Use of Mobile Scanning for Labels and Package Leaflet

Why the inclusion of mobile technology features is necessary in the Product Information

Even if physical or paper-based documents remain the most prevalent way of providing important information to users, we must consider that the Internet is increasingly being used as a vast source of information, particularly for health purposes.

With the technological advances, mobile is increasingly present in our lifestyles. It has led to us being more connected and open to these technologies, especially for all types of research and access to information. It, therefore, became clear that the pharmaceutical world could not escape from this revolution and that it had to adapt and be more future-oriented towards mobile scanning and other technologies such as QR codes (short for Quick Response Codes) and other two-dimensional (2D) or Near-Field Communication (NFC) barcodes. For example, to provide easy access to information on medical products for patients and healthcare professionals, and all this only from smartphones or other mobile devices!

Even if mobile technologies do not replace the paper version (printed leaflets, for example), the goal of using them can be various: provide easy and quicker access to data through platforms where people can retrieve information updated by the industry or the National Competent Authority (NCA) but also permits to find more easily the batch number and the expiry date for the persons impacted by visual impairment or for manufacturing, stock control, and safety aspects. This permits increased Product Information (PI) utility (video/audio). They also offer the possibility of not printing a document for an ecological purpose.

The challenges of the inclusion of mobile technologies in product information

Even if mobile technologies can provide easy access to data or complementary details, the inclusion of them should require a regular review of the information published for:

• Ensuring that regulations are suited to the current technological developments.
• Encouraging innovation.
• Ensuring patients receive safe, efficacious, and quality medicinal products on time.
• Ensuring that new or updated requirements do not contradict existing national and regional standards.

The discrepancy between the written PI and the electronic PI

Moreover, it should be noted that the PI and the additional risk minimization measures in Educational Materials must contain and provide sufficient information about the medicinal product for the patients and the healthcare professionals. The mobile technologies may include complementary information to help better clarify but should not provide additional and/or new information. Patients and professionals must be aware that even if mobile technologies can provide them with information, they should be careful about the content of the data since some information can be different from the printed version. The PI updated to the latest variation approved for the medicinal product in the system will not be implemented in the printed version simultaneously, even if printed versions must be updated as soon as possible. These discrepancies between the version available in the mobile technology and the printed one can lead to confusion and/or misunderstanding for patients and professionals. Everyone must be alerted on this aspect.

For that reason, the following sentence to inform users about the potential discrepancies with the PI provided via mobile technology should be included:

<Latest approved information [add the type of information, e.g., product information, educational material, video, etc.] on this medicine is available by scanning [the QR code][other two-dimensional (2D) bar code][Near-field Communication (NFC)] included in the <PL> <outer carton> with a smartphone/device. The same information is also available on the following URL: [URL to be included]

<and the <NCA> website >>

In the case that only the URL is mentioned in the PI (information not linked via mobile technology), the following sentence should be included:

<Latest approved information [add the type of information, e.g., product information, educational material, video, etc.] on this product is available on the following URL: [URL to be included] <and the <NCA> website >>.

This information should be inserted at the end of the PI as the last sentence, if possible. However, in the case of multilingual packaging, the recommendation is to include it at the beginning of the document.

How the mobile technologies can be included in MRP/DCP procedures

For all the reasons presented previously, the Co-ordination group for Mutual Recognition and Decentralised procedures – human (CMDh) agreed to implement this technology in the electronic versions of the Product Information and the educational material for the patient for MRP/DCP procedures but not without some requirements and rules to follow.

For new Marketing Authorization Applications (MAA) to include mobile technologies, a declaration must be made to be evaluated during the assessment. This notification should be acceptable no later than D106 of the procedure and will be rejected if you declare this during the national phase.

This could be submitted through European Art 61(3) notification or included in a post-authorization procedure (Type IB or Type II variations with impact on PI) for authorized products.

The mobile technology feature in MRP/DCP inclusion is divided into 4 phases :

• Submission during the MRP/DCP procedure
• Assessment during the procedure
• To be submitted and assessed at a national level in those MSs where the mobile technology feature is intended to be used
• After the national phase

Submission during the MRP/DCP procedure

During the submission, the applicant should provide within the MAA, notification or variation dossiers (depending on the status of the medicine) in section 1.3.1 of the Module the following documentation:

• Declaration of the content, URL, intended location of the mobile technology feature in the labeling and/or Package Leaflets (PL), and a list of Member States where the mobile technology feature is intended.
• Description and differentiation of the possible intended groups that use the mobile technology feature (health care providers or patients) and how intended information will be found and distinguished by these groups in case a platform/pdf is used.
• Declaration from the MAH/applicant in which they confirm that the mobile technology feature content complies with Article 62 of Directive 2001/83 EC and with the requirements requested by CMDh or the EU Commission. This declaration must mention that the information accessible through the mobile technology will remain unchanged after approval and that if any changes to the content are needed, a new variation or notification submission will be made. This excludes the PI/educational material updates resulting from approved modifications. The MAH/applicant must provide the link to the NCA website when it is mandatory and must confirm that the mobile technology hosting the information and web domain rights will remain valid while the authorization of the mobile technology is in place.
• Declaration of fulfillment with requirements of section 5.1.3
• For complementary information elements, documentation in English must be submitted to facilitate the assessment of the content (e.g., videos) and visual presentation of the intended platform or PDF. The MAH/applicant must ensure that the mobile feature is necessary and easy to use by the patient

Countries may propose and set minimum requirements for adopting digital e-PILs or digital platforms.

Assessment during the procedure

The assessment of the documentation provided through the use of mobile technology is provided by the Reference Member State (RMS) during the MRP/DCP procedure and agreed upon with Concerned Member States (CMSs) as part of the EU common phase of the assessment procedure. The RMS reviews declarations submitted as per section 5.1.

CMSs should inform if the mobile technology feature is intended for use in their Member States (MS).

The acceptability results will be based on the final English version of the platform hosting the information.

The acceptance of the mobile technology will only apply to those MS who accept the inclusion of the mobile scanning technologies.

The final content of the mobile technology in the languages required by MS will be provided at a national level for final refinement and acceptance of inclusion.

To be submitted and assessed at a national level in those MSs where the mobile technology feature is intended to be used

The non-statutory information, the final content of the mobile technology feature (videos and visual presentation of the platform), and the educational material will have to be finally adapted and approved by NCA after the End of Procedure (EOP) if applicable by MS.

Final documentation (e.g., mock-ups including the mobile technology feature) will be assessed by Member States at a national level, if applicable.

The mock-ups must be provided during the national phase for New MAAs, and an updated version should be provided for those countries requiring artwork for variations notifications.

After the national phase

After the national phase, if an applicant wants to include the mobile technology in the Product Information in another Member State(s) not stated in the declaration form submitted in the European procedure where the mobile technologies features were approved, this can be submitted nationally with the member states concerned. The MAH must provide the details of the procedure in which the dossier has been approved to facilitate national adaptation, assessment, and approval.

Location of the mobile technology feature in the Product Information

The applicant must consider and evaluate the following criteria depending on their case and their products to choose where they will include the mobile technology features:

• If they wish to include them in the leaflet and/or,
• In the primary packaging, especially for medicinal products used at hospitals, or the outer carton, in particular for OTC medicinal products.
• If this inclusion does not negatively impact the legibility.
• If the carton’s inner lid/inner flap can be used in the case of small-size packages (Eye-drops, small-size vials, etc.), multilingual packs, and the existence of national barcodes.
• If the URL linking to the content can be displayed along with the mobile technology feature to permit easy access to the information to users without a smartphone or device via the web.
• If the outer packaging and the package leaflet include symbols or pictograms to clarify information mentioned in Articles 54 and 59(1) and other information compatible with the summary of the product characteristics that are useful to the patient, to the exclusion of any element of a promotional nature and if the requirements defined by these articles are respected, the use of mobile technologies will be possible in the outer (and immediate) packaging and the PL.
• Suppose the packaging contains the unique identifier carried by a two-dimensional barcode, as set out in Directive 2011/62/EU (Falsified Medicines Directive). In that case, it is recommended to use the residual storage capacity of the two-dimensional barcode to include the information related to the mobile technology. This would reduce the number of visible barcodes on the packaging and the risk of confusion or misunderstanding when scanning to verify the authenticity of the medicinal product.

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