVS implementation

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05.12.2017

Template NMVO Statutes

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05.12.2017

White Paper on EMVS Data Upload

Letters of Announcement

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05.12.2017

2017/03/10 | Release of the OBP Portal

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05.12.2017

2017/03/16 | New NMVO Section

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05.12.2017

2017/03/16 | Training Video for the OBP Portal

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05.12.2017

2017/07/24 | EU Hub 2 availability and New Release of the OBP Portal

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05.12.2017

2017/07/24 | Updated Credential Handling for the OBP Portal

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05.12.2017

2017/09/06 | EMVO On-boarding / NMVO Contracting

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05.12.2017

2017/10/03 | EU HUB 2.0 and EMVO Gateway 3.0

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05.12.2017

2017/10/04 | New release of OBP Portal

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08.12.2017

2017/12/06 | New EU Hub Release 1.3

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08.12.2017

2017/12/06 | New version of .NET and Java SDKs

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15.01.2018

2017/12/15 | On-boarding Fee

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15.01.2018

2018/01/04 | Technical On-boarding Training Video

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15.01.2018

2018/01/08 | On-boarding Fee rise: A week left

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15.01.2018

2018/01/12 | Last Opportunity for a Timely On-boarding

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31.01.2018

2018/01/31 | Company Type

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05.02.2018

2018/02/05 | Target Market for testing and certification

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09.02.2018

2018/02/09 | EMVO ON-BOARDING – Only one year left!

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22.02.2018

2018/02/22 | New version of .NET SDK available

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27.02.2018

2018/02/27 | EMVO Website 2.0

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02.03.2018

2018/03/05 | Momentary Unavailability of the German National System

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12.03.2018

2018/03/12 | 500 Participation Agreements signed!

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16.03.2018

2018/03/16 | EMVO Notice to Future On-Boarding Partners

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04.04.2018

2018/04/04 | OBP Portal – New Release

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12.04.2018

2018/04/12 | NMVOs Progresses in the On-boarding

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19.04.2018

2018/04/19 | EU Hub Down for Maintenance

Workshops

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05.12.2017

EMVO MS Workshop COM

EMVO NCA Workshop 2016.12.13 – Brussels
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05.12.2017

Flat Fee Allocation Model Voluntary Use

EMVO NCA Workshop 2016.12.13 – Brussels
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05.12.2017

State of Play – EMVS and Connected Systems

EMVO NCA Workshop 2016.12.13 – Brussels
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05.12.2017

State of Play – Hub On-boarding

EMVO NCA Workshop 2016.12.13 – Brussels
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05.12.2017

Supervison by NCA and Access to Data

EMVO NCA Workshop 2016.12.13 – Brussels

Videos

EMVO Training Video – On-boarding Partner Portal

This training video has been created for pharmaceutical companies that have to connect to the European Hub for the purpose of serialization of their product, established in the Falsified Medicines Directive of the European Commission (2011/62/EU).

EMVO Training Video – Technical On-boarding

This training video has been created for pharmaceutical companies that have to connect to the European Hub for the purpose of serialization of their product, established in the Falsified Medicines Directive of the European Commission (2011/62/EU). This video will allow the On-boarding Partners to get acquainted with the steps and requirements related to the Technical On-boarding. Furthermore, it will show you a practical example and provide you with guidance throughout the Technical On-boarding process.

EMVO OBP Checklist for Contractual On-boarding

This is a Checklist for EMVOs On-boarding Partners to speed up the OBP Portal Procedure. Please find and keep all the information mentioned in this checklist clip before requesting access to the OBP Portal.

EMVO OBP Description

This is a description of EMVO On-boarding Partners (OBPs). Please view this clip to make sure you are eligible before starting the On-boarding Process to the European Medicines Verification Organisation (EMVO) and the EU Hub.