Yes, according to the CMDh position paper on the use of mobile scanning of package leaflets and labelling, the following options are available:

• A website of the national regulatory authority
• Dedicated pages set up by the marketing authorisation holder for the mobile devices in the Member States, which do not require the mobile devices to be linked to the website of their national competent authorities.
• A linked, stand-alone PDF document

If the pharmaceutical company is taking responsibility for publishing the digital package leaflet, e.g. via the platform https://www.gebrauchsinformation4-0.de, the higher federal authorities would not object to the inclusion of the following text under the heading "Further sources of information".

„Die vorliegende gedruckte Gebrauchsinformation enthält die für die Sicherheit des Arzneimittels relevanten Informationen. Gebrauchsinformationen von Arzneimitteln werden fortlaufend überarbeitet und an den aktuellen wissenschaftlichen Erkenntnisstand angepasst. Daher wird im Auftrag und in eigener Verantwortung unseres Unternehmens zusätzlich eine aktuelle digitale Version dieser Gebrauchsinformation unter https://www.gebrauchsinformation4-0.de von der Roten Liste Service GmbH <andere werbefreie Homepage> bereitgestellt und kann auch mit einem geeigneten mobilen Endgerät/Smartphone durch einen Scan <des linearen Barcodes> <des Matrix-2D-Codes/QR-Codes> <über Near Field Communication (NFC)> <auf der Arzneimittel-Packung> <in dieser Gebrauchsinformation> mit der App [Namen angeben, z. B. „Gebrauchsinformation 4.0 (GI 4.0)]“, abgerufen werden.“

The submission can either be made via a European notification according to Art. 61 3. of Directive 2001/83/EC, as only the package leaflet is affected, or, in the case of purely nationally authorised medicinal products, as a variation according to section 29 (1) AMG or as an additional change ("editorial change") in the context of a type IB or type II variation concerning the product information.

The European Medicines Agency (EMA) is the competent authority for centrally authorised medicinal products. The Paul-Ehrlich-Institut recommends to contact the EMA in case of questions.

Since 9 February 2019, the medicinal products for human use (in accordance with Directive 2011/62 / EU in conjunction with Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83 / EC) must be equipped with additional safety features and a device for detecting possible manipulation (anti-tempering device). In Germany, prescription drugs for human use under the responsibility of the Paul-Ehrlich-Institut (PEI) (in accordance with Article 54a of Directive 2001/83/EC) as well as parallel imports and their pack sizes may be marketed only if they comply with the provisions of Section 10 (1c) of the German Medicines Act (AMG). According to Article 5 (3) of Delegated Regulation (EU) 2016/161, the barcode shall be printed on the packaging by the manufacturer.

In addition to the exceptions listed in Annex I to Delegated Regulation (EU) 2016/161, the following groups of medicinal products under the responsibility of PEI are also exempted from the provisions of Section 10 (1c) AMG:

• blood components excluded from the scope of the Directive in accordance with Article 3 (6) of Directive 2001/83/EC
• tissue preparations, unless they are industrially produced tissue preparations within the scope of Directive 2001/83/EC
• stem cell preparations for hematopoietic reconstitution from the bone marrow, peripheral blood or umbilical cord blood
• advanced therapy medicinal products (ATMPs) within the meaning of Article 3 (7) of Directive 2001/83/EC.

Issues of trademark law remain unaffected by the above statements, as they are not subject to a marketing authorisation.

Purely nationally authorised drugs

For purely nationally authorised medicines, the requirements and instructions of the CMDh apply accordingly. By way of derogation, a national notification of change pursuant to Section 29 (1) AMG instead of a notification pursuant to Article 61 (3) of Directive 2001/83 / EC must be submitted to include the standard declaration for recording the safety features in the product information as part of a procedure regarding the product information by adapting the template of the Quality Review of Documents Group (QRD) to the product information.

Medicinal Products Authorised by European Procedures

For the introduction of the safety features and the device for detecting a possible manipulation please note the requirements and hints of the implementation plan of the European Medicines Agency (EMA) for medicines authorised by means of the centralised authorisation procedure or the implementation plan and the Question & Answers (Q & A) of the Co-ordination Group for Mutual Recognition and Decentralised Procedure-Human (CMDh) for MRP / DCP-approved medicinal products. Further information can be found in the European Commission's Question & Answer document (EC).

However, for medicinal products for which the anti-tempering device is not compulsory under Article 54a (1) of Directive 2001/83/EC, anti-tempering devices may be fitted by marketing authorisation holders in order to protect patients, after consultation with the authorising authority.

For pharmaceuticals that are marketed within the scope of the Medicines Act (Arzneimittelgesetz, AMG) and on whose external package safety features and an anti-tempering device are to be installed pursuant to Section 10 (1c) AMG, the safety features should always be printed directly on the secondary packaging.

In certain cases, the use of suitable adhesive labels is possible (see Section 2.21: Safety features for medicinal products for human use). Such cases are:

• Medicines for which direct printing is not possible due to the nature of the packaging, e.g.

  • glass / plastic,
  • without external package
  • cellophane
• Medicinal products placed on the market through parallel trade (parallel import and parallel distribution) and where reboxing is not carried out.

The European Commission points out that, for medicinal products whose packaging has been lawfully opened, the packaging must be resealed completely and no signs of the original and open anti-tampering device (ATD) should be visible (see paragraph 1.21: Safety features for medicinal products for human use).

If, due to the nature of the tamper-proofing device, it should not be possible to reseal the original packaging, the reboxing may be considered as a suitable measure to implement the requirements of the Falsifying Medicines Directive and the requirements of Article 47a of Directive 2001/83 / EC.

It should be noted that the supervision of labelling of medicinal products is the responsibility of the competent national authorities.