Requirements for product and service information and labelling
Bionorica is a company in the pharmaceutical industry. Therefore, our product information accounts for a wide range of aspects:
- Bionorica pharmaceuticals distributed worldwide always include a package leaflet allowing patients to obtain information about
- the safe use in the described drug indication,
- how to administer the drug and the dosage,
- the composition of the product (active herbal ingredients and pharmaceutical excipients),
- possible side effects
- storage and shelf life of the product
and other information at a glance. - Bionorica products are not subject to any special precautionary measures with regard to disposal in accordance with the German Medicinal Products Act (AMG), second section – Requirements for medicinal products, § 10 Labelling, No. 13. Our products can therefore be disposed of in Germany as follows:
Empty containers:
- Emptied amber glass in used glass collection
- Droppers, closures and empty blisters in the Yellow Bag (“Gelber Sack”)
- Paper and cardboard with waste paper or in the blue bin
Full containers:
- Can be handed in at pharmacies
- Disposal via residual waste / household waste
- Remaining product can be emptied in the sink
Nevertheless, European legislation also requires the submission of an “Environmental Risk Assessment” for medicinal products. This report must be submitted within the scope of the required marketing authorization application for each medicinal product and assesses the risks of the entry of medicinal product ingredients into the environment and the required precautionary measures.
Hints on the correct disposal of medicinal products are also provided by the German Environment Agency (see link. It should be noted that there is no uniform regulation in Germany on the disposal of medicines and pharmaceuticals. A website (link) promoted by the Federal Ministry of Education and Research (BMBF) provides information for consumers about the disposal procedures specific to their place of residence.
As Bionorica preparations are available in more than 40 countries, different legislation applies in each country with regard to the labelling obligations for our products. Further information on this topic can be found on the respective country-specific product websites and/or company websites of Bionorica or our local sales partners, for example in the digitally accessible package insert or the instructions for use.
Bionorica’s associated procedures apply 100% to all our products, as does the verification of compliance with rules and regulations.
No violations related to product and service information and labelling
At no time during the 2021 reporting year did Bionorica identify any violations of regulations and/or voluntary rules of conduct that could have an impact on the health of patients and the safety of Bionorica medicinal products or that were related to product information and labelling.