The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) issued guidance dedicated to the regulatory requirements of protective elements on colored drawings on medical device packages. In particular, the document describes specific aspects to be considered by medical device manufacturers when creating a draft drawing of packaging.
The current document is an updated version (1.3.) of the Q&A document initially published by the JAZMP on August 9, 2017. The present guidance is intended to provide medical device manufacturers with additional information regarding the way the colored drawing on packaging should be designed in order to comply with the applicable national regulations.
JAZMP Requirements on DataMatrix Codes
Firstly, the document describes the requirements regarding the two-dimensional DataMatrix codes to be placed on the packaging. The agency states that there are no strict requirements regarding the particular place on the packaging the code should be placed at. Thus, the medical device manufacturer is allowed to choose the location of the DataMatrix code at its sole discretion depending on the requirements based on the manufacturing process, providing that it does not overlap other information placed on the labeling.
According to the JAZMP recommendations, the medicinal product code (PC) and serial number (SN) should be placed nearby the two-dimensional DataMatrix code, while the shelf life indication (expiry date) and the batch number could be located in another place.
At the same time, the agency states that in case if the packaging dimensions (the total sum of the lengths of the two longest sides of the package) are less than 10 cm, exceptions could be applied.
It is also important to mention that in case if the medical device manufacturer provides information in readable form (e.g. medicinal product code, serial number, and national identified), it should be accompanied by the appropriate abbreviation.
If under the national regulation, certain information is not required to be provided, the manufacturer is allowed to create the Slovenian version of the package without adding such information. At the same time, such information could be added to the multilingual version of packaging.
The JAZMP states that the unique tag data should not be included in the two-dimensional QR code, while it should be included in a two-dimensional DataMatrix code instead. Thus, the labeling could contain both DataMatrix code with main information and QR code with the additional details. At the same time, the agency encourages the medical device manufacturers to use free space in DataMatrix code to include such additional information in order to avoid placing additional codes on the labeling that sometimes could lead to confusion when scanning codes.
Packaging Colour Scheme Approval
The document issued by JAZMP also describes the approach to the approval of color schemes used for the packaging of medical products (including medical devices). According to the guidance, in order to be approved, the packaging should contain the following elements:
- the two-dimension DataMatrix code,
- the abbreviations related to the product code, serial number, and expiry date. #
The medical device manufacturers are advised to provide a colored draft of packaging in the course of application process together with the other documents or when applying for changes to the wordings in labeling/packaging as a separate regulatory procedure.
The agency also states that in accordance with the current regulations on labeling and instructions for use, the packaging should also include the EAN code. Thus, the draft package sample submitted by the medical device manufacturer should also contain blank space for such code or printed code itself. The sample should also contain indications of places for the two-dimension DataMatrix code and label data to be provided in a human-readable form.
According to the guidance, certain changes to the labeling could be introduced without the prior approval of the authority, providing that such changes do not affect the readability of the information the labeling contains. Such changes could include, inter alia, the following ones:
- the introduction of security elements,
- changes to the layout of the text,
- changes to the dimensions of the outer packaging,
- the perforation added to protect against interference with the medicinal product.
Under the general rule, the medical device manufacturer shall submit the sample of the labeling before placing the device on the Slovenian market for the purpose of obtaining prior approval.
In case if the outer packaging of the medical device requires the installation of the protective elements, the manufacturer is not obliged to notify the authority about such installation. However, there is a requirement to notify the JAZMP in the case is such elements are being installed for patient protection purposes, or impact the readability of the information the packaging contains (for example, in a case when the manufacturer has to reduce the font size to be able to place additional information).
In accordance with the applicable requirements on packaging and labeling, the medical device manufacturer shall duly notify the authority about any changes related to the general appearance and shape of color elements of packaging. At the same time, exclusion from this rule could be applied in case if such changes are related to the introduction of protective elements, or if they are being implemented in the course of another regulatory procedure.
When applying for marketing authorization, the applicant (the medical device manufacturer, its authorized representative, importer, or supplier) shall provide the JAZMP with the following information:
- the national identifier of the medicinal product,
- the name of the product,
- the sample of the packaging itself.
The same set of information should be provided when notifying the agency about any changes to the labeling and packaging of the medicinal product. This information should be provided in the electronic form.
Additional Labeling and Packaging Requirements
The present questions and answers document also highlights certain additional aspects related to the labeling and packaging requirements applicable in Slovenia.
According to the document, foreign medicinal products should be supplied with the Slovenian sticker indicating that the product in question has been properly authorized for being marketed in Slovenia, even if it’s initial labeling already contains all important information. Thus, the protective elements placed on the packaging of a foreign medicinal product could be used to identify the product and verify its authenticity, providing that they are properly accompanied by the national sticker confirming that the product has been included into the national register of medicinal products (including medical devices).
Starting from February 9, 2019, the applicant shall also provide the GTIN number for the unique label of a medical device. In the case of previously approved medical devices, the manufacturer (or another party responsible for placing the device on the market) shall either provide the authority with the GTIN number assigned to the device or inform them about the intent to use the NTIN number.
Summarizing the information provided here above, the guidance issued by the JAZMP covers the most important aspects related to the labeling and packaging requirements for medical devices intended to be marketed in Slovenia.
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