The product code shall comply with Article 4(b)(i) and Article 5(5) of Commission Delegated Regulation (EU) 2016/161 (so called Delegated Acts). The product code is not allocated or approved by the Institute. The marketing authorisation holder has to safeguard the upload of the data elements of the unique identifier, the coding scheme of the product code, and other data to the repositories system, as referred to under Article 33(2) of Delegated Acts, prior to the release of the medicinal product by the manufacturer. Pursuant to the Delegated Acts, the product code has to be coded as a data element of a unique identifier in the data matrix in compliance with the coding scheme and at the beginning has to bear characters specific for the applied coding scheme. Furthermore, it has to contain characters or character sequences identifying the product as a medicinal product. The resulting code has to have less than 50 characters and has to be globally unique. Product codes which are compliant with the ISO/IEC 15459-3:2014 and ISO/IEC 15459-4:2014 standards are considered to be meeting the requirements set forth by these Delegated Acts. In the Czech Republic, 2D codes are allocated by GS1 Czech Republic. The product code may assume the GTIN, NTIN, EAN format or another code format.
The serial number has to comply with Article 4(b)(ii) of the Delegated Acts. A serial number is a numeric or alphanumeric sequence containing the maximum of 20 characters generated by a deterministic or nondeterministic randomisation algorithm. The probability that the serial number can be guessed must be negligible and less than 1:10 000 (as per Article 4(c) of the Delegated Acts).
SÚKL code should not form part of the unique identifier or human readable data associated with the UI.
Nevertheless, SÚKL code has to be printed elsewhere on the packaging. This obligation is set forth by Section 37, paragraph 1 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, and also by point A, paragraph 7 of Annex 5 to Decree No 228/2008 Coll., on Marketing Authorisation of Medicinal Products, as amended. To facilitate identification, SÚKL recommends to introduce the SÚKL code with the words “SÚKL kód”. Neither this code, nor the introductory words are to be provided as part of the texts of the labelling (in the QRD template).
The Act on Pharmaceuticals does not set forth the implementation of a national reimbursement number or another national number identifying the medicinal product in the NN format on the outer packaging of medicinal products. In case point 18 of the particulars to appear on the outer labelling (in the QRD template) contains the abbreviation “NN”, this abbreviation shall be deleted from the text within the scope of subsequent variations to marketing authorisation with impact upon the labelling. For the deletion of the NN from the labelling, it is not necessary to submit any separate variation to marketing authorisation. Cases where the NN is provided in the labelling (in the QRD template), but not on the product mock-up shall not be considered noncompliance or quality defect.
The order of the product code (PC) and serial number (SN) does not need to be consistent with the order provided for under article 4 of Commission delegated regulation (EU) 2016/161. Where the size of the packaging allows, it is advisable to show the PC and SN next to the 2D code.
Abbreviations for the product code (PC), serial number (SN), batch number (Lot/č.š./Č. šarže), and expiry date (EXP/Použitelné do) do not have to be provided on the product packaging directly in front of the respective “figure”, but have to be shown in a manner allowing for clear identification of these data elements.
Where the sum total of the two longest dimensions of the packaging is equal to or less than ten centimetres, the elements of the unique identifier do not have to be printed on the packaging in a human readable format.
Delegated acts do not define the batch number and expiry date as human readable data, yet it is mandatory to provide these data on the packaging of all medicinal products, regardless of whether these should bear safety features, or not. The batch number and expiry data do not have to be shown directly next to the 2D code, but where the pack size allows, it is recommended to show these data on the same side as the 2D code.
The submission of a mock-up is required only in case the readability of the packaging is affected (change of font size, large shifts of text, etc.). In such a case, the mock-up may be submitted as part of a variation to/extension of marketing authorisation within the scope of which items 17 and 18 of the labelling are added. If the mock-up is not submitted within the scope of this procedure and the marketing authorisation holder thereafter finds out that the actual implementation of the 2D code on the packaging affects readability thereof, it is necessary to submit the respective mock-up as part of a separate “P” type variation.
In case the ATD is located on the outer packaging, or located on the immediate packaging (because no outer packaging exists) and the package closing system is not affected, but the addition of the ATD will influence the readability of the packaging (change of font size, large shifts of texts, etc.), it is necessary for the marketing authorisation holder to submit the respective mock-up within the scope of a separate “P” type variation.
In case the ATD is to be located on the immediate packaging, because no outer packaging exists, and, concurrently, the ATD affects the package closing system, it is necessary for the marketing authorisation holder to mention this information in Module 3 (section 3.2.P.2.4 and/or 3.2.P.7). The introduction of an ATD on the immediate packaging where the packaging closing system is, concurrently, affected, shall require a submission of a B.II.e variation to marketing authorisation - a classification guideline refers. Should the ATD affect the readability of the packaging, the variation to marketing authorisation shall include also the submission of the relevant mock-up.
Human medicinal products which may be dispensed without medical prescription and which are not listed under Annex II to Commission delegated regulation (EU) 2016/161 (so called “black list”) must not bear safety elements (the UI or the ATD). Nevertheless, pursuant to Section 37, paragraph 8 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, the technical solution ensuring the medicinal product integrity employed by the marketing authorisation holder on the outer packaging of a medicinal product the dispensing of which does not require medical prescription and which has not been black-listed, shall not be considered a safety feature referred to under Commission delegated regulation (EU) 2016/161 (i.e. the safety feature regulation).
In Section 37, paragraph 1 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, the words “European Article Number (EAN)” have been replaced with the words “internationally recognised identification standard”. This corresponds to the EAN code or the 2D code. If the medicinal product is to be dispensed without medical prescription and is not listed under Annex II to Commission delegated regulation (EU) 2016/161 (on so called “black list”), its packaging may continue to show the EAN code, or the EAN code may be replaced with the 2D code at the discretion of the marketing authorisation holder.
In respect of products for which the provision of a unique identifier in the form of a 2D code is mandatory after 9 February 2019, the packaging may also continue to display the EAN code, unless readability is adversely affected. Nevertheless, wherever practicable, for these products SÚKL recommends to opt for the presentation of the 2D code only, and to limit the parallel provision of both the EAN code and the 2D code to the shortest period possible.
The abbreviations PC and SN may be printed on the packaging of medicinal product batches the manufacture of which had been completed (i.e. which had been certified for release by the qualified person – question 11 refers in more detail) prior to 9 February 2019, without printing the specific PC and SN details and the 2D code. At the same time, it is possible to print the specific detail for the PC only. It is not possible, however, to show both specific PC and SN details for the PC and SN abbreviations, and not print the 2D code (or vice versa).
The following groups of packaging will be available on the market at the same time:
After 9 February 2019, the obligations stipulated by the Commission delegated regulation (EU) 2016/161 shall fully apply to the first and second group, but not to the third, fourth, and fifth group. Following the aforementioned recommendations in the implementation of the requirements set forth by the Commission delegated regulation (EU) 2016/161 can ensure easy and clear distinction of these groups of medicinal products.
In those cases where the packaging of a medicinal product shows the 2D code, the respective UI should be uploaded in the repository system regardless of whether the ATD is also present on the packaging, or not.
Only in case of the safety feature implementation, the statutory timeline of 180 days for the placement of a product onto the market in a presentation preceding the implementation of the concerned variation to marketing authorisation after the approval of the variation to marketing authorisation (pursuant to Section 35, paragraph 2 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals) as amended) shall not apply.
All packs of medicinal product batches subjected to the obligation to bear safety features on the packaging, the manufacture of which was completed (i.e. those that have been certified for release by the qualified person - explanation follows below) prior to 9 February 2019, without containing safety features on the packaging, may be placed onto the market of the Member State for which they have been manufactured, and further distributed for their entire shelf-life. Pursuant to Annex 16 to the EU Guidance on Good Manufacturing Practice for medicinal products for human and veterinary use, “Certification by a Qualified Person (QP) and Batch Release”, the process of batch release consists of the following:
Nevertheless, where the safety features were implemented within the scope of a single procedure together with another variation to marketing authorisation, this exemption shall apply only to the safety features; other variations shall be governed by the final sale referred to under Section 35, paragraph 2 of the Act on Pharmaceuticals.
The deadline of the 9th February 2019 for the implementation of the new QRD template applies only to medicinal products that shall bear the safety features. The new QRD template (introducing sections 17 and 18 of the labelling with the statement „not applicable“) should be implemented for other medicinal products within the next procedure affecting the product information.
The Institute allows for the placement of individual batches of a medicinal product onto the market in the Czech Republic, if the data on the labelling are in a language other than the Czech pursuant to Section 38 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, and Section 3, paragraph 6(b) of Decree No 228/2008 Coll., on the marketing authorisation of medicinal products, as amended; for more information please our website.
In case of placement onto the market of a foreign-language batch of a medicinal product manufactured without safety features prior to 9 February 2019, or a medicinal product listed under Annex I to Commission Delegated Regulation (EU) 2016/161 (so called white list), the packaging of such a product does not have to bear the safety features.
In case of placement onto the market of a foreign-language batch of a medicinal product manufactured after 9 February 2019, if the product is subjected to the obligation to incorporate safety features in the packaging, the safety features (UI and ATD) on the packaging of such product in the form present on the foreign-language packaging shall be acceptable, nevertheless, a sticker or Czech package leaflet attached to the packaging externally, e.g. with a rubber band/tape must not conceal the safety features. In case the Czech package leaflet is placed inside the outer packaging, which means the integrity of the ATD had to be broken, the outer packaging of the product shall bear a new adequate ATD, which shall conceal the original broken ATD. In case the outer packaging was subject to re-packaging (replacement of the outer packaging), it is necessary to remove the original UI from the repository system and to place new safety features (both UI and ATD) on the product packaging and upload the new UI to the repository system.
In case a specific therapeutic programme has been approved for a medicinal product the packaging of which bears safety features, it is necessary to place a sticker as well as the Czech package leaflet, if applicable, (which should be attached externally with a rubber band/tape) in a manner which will not conceal the safety features (UI and ATD). In case the outer packaging was subject to re-packaging (replacement of the outer packaging), it is necessary to remove the original UI from the repository system; the new product packaging does not have to bear new safety features.
In case of approval of a specific therapeutic programme for a medicinal product the packaging of which does not bear safety features, the safety features (IU and ATD) shall not be added to the product packaging.
In case a parallel import is approved for a medicinal product the packaging of which bears safety features, pursuant to Section 45(f) of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, the repackaging of the medicinal product for human use has to include a removal of the existing unique identifier and its replacement with a new unique identifier following the procedure outlined in the Safety Feature Regulation.
Repackaging shall mean the replacement of the outer packaging or relabelling with a sticker.
If the medicinal product is repackaged in a new outer packaging, in accordance with Article 5 and Article 7 of Commission delegated regulation (EU) 2016/161, manufacturers shall print the 2D code on a smooth, uniform, low-reflecting surface of the packaging and further shall print data elements of the unique identifier (the product code and serial number) on the packaging in human-readable format.
1. What are the national requirements for product code (PC), how is it generated and what format should it assume?
2. What are the requirements governing the serial number (SN)?
3. Will it be mandatory to specify the SÚKL code as the national reimbursement number or another national number identifying the medicinal product? And is it necessary to incorporate the SÚKL code in the unique identifier (UI)?
4. What is the sequence of human-readable data?
5. When is it necessary to submit a mock-up in the implementation of a 2D code?
6. When, if an anti-tampering device (ATD) is implemented, is it necessary to submit a mock-up?
7. Is it possible to implement the ATD for medicinal products dispensed without medical prescription which, at the same time, are not included on the list provided by Annex II to Commission delegated regulation (EU) 2016/161 (so called “black list”)?
9. Will it be possible to show the EAN code on the packaging of a medicinal product after 9 February 2019?
10. Prior to 9 February 2019, is it possible to print the abbreviations PC and SN on the packaging of a medicinal product without printing the PC and SN details/2D code at the same time?
11. Will the statutory timeline of 180 days applicable to the placement of a product on the market in the presentation preceding a variation to marketing authorisation apply to the implementation of safety features?
12. Should be the new QRD template (introducing sections 17 and 18 of the labelling) implemented by the 9th of February 2019 also for medicinal products that shall not bear the safety features?
13. In what form should the safety features appear on the packaging of a medicinal product imported as a foreign-language batch?
14. In what form should the safety features appear on the packaging of a medicinal product which is subject to an approved specific therapeutic programme?
15. In what form should the safety features appear on the packaging of a parallelly imported medicinal product?
Questions and answers
Questions and answers amending practical information on the implementation of safety features.