In Switzerland, only medicinal products that comply with the\nlegal, internationally harmonised requirements in terms of safety, efficacy and\nquality are permitted to come onto the market. In Switzerland, Swissmedic, the\nSwiss Agency for Therapeutic Products, decides on the basis of a thorough\nreview whether a medicine fulfils the legal requirements and can be authorised\nfor sale. This procedure is designed to protect patients from harm and from\nimitation products. <\/p>\n\n\n\n
In order to have a medicinal product authorised by Swissmedic, the\napplicant must provide extensive documentation, demonstrating to the authority\nthe efficacy, quality and safety of the product in question. The identity,\npurity and active substance content of the medicinal product must also be documented.<\/p>\n\n\n\n
Medicines can then be reimbursed by statutory health insurance\nproviders if the Federal Office of Public Health (FOPH) places them on the List\nof pharmaceutical specialities (LS). Inclusion in this list depends on\nfulfilment of the \u201cWZW\u201d criteria, standing for effectiveness, appropriateness\nand cost-effectiveness. The decision on inclusion is taken by the FOPH at the\nrecommendation of the Federal Medicines Commission (FMC).<\/p>\n\n\n\n
The\nmanufacturer or distributor of a medicinal product can request Swissmedic to\ninitiate a fast-track authorisation procedure for a promising product for the\ntreatment of a severe, disabling or life-threatening disease for which no or\nonly unsatisfactory treatment options with authorised medicinal products are\navailable, or if the new medicine is expected to provide a major therapeutic\nbenefit. <\/p>\n\n\n\n
If the\nrequested authorisation is denied, the applicant can discontinue the\nauthorisation request, apply for the application to be reconsidered, submit an\nappeal, or submit a new application.<\/p>\n\n\n\n
Since 2016, there have been increasing delays in the inclusion of innovative medicines in the compulsory health insurance system. This means that patients are having to wait longer and longer for full and equal access, even though these medicines and therapies have been approved. This negative trend has recently intensified. The statutory deadline of 60 days (KLV Art. 31b) is being exceeded by a factor of several hundred every year and is only being met in rare cases. Moreover, Switzerland is falling further and further behind in terms of access to new innovative medicines: compared to Germany, only about half of the new innovative therapies are fully available in Switzerland. In terms of broad and equal reimbursement via the specialty list, Switzerland is now only just ahead of Bulgaria. This is detrimental to patients, as many of them cannot afford to wait so long.<\/p>\n\n\n\n
Swissmedic decides on the basis of a medicinal product\u2019s\nbenefit-risk profile whether it can be sold and dispensed only on presentation\nof a doctor\u2019s prescription (prescription-only) or without a prescription\n(prescription-free). Swissmedic accordingly divides medicinal products into\nfour dispensing categories. Prescription-only medicines are assigned to\ndispensing category A or B, those available without a prescription to category\nD or E.<\/p>\n\n\n\n
Advice from a specialist is usually required in order to use a\nmedicine correctly. This is why most medicines have to be obtained from\nspecialist sources. Medicines in categories A and B are only available in\npharmacies, while those in category D can also be sold in drugstores if\nspecialist advice is provided. In some cantons doctors are also authorised to\ndispense medicines directly to patients (self-dispensing doctors). The same\napplies to trained staff in hospitals.<\/p>\n\n\n\n
Prescription-free medicines are also referred to as OTC, standing\nfor over-the-counter. These products are intended for self-medication, or in\nother words for use by the patient on their own responsibility. Medicines in\ncategory E can be sold without a prescription and without specialist advice in\nall retail outlets.<\/p>\n\n\n\n
The information on the pack containing the medicine is intended to\nensure that a medicinal product can be identified as such with as little room\nfor error as possible. Each pack of medicine must therefore display the\nrequired information. This includes the proprietary name of the medicine and\nthe active ingredient it contains as well as other important information about\naspects such as safety and correct storage. Every pack also contains a patient\ninformation leaflet in the country\u2019s three official languages. It provides information\non the purpose of the medicine, how to use it correctly and the symptoms of any\nundesirable effects that the product may have. The contents of the patient\ninformation leaflet are regulated by strict legal conditions.<\/p>\n","protected":false},"excerpt":{"rendered":"
In Switzerland, only medicinal products that comply with the legal, internationally harmonised requirements in terms of safety, efficacy and quality are permitted to come onto the market. In Switzerland, Swissmedic, the Swiss Agency for Therapeutic Products, decides on the basis of a thorough review whether a medicine fulfils the legal requirements and can be authorised […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4142,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4184","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\n