Due to the early revision of the ordinance on veterinary medicinal products legislation and the inclusion of the applicability of good distribution practice (GDP) for veterinary medicinal products and active substances in Annex 4 of the Medicinal Products Licensing Ordinance (MPLO; SR 812.212.1), the application forms for establishment licences have been revised. A differentiation can now be made according to whether activities requiring a licence involve veterinary or human medicinal products, and active substances and intermediates can now be selected for GDP activities.
In addition, there are new fields in the forms to enter the Organisation Management Service Identifier (OMS-ID) from the European Medicines Agency (EMA), which has become necessary due to the changes in the European regulations on veterinary medicines (Regulations 2019/6 and 2021/16, Article 9(h); see here).
Using the new versions of the forms for the submission of applications is mandatory as of 28 January 2022.