Pharmaceuticals Division
Responsibility of the Office of Public Health in the area of medicinal products
In the area of medicinal products, the Office of Public Health is responsible for
- Medicinal products
- Blood
- Human tissues and cells
- Narcotics
Tasks of the Pharmaceuticals Division of the Office of Public Health (incomplete)
Listed below are the tasks performed by the Medicinal Products Division of the Office of Public Health:
- Issuing licenses for the manufacture and wholesale of medicinal products
- Issuing retail trade licenses
- Regular monitoring of manufacturers, wholesalers and retailers through inspections
- Issuing GMP certificates (good manufacturing practice)
- Monitoring of narcotics
- Issuance of authorization to handle narcotics
- Issuing of authorization for blood collection for transfusions or for the production of therapeutic products
- Issuance of authorization to handle human tissues and cells
- General market surveillance
- Authorization of medicinal products within the EEA
- Cooperation with the Swiss and European medicinal product authorities
International cooperation
The following are the international collaborations:
- Cooperation with the Swiss Agency for Therapeutic Products SwissmdicLinkto the website of the Swiss Agency for Therapeutic Products Swissmedic
- Cooperation with the member states of the EEA: Liechtenstein, like Norway and Iceland, is an observer on the EU Pharmaceutical Committee and on the Management Board of the European Medicines Agency (EMA) Link to the EMA website
- Cooperation within the framework of PIC/S Link to the PIC/S website
Agreements with third countries
The agreements with third countries are listed below:
- MRAs (Mutual Recognition Agreements) are agreements on the mutual recognition of conformity assessments of certain industrial products that are subject to mandatory testing and certification upon market entry. The mutual recognition of such conformity assessments is intended to facilitate trade and market access for the regulated products. Each contracting party can have the products inspected, tested and certified in its own country with regard to conformity with the regulations of the importing country prior to export. The Parties recognize these tests and certificates issued by the contractually designated conformity assessment bodies of another Party. Time-consuming and cost-intensive duplicate testing can thus be avoided. However, MRAs do not lead to the adoption or harmonization of product regulations.
- The EEA countries have MRAs with annexes for GMP (good manufacturing practice for medicinal products) with Canada, Australia and New Zealand.
Contact persons
-
Dr. Vlasta Zavadova [email protected] +423 236 7325