Regulatory Open Forum

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  • 1.  Cross-labelling

    Posted 19 days ago

    Hello, I need your expertise to get more information about the regulatory strategy I am working on.

    My company would cross-label a medicinal product with a medical device to use the resulting entity for the same medical procedure. It's not a combination product, as the two do not combine, and the medical device is not used to deliver the drug. They would be cross-labeled for the user's convenience only.

    The two products are approved, and their intended use, product characteristics, and packaging and labeling have not changed. Thus, the change does not alter the essential characteristics of the products, and they remain compliant with their regulatory requirements and approvals.

    I think that notifying the competent authority about the change is sufficient. Or do I need to open a formal Variation request? What is your experience in such cases?

    Thank you

    Mauro



  • 2.  RE: Cross-labelling

    This message was posted by a user wishing to remain anonymous
    Posted 12 days ago
    This message was posted by a user wishing to remain anonymous

    Is it known as "cross-labeling" in the jurisdiction where you want to distribute it? There are various names for different kinds of co-packaging arrangements in different places, and different regulations applicable in each.




  • 3.  RE: Cross-labelling

    Posted 11 days ago

    Hi Mauro,

    It is not clear what you are doing to "create" this "cross-labeling".  You state that the packaging and labeling have not changed. 

    If you are changing the labeling of the drug or medicinal product, regardless of the region, you would need to provide some notification or submission to the competent authority.  As for changing the label of the medical device to call out its use with the drug or medicinal product, your regulatory notification may depend on the approved indication and the region. 

    FYI, the formal term "cross-labeled" is only used in the USA and only for combination products and has very specific requirements.  Providing the specific brand and name of a device (in a drug label) and vice versa has different terminology and requirements when the use of the two together are not required, and their use in the market is not exclusive to each other. 

    Please clarify what you are doing (promotion?) to create the cross labeling.

    Also, are you co-packaging? If so, you are creating a new drug product and must submit this to the CA.

    Hope you can clarify.



    ------------------------------
    Lee Leichter RAC
    President
    P/L Biomedical
    Fort Denaud FL
    United States
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  • 4.  RE: Cross-labelling

    Posted 11 days ago

    Thank you for your reply, Lee.

    I acknowledge that the term "cross-labeling" lacks a specific definition within EU regulatory frameworks, particularly in comparison to its usage in the USA, where it pertains to combination products. Nevertheless, it's my understanding that the principles and regulations governing the labeling and use of medicinal products grouped with medical devices still apply, even in cases where they do not physically combine but rather interoperate together.

    Let's consider, for instance, a scenario involving sterile cold water or gel used for pre-cooling the skin alongside a pre-filled syringe. Both products are individually approved, packaged, and labeled according to their respective regulations. As a drug manufacturer, my intention is to recommend, within my drug leaflet, the use of a specific brand of sterile cold water or gel. This recommendation stems from testing and clinical evidence demonstrating a reduction in overall pain during needle insertion when this specific brand is used in conjunction with my drug.

    In light of this, I understand that it's necessary to include information about this specific device in my drug's leaflet and to notify the Regulatory Authority of this addition. It's important to clarify that this does not constitute a combination product, as the device itself is not a part of the medicinal product. Instead, it serves as an accessory to the medical procedure. Users retain the freedom to opt for alternative skin coolers or topical anesthetics, as these are commonly used for the same medical procedure.

    I want to emphasize that there is no co-packing involved in this scenario yet. However, the option to explore cross-labeling for promotional purposes remains under consideration.

    I hope this gives you additional information and clarity. Please let me know if you require any further information.

    Thanks again for your support,

    Mauro



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    Mauro
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  • 5.  RE: Cross-labelling

    Posted 11 days ago
    Edited by Linda Busklein 11 days ago

    Hello,

    You could Google the following 2 titles.  These may help. 

     

    Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)

    Guideline on quality documentation for medicinal products when used with a medical device

     



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  • 6.  RE: Cross-labelling

    Posted 10 days ago

    Thank you, Linda. Unfortunately the, the first focuses on combination products, which in my opinion does not apply as there is no combination.

    Section 6.2 of the second one applies to my understanding but doesn't clarify the presentation of the final product.

    Thanks again for your reply

    Mauro



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    Mauro
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  • 7.  RE: Cross-labelling

    Posted 11 days ago

    Hi Mauro,

    This does help clarify your question.  Yes, I agree this is not a combination product or a Drug Device Combination (EU). I also see that you understand that to add this to the drug label that you must notify the drug CA.

    However, you must be cautious about how you add this to your drug leaflet to ensure you are not adding a claim which may result in the request for additional data.  If you state that the use of the cooling gel prior to injecting of your drug reduces the pain sensation, that may precipitate a request that this be validated with some actual data.  Also, you could be asked to establish that this cooling does not impact the pK or bioavailability of the drug when injected (Once it is in your labeling, this can stimulate the curiosity of the CA and result in some unusual requests.)

    Also, adding the drug name to the device (to complete the cross labeling) may precipitate additional data requests from the NB depending on the Device Class.

    I am not sure I understand the motivation for this, but there are risks in going down this path, so the "benefit" should be high.

    Good Luck.



    ------------------------------
    Lee Leichter RAC
    President
    P/L Biomedical
    Fort Denaud FL
    United States
    ------------------------------



  • 8.  RE: Cross-labelling

    Posted 10 days ago

    Thank you for your additional input, Lee. It is much appreciated. The interaction is tested and it is the same as that of known products on the market. I have supportive data on that, but I will consider the benefits and risks of the challenges faced by the EU Regulatory Authority as you suggest. I think the major risk is to consider the device as an accessory to the medicinal product rather than for the medical procedure. But I am building a rationale for that. Let's see.

    Thanks again,

    Mauro



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    Mauro
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  • 9.  RE: Cross-labelling

    Posted 11 days ago
    Edited by Mauro Rinaldi 11 days ago

    Hi Anon, I acknowledge that the term "cross-labeling" lacks a specific definition within EU regulatory frameworks, particularly in comparison to its usage in the USA, where it pertains to combination products. Nevertheless, it's my understanding that the principles and regulations governing the labeling and use of medicinal products grouped with medical devices still apply, even in cases where they do not physically combine but rather interoperate together.

    Mauro



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    Mauro
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