Commentaries: Art. 46

For the placing of products on the market and administration of radiopharmaceuticals in humans, the provisions of the TPA¹apply.
Approval is required from the FOPH for:
1. the marketing authorisation of radiopharmaceuticals in accordance with Article 9 paragraph 1 of the TPA;
2. the simplified authorisation of radiopharmaceuticals in accordance with Article 14 of the TPA;
3. the authorisation of radiopharmaceuticals for a limited period in accordance with Article 9 paragraph 4 of the TPA.
The FOPH shall grant approval based on the documents received as part of the application for authorisation, and on the assessment and reasoning of the Expert Commission for Radiopharmaceuticals.
Radiopharmaceuticals must be labelled as such. Their package labelling must include at least the following radiological protection-related information:
1. the preparation name;
2. the hazard warning symbol in accordance with Annex 8;
3. the radionuclides and their activity at the time of calibration;
4. the calibration time and the expiry time.
For the labelling, the provisions of the medicinal products legislation also apply.
Long-lived radionuclide impurities relevant to disposal must be indicated in the accompanying documents.

Art. 46