Promees

Authority administration

National Public Health and Medical Officer Service authorizations

We are at your service, if you need help regarding:

  • the notification of the activity licenses to the National Public Health and Medical Officer Service–when starting an activity (usage, storage, manufacturing, etc.) with dangerous substances or mixtures, and in every other case, when there is a change in the activity type, or a new agent gets into the scope of application; a notification shall be given via the online interface
  • in generating UFI code on the ECHA interface and in submission of poison center (PCN) notifications – In the case of distribution of mixtures with a physical and/or health hazard classification for professional and/or consumer (and not exclusively industrial) use, a UFI code generation and a PCN notification are required. The UFI code must be displayed on the label, so the labels must also be modified. A temporary exemption from the PCN notification obligation applies until 01.01.2025 for hazardous mixtures notified to the NNK (ÁNTSZ) before 2021
  • imported or manufactured hazardous mixtures in the OKBI registration – Notification of hazardous mixtures for industrial use only. In the case of placing on the market or using dangerous mixtures imported from outside Hungary or manufactured in Hungary, the data of the mixture must be reported through the IT system of OKBI. This obligation is expected to be in effect until 01.01.2024, after that PCN notification will be required. During the transition period, PCN limited submission to these mixtures can be chosen instead of OKBI registration
  • biocide authorization processes – In the case of an approved active substance, the documentation required for a marketing authorization must be submitted via the ECHA website. In the case of an active substance not included in the list of approved active substances, temporary authorization is only possible through the NNGyK. The temporary license is valid until the active ingredient is on the approved list! After that, the final authorization must be initiated on the ECHA interface, and the NNGyK must be informed of this
  • in the notification related to carcinogenic and mutagenic substances – XCIII of 1993 on occupational safety. Act IV/A. According to the chapter, the official notification about the exposure of people working with carcinogenic and mutagenic substances is carried out as part of our general occupational health and safety service
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