Vision, values and strategy
We strive to take a leading role among medicines agencies in Europe.
We are the national competent authority for regulation of medicinal products, medical devices, blood and tissues and a partner to competent authorities and agencies throughout Europe.
- We are dedicated to promoting and protecting both human and animal health by safeguarding and shaping the regulatory and scientific environment to ensure high-quality medicinal products and medical devices with a balanced benefit-risk ratio.
- Our scientific and regulatory experts are the knowledge carriers of our organisation. Therefore, we conceive ourselves as a learning and teaching organisation.
We are committed to working for the health of humans, animals, and plants in a sound and responsible manner. We stand by our actions and decisions.
We are guided by facts, are impartial, and act with integrity.
We do the right things, and we do them in a service- and results-oriented manner. As a team, we strive for innovation, interdisciplinarity, and excellence.
We live and promote the European idea. We actively participate in shaping the European regulatory environment, thereby contributing to safeguarding health in Europe.
AGES MEA is entrusted by the Health and Food Safety Act (GESG) with the execution of the tasks of the Federal Office for Safety in Health Care (BASG).
Pursuant to § 8 (7) GESG, the acceptance of third party contracts is prohibited for this business division. AGES MEA thus operates independently of parties whose activities are regulated by the material laws under the jurisdiction of the BASG. The services of the BASG are available to all applicants and notifiers who are entitled under the material laws. The procedures shall be applied without discrimination. The fees to be paid are determined by the BASG.
AGES MEA's legal status ensures that its personnel are kept free from any influences that might affect their professional judgment. The AGES MEA experts act on behalf of the BASG and in this capacity are subject to the duty of truth, against which the right to issue instructions cannot penetrate. The personnel is obliged to secrecy, impartiality and the protection of confidential data.
The employees of AGES MEA may not be involved in the development, production or distribution of the drugs or medical devices they review and may not be owners or authorized representatives of interested parties in the field of their professional activities in AGES MEA in the execution of the above-mentioned material laws. They shall not engage in any activity which may adversely affect the independence of their judgment or their integrity in the performance of their duties.
Pursuant to Directive 2001/83/EC, Article 126b and Section 82a of the German Medicines Act (AMG), all employees of the BASG and the AGES MEA are obliged to submit annual declarations to the BASG regarding any grounds for bias. The criteria used for the evaluation are the AVG § 7 and the "European Medicines Agency policy on the handling of competing interests of scientific committees' members and experts" of the European Medicines Agency; the evaluation process follows a guideline of the Heads of Medicines Agencies.
These criteria defined for the implementation of the Medicines Act are also applied analogously for the implementation of other material laws within the competence of the BASG (Medical Devices Act, Blood Safety Act, Tissue Safety Act and Addictive Substances Act).
- Code of conduct (L_7962)| 43 KBThe Code of Conduct of AGES applies to the employees of the Medical Market Supervision business unit.05/07/2018
1. Ensuring sustainable and successful positioning on the market and within the EU network
- Lead and competently assess regulatory procedures
- Participate actively in the EU-network
- Recognise and incorporate future-oriented developments
2. Maintaining an active communication strategy
- Keep partners proactively informed
- Communicate decisions in a transparent way
3. Acting in a customer-and service-oriented way
- Take action to ensure availability of medicines
- Conduct dialogue with relevant stakeholders
- Use market analysis and observation to assess the impact on the pharmaceutical market
- Create added value for the customer
4. Using resources (infrastructure, human- and time-resources) in an efficient and effective manner
- Establish or amend processes timely according to new legislation
- Take consistent decisions
- Further expand and optimise process management on an ongoing basis
- Assure cost coverage
5. Actively pursue digitalisation
- Establish BASG as central data hub and platform for Austria
- Implement national and European requirements promptly
- Use new opportunities of digitalisation for support
- Evaluating and using artificial intelligence (AI) and smart data possibilities