Change of excipients and declaration

What consequences does a change of excipient as per the “old regulations” have on the declaration?

If an excipient is to be switched for another excipient in the composition of a medicinal product, it is not obligatory to implement the change in the full declaration simultaneously in the market product information and on the packaging. In particular if the renewal of the authorisation of the medicinal product is still a few years away, it may be in the marketing authorisation holder’s interest to implement the full declaration at a later point in time. In so doing, the following points are to be noted with regard to the change of excipient: (1) The declaration of the new excipient must as a matter of principle take place in accordance with the “old regulations” before a switch to TPO4 (i.e., Appendix 3 of the TPLRO applies before the revision). (2) It is a possible option to insert only the declaration of the new excipient (in the new template) and to wait until the extension of the authorisation to submit application for variation A. 109. (3) Naturally, the applicant also has the option of implementing the changes required in line with the revised regulations straight away at the time of the change of excipient.

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Dr. Katharina Oehler
Scientific and Managing Director

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