Lists and directories


Notes


Notes

The medicines lists provided on the Swissmedic website will be updated monthly.

Accuracy of data

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.

1. Human medicines


These lists contain all the medicinal products authorised by Swissmedic apart from authorised homeopathic and anthroposophic medicinal products without indication authorised by the notification procedure:

3 Excel tables:

  • List of authorised medicines
  • Extended list of medicines
  • List of authorised packaging Authorised medicines

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.


1.1. Gene technology and medicines

This list includes human medicinal products manufactured by means of gene technology.


1.2. Insulins for use in humans

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.


1.3. Co-marketing medicines

Swissmedic publishes lists of all authorised co-marketing medicines in Switzerland, including the corresponding basic preparations.


1.4. Temporary authorisations for medicinal products for the treatment of life-threatening diseases

According to the Therapeutic Products Act (Art. 9a TPA), Swissmedic can issue temporary authorisations for the distribution and dispensing of medicinal products to treat life-threatening 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).


1.5. Important medicinal products for rare diseases (orphan drugs in the case of human medicines)

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).


1.6. Notifications of no marketing or interruptions to distribution of authorised human medicines

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.


1.7. Reallocations to dispensing category B in accordance with Art. 45, para. 3 of the Therapeutic Products Ordinance (TPO; SR 812.212.21)

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. Each month, Swissmedic publishes a list of the medicinal products reallocated from C to B for which the new classification has taken legal effect.

Co-marketing medicines are not reclassified by Swissmedic (for changes see the corresponding basic preparations).


2. Complementary medicine


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.


2.1. Medicinal products without indication no longer authorised by the notification procedure in accordance with KPTPO

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.


2.2. Notifications of no marketing or interruptions to distribution of authorised medicinal products

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.

 

3. Veterinary medicines


These lists contain all veterinary medicines authorised by Swissmedic.

3 Excel tables:

  • List of authorised veterinary medicines
  • Extended list of veterinary medicines
  • List of authorised packaging

3.1. Gene technology and medicines

This list includes veterinary medicinal products manufactured by means of gene technology.


3.2. Co-marketing medicinal products

The list contains all co-marketing veterinary medicines authorised by Swissmedic, including the corresponding basic preparations.

 

3.3. Temporarily authorised veterinary medicinal products for the treatment of life-threatening diseases

Temporary authorisations for medicinal products for the treatment of life-threatening diseases
According to the Therapeutic Products Act (Art. 9a TPA), Swissmedic can issue temporary authorisations for the distribution and dispensing of medicinal products to treat life-threatening 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).


3.4. Important veterinary medicinal products for rare diseases (MUMS: Minor Use, Minor Species)

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).


3.5. Notifications of no marketing or interruptions to distribution of authorised veterinary medicines

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.


3.6. Veterinary medicines in pet and bee-keeping shops

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.

 


4. Narcotics and precursors


Directories

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.


4.1. Export of and trading in medicinal products that can be used to execute people, according to Art. 21 TPA

List of medicinal products that can be used to execute people and that require a licence (according to Art. 50 MPLO).


4.2. Establishment licence for handling controlled substances

Establishment licence for handling controlled substances (Art. 2 letter h NarcCO)


4.3. Cantonally authorised medical professionals and enterprises

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.


4.4. Blocked forms for prescription of narcotics

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 (XLS, 260 kB, 12.06.2019)Blocked forms for prescription of narcotics by medical professionals

Forms for prescription of narcotics by medical professionals


5. Vaccines and blood products


This list includes authorised vaccines and blood products. 

The list shows which of these therapeutic products are subject to: 


7. Authorised procedures and active substances


7.1. Lists of active substances


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

  • Active substances and other ingredients of medicines used in complementary medicine (Index therapeuticus (IT) group 20);
  • Active substances and other ingredients that are exclusively used in magistral or officinal formulations;

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.


7.2. Authorised procedures


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.


8. Document protection


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).


9. Authorisation holders


9.1. Establishment licences / Blood and labile blood products


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”.

Establishment licences issued under the old legislation will retain their validity until their expiry date.

Holders of establishment licences issued under the old legislation appear in the following list:

  • “Establishment licences issued under the old legislation”.

During the transitional period lasting until all establishment licences issued under the old legislation and not renewed under the new legislation have expired, it should be borne in mind that a licence holder may appear in either of the two published lists. 

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:

  • “Establishment licences according to the new legislation”

Establishment licences issued under the old legislation will remain valid until their expiry date. Concerned licence holders are included in the following list:

  • "Establishment licences for the handling of blood and labile blood products according to the old legislation”

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:

  • manufacture or trade in medicinal products
  • act as a trader in or agent for medicinal products

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
The “Date” column in the “Establishment licences issued under the old legislation” list shows the expiry dates of establishment licences issued under the old legislation.
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.


9.2. Microbiological laboratories


Legal basis
Pursuant to Art. 16 or the Epidemics Act (EpidA, SR 818.101), laboratories that perform microbiological analyses for the purpose of detecting transmissible diseases are required to hold an establishment licence issued by Swissmedic.

Each 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).

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 microbiology laboratories granted from 1 January 2019 have been issued under a new process.

Holders of establishment licences issued under the new process appear in the following list:

  • “Laboratory establishment licences issued under the new process”.

Laboratory establishment licences issued under the old legislation will retain their validity until their expiry date. Holders of establishment licences issued under the old process appear in the following list:

  • “Laboratory establishment licences issued under the old process”.

During the transitional period lasting until all establishment licences issued under the old process and not renewed under the new process have expired, it should be borne in mind that a licence holder may appear in either of the two published lists. 

These lists contain the following information:

  • Name and address of the laboratory
  • Name of the laboratory manager
  • Analytical testing services provided 

Date of validity of establishment licences and pending applications
The “Date” column in the “Laboratory establishment licences issued under the old process” list shows the expiry dates of establishment licences issued to microbiology laboratories under the old process. 

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.


9.3. Licence holders of transplant products


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:

  • manufacture or trade in
  • or act as a trader in or agent for

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”.

Establishment licences for TPs, GTPs or GMOs issued pursuant to the old legislation will retain their validity until their expiry date or for five years at the most from 1 January 2019.

Holders of establishment licences issued under the old legislation appear in the following list:

  • “Establishment licences for TPs, GTPs or GMOs issued under the old legislation”. 

During the transitional period lasting until all establishment licences issued under the old legislation and not renewed under the new legislation have expired, it should be borne in mind that a licence holder may appear in either of the two published lists.   

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.

Date of validity of establishment licences and pending applications
The “Date” column in the “Establishment licences issued under the old legislation” list shows the expiry dates of establishment licences issued under the old legislation.

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.

 
 

10. Addresses



11. Allocation of IT groups


The list shows the medicine groups with the relevant Case Managers and Case Management Assistants.


Last modification 14.06.2019

Top of page