Information Prev 1 2 3 4 5 6 Next 27.02.2017 Modification of the form “Variation requiring notification” enter into force immediately ZL301_00_001e_FO 20.12.2016 Modification of the information sheet "Explanations regarding fast-track authorisation procedure" enter into force immediately ZL000_00_026e_MB 14.12.2016 Adaptation of formal requirements as of 1 January 2017 ZL000_00_001e_WL 18.11.2016 Adjustment of regulatory documents relating to authorisation as of 18 November 2016 ZL000_00_001e_WL / ZL000_00_002e_VZ / ZL000_00_002e_FO / ZL000_00_037e_MB / ZL301_00_001e_FO 01.09.2016 Changes as of 1 September 2016 ZL303_00_001d WL / ZL303_00_001d FO / BW303_00_001d WL 25.07.2016 Changes as of 1 July 2016 The new versions of the affected documents enter into force as of 1 July 2016. The previous versions of the forms will continue to be accepted during a transitional period lasting until 30 November 2016. 17.06.2016 eDok update - new eDok Guidance and NTA TAM structure Veterinary products: adjustments of NTA TAM structure to new specification 29.03.2016 Unequivocal identification of variations requiring notification In January 2016, Swissmedic modified the process for variations requiring notification pursuant to Art. 11, para. 2 of the Ordinance of 17 October 2001 on Therapeutic Products (TPO; SR 812.212.1). 01.03.2016 Changes as of 1 March 2016 New requirement for new applications for authorisation as a result of the Nagoya Ordinance / Additional information on submitting Drug Master Files and Active Substance Master Files 01.03.2016 Change in practice in the classification of herbal substances or preparations for oral administration to animals and in products for bees Herbal products that are administered orally to animals as feeds or as veterinary medicinal products are classified jointly by Agroscope and Swissmedic.