Q & A
1. Print unique codes, change the layout and artwork, on individual packs of prescription medicine
Q. 1.1 Why do we need to print the two dimensional code (2D Data Matrix) on each individual pack during production?
A. Each two-dimensional code will include elements unique to each individual pack. This ensures that every pack in the legal supply chain will have its own unique identity.
Q. 1.2 Can we print the 2D code on a label that we put on the individual pack’s during production?
A. Discussions on this issue are ongoing. However, if this option adopted, it will be as an exception to the converging position that codes should be printed directly on the packages.
Q. 1.3 Is there a requirement as regards the order: product code, serial number, batch number and expiration date in which they should be printed in readable form?
A. The order given in the QRD template is: product code, serial number and possibly national number (currently not included in our case). These should be printed in an eye readable form next to the 2D code if the dimensions of the package allow see Article 7 of Regulation 161/2016. Batch number and expiry date should also be printed in legible form, but there is no requirement to do this next to the 2D code.
Q. 1.4 Where can we apply for serial numbers for e-verification?
A. Each company is responsible for creating and managing its own serial numbers for e-verification. For how the alphanumeric serial number should be composed, see Regulation.
Q. 1.5 Where do we get a company prefix?
A. The Company prefix is provided by GS1. Therefore, check internally if there is already a company prefix to be used, as well as how the GTIN structure can be built up in Cyprus. This can be done by communicating with GS1 Cyprus (Tel.: +35722889737)
Q. 1.6 Where do we apply for a new GTIN?
A. Each company is responsible for creating and managing their own GTIN’s. A GTIN of the company prefix +product reference + control digit
Q. 1.7 Our GTIN has 14 digits, but the barcode can only contain 13 digits. How do we handle this?
A. By removing the initial zero in a GTIN-14, a GTIN-13 is obtained
Q. 1.8 When I remove the initial zero in our 14-digit GTIN, which starts with two zeros, the second zero disappears, which makes it a UPC 12. How do you handle this?
A. There is no difference between an EAN 13 and a UPC with 12 digits. It is the same barcode
Q. 1.9 The number GS1 of Greece of our company includes the prefixes 520 and 521. Does this create a conflict in the corresponding GS1 of Cyprus with a 529 prefix?
A. There is no problem in the handling of packs from Greece in the Cyprus market. There are no conflicts with prefixes, whether these are from Greece or from any other country. Company prefixes and codes (GTIN) are structured in such a way, so as not to allow duplication.
Q. 1.10 How should the individual packs of parallel imported drugs be?
A. The parallel importer before placing each individual pack on the market has the obligation to decommission the serial code of the manufacturer and to create a new, own serial code, which should be printed on the new individual pack, so that, it will be possible to verify the authenticity of the medicinal product before it is made available to the public. The same procedure is applicable in case the product is imported from a parallel trader again decommissioning and re-commissioning with a new serial code will be necessary. This directly implies that the process of decommissioning and re-commissioning can be effected more than once for parallel products. According to articles 16 and 17 of Regulation 161/2016, security features can be removed, covered and replaced on a pack.
Q. 1.11 What does a 2D code contain?
A. The 2D code contains the following elements:
- Product code (GTIN or unique NTIN)
- Unique serial number (randomized) for each individual pack
- Batch number
- Date of expiration
More information is available in the Delegated Regulation 161/2016
2. Uploading unique codes to the European hub (EU hub)
Q. 2.1 Retrospective upload – is it necessary?
A. Yes, it is very important that the system does not produce an excessive number of false alarm signals. False alarm signals will result in undermining the confidence in the system and will pose an obstacle in the normal trade of medicines.
Retrospective loading should be done when the MAH’s distribute packs falling within the scope of the Regulation (requiring security features) in destination countries where the National Medicines Verification Systems (NMVS’s) are fully operational. In the case of packs intended for more than one countries (multinational packs), data that cannot be routed from the EU Hub to one of the countries due to a non operational NMVS, will be returned to the MAH for retrospective upload when the NMVS in this country is up and running.
Q. 2.2 Must we indicate to the EU Hub in which countries an individual pack is to be sold?
A. Yes, for each individual physical pack, you should indicate in which market (s) it is intended for sale
Q. 2.3.How do we upload the common packs (multi country packs) to the EU Hub? For example, the packs intended for both Greece and Cyprus?
A. For packs intended to be distributed in more than one country (eg common packs for Greece and Cyprus) the entire quantities intended for both countries have to be loaded to the European Hub. The same is valid for multi country packs, the quantities of which, should also be loaded to all countries intended for sale. None of these multi country packs will be charged to our National Repository as Cyprus packs. Therefore, KOEΦ will not bear any additional cost for these packs. This has been achieved through a special arrangement/agreement between KOEΦ and the CyMVS software provider.
Q. 2.3 Should the individual pack information be loaded to the European hub centrally at European Company level, or can they be loaded by the company producing the packages?
A. They must be loaded centrally. There will be one data communication connection per company, from where information will be collected from all production units and other sub-contractors. This is important for security reasons. The process of accessing the EU Hub by a company is demanding and includes several key steps such as: investigation, legal verification, contracts, and technical testing of the connection. Detailed information can be found on the EMVO website (https://emvo-medicines.eu/)
Q. 2.4 Are contract manufacturers able to register individual pack information on the European hub?
A. Each marketi authorization holder shall designate an “On-Boarding Partner, OBP” that communicates and signs contracts with EMVO. Normally, all uploads to the EU Hub will be performed via an integrated interface between the company’s system and the EU Hub. There will only be one (1) connection per company, i.e. data from all manufacturing facilities and contract manufacturers must be collected and uploaded to the EU Hub via this interface.
It will also be possible to manually upload data via a web-based portal, EMVO Gateway. This is a possible second connection between the company and the EU Hub. Through this portal, companies can upload data prior to the development of their automated interface. Using the Gateway an OBP can also create an account for one or more contract manufacturers to handle the upload. The account can be limited as to what activities can be performed as well as specific packaging (SKU). This method can work effectively for small companies with limited data volumes.
Q. 2.5 What happens if we upload the same information more than once?
A. Nothing. The EU Hub detects that the information has already been loaded and does not allow duplication to occur. If you upload information a second time, for a product that is only intended for a specific country, you will receive an error message indicating that this has already been loaded. If during the transition period until February 2019 information is loaded for a multi-market pack and not all the relevant NMVS’s are up and running then, only the information for the market with a functioning NMVS is accepted. For the other markets, the information must be reloaded retrospectively, when their NMVS system is up and running. This could lead to upload of the same information several times. However, this does not create any problems for the EU Hub.
3. Medical samples, products for research, etc.
Q. 3.1 Are drug samples excluded from the requirement for safety details?
A. No individual packs to be used as free samples or samples for the authorities should have security details and should be uploaded to the EU Hub. Before being submitted to the recipient, they must be deactivated by the product owner (via EU Hub). We expect to have sample status categories such as free samples and sample NCA (National Competent Authority) which should be labelled when deactivated. If samples are taken from a commercial batch, you must disable (status as above) and label the packs according to the regular procedures for free samples
Q. 3.2 What about clinical trial material?
A. Products under development and not authorized products are excluded. If a trial product is authorized and has a market authorization license, it should be deactivated upon disclosure
Q. 4.1 The CyMVS shall be funded by Market Authorization Holders in accordance with the Regulation 161/2016. What will the cost be?
A. The cost of the total CyMVS will be shared between Marketing Authorization Holders (MAH’s) or any other legally responsible entities that have medicinal products on the Cyprus market, falling within the scope of the Regulation. If a company has multiple MAH’s (x) then, it will have to pay x times the annual fee. MAH, but also stakeholders (we refer to these persons as the persons responsible for placing the product on the Cyprus market) should pay KOEΦ the set fee. It is expected that KOEΦ will sign agreements with the users of the system in 2018. Currently, the costs of operating the CyMVS cannot be accurately calculated however, a rough estimate indicates that they will be within a very reasonable range compared to other EU countries. The payable fees will be communicated at a later stage, during 2018, when the running costs of the system to be purchased will be available.
Q. 4.2 When do we start paying?
A. This fee will be charged from 2019 to cover the yearly operational expenses of the system, when it is up and running
Q. 4.3 Are there any additional fees that companies should plan for?
A. A one time, setup/deployment fee has been decided which will be communicated soon to the MAH’s. This fee is intended for covering the costs of system setup and deployment only and should be paid within the coming months (2017- 2018) according to a time schedule which will allow for discounts in case of early payment.
5. Drug Wholesalers/Distributors
Q. 5.1 Should the drug wholesaler/distributor always verify all codes upon delivery?
A. It will not always be required. If a MAH wishes the wholesaler to verify all codes upon delivery, it can of course be arranged as an additional service. In such a case, an agreement between the two should be made.
For more information regarding the obligations of the wholesalers please refer to the Delegated Regulation
Q. 6.1 Who needs a contract?
A. (a) For the “pilot phase”, the following applies: Manufacturers (MAHs) participating shall be affiliated with the European Hub through their OBPs (On-boarding Partners). Pharmacies and wholesalers enrolled in the pilot must have signed an agreement / contract with KOEΦ. Participating Cyprus MAH’s, with products on the Cyprus market, will also need to have a contract with ΚΟΕΦ.
b) Before February 9th, 2019 all Manufacturers (MAHs) shall be affiliated with the European Hub through their OBP (On-boarding Partners). All pharmacies and drug distributors (wholesalers) must have signed an agreement / contract with ΚΟΕΦ. All MAHs (Responsible for Product Marketing in Cyprus) must have an agreement / contract with ΚΟΕΦ because the fees for the system will be invoiced to them.
Q. 6.2 When will contract templates be obtained?
- Pharmacy / Distributors – 2018
- MAH’s – 2018
7. Pilot ( definition column to the right)
Q. 7.1 What is the purpose of the Pilot and what is the purpose?
A. The “Pilot phase” refers to the test activity to be conducted during a qualification period for the CyMVS and its environment, “end-to-end” i.e. including connection to the EU. Hub and end users system. It also means that the pilot phase covers not only purely technical aspects but also the surrounding procedures which all together constitute the complete system.
Q. 7.2 Which stakeholders will participate in the Pilot phase?
A. Pharmaceutical companies, wholesalers and pharmacies
Q. 7.3 Will we be using genuine goods?
A. Yes, you will use genuine goods, but you will simulate falsified goods.
Q. 7.4 What are the criteria for participating in the Pilot phase (pharmacy and wholesalers)?
The participants must have already modified their computer systems so as to allow connection of the pilot system to their SME’s. This means that the following should be in place:
- Development and testing of the new functionality in their own systems.
- Development / change of internal processes that must be adapted to the new working environment of the directive and to be tested in the Pilot phase
- Connection to SME’s in accordance with the on-boarding routine under development
- Connection to the production environment after ΚΟΕΦ’s approval
Q. 7.5 What are the criteria for participating in the Pilot (MAH)?
A. For participating as a MAH in the first part of the Pilot phase 1, the following should be in place.
- Connected to the EU Hub.
- Serialized outpatient products on the Cyprus Market loaded on the EU Hub.
- Routines for handling suspicious packs.
- Incorrect codes and tests to handle these.
For Pilot phase 2 there is no limit to the number of MAH’s or serialized products on the Cyprus market. Nor does the MAH need to be formally included in Pilot phase 2. The only requirement is that the security features are uploaded to the EU Hub, either before the products are distributed or retrospectively before Pilot part 2 starts.
Q. 7.6 How extensive is the Pilot phase?
A. The pilot will be implemented in two parts where the first part will be carried out with a very limited number of participants and only a few packs. The second part of the pilot test is not strictly defined in time and is mainly focused on tests of functionality in relation to routines / SOPs.
Q. 7.7 What happens when the Pilot phase has ended?
A. The pharmacies and wholesalers participating in the pilot continue to use their developed systems for their SME’s. We start the ramp-up phase, and all users covered by the Regulation 161/2016 will have to connect their SME’s under the “On-boarding” SOP qualifying under the Pilot phase.
Q. 7.8 How to get more information about the Pilot phase?
A. ΚΟΕΦ will continuously release further information as the project progresses. The next step involves a more detailed planning that will start immediately and extend to 2008. Such planning also involves the pilot phase.
Q. 7.9 What If we are MAH / manufacturer and want to participate in the Pilot phase?
A. You must contact ΚΟΕΦ
8. Where do the provisions apply?
Q. 8.1 Are the provisions for OTC products the same as for prescription products?
Α. The provisions do not apply to OTC products other than those listed in Annex II of Regulation 161/2016 (currently only omeprazole capsules 20 and 40 mg)
Products to have safety features are determined only by the classification (OTC or prescription-only) as decided by the Drugs Council and implemented by the Pharmaceutical Services.
Q. 8.2 Are the provisions applicable for veterinary medicinal products too?
Α. No, the rules apply only to human medicines.
Q. 8.3 Can you get an exception for some medicines?
Α. The Pharmaceutical Services cannot grant exceptions for single products.
The European Commission assesses the medicines to be included in Annex I and Annex II of Regulation 161/2016.