Q&A

1.1 How do different categories of users relate to HMVS?

Both private pharmacies and pharmacies of hospitals and clinics will be connected to the National Repository of Medicines through the Social Security e-Government (IDIKA), with the latter operating as a single connector. Companies with wholesale licenses (i.e. pharmaceutical wholesalers, Third Parties, logistics, 3PLs and pharmaceutical distribution centers) will connect directly to HMVS.

1.2. Do the provisions apply to non-prescription products as well as prescription products?

No, the provisions do not apply to over-the-counter products other than those specified in Annex II to the Regulation (currently only omeprazole 20 and 40 mg capsules). The products that will have safety features are determined only by the categorization (OTC or prescription only) as notified by the Pharmaceutical Services. The Regulation provides for the possibility of exemptions for both prescription and non-prescription products drugs with a specific procedure.

1.3. Do the provisions also apply to veterinary medicinal products?

No, they apply only to human medicines.

1.4. Can you obtain an exemption for certain medicines?

Pharmaceutical services may not issue exemptions for individual medicinal products. They may propose through Annexes III and IV such exemptions to the European Commission, which evaluates the medicinal products to be included in Annexes I and II of the Regulation and makes the appropriate arrangements. These proposals can be made either on the initiative of the Local Authorities or made by the companies to the Local Authorities and if the Local Authorities Principles agree to be forwarded to the European Commission.

1.5. What should be done in the case of medicinal products intended for clinical trials?

Excluded are products in development phase and unauthorized (without marketing authorization). If a test is being done with a licensed product then it should be deactivated before use.

2.1 Why do you need to print the 2D Data Matrix (DM) on each individual package during production?

Each two-dimensional code will include elements that are unique to each individual package. This ensures that each individual package in the legal supply chain of medicines will have its own identity.

2.2 What elements does a two-dimensional code (2D, Data Matrix / DM) include?

It includes the following elements:

• Product code (GTIN)
• Unique serial number (alphanumeric, randomised up to 20 characters) for each individual pack
• Batch number
• Expiry date
• a national reimbursement number or other national number identifying the medicinal product, if required by the Member State in which the product is intended to be placed on the market.  For Greece this will be the code of the EOF authenticity strips, which has been agreed to be received electronically by EMVS/HMVS during verification and thus does not need to be encoded within the two-dimensional code (Data Matrix). See EOF announcement (8/10/2024) note. (i): https://www.eof.gr

2.3 Is there a relevant requirement for the order in which the product code, serial number, batch number and expiry date should be printed?

1. Producers may choose the order in which the CDM data will be printed, provided that all the data required by the Regulation and the National Health Authorities are included.
2. The product code, serial number and, optionally if required, the national compensation number (in the case of Greece it is not required to be printed), should be printed in human-readable form, next to the two-dimensional code, if the dimensions of the package allow (see Article 7 of Regulation & Q 2.8 of Q&A). The batch number and expiry date should also be printed in legible form. But there is no requirement for this to be done next to the two-dimensional code and they can be printed anywhere on the box.

2.4 Where should I apply for serial numbers for online verification?

Each company is responsible for creating and managing its own serial codes for electronic verification. For how the alphanumeric serial code should be composed, see Rules of Procedure. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0161

2.5 Where do you get the company prefix?

The corporate prefix is provided by the GS organization. Therefore, check internally if your company already has a prefix to be used and how the GTIN is structured in Greece. You may obtain relevant information by contacting GS1.

2.6 How to create a new GTIN?

Each company is responsible for creating and managing its own GTINs (Global Trade Item Number). A GTIN consists of the following parts: company prefix, product reference, and check digit.

2.7 The GS1 Greece number in our company uses the prefixes 520 and 521. Is there a conflict in the corresponding GS1 Cyprus organization with prefix 529?

There is no conflict with the prefixes of other countries, whether they are from Greece or any other country. Corporate prefixes and codes (GTINs) are structured in such a way that they do not allow duplication.

2.8 What procedure should be carried out for each individual package of a parallel imported medicinal product?

Before placing each individual pack on the market for supply, the parallel importer shall be obliged to deactivate the existing manufacturer’s code and create a new code of his own to be printed on the new individual package, to allow the authenticity of the medicinal product to be verified before being made available to the public. The same procedure shall apply where the product is imported by a parallel exporter intending to reintroduce it – Deactivating and creating a new serial code will again be necessary. It implies that the process of deactivating and reactivating a parallel product can be carried out more than once. According to Regulation 2016/161, articles 16 and 17, safety elements can be covered/replaced in an individual package.

2.9 Can you print the two-dimensional code on a label that you will affix to each individual package during production?

We quote the relevant question/answer no. 2.21 from ‘Safety Features Q&A v.21/May 2024’. According to Q&A this is only permissible for parallel importers and under the conditions mentioned in the relevant reply.eQuestion: Is it acceptable to use stickers to place the unique identifier on the outer/immediate packaging?

Answer: As a rule, the unique identifier must be printed on the packaging (Article 5(3) of Commission Delegated Regulation (EU) 2016/161).

For medicinal products subject to parallel import and parallel distribution it is possible to use a sticker (adhesive label) provided that the sticker cannot be removed without being damaged and that the sticker fulfils the quality of the printing requirements set out in Article 6 of the Commission Delegated Regulation (EU) 2016/161 (case C147/20, Novartis Pharma GmbH v Abacus Medicine A/S).

The replacement of the unique identifier must be conducted in accordance with applicable Good Manufacturing Practice principles. Moreover, all applicable labelling requirements in Directive 2001/83/EC must be met and the sticker must not impair the readability of other required labelling elements.

3.1 Do you have to indicate to the European Hub in which countries an individual package will be marketed?

Yes, for each individual physical package, you will need to indicate in which market(s) it will be made available.

3.2 How will common packages between Greece and Cyprus or packages intended for more than one country be loaded onto the European Hub?

For packages of medicines intended to be distributed in more than one country, e.g. those concerning Greece – Cyprus (common packs or shared packs), the entire quantity will be loaded at the European Node, specifying as destination all the countries to which they are to be supplied.

3.3 Should information on individual packs be uploaded to the European node at central level of the pharmaceutical manufacturers or by the pack manufacturer?

They should be uploaded centrally. There will be one (1) communication link (for data loading) per pharmaceutical manufacturer, from where information will be collected from all manufacturing units and other contracting companies. Maintaining very high security standards, the company’s access process to the EU Hub is thorough and includes decisive steps: investigation, Verification of the legality of the company, relevant contract as well as technical tests related to the connection. Detailed information can be found on the EMVO website (https://emvo-medicines.eu/).

3.4 Are the companies contracting with the MAHs able to register individual package information on the European hub?

Each MAH will appoint an “On Boarding Partner (OBP)” who will communicate and sign contracts with EMVO. Normally, all uploads to the EU Hub will take place via an integrated interface between the company’s system and the EU Hub. There will be only one (1) such connection per company, i.e. data from all production facilities will have to be collected and uploaded to the EU Hub through this interface.

It will also be possible to upload data manually via the EMVO Gateway. Therefore, there could be a second possible connection for a company. Through this second web portal, companies will be able to upload data before the automated interconnection is completed. In this way, the OBP will be able to create an account for one or more external partners who will manage data loading. The account can be limited in terms of the activities that can be done as well as for specific packages (SKUs). This solution will be able to work for small companies with a limited amount of data.

3.5 What happens if you upload the same information more than once?

The EU Hub acknowledges that the information is already available and prevents it from being loaded a second time. If you upload information a second time for a product intended only for a country, you receive an error message informing you that this has already been done. If during the transitional period, until February 2025, information is provided for a multi-market product and not all relevant NMVS are in operation, only market information with NMVS in operation is accepted. For other markets, the information must be reloaded, retrospectively, when the NMVS are put into operation, i.e. there may be several loads of the same information. But this is not a problem for the European Hub.

3.6. Since when can MAHs/producers proceed with the application of safety features of Greek packaging (note ii EOF Announcement https://www.eof.gr)?

Optionally and to be ready by the date of application, MAHs / producers can proceed with the implementation of the safety features of Greek packaging – without negating the obligation to affix the authenticity tape, thus providing the possibility to carry out any necessary checks. HMVO will confirm when relevant data can be uploaded to EMVS/HMVS.

4.1 The coverage of the costs for the implementation and operation of the computer system will be paid by the MAHs in accordance with Regulation 161/2016. What will it cost?

The subscription will be calculated per CAC (as indicated in the Regulation), based on the recent list of active CACs sent to us by EOF. The indicative* subscription is six thousand and five hundred euros (€6,500.00+VAT), i.e. the total amount payable  of eight thousand sixty euros (€8.060), including both the admission fee and the annual subscription (as these are specifically defined in the Convention and the Articles of Association of HMVO) for each MAH and must be paid by 10/1/2025. For each subsequent year, for those already registered, the annual contribution will be due, as it will be adjusted each time by decision of HMVO.

*Indicative due to the uncertain number of SARs to be registered and economic conditions.

4.2 When should you start paying?

The invoices must be paid by January 10, 2025.

5.1 Obligations of Wholesalers / distributors regarding the verification of Security Features and the deactivation of the unique identifier.

The obligations for the above system users are referred to in Articles 20-24 of REGULATION (EU) 2016/161.