The medicines lists provided on the Swissmedic website will be updated monthly.
The information in the tables corresponds to the current status in the Swissmedic database. Please contact us if any of the information is incorrect or erroneously incomplete.
These lists contain all the medicinal products (with indication) authorised by Swissmedic and the authorised homeopathic and anthroposophic medicinal products without indication not authorised by the notification procedure:
5 Excel tables:
This list contains the medicines authorised in the Canton of Appenzell Ausserrhoden and is maintained by the Medicines Inspectorate of the Canton's Department of Public Health.
This list contains all complete applications received for authorisation, for additional indications or for extensions of the authorisation of human medicinal products as per Art. 68 para. 1 (a) TPO. These are published within 60 days of receipt of the complete application. Following an official decision, these applications are then removed from the list.
This list includes human medicinal products manufactured by means of gene technology.
Insulins are used worldwide for the treatment of diabetes mellitus. Human insulins and insulin analogues are currently available on the market.
Animal insulins have not been available on the market in Switzerland since 31.10.2015.
Certain aspects relating to the manufacture and mode of action of insulins are explained below.
Swissmedic publishes lists of all authorised co-marketing medicines in Switzerland, including the corresponding basic preparations.
Under the Therapeutic Products Act (Art. 9a TPA), Swissmedic temporarily authorises medicinal products for life-threatening or debilitating diseases. The implementing provisions were incorporated in the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO, SR 812.212.23).
According to the Therapeutic Products Act (Art. 14 para. 1 letter f TPA), important human and veterinary medicinal products for rare diseases are eligible for the simplified authorisation procedure. The implementing provisions are specified in the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO, SR 812.212.23).
The Ordinance on Medicinal Products (Art. 11 TPO, SR 812.212.21) states that authorisation holders must notify the Swiss Agency for Therapeutic Products of all medicinal products whose distribution is interrupted for more than one year (interruption to distribution) or that are not placed on the market within one year after authorisation has been granted (no marketing).
This list contains all notifications of no marketing/interruption to distribution received by Swissmedic. It shows the date from which the medicinal products are not available on the market.
Medicinal products for which the authorisation holder has notified Swissmedic that distribution will be resumed after interruption or started after first authorisation, or for which the authorisation has been converted to an export authorisation, will no longer be included on this list. The list will be updated monthly.
Monthly publication of legally approved reclassifications in accordance with Art. 45, para. 3 TPO as of June 2019
Medicinal products formerly in dispensing category C, which was discontinued as of 1 January 2019, are officially being reallocated to categories D or B. Swissmedic will publish an updated list as soon as any changes are made to the status of the listed classifications into dispensing category B.
Classification of the co-marketing medicinal products depends on how the related basic product is classified.
On the basis of the revised Therapeutic Products Act (TPA), naturopaths with a federal diploma (NP FD) are entitled independently to dispense (non-prescription) medicinal products used in complementary medicine (Art. 25 TPA, Art. 49 TPO), provided they have acquired the necessary expertise in the corresponding specialist area.
A prerequisite for any dispensing of medicinal products is a corresponding retail trade permit issued by the canton in which the applicant is domiciled (Art. 30 TPA).
List I
The medicinal products of the various schools of therapy with and without indication that are listed in List I may be dispensed by NP FD of the corresponding specialty.
In List I, preparations containing Hypericum perforatum, Ginkgo biloba or senna are only listed from potency D2/C1 or a comparable dilution.
List I does not include any anthroposophic medicinal products with or without an indication; these are excluded from dispensing by NP FD.
List I – Herbal and complementary medicines with and without indication (dispensing category D)
List II
The medicinal products of the various schools of treatment without indication authorised in the notification procedure that are listed in List II may be dispensed by NP FDs of the corresponding specialty subject to the following restrictions:
List II – Medicinal products without indication authorised under the notification procedure (dispensing category D)
Based on the list of
Medicinal products without indication authorised under the notification procedure in accordance with KPTPO (XLS, 3 MB, 31.08.2024)
List III
The Chinese medicinal products without indication authorised in the notification procedure that are listed in List III may be dispensed by NP FDs specialising in traditional Chinese medicine (TCM).
List III – Chinese medicinal products without indication authorised under the notification procedure (dispensing category D)
Currently: No authorized asian medicinal products without indication (notification procedure) (22.04.2024)
Complementary medicinal products without indication that are not authorised in the notification procedure can be found in the lists in sections 1.1, 1.2, 1.8 and 1.10.
Medicinal products without indication authorised by the notification procedure in accordance with KPTPO
The Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Complementary and Phytotherapeutic Products (KPTPO; SR 812.212.24) states that most homeopathic, anthroposophic and Asian medicinal products without indication, as well as medicinal products for gemmotherapy without indication, may be authorised based on a notification procedure (Art. 5, 27, 28 and 31 KPTPO).
The lists contain the medicinal products authorised by this procedure at the time of the update.
Currently: No authorized asian medicinal products without indication (notification procedure) (22.04.2024)
The lists contain the medicinal products that are no longer authorised by this procedure and those for which an application for extension of the authorisation was not submitted on time.
The medicinal product notifications for which no expiry date is entered are already no longer marketable at this time.
The complementary medicines without indication shown in the following list are authorised by the notification procedure according to Art. 5, 25, 27, 28 and 31 of the Complementary and Phytotherapeutic Products Ordinance (KPTPO; SR 812.212.24). The list will only be updated as required.
* Including immunological veterinary medicinal products
This list includes all complete applications received for authorisation, for additional indications or for variations with assessment according to Section I of the form Variations VMP HMV4 (until 28 January 2022 “extensions”) for veterinary medicinal products according to Art. 68 para. 1 let. a TPO. These are published within 60 days of receipt of the complete application. Following an official decision, these applications are then removed from the list.
This list includes veterinary medicinal products manufactured by means of gene technology.
The list contains all co-marketing veterinary medicines authorised by Swissmedic, including the corresponding basic preparations.
Under the Therapeutic Products Act (Art. 9a TPA), Swissmedic temporarily authorises medicinal products for life-threatening. The implementing provisions were incorporated in the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO, SR 812.212.23).
According to the Therapeutic Products Act (Art. 14 para. 1 letter f TPA), important medicinal products for rare diseases are eligible for the simplified authorisation procedure. The implementing provisions are specified in the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO, SR 812.212.23).
The Ordinance on Medicinal Products (Art. 11 TPO, SR 812.212.21) states that authorisation holders must notify the Swiss Agency for Therapeutic Products of all veterinary medicinal products whose distribution is interrupted for more than one year (interruption to distribution) or that are not placed on the market within one year after authorisation has been granted (no marketing).
This list contains all notifications of no marketing/interruption to distribution of veterinary medicines received by Swissmedic. It shows the date from which the veterinary medicines are not available on the market.
Veterinary medicinal products for which the authorisation holder has notified Swissmedic that distribution will be resumed after interruption or started after first authorisation, or for which the authorisation has been converted to an export authorisation, will no longer be included on this list. The list will be updated monthly.
Art. 9 of the Veterinary Medicinal Products Ordinance (VMPO, SR 812.212.27) specifies what veterinary medicinal products may be dispensed under what conditions in pet and bee-keeping shops and that Swissmedic designates those medicinal products that may be dispensed by these outlets. The corresponding veterinary medicinal products are included in both lists. Medicines for treating parasite infestations in bees may also be used by bee-keeping shops.
Directory of all authorised narcotic-like medicines on the Swiss market and directory of raw materials and raw materials and products suspected of having effects similar to narcotics.
Both of these directories are non-exhaustive lists of all controlled substances.
Only the directories in accordance with the Narcotics Lists Ordinance NarcLO-FDHA are binding.
List of medicinal products that can be used to execute people and that require a licence (according to Art. 50 MPLO).
Establishment licence for handling controlled substances (Art. 2 letter h NarcCO)
The MedReg register of medical professions and the enterprises module (Betriebemodul/module Entreprises) are the authoritative registers listing all medical professionals, public pharmacies, healthcare institutions, scientific institutes and cantonal offices that are authorised by the cantonal authorities to procure narcotic substances.
The registration and updating of the data by the cantons are governed by Art. 75 of the Narcotics Control Ordinance (NarcCO) while publication of the data is subject to Art. 66 NarcCO.
Licence holders who want to check the entitlement to procure narcotics to fulfil their statutory duty of care (under Art. 10 NarcCO, Art 28 TPA, Art. 15 MPLO, Annex 4 to the EU Good Manufacturing Practice (GMP) guidelines) should proceed as follows:
Access to standard BetReg interface (cantonally licensed establishments und medical professionals)
Application to Swissmedic for access to standard BetReg interfaces
Theft/loss of prescriptions for narcotics
All of the listed prescriptions are blocked. The relevant cantonal authority should be informed immediately if one of these prescriptions is presented.
Theft/loss of prescriptions for narcotics (XLSX, 444 kB, 20.11.2024)Blocked forms for prescription of narcotics by medical professionals
Forms for prescription of narcotics by medical professionals
Authorised vaccines, blood products and other immunological medicinal products for human use are listed here.
The list shows which of these therapeutic products are subject to:
Following the entry into force of the revised Therapeutic Products Act, Swissmedic publishes additional information of general interest relating to therapeutic products. On the basis of Art. 67 para. 1 TPA and the implementing provisions of Art. 68 para. 1 let. e TPO, the Agency publishes a SwissPAR summary evaluation report for all human medicinal products with a new active substance, as well as for transplant products, for which a decision to approve or reject authorisation has been issued.
In addition to the full SwissPAR, Swissmedic is publishing an abridged version of the SwissPAR known as the ‘Public Summary SwissPAR’.
The adjacent List of active substances contains all active substances that may be marketed in Switzerland as ingredients of authorised ready-to-use medicinal products (in accordance with Art. 9 TPA).
The following are not included in the list
It should be noted that the stated dispensing category applies to an authorised medicinal product, not to a particular active substance. Swissmedic reviews and approves the dispensing category for each new medicinal product applied for, and the active substance plays an important, but not exclusive, role in this process (the indication, dosage, pack size etc. also determine the dispensing category).
The List of active substances is updated monthly.
Procedures for inactivating pathogenic agents (pathogen inactivation) in labile blood products that were authorised according to Art.19 of the Therapeutic Products Ordinance (TPO) are listed below.
1) Please consult the Information for healthcare professionals for the complete wording for the protected indication, dosage recommendation, route of administration, pharmaceutical form, dosage or target animal species.
2) If the distribution of a medicinal product intended purely for paediatric use, and for which the authorisation holder has obtained document protection according to Art. 11b paras. 3 and 4 TPA or Art. 140n or 140t of the Patents Act of 25 June 1954 (PatA), is discontinued, the corresponding authorisation documentation can be acquired from the authorisation holder free of charge (Art. 11 para. 3 and 5 TPO).
Following the entry into force of the new Therapeutic Products Act (TPA, SR 812.21) and the revised Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1), establishment licences granted from 1 January 2019 have been issued under the new legislation.
Holders of establishment licences issued under the new legislation appear in the following list:
“Establishment licences issued under the new legislation”.
Blood and labile blood products
With the entry into force of the new legislation on 1 January 2019, establishment licences for activities with blood and labile blood products were integrated into the general approval process for medicinal products. Under the new legislation, licence holders for these activities will therefore be included in the general list:
This list does not include facilities that possess a cantonal licence for the storage of blood or blood products.
Legal basis
Pursuant to Articles, 5, 18, 28 and 34 of the Therapeutic Products Act (TPA, SR 812.21), companies that:
are required to hold an establishment licence issued by Swissmedic. Swissmedic (blood and blood products are also considered to be medicinal products). Those who draw blood from persons in order to use or forward it for transfusions or for the manufacture of therapeutic products require an establishment licence from Swissmedic (Art. 34 para. 1 TPA). However, companies that only store blood or blood products require an establishment licence from the canton (Art. 34 para. 4 TPA).
Company names and registered offices
The company names and addresses that appear in this list are those entered in the Commercial Register. Incidentally, establishment licences are always made out in the name of the legal entities listed in the Commercial Register (if such an entry exists).
Date of validity of establishment licences and pending applications
In most cases, establishment licences issued from 1 January 2019 under the new legislation are valid for an unlimited period.
Validity
Establishment licences are the sole legally authoritative documents. Suppliers and customers must therefore always inspect their business partners’ establishment licence. The lists are published solely for information purposes and do not in any way absolve suppliers and customers from their duty to exercise due care, especially in view of the fact that the lists do not mention certain restrictions.
If an activity has been erroneously assigned to a company in one of the lists, the company in question cannot demand that Swissmedic issue or uphold a licence for this activity.
Legal basis
Pursuant to Art. 16 or the Epidemics Act (EpidA, SR 818.101), laboratories that perform microbiological analyses for the purpose of detecting or excluding transmissible diseases are required to hold an establishment license issued by Swissmedic.
At least once a year, the Swiss Agency for Therapeutic Products publishes a list of laboratories that have been licensed under Art. 22 of the Ordinance on microbiology laboratories (SR 818.101.32).
Holders of establishment licenses appear in the above list. The analysis areas and activities (per operating site) are listed as follows:
| SE 1 Patient diagnostics |
||
|---|---|---|
| SE 1.1 | Serology | |
| SE 1.2 | Nucleic acid amplification (NAAT) | |
| SE 1.3 | Cultivation and / or direct evidence | |
| SE 1.4 | (particularities) | |
| SE 2 Screening | ||
| SE 2.1 | Serology | |
| SE 2.2 | Nucleic acid amplification (NAAT) | |
| SE 2.3 | (particularities) | |
| SE 3 Environmental analysis |
||
| SE 3.1 | Group 3 organisms | |
| SE 3.2 | Group 4 organisms | |
| SE 3.3 | (particularities) | |
The list contains the following information:
Date of validity of establishment licenses and pending applications
The expiry date of establishment licenses for microbiology laboratories is published in the list. The establishment license is valid for five years and the renewal application must be submitted no later than six months before the license expires.
Validity
Establishment licenses are the sole legally authoritative documents. Suppliers and customers must therefore always inspect their business partners’ establishment license. The list is published solely for information purposes and does not in any way absolve suppliers and customers from their duty to exercise due care, especially in view of the fact that the list does not mention certain restrictions.
If an activity has been erroneously assigned to a company in the list, the company in question cannot demand that Swissmedic issues or upholds a license for this activity.
Legal basis
Pursuant to Articles, 5, 18, 28 and 34 of the Therapeutic Products Act (TPA, SR 812.21) and Art. 1 para. 2 of the Medicinal Products Licensing Ordinance, an establishment licence issued by Swissmedic must be held by companies that:
transplant products (TPs), gene therapy products (GTPs) and/or genetically modified organisms (GMOs).
Following the entry into force of the new Therapeutic Products Act (TPA, SR 812.21) and the revised Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1), establishment licences for TPs, GTPs or GMOs granted from 1 January 2019 have been issued under the new legislation.
Holders of establishment licences issued under the new legislation appear in the following list:
“Establishment licences for TPs, GTPs or GMOs issued under the new legislation”.
Company names and registered offices
The company names and addresses that appear in this list are those entered in the Commercial Register. Incidentally, establishment licences are always made out in the name of the legal entities listed in the Commercial Register.
Validity
Establishment licences are the sole legally authoritative documents. Suppliers and customers must therefore always inspect their business partners’ establishment licence. The lists are published solely for information purposes and do not in any way absolve suppliers and customers from their duty to exercise due care, especially in view of the fact that the lists do not mention certain restrictions.
If an activity has been erroneously assigned to a company in one of the lists, the company in question cannot demand that Swissmedic issue or uphold a licence for this activity.
Addresses of inspectorates and other cantonal bodies
Allocation of ATC code for human medicinal products (excl. CHM)
The list shows the allocation of medicinal product groups according to the ATC code for all human medicinal products (excluding complementary and herbal medicines), along with the relevant Regulatory Managers and Regulatory Associates.
Allocation of complementary and herbal medicines (CHM)
The list shows the allocation of medicinal product groups according to the ATC code for herbal medicines and for complementary medicines in accordance with the Index Therapeuticus (IT groups), along with the relevant Regulatory Managers and Regulatory Associates.
Swissmedic makes public data available to interested users – in machine-readable form and updated every month – on the Swiss administration's OGD portal.
On the first working day of each month, data relating to authorised human and veterinary medicines are generated in XML files and made available on the OGD portal for download by interested users.
The dataset is based on the last calendar day of the previous month for medicines with the authorisation status "authorised", "temporary" or "suspended". Also published are medicines whose authorisation status has changed since the last publication (“no longer authorised” or “temporary authorisation expired”).
Data relating to human and veterinary medicines
The overview shows all manufacturers, importers and authorised representatives domiciled in Switzerland registered at Swissmedic. The list is updated daily.
The following list sets out the batches of blood products and vaccines released by the OMCL in the relevant month. Release was in accordance with Art. 21 TPLRO based on in-house laboratory tests and review of the manufacturer's documentation or recognition of a batch release certificate from an EU/EEA-OMCL (notification).
Approved batches of blood products and vaccines
Disclosure of Swissmedic procurement from CHF 50,000 for 2023 (according to Art. 27 PPO)
