Welcome to our Knowledge Database section. All of the information from this section is also available in the documents, available in our EMVO Documents Overview. Here, we summarised information assigned to the following topics:

  1. General Questions
  2. Questions concerning the Contractual On-boarding
  3. Questions concerning the Legitimacy Check
  4. Questions concerning the Technical On-boarding
  5. Questions concerning the Data Upload
  6. Questions concerning the CMO and 3PL Connection

If you have a question that isn’t answered here, please contact us helpdesk@emvo-medicines.eu.
 

1. General

101 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.
 

102 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.
 

103 What are the EMVO bank details?

 
Bank owner: EMVO
Bank name: ING Luxembourg
IBAN CODE: LU54 0141 3552 8230 0000
BIC CODE: CELLLULL
 

104 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.
 

105 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 and the Delegated Regulation are also available in our Documents Overview.
 

2. Contractual On-boarding

201 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 PA.
  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 PA.
  6. The group of MAHs represented by the OBP either consists of MAHs without parallel distribution activities or MAHs with parallel distribution activities (Parallel Distributors).

Hints:

202 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 is available in our Documents Overview.
 


205 What is the difference between MAH with or without parallel distributing activity?

 
A MAH without parallel distributing activity (e.g. manufacturer) is a producer of original packs/product, not sourced from a repacking operation.
A MAH with parallel distributing activity ( e.g. parallel distributor) is a manufacturer who produces own label packs/product where the content is sourced from a repacking process.
 


206 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.a. 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
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.
 


 

202 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 is available in our Documents Overview.
 

203 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.
 
Hint:

201 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 PA.
  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 PA.
  6. The group of MAHs represented by the OBP either consists of MAHs without parallel distribution activities or MAHs with parallel distribution activities (Parallel Distributors).

Hints:

202 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 is available in our Documents Overview.
 


205 What is the difference between MAH with or without parallel distributing activity?

 
A MAH without parallel distributing activity (e.g. manufacturer) is a producer of original packs/product, not sourced from a repacking operation.
A MAH with parallel distributing activity ( e.g. parallel distributor) is a manufacturer who produces own label packs/product where the content is sourced from a repacking process.
 


206 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.a. 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
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.
 


 


 

204 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.
 
Hint:

603 How does a CMO get serialisation data into the EMVS?

 
There are two options to fix this.

  1. The CMO can send the data to the OBP and let the OBP upload it directly.
  2. The OBP can create an account for the CMO using a Gateway provider (e.g. the EMVO-Gateway).

 


 

205 What is the difference between MAH with or without parallel distributing activity?

 
A MAH without parallel distributing activity (e.g. manufacturer) is a producer of original packs/product, not sourced from a repacking operation.
A MAH with parallel distributing activity ( e.g. parallel distributor) is a manufacturer who produces own label packs/product where the content is sourced from a repacking process.
 

206 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.a. 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
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.
 

207 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.
 

211 Is the Participation Agreement confidential?

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

212 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.
 

213 When is the On-boarding Partner (OBP) required to sign the Participation Agreement?

 
After the company information is filled in and the Authorised Representative is appointed.
 

214 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.
 

215 What is a Copy of Proof?

 
A copy of proof consists in an objective document attesting that the Authorised Representative has the authorization 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 PA you would be required to send us as well as to further pursue the legitimacy check.
 
The List of all the relevant registers or entities for your country is available in our Documents Overview.
 

221 Which information on the invoicing form is obligatory vs. optional?

 
EMVO_invoicing form sample
 

Which information on the invoicing form is obligatory vs. optional?

Please have a 2nd look on the invoicing form from step 3.5 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 the other details are optional.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

222 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.
 

223 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’.
 

224 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.
 

231 Where can I find the payment term (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.
 

232 What’s the amount of the On-boarding Fee? 

 
The On-boarding fee is between 3 and 20 thousand Euro depending on the number of marketing authorization holders of the On-boarding Partner in Europe (European Economic Area and Switzerland).
 

On-boarding fee
OBP with >12 MAHs 20’000 €
OBP with 6 – 12 MAHs 10’000 €
OBP with 3 – 5 MAHs 8’000 €
OBP with 2 MAHs 6’000 €
OBP with 1 MAH 3’000 €

 

233 What is included in the On-boarding Fee? 

 
The On-boarding Fee is a one-time fee which  includes connecting the On-boarding Partner (OBP) with all its MAHs to the EU Hub: One Fee per OBP. The On-boarding Fee is independent of the countries in which the MAH’s act.
 

234 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

301 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.
 

302 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.
 

303 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 it will be asked to provide a minimum of one MAH and a maximum of three, with a minimum of one product for each of them, and a maximum of three.
 
However, the OBP will be asked to provide EMVO with a complete list of all MAH for which it is going to upload data in the European Hub, before establishing a connection.
 
Moreover, this list will have to be continuously updated, if any change occurs in the MAH affiliated to the OBP.
 
Finally, the invoice that will be issued for the OBP depends on the number of MAH for which it is going to upload data in the European Hub at the moment of the connection. Therefore, the OBP will have to declare a number consistent to the number of MAHs in the list on the portal, before being allowed to establish a connection.
 

304 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

401 What is an OBP Gateway Provider?

 

  • A On-boarding Partner (OBP) Gateway Provider is a third-party contractor engaged by the OBP, who assists in whole or part of with the development, implementation, provision, use and/or operation of the OBP interface to the EU Hub via a Gateway Connection.
  • Every OBP Gateway Provider has to be promoted by at least one OBP in the On-boarding Process.
  • EMVO validates and approves the proposed Gateway Providers.

Go ahead with

403 Who are the registered Connection Providers (Gateway Providers)?

 
OBPs can choose to connect to the EU Hub via a direct connection (data send from OBPs system straight to EU Hub) or a Gateway Connection (data sent first to a Gateway Provider. The Gateway Provider sends it through to the EU Hub)
 
Contract Landscape
 
A list of the existing OBP Connection Providers and their On-boarding Status with EMVO can be found here.
 
Hints

402 What is the difference between a certified, registered, and sponsored Gateway Provider?

 

Gateway (Connection) Providers
Sponsored Gateway Provider When the Gateway Provider has a first customer, which means they’ve been named by the OBP during their on-boarding, the Gateway Provider becomes ‘Sponsored’. From that moment the Gateway Provider will be contacted to start the manual on-boarding in order to have access to the EU Hub.
Registered Gateway Provider The Gateway Provider becomes ‘Registered’ when they’ve signed the License Agreement with EMVO and a Support Contract with Solidsoft. Solidsoft will guide the Gateway Provider to get access to their dedicated Integrated Test Environment. This Connection can be used as a sandbox environment to develop the Connection for their customers.
Certified Gateway Provider A ‘Certified Gateway Provider’ means that the first customer passed successfully the Full-Certification Test via their Gateway Connection. Next OBPs who intent to use this Certified Gateway Provider are allowed to perform a mini-certification test in the Integrated Quality Environment.

 


404 Can I purchase a Direct Connection as a module of my existing IT System?

 
Yes, your IT software supplier may decide to offer a module off-the-shelf to allow your existing IT System to connect with a Direct Connection to the EU Hub.
 


451 What is the EMVO Gateway?

 
EMVO Gateway
 
Essentially the EMVO Gateway is an alternative means of connecting to the European Hub. (alternate to developing a direct connection).
 
The direct connection will suit many OBP’s however it is complex to realise (deliberately complex). The EMVO Gateway provides a lower effort route to connection using typically understood techniques and is aimed at those OBP’s who want to participate in pilot programs but do not yet have a direct connection established or smaller OBP’s who have no need for the direct connection because their volumes of batches are much lower. It’s highly manual in operation so not well suited to automated processes, however it is a very effective means for connecting easily with the European Hub and wider EMVS.
 


To download the OBP On-boarding Guideline and the OBP On-boarding Presentation, please visit our Documents Overview.
 
 

402 What is the difference between a certified, registered, and sponsored Gateway Provider?

 

Gateway (Connection) Providers
Sponsored Gateway Provider When the Gateway Provider has a first customer, which means they’ve been named by the OBP during their on-boarding, the Gateway Provider becomes ‘Sponsored’. From that moment the Gateway Provider will be contacted to start the manual on-boarding in order to have access to the EU Hub.
Registered Gateway Provider The Gateway Provider becomes ‘Registered’ when they’ve signed the License Agreement with EMVO and a Support Contract with Solidsoft. Solidsoft will guide the Gateway Provider to get access to their dedicated Integrated Test Environment. This Connection can be used as a sandbox environment to develop the Connection for their customers.
Certified Gateway Provider A ‘Certified Gateway Provider’ means that the first customer passed successfully the Full-Certification Test via their Gateway Connection. Next OBPs who intent to use this Certified Gateway Provider are allowed to perform a mini-certification test in the Integrated Quality Environment.

 

403 Who are the registered Connection Providers (Gateway Providers)?

 
OBPs can choose to connect to the EU Hub via a direct connection (data send from OBPs system straight to EU Hub) or a Gateway Connection (data sent first to a Gateway Provider. The Gateway Provider sends it through to the EU Hub)
 
Contract Landscape
 
A list of the existing OBP Connection Providers and their On-boarding Status with EMVO can be found here.
 
Hints

402 What is the difference between a certified, registered, and sponsored Gateway Provider?

 

Gateway (Connection) Providers
Sponsored Gateway Provider When the Gateway Provider has a first customer, which means they’ve been named by the OBP during their on-boarding, the Gateway Provider becomes ‘Sponsored’. From that moment the Gateway Provider will be contacted to start the manual on-boarding in order to have access to the EU Hub.
Registered Gateway Provider The Gateway Provider becomes ‘Registered’ when they’ve signed the License Agreement with EMVO and a Support Contract with Solidsoft. Solidsoft will guide the Gateway Provider to get access to their dedicated Integrated Test Environment. This Connection can be used as a sandbox environment to develop the Connection for their customers.
Certified Gateway Provider A ‘Certified Gateway Provider’ means that the first customer passed successfully the Full-Certification Test via their Gateway Connection. Next OBPs who intent to use this Certified Gateway Provider are allowed to perform a mini-certification test in the Integrated Quality Environment.

 


404 Can I purchase a Direct Connection as a module of my existing IT System?

 
Yes, your IT software supplier may decide to offer a module off-the-shelf to allow your existing IT System to connect with a Direct Connection to the EU Hub.
 


451 What is the EMVO Gateway?

 
EMVO Gateway
 
Essentially the EMVO Gateway is an alternative means of connecting to the European Hub. (alternate to developing a direct connection).
 
The direct connection will suit many OBP’s however it is complex to realise (deliberately complex). The EMVO Gateway provides a lower effort route to connection using typically understood techniques and is aimed at those OBP’s who want to participate in pilot programs but do not yet have a direct connection established or smaller OBP’s who have no need for the direct connection because their volumes of batches are much lower. It’s highly manual in operation so not well suited to automated processes, however it is a very effective means for connecting easily with the European Hub and wider EMVS.
 


To download the OBP On-boarding Guideline and the OBP On-boarding Presentation, please visit our Documents Overview.
 
 

404 Can I purchase a Direct Connection as a module of my existing IT System?

 
Yes, your IT software supplier may decide to offer a module off-the-shelf to allow your existing IT System to connect with a Direct Connection to the EU Hub.
 

405 What should I fill in in the field "Name of Gateway Provider"?

 
The Gateway provider is the provider of a Gateway connection to the EU Hub. You have to decide with whom you want to connect. For example if you choose for the EMVO Gateway connection, you complete this field with “EMVO Gateway”.
 

406 If an OBP opts for a certified Gateway provider, is a full-certification test required?

 
As a certified gateway provider already has a stable and secure connection with the EU Hub, the OBP can skip the sandbox tests in the Integrated Test Environment and fulfil immediately a mini certification test in Integrated Quality Environment to grant access to the production environment.
 
Hint:

407 What is the difference between a mini- and a full-certification?

 
The set of questions for a mini-certification test is limited versus a full-certification test as the certified gateway has already proven to be stable and secure.
 

407 What is the difference between a mini- and a full-certification?

 
The set of questions for a mini-certification test is limited versus a full-certification test as the certified gateway has already proven to be stable and secure.
 

408 About Contract – relationship with OBP Connection provider: we are going to select our Provider from a shortlist (3). Since the Partner should agree with conditions Session 5.3 and Appendix 1, how can we submit to them the conditions in Appendix 1?

 
We expect that you will have a contract with your provider about the related services. The conditions of Appendix 1 should be part of that contract.
 

411 Is a regular provision of respective ISO 27001 certificates in place and is this covered by the contract between EMVO and manufacturers?

 
Solidsoft Reply is ISO 27001 certified. EMVO does not deem it necessary for each manufacturer to also be ISO 27001 accredited.
 

412 Will manufacturers be informed in case of incidents related to their data (network intrusion, loss of data etc.)? If no assessment can be made whose data is affected, will all manufacturer be informed?

 
Yes, Manufacturers will be informed.
 

413 Are there requirements to the hardware and the internet connection of the local organization? Do we need to have a static IP address? Is VPN communication with the HUB going to be established?

 
No, there are not any hardware requirements in the form of a list. Your chosen service provider will already be aware of the security requirements and the need for a fixed endpoint. VPN is not used.
 

414 Are GTIN (or other standards) codes mandatory during the on boarding procedures?

 
The EMVS supports both the GS1 standard and the IFA PPN standard and doesn’t provide benefit either way. However the GS1 standard does provide measurable supply chain benefit for all stakeholders and is much the preferred option.
 

415 I have to name the client for the connection details. What information of the client is needed here (e.g. the DNS or the IP address of the server)? Or is it simply our company?

 
We offer you to define your name for the client. You should use your company name suffixed by the gateway provider or 3rd party provider name. This allows to easily identify your client connection with the European Hub such that for future maintenance or even disconnection requests, we can be certain that any amendments are made to the correct instance.
 

416 In the EMVO connection details, I have to define the connection type – and the connection technology. For both connection types (direct- or gateway), Java or .NET can be chosen. Can we also opt for another technology?

 
EMVO can only provide support for clients using one of the technologies we have specified and any deviation from this may entail additional costs which will have to be borne by either the connection provider or the On Boarding Partner.
 

417 Do we have to re-certify if there are security updates, major or minor releases of Java or .Net Framework?

 
Yes, if the changes you mention have a material effect on the interface you utilize. If not – the risk is entirely on your side.
 

418 Once on-boarded on the Production environment, is recertification required?

 
Yes. Certification is a vital step to ensure the integrity of all solutions connecting with the European Hub and demonstrates a key step as required under Good Automated Manufacturing Practice (GAMP) validation requirements. Therefore, re-certification is required when issues are found in the interface software of the On-boarding Partner or when EU Hub software is updated.
 

421 Batch information included in pack data. –> Batch information (in EU Hub) required prior to pack data upload?

 
No, you send it with the pack data unless you use the current EMVO Gateway in which case you send it first. Next revision of the EMVO Gateway will also take the batch information at the same time as the pack data.
 

422 Batch upload before sending packaging data or is a batch automatically created by sending serialization data?

 
Almost, you state the product code, batch and expiry as part of the pack upload process and the batch header information is created from this data.
 

423 Batch status attributes? Which status is available (active and recall or several ones?)

 
You don’t apply these they happen automatically on upload and are set to Active. Subsequently however you will be able to set a batch recalled.
 

424 Distribution of Serial Numbers batch-related –> release per batch or per process order?

 
Entirely your choice, we don’t insist on one model or the other but remember that the serial numbers are unique to the product code not only the batch.
 

431 How and when is a data input by OBP to the EU Hub available to National Systems?

 
When the OBP sends data to the European Hub it is propagated to the relevant national systems almost immediately.
 

432 Is the inputted data to each environment of the EU Hub available in the National Systems?

 
No. Only the production system is guaranteed to be connected to real national systems. ITE always uses simulated national systems, IQE may use a mix of simulated and real (but integration versions) national systems.
You will have to enquire when ready to send data to determine if the market you wish to communicate with is truly connected.
 

433 Does the connection between EU Hub and a National Repository follows the structure of the three environments? (Test, Quality, Prod)

 
No. National Repositories will follow a different path. Your provider (whoever that is) will have a support contract with SolidSoft Reply (EU Hub) and as a result will have a development and test environment all of their own. Integration tests will be performed there and then transit to our IQE for certification testing – then to Production.
 

434 Are you planning to migrate data from one to another environment?

 
No. We are absolutely not planning any data migration from any environment.
 

435 Is there any document that could help understanding the data trip during the setup?

 
Yes. There is a slide presentation available to this topic.
 
The presentation is currently in a draft stage. As soon as the work is completed the presentation will be available in the EMVO Download Section.
 

436 Can a company decide if it prefers to have a separate connection for each of its MAHs to the EU Hub instead of assigning only one connection?

 
In general, No. EMVO allows in maximum two connections to the EU Hub per OBP. (i.e. 1 direct + 1 gateway; 2 gateway)
 
Connection Types
 
Hint:

603 How does a CMO get serialisation data into the EMVS?

 
There are two options to fix this.

  1. The CMO can send the data to the OBP and let the OBP upload it directly.
  2. The OBP can create an account for the CMO using a Gateway provider (e.g. the EMVO-Gateway).

 


 

441 Is there a predefined order of 4 elements of the label, i.e. can we put the elements in the following order? Product code (recommended GTIN), Serial number, Expiry Date and Batch Number

 
Technically there is no restriction on the order of the data elements within the code beyond that the GTIN/Product code is first. However there are recommendations in the GS1 standard so they would be advised to read this. Put all the fixed length fields first (expiry) and always end with a variable length field (lot or serial) this way you minimize the code size.
 

451 What is the EMVO Gateway?

 
EMVO Gateway
 
Essentially the EMVO Gateway is an alternative means of connecting to the European Hub. (alternate to developing a direct connection).
 
The direct connection will suit many OBP’s however it is complex to realise (deliberately complex). The EMVO Gateway provides a lower effort route to connection using typically understood techniques and is aimed at those OBP’s who want to participate in pilot programs but do not yet have a direct connection established or smaller OBP’s who have no need for the direct connection because their volumes of batches are much lower. It’s highly manual in operation so not well suited to automated processes, however it is a very effective means for connecting easily with the European Hub and wider EMVS.
 

491 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 organization. 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 3rd parties directly to the European Hub to act on behalf of another party.
 

5. Data Upload

501 Do you provide the EMVS Master Data Guide as download?

 
Yes. The EMVS Master Data Guide is available in our Documents Overview.
 

503 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.
 

504 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.
 

505 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.
 

506 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.
 

507 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.
 

508 How is the process to connect the batch data (section 6.1) 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 it’s 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.
 

509 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.
 

6. CMO and 3PL Connection

CMO’s (Contract Manufacturing Organisations) and 3PL’s (Third Party Logistics providers) are employed by OBP’s (On-Boarding Partners) to provide services on their behalf and will generate data that has to be provided to the EMVS by some means. CMO's and 3PL's do not hold any rights and therefore no responsibility concerning the product.

601 Where can I consult general information related to CMO and 3PL Connection to EMVS ?

 
A general overview concerning the CMO and 3PL Connection Options to the EMVS can be consulted in our Documents Overview under the name Connecting Systems to the EMVS.
 

602 Can a CMO connect directly to the EMVS?

 
No, CMO’s have no contractual relationship with the EMVS and thus are not permitted to upload data. Uploaded data is also always attributed to the party who uploads it and for a CMO the data they produce will need to be attributed to the party employing them – aka the OBP. Thus a direct connection for a CMO will not function technically or contractually.
 

603 How does a CMO get serialisation data into the EMVS?

 
There are two options to fix this.

  1. The CMO can send the data to the OBP and let the OBP upload it directly.
  2. The OBP can create an account for the CMO using a Gateway provider (e.g. the EMVO-Gateway).

 

604 Can a CMO upload master data?

 
No, unless the OBP has allowed a facility to do this. This is described in the following FAQ.

Hint:

603 How does a CMO get serialisation data into the EMVS?

 
There are two options to fix this.

  1. The CMO can send the data to the OBP and let the OBP upload it directly.
  2. The OBP can create an account for the CMO using a Gateway provider (e.g. the EMVO-Gateway).

 


The EMVS Master Data Guide is available in our Documents Overview.
 

605 Can an OBP use the EPCIS standard to upload data to the EMVS?

 
No, not directly however if the OBP has internal systems that support EPCIS and that are also connected with the EMVS, it would be possible for the OBP to support this.
 

606 Who is legally responsible for data placed into the system that was initially generated by a CMO?

 
The OBP who owns the account under which the data was uploaded. Data upload is always the responsibility of the connection owner (OBP).
 

607 Should serialization data be uploaded by the Marketing Authorization Holder (MAH) or could be uploaded by a Contract Manufacturing Organization (CMO) delegated by MAH?

 
Each On Boarding Partner gets one connection to the EU Hub so there will be no connection of CMOs to the EU Hub. Delegation under certain circumstances is possible but only when delegated under the full control of the On Boarding Partner, EMVO does not grant access for 3rd parties acting as delegates.
 

611 Can a 3PL connect directly to a national system?

Yes, using the profile of a Wholesaler.

612 Can a 3PL connect directly to the European Hub?

No, not currently. However a 3PL could use facilities provided by the OBP and upload data via the OBP – e.g. a gateway connection.

613 Can a 3PL connect directly to multiple national systems where they operate as a multi-national distribution centre?

Technically yes, however this will potentially involve the development of multiple interfaces (for the different technical implementations of national system) however this is likely to be entirely dependent on whether the 3PL has a wholesaler licence in each of the markets they wish to connect with.

614 Can a 3PL use the EPCIS standard to upload data to the EMVS?

No, not directly however if the OBP has internal systems that support EPCIS and that are also connected with the EMVS, it would be possible for the OBP to support this.