Optimisation of labelling phase for human medicinal products

Following the scientific review in the marketing authorisation process, major delays arise in the labelling phase as a result of additional text review rounds. As early as October 2017, Swissmedic evaluated and implemented various measures designed to shorten the labelling phase (see SMJ 07/2017). Although these measures are showing the first positive effects, and the labelling dialogue is now initiated in most cases as early as the List of Questions (LoQ) phase, there is still considerable potential for further savings in the labelling phase.

Swissmedic is therefore introducing various measures for human medicinal products in order to avoid text review rounds.

1. All new applications:
   It is now compulsory for the applicant to submit the packaging texts (cartons, blisters, labels) in the form of design layouts (mock-ups) already with the initial application. Previously, the submission of mock-ups was only recommended.
2. New applications with a new active substance and additional indications:
   Swissmedic will now always send the annotated manuscript of the Information for healthcare professionals and the annotated mock-ups of the packaging texts with the List of Questions. Previously, these were not sent if an approval appeared doubtful at the time of the LoQ.
3. All applications with product information texts:
   If individual text passages do not satisfy the requirements of the TPLRO or the guidance document Product information for human medicinal products HMV4, Swissmedic will increasingly formulate product information texts itself to accompany the preliminary decision of approval. If this is not possible or useful, Swissmedic will describe the requirements pertaining to the text passages to be revised in greater detail than before. Companies are required to adopt the text passages specified by Swissmedic or consistently to take into account the content-related requirements when producing the manuscripts.
   If Swissmedic and the applicant have differing opinions on individual aspects, and if the applicant fails to submit any new facts to support its own point of view, Swissmedic will order the texts to be produced in accordance with the requirements stated in the preliminary decision of approval.

Measure 1 will take effect on 1 October 2020, after a transitional period of three months. Measures 2 and 3 take effect immediately and also apply to all ongoing applications that have not yet reached the List of Questions milestone by 1 July.