Can the revised TPLRO also be implemented without the submission of an A.109 variation application?
Correspondence with Swissmedic has shown that the Marketing Authorisation Holder may also implement new fix titles, fixed texts as well as amendments to wording without submitting an A.109 variation application (e.g. within the context of a separate variation application relating to the medicinal product information). Ifa product’s full composition has already been declared (and there are no requirements to include any warnings for “excipients of particular interest”) and there are no amendments required for the fixed texts , the revised TPLRO may be implemented WITHOUT the need for an A.109 variation application (i.e. only the Information for Professionals needs to be translated into Italian).
How should the new fixed titles and fixed texts be addressed in cases where variation A.109 (full declaration) has not yet been implemented?
The new templates need to be used for variation applications related to the medicinal product information since 01.07.2019. The use of the new fix titles and fix texts on the new template for medicinal product information variations does not call for the submission of a A.109 variation. The changes are considered to be editorial adaptations once the presently approved texts contain content with the same meaning. Changes to the content of the medicinal product information based on scientific evidence should be submitted as Type II applicationsAlso included in editorial adaptations are the inclusion of “no information” or similar, under the new obligatory subtitles. The incorporation of fixed texts such as «Reporting suspected adverse reactions after authorisation […]» at the end of the «Undesirable effects» section is not part of the requirements for a A.109 variation and may be considered to be an editorial change. This text should be added with the application where the new template is used for the first time or at the latest with the A.109 application.
Should the fixed texts on pregnancy or storage conditions or wording changes (e.g. from «Hepatic dysfunction» to «impaired hepatic function») in the new template be used?
These texts are unchanged requirements, which have appeared in the Swissmedic guidance documents in this form for a long time now and which have therefore been incorporated in the templates. Any currently approved text may thus continue to be used. Adaptation of the fixed texts is not considered to be an A.109 variation, but is either an editorial adaptation or a Type II variation - when the alignment is associated with a change in text content based on scientific evidence which should be referenced..