Swissmedic decides independently on the authorisation of veterinary medicines in Switzerland.
The Swissmedic staff have a variety of qualifications and backgrounds.
Swissmedic is responsible for the availability of veterinary medicines in Switzerland.
When authorising a veterinary medicine, Swissmedic always accepts the decision of the EU.
Swissmedic grants an authorisation for the veterinary medicinal product that enables the authorisation holder to generate the most profit.
Politics has a significant influence on which veterinary medicines should be authorised in Switzerland.
If an important medicinal product is not available in Switzerland, Swissmedic can mandate a company to submit an authorisation application for this product.
An expert committee of acknowledged experts from a wide variety of specialist areas supports Swissmedic in deciding on an authorisation or rejection of an application.
A veterinary medicinal product is authorised immediately when an illness emerges in Switzerland.
The reporting of adverse reactions by veterinarians during their use of a veterinary medicine is very valuable for Swissmedic.
If a quality defect is identified, Swissmedic always initiates an immediate recall of the affected batches of a veterinary medicinal product
Importing veterinary medicines that are not authorised in Switzerland from a country with comparable medicinal product control according to VMPO Article 7 is an important option if no authorised alternative is available.
Swissmedic makes it more difficult to access the Swiss market by imposing unnecessarily stringent Swiss-specific requirements for veterinary medicines.
Swissmedic is networked with foreign regulatory authorities.
In the EU, each individual member state also has its own authority responsible for the authorisation of veterinary medicines.
Swissmedic regularly withdraws authorisations for veterinary medicines.
True. When Swissmedic receives an application for the authorisation of a veterinary medicinal product, it checks the plausibility of the submitted data with regard to efficacy, safety and quality. If the benefit-risk assessment is positive, the product is authorised. Existing official decisions by countries with comparable medicinal product controls are taken into account.
True. Fourteen highly qualified personnel work in the Veterinary Medicines Division, including veterinarians and experts in pharmacy, biology and chemistry with many years of experience. The team is supported by external specialists on the Veterinary Medicines Expert Committee (VMEC).
False. Swissmedic cannot compel companies to submit or maintain an authorisation, and has no influence on quantities or the timing of a market launch.
Following authorisation, manufacturing problems, quality defects or a lack of active substances can lead to bottlenecks. Only safe veterinary medicines may be placed on the market.
False. Swissmedic follows international guidelines and takes account of decisions made by comparable authorities. It offers various authorisation procedures and, if requested to do so by companies, can dispense with its own assessment of veterinary medicinal products recently authorised in the EU. However, Swissmedic always makes its own decisions on authorisation in Switzerland, which always requires a company to submit an application.
Even after authorisation, Swissmedic still takes account of amendments to authorisations in other countries.
False. Swissmedic has no influence on the prices of veterinary medicines, which are set by the industry. Authorisation is granted independently of economic factors and solely on the basis of scientific data. Safety, efficacy and quality are the deciding factors.
False. Swissmedic decides independently on applications on the basis of legal requirements. The Therapeutic Products Act stipulates that Swissmedic should only authorise high-quality, safe and effective veterinary medicinal products.
False. An authorisation application cannot be mandated, and a withdrawal of authorisation cannot be rejected. Swissmedic has no legal basis to do so, and is not allowed to intervene in the market.
True. The Veterinary Medicines Expert Committee (VMEC) consists of 17 professionals from various fields of veterinary medicine, including small animal, equine, bovine, and poultry medicine, virology, microbiology and parasitology. They support Swissmedic in the scientific assessment of authorisations, market surveillance, and the licensing of medicines. The committee meets several times a year.
False. Swissmedic can only authorise a veterinary medicinal product if a company submits an application for authorisation and if the resulting benefit-risk assessment is positive.
True. Swissmedic records all reports of adverse reactions to veterinary medicines. Pharmacovigilance improves safety for animals and humans. Processing these reports enables signals (indications of previously unknown causal relationships) to be identified, and corresponding measures taken. If serious reactions are involved, just a few reports are sufficient. Possible measures include modification of the "Side effects", "Contraindications" or "Special warnings".
Here you can find the annual reports of adverse reactions to veterinary medicinal products.
False. The quality defect is assessed on the basis of the data. If the benefit-risk assessment reveals an increased health risk to animals or users, a recall is carried out. Factors such as the supply situation are taken into account.
True. However, in order to avoid authorisation withdrawals and any negative impact on the security of supply, veterinarians should only import these medicines in exceptional cases and if they do not compete with authorised veterinary medicinal products that are temporarily unavailable. Moreover, the safety for animals, humans, food and the environment cannot be monitored according to the usual standards, since there is no authorisation holder in Switzerland to take responsibility, and the scientific documentation is lacking.
False. Swissmedic complies with globally harmonised requirements for authorisation, GMP and GDP. No Switzerland-specific studies are required. Only packaging materials and medicinal product information are subject to national requirements. Global guidelines are drafted in international organisations (e.g. VICH), with input from authorities and industry. After they enter into force, they are then implemented by national authorities such as Swissmedic. This ensures that quality, safety and efficacy are harmonised – for the benefit of companies and authorities.
True. Swissmedic works internationally on the harmonisation of guidelines for therapeutic products, e.g. within the framework of VICH, regularly sharing information with foreign partner authorities on a bilateral basis. Swissmedic works closely with the British Veterinary Medicines Directorate and offers an authorisation procedure for the concurrent authorisation in Switzerland and the United Kingdom.
True. There are various authorisation procedures in Europe.
In the centralised procedure, the EMA coordinates a Committee for Veterinary Medicinal Products (CVMP) with members from the authorities of all EU states. After assessing an application, the CVMP forwards a scientific recommendation to the European Commission, which then approves or rejects authorisation. Although a centralised authorisation is valid in all member states, it does not automatically lead to market availability in every country.
In decentralised procedures, the respective national authorities process the applications. One authority is responsible for the main review, while the other authorities conduct a peer review. The authorisation is valid only in those member states in which the company concerned has submitted the authorisation application.
False. Swissmedic revokes authorisations only in serious exceptional cases. In the last 10 years, no authorisation for a veterinary medicinal product has been revoked against a company's will. In most cases, authorisations disappear because the companies withdraw them on their own initiative.