Approval Of Vaccines

2023 Author: Wallace Forman | [email protected]. Last modified: 2023-11-27 18:19

Approval of vaccines

In Austria, vaccines are subject to the provisions of the Medicines Act and - like all other medicines - are approved by the Federal Office for Health Safety (BASG) / AGES Medical Market Authority.

navigation

• Continue reading
• more on the subject
• Advice, downloads & tools

Admission

Various requirements must be met when a new vaccine is approved. This includes proof of:

• Safety,
• Compatibility and
• Effectiveness of the vaccine.

The BASG / AGES medical market supervisory authority only grants national approval when all the requirements for the effectiveness and safety of the vaccine have been met in several development steps (manufacture, non-clinical and clinical studies) in accordance with the statutory and regulatory requirements and scientific standards. You can find detailed information under Approval of Medicinal Products.

A list of all approved vaccines in Austria can be found at www.basg.gv.at.

Storage of vaccines

Vaccines are sensitive products. Moisture, storage temperatures that are too high or too low, or light can affect their quality. If stored improperly, their effectiveness and compatibility can be impaired. Storage information can be found in the product information and instructions for use of each vaccine.

As a rule, patients obtain the vaccine from the pharmacy. It is essential to ensure that the temperature for transport and storage specified in the technical information is maintained.

When handling vaccines, keep the following in mind:

• Basically, vaccines are stored under light protection at + 2 ° C to + 8 ° C and must be protected from freezing.
• When transporting vaccines in cooling bags, make sure that no frozen ice packs (-20 ° C) are in direct contact with the vaccine packaging, as the cold transmission can freeze the vaccine.
• There is a cold chain obligation for live vaccines.