1. Question: Will the SR require labeling on the box in the order: PN (GTIN), LOT, EXP, SN, unlike other countries where the order is: PN (GTIN), EXP, LOT, SN. What is the order of the data?
Answer: The order is as follows: PN (GTIN), SN, (EXP, LOT - not specified) in accordance with the instructions of the European Medicines Verification Organization - EMVO and the European Commission. The Slovak Republic does not change the order and complies with the Delegated Regulation. In addition, they will not require any national labeling. The EU cluster follows the QRD Templat, which determines the exact order. Abbreviations: PN - Product number, LOT, EXP (expiration date) SN - serial number.
2. Question: Would it be possible to place a two-dimensional barcode on the packaging of human medicinal products voluntarily, which would not have protective features if the information included in the bar code did not serve for the purpose of identifying and authenticating medicinal products without a unique identifier?
Answer: Yes, if the relevant labeling provisions of Title V of Directive 2001/83 / EC are met. As an example, two-dimensional barcodes can be mentioned, in which the encoded price, payment terms, etc.
3. Question: Can one-dimensional bar codes with protective elements be placed on the packaging of human medicinal preparations in addition to two-dimensional barcodes that have a unique identifier?
Answer: Yes, if the location of the two barcodes does not affect the negative readability of the outer packaging.
4. Question: Is there a contract for marketing authorization holders already in place to pay a fee for the Slovak Medicines Certification Organization?
Answer: We plan to prepare a MAH contract in June or July, and then ask the MAHs for the subsequent signing of the contract. The information will be published in the "News" or "MAH" section.
5. Question: Do you have an estimated fee for MAHs - the initial fee and the annual fee?
Answer: No initial registration fee for Slovakia. The annual fee should be EUR 8,000 for the years 2019 and 2020 (the amount of the fee depends on various factors such as the number of MAHs in that year). In during this year, a mechanism for the calculation of fees will be published, as well as the price list for year 2019. This information will be published in the "News" or "MAH" section.
No other charges are planned.
6. Question: As of today, the products sold in Slovakia by our company are bearing a linear EAN-13 code containing the GTIN number.
a) Will this EAN-13 code need to remain on the packaging until 9th February 2019 or can it be omitted at any time when the UI is introduced?
b) Will it be allowed to keep the EAN-13 code even after introduction of the UI?
c) Will it be allowed to keep the EAN-13 code on the packaging also after 9th Feb 2019?
a) EAN -13 code need to remain on packaging until 9th Feb 2019 even UI will be introduced on this packaging. It is due to maintain of existing logistic process in official supply chain, which will be valid by 9th Feb 2019.
b) Yes – and it is mandatory for packaging produced and issued to market before 9th Feb 2019.
c) There is no clear guideline yet for this situation. We are waiting for decision of NCA in this area. But even if there will be ban for usage of EAN 13 code on packaging produced after 9th Feb 2019, we expect there will be temporary period to create space to manage such situation by drug producers.
New - 7. Question: What are the Marketing Authorization Holder's (MAH-a) obligations if he is also a Distributor authorized to distribute medicines on the Slovak market? Does such a MAH be connected to the National Verification System SK-NMVS? Or can he verify / decommission medicines through the EU HUB or through its OBP , which is connected to the EU HUB?
Answer: The Marketing Authorization Holder (MAH) may decide which of the options to use. If such a MAH has a distribution license in Slovakia, he / she may request the SOOL to join the national verification system and perform the verification and decommissioning of the product via the national system. In this case, both variants are allowed.
New - 8. What is the case with multilingual packaging? If the country with which we share the packaging is defined by the fifth line (their national requirement). Can this be displayed in a readable format on a pack? Can this information be contained in a 2D code?
Answer: Yes, the fifth line (national number) may also be included on the medicine pack. And so it can be incorporated into the 2D code. The system should be able to use only the information that is needed for the Slovak market (ie product code, serial number, expiration date and batch) based on the Application Identifiers that are selected in the 2D Code.
New - 9. How will SOOL proceed with flat fee payments to MAHs who have registered medicines through a centralized procedure and are registered by the European Medicines Agency (EMA) and the European Commission has issued a decision on registration?
Answer: Given that the MAH submits a marketing authorization to the European Medicines Marketing Authorization by a marketing authorization in all EU Member States, regardless of whether there is a real interest in marketing the product in the Slovak Republic, by submitting an application for registration through a centralized procedure through EMA. In view of this fact, SOOL has developed an analysis of the number of MAHs of centralized medicines.
- SOOL will identify the number and list of MAHs registered in the Slovak Republic only by a centralized procedure with a valid Commission decision issued by the European Commission and falling within the scope of the FMD.
- SOOL, in cooperation with NCA, on the basis of reports resulting from the MAH's obligation to report the marketing of the product in the Slovak Republic in accordance with Act 362/2011 on Medicines and Medical Devices, will establish the actual status of marketed medicinal products in the Slovak Republic (marketed medicinal products).
- SOOL will carry out re-check of marketed medicinal products registered by a centralized procedure and check via IMS dat (on a monthly basis), confirming the number of MAHs that are required to contribute financially to the use of the SOOL verification system.
- The obligation to pay a fee for the use of the SOOL verification system is provided by the MAH of Centralized Medicines who are placing a centralized medicines on the market in the SR under the FMD.
- The SOOL fee is identical for the MAH of centralized medicines in accordance with the established "flat fee" model.
All procedures, except for the above instructions for MAH for centralized medicines, are described in Principles for Creation a Fee Model for the Slovak Medicines Verification System usage by Marketing Authorization Holders.