Are you over 18 and want to see adult content?
More Annotations
![A complete backup of https://isafjordur.is](https://www.archivebay.com/archive6/images/27814d95-3415-44ec-bfe9-cf6cd274f4f7.png)
A complete backup of https://isafjordur.is
Are you over 18 and want to see adult content?
![A complete backup of https://craft-sports.de](https://www.archivebay.com/archive6/images/821abd68-fb56-4b95-8d40-44d27b590537.png)
A complete backup of https://craft-sports.de
Are you over 18 and want to see adult content?
![A complete backup of https://houstonastrosjersey.us](https://www.archivebay.com/archive6/images/6f2491cb-9796-4882-95e0-3c57f001430c.png)
A complete backup of https://houstonastrosjersey.us
Are you over 18 and want to see adult content?
![A complete backup of https://qubole.com](https://www.archivebay.com/archive6/images/558748a9-5dd3-4f8a-b5cc-7b0c6d0abf82.png)
A complete backup of https://qubole.com
Are you over 18 and want to see adult content?
![A complete backup of https://imperiyanews.ru](https://www.archivebay.com/archive6/images/ef9adb5e-d63d-4238-9a72-ea0aeb1a6350.png)
A complete backup of https://imperiyanews.ru
Are you over 18 and want to see adult content?
![A complete backup of https://preservationvirginia.org](https://www.archivebay.com/archive6/images/3f653e8d-8faf-4c74-aa60-8017dc3510b6.png)
A complete backup of https://preservationvirginia.org
Are you over 18 and want to see adult content?
![A complete backup of https://hotspotenergy.com](https://www.archivebay.com/archive6/images/f07abbe4-c841-449f-87fc-924db5698757.png)
A complete backup of https://hotspotenergy.com
Are you over 18 and want to see adult content?
![A complete backup of https://software4students.co.uk](https://www.archivebay.com/archive6/images/5e923eed-6678-4c5d-94e7-397dc226ef7b.png)
A complete backup of https://software4students.co.uk
Are you over 18 and want to see adult content?
![A complete backup of https://cemtrex.com](https://www.archivebay.com/archive6/images/0d8c34bc-be54-456a-bed5-d693f7947708.png)
A complete backup of https://cemtrex.com
Are you over 18 and want to see adult content?
![A complete backup of https://fxflat.com](https://www.archivebay.com/archive6/images/38a4495d-84db-4530-bf04-9d8eac38335c.png)
A complete backup of https://fxflat.com
Are you over 18 and want to see adult content?
![A complete backup of https://kiwisearches.com](https://www.archivebay.com/archive6/images/0c0d4d26-3ef7-42bf-88b7-4a0480e5fa71.png)
A complete backup of https://kiwisearches.com
Are you over 18 and want to see adult content?
Favourite Annotations
![A complete backup of www.stickamgirls.net](https://www.archivebay.com/archive5/images/34f19805-e1ae-41ff-894c-2879662cbf2b.png)
A complete backup of www.stickamgirls.net
Are you over 18 and want to see adult content?
![A complete backup of www.aristoshemales.com](https://www.archivebay.com/archive5/images/6c9db399-de46-4976-9a7f-439185785486.png)
A complete backup of www.aristoshemales.com
Are you over 18 and want to see adult content?
![A complete backup of www.planetsuzy.org](https://www.archivebay.com/archive5/images/2d83b4da-0228-4971-a10e-c9ef8e079016.png)
A complete backup of www.planetsuzy.org
Are you over 18 and want to see adult content?
![A complete backup of noodlemagazine.com](https://www.archivebay.com/archive5/images/c8e13b7a-4a2e-4d09-b67f-8ffd8e941fb6.png)
A complete backup of noodlemagazine.com
Are you over 18 and want to see adult content?
![A complete backup of www.www.vintagemags.org](https://www.archivebay.com/archive5/images/c5d7a9ee-343f-46db-a1cc-0c6b6b213b8b.png)
A complete backup of www.www.vintagemags.org
Are you over 18 and want to see adult content?
![A complete backup of www.muscletease.com](https://www.archivebay.com/archive5/images/4f9f9ae2-5f2d-4310-ba32-797229e09f50.png)
A complete backup of www.muscletease.com
Are you over 18 and want to see adult content?
![A complete backup of www.www.partyflock.nl](https://www.archivebay.com/archive5/images/4aada40a-ebcf-49b2-b42f-713efc404a58.png)
A complete backup of www.www.partyflock.nl
Are you over 18 and want to see adult content?
![A complete backup of www.www.onlytorrents.com](https://www.archivebay.com/archive5/images/beeb4d7e-fd10-4c92-a6e0-695c7685c816.png)
A complete backup of www.www.onlytorrents.com
Are you over 18 and want to see adult content?
Text
animale.
ACCESS CONSORTIUM
The Access Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore's Health Sciences Authority (HSA), the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland and the Medicines and Healthcare products Regulatory Authority(MHRA) of the United Kingdom 1.FEES - SWISSMEDIC
Procedural costs ; For administrative actions in the context of its supervisory duties, Swissmedic levies charges that are calculated either on the basis of the flat fees set out in Annexes 1 and 2 of the Ordinance on the fees charged by the Swiss Agency for Therapeutic Products (Fee Ordinance-Swissmedic; SR 812.214.5) or according to the actual work incurred (Art. 4 para. 1 FeeO-SwissmedicCLINICAL TRIALS
Clinical trials. Clinical trials may only be carried out in Switzerland if they have been approved by a Cantonal Ethics Committee, upon which Swissmedic is notified and is required to state any objections within 30 days (notification procedure). During the trials, adverse reactions and amendments must always be reported to the EthicsCommittees
HOMEPAGE TRANSLATE THIS PAGE Swissmedic ist die Schweizerische Zulassungs- und Aufsichtsbehörde für Arzneimittel und Medizinprodukte. Das Institut gewährleistet, dass in der Schweiz nur qualitativ hochstehende, sichere und wirksame Heilmittel erhältlich sind – ein wichtiger Beitrag HOMEPAGE TRANSLATE THIS PAGE Swissmedic est l’autorité d’autorisation et de surveillance des produits thérapeutiques. L’institut veille à ce que seuls des produits thérapeutiques sûrs, efficaces et d’une qualité irréprochable soient disponibles en Suisse, contribuant ainsi de manière prépondérante à la protection de la santé humaine etanimale.
ACCESS CONSORTIUM
The Access Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore's Health Sciences Authority (HSA), the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland and the Medicines and Healthcare products Regulatory Authority(MHRA) of the United Kingdom 1.FEES - SWISSMEDIC
Procedural costs ; For administrative actions in the context of its supervisory duties, Swissmedic levies charges that are calculated either on the basis of the flat fees set out in Annexes 1 and 2 of the Ordinance on the fees charged by the Swiss Agency for Therapeutic Products (Fee Ordinance-Swissmedic; SR 812.214.5) or according to the actual work incurred (Art. 4 para. 1 FeeO-SwissmedicCLINICAL TRIALS
Clinical trials. Clinical trials may only be carried out in Switzerland if they have been approved by a Cantonal Ethics Committee, upon which Swissmedic is notified and is required to state any objections within 30 days (notification procedure). During the trials, adverse reactions and amendments must always be reported to the EthicsCommittees
HOMEPAGE
Swissmedic is the national authorisation and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe and effective medical products are available in Switzerland, thus making an important contribution to the protection of human and animalhealth.
SIDE EFFECTS OF COVID-19 VACCINES IN SWITZERLAND 2,701 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated. Up to 2 June 2021, Swissmedic evaluated 2,701 reports on suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland. LICENSING - SWISSMEDIC Licensing of medicinal and transplant products. Companies that manufacture or distribute medicinal or transplant products in Switzerland (manufacturing, wholesale, import, export and trade in foreign countries) require an establishment licence. Swissmedic issues this licence on the basis of a successful inspection or otherevaluation.
COVID-19 VACCINE FOR YOUNG PEOPLE AGED 12 TO 17: MODERNA COVID-19 Vaccine Moderna, which was authorised as protection against the new coronavirus at the beginning of 2021, has until now been authorised for use in persons aged 18 and over. MUTUAL RECOGNITION AGREEMENTS Mutual Recognition Agreements. Mutual Recognition Agreements (MRAs) on conformity assessments constitute a significant trade policy instrument within the framework of the World Trade Organization (WTO) that are intended to overcome technical obstacles to trade in the state-regulated sector. In contrast to information exchangeagreements, the
SWISS PUBLIC ASSESSMENT REPORT (SWISSPAR) Swiss Public Assessment Report (SwissPAR) 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 aSwissPAR
VALIDITY OF GMP CERTIFICATES Swissmedic would like to make it clear that GMP certificates issued by Swissmedic and based on a routine GMP inspection in 2017 or 2018 will remain fully valid until the end of 2021 (or until the next routine inspection), provided the scope of activities described in the certificates corresponds to the currently valid establishment licence.2020 ANNUAL REPORT
3 6 Forewords 6 Challenges surmounted 7 A year dominated by the coronavirus 8 Swissmedic at a glance 8 Core tasks of Swissmedic 9 Keyissues in 2020
NOTES ON USING SWISSMEDIC TEMPLATES FOR INFORMATION FOR There are two versions of Swissmedic's templates for Information for healthcare professionals and Patient information for human medicinalproducts
GUIDANCE DOCUMENT
Guidance document. In order to standardise document names, the published "Administrative Ordinances" (VV) are being replaced by "Guidance documents" (WL). The function and effects of the document are not changed as a result of the name change. During the transitional phase, small adjustments to existing Administrative Ordinances will continue HOMEPAGE MEDIAJOB VACANCIESEGOV PORTAL (APPLICATIONS)ELVISFSCA AND RECALLSQUESTIONS AND ANSWERS Swissmedic is the national authorisation and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe and effective medical products are available in Switzerland, thus making an important contribution to the protection of human and animalhealth.
MEDICAL DEVICES
Market access. Single Registration Number (SRN) Unique Device Identifiers (UDI) Notification for classes I, Im & Is and systems. Notification of custom-made devices. Notification of IVD medical devices. Notification of devitalised human tissue. Authorisations for non-conforming medical devices. Dispensing & HOMEPAGE TRANSLATE THIS PAGE Swissmedic ist die Schweizerische Zulassungs- und Aufsichtsbehörde für Arzneimittel und Medizinprodukte. Das Institut gewährleistet, dass in der Schweiz nur qualitativ hochstehende, sichere und wirksame Heilmittel erhältlich sind – ein wichtiger Beitrag HOMEPAGE TRANSLATE THIS PAGE Swissmedic est l’autorité d’autorisation et de surveillance des produits thérapeutiques. L’institut veille à ce que seuls des produits thérapeutiques sûrs, efficaces et d’une qualité irréprochable soient disponibles en Suisse, contribuant ainsi de manière prépondérante à la protection de la santé humaine etanimale.
CLINICAL TRIALS
Clinical trials. Clinical trials may only be carried out in Switzerland if they have been approved by a Cantonal Ethics Committee, upon which Swissmedic is notified and is required to state any objections within 30 days (notification procedure). During the trials, adverse reactions and amendments must always be reported to the EthicsCommittees
SWISS PUBLIC ASSESSMENT REPORT (SWISSPAR) Swiss Public Assessment Report (SwissPAR) 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 aSwissPAR
MUTUAL RECOGNITION AGREEMENTS Mutual Recognition Agreements. Mutual Recognition Agreements (MRAs) on conformity assessments constitute a significant trade policy instrument within the framework of the World Trade Organization (WTO) that are intended to overcome technical obstacles to trade in the state-regulated sector. In contrast to information exchangeagreements, the
RISK MANAGEMENT (SIGNALMANAGEMENT, PSURS, RMPS/RMP … Risk Management (Signalmanagement, PSURs, RMPs/RMP summaries) The guidance document was updated and the existing procedure specified in greater detail. Changes have also been made to the reporting time limits in section 7, and the publication deadline has been added in section 11. The «PSUR/ PBRER for human medicines HMV4» form has beenupdated.
IMPLEMENTATION OF THE NEW MEDICAL DEVICES REGULATIONS Context. On 25 May 2017 the Commission of the European Union introduced two new Medical Devices Regulations into law. Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) will replace the existing regulations dating from the 1990s. As of May 2024 at the latest, it will only be legally GUIDANCE DOCUMENT TIME LIMITS FOR AUTHORISATION Guidance document Time limits for authorisation applications HMV4 VM-ID: ZL000_00_014e / V3.1 / stb / dei / 01.03.2021 2 / 12 Swissmedic • Hallerstrasse 7 • 3012 Berne • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12 HOMEPAGE MEDIAJOB VACANCIESEGOV PORTAL (APPLICATIONS)ELVISFSCA AND RECALLSQUESTIONS AND ANSWERS Swissmedic is the national authorisation and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe and effective medical products are available in Switzerland, thus making an important contribution to the protection of human and animalhealth.
MEDICAL DEVICES
Market access. Single Registration Number (SRN) Unique Device Identifiers (UDI) Notification for classes I, Im & Is and systems. Notification of custom-made devices. Notification of IVD medical devices. Notification of devitalised human tissue. Authorisations for non-conforming medical devices. Dispensing & HOMEPAGE TRANSLATE THIS PAGE Swissmedic ist die Schweizerische Zulassungs- und Aufsichtsbehörde für Arzneimittel und Medizinprodukte. Das Institut gewährleistet, dass in der Schweiz nur qualitativ hochstehende, sichere und wirksame Heilmittel erhältlich sind – ein wichtiger Beitrag HOMEPAGE TRANSLATE THIS PAGE Swissmedic est l’autorité d’autorisation et de surveillance des produits thérapeutiques. L’institut veille à ce que seuls des produits thérapeutiques sûrs, efficaces et d’une qualité irréprochable soient disponibles en Suisse, contribuant ainsi de manière prépondérante à la protection de la santé humaine etanimale.
CLINICAL TRIALS
Clinical trials. Clinical trials may only be carried out in Switzerland if they have been approved by a Cantonal Ethics Committee, upon which Swissmedic is notified and is required to state any objections within 30 days (notification procedure). During the trials, adverse reactions and amendments must always be reported to the EthicsCommittees
SWISS PUBLIC ASSESSMENT REPORT (SWISSPAR) Swiss Public Assessment Report (SwissPAR) 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 aSwissPAR
MUTUAL RECOGNITION AGREEMENTS Mutual Recognition Agreements. Mutual Recognition Agreements (MRAs) on conformity assessments constitute a significant trade policy instrument within the framework of the World Trade Organization (WTO) that are intended to overcome technical obstacles to trade in the state-regulated sector. In contrast to information exchangeagreements, the
RISK MANAGEMENT (SIGNALMANAGEMENT, PSURS, RMPS/RMP … Risk Management (Signalmanagement, PSURs, RMPs/RMP summaries) The guidance document was updated and the existing procedure specified in greater detail. Changes have also been made to the reporting time limits in section 7, and the publication deadline has been added in section 11. The «PSUR/ PBRER for human medicines HMV4» form has beenupdated.
IMPLEMENTATION OF THE NEW MEDICAL DEVICES REGULATIONS Context. On 25 May 2017 the Commission of the European Union introduced two new Medical Devices Regulations into law. Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) will replace the existing regulations dating from the 1990s. As of May 2024 at the latest, it will only be legally GUIDANCE DOCUMENT TIME LIMITS FOR AUTHORISATION Guidance document Time limits for authorisation applications HMV4 VM-ID: ZL000_00_014e / V3.1 / stb / dei / 01.03.2021 2 / 12 Swissmedic • Hallerstrasse 7 • 3012 Berne • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12 SIDE EFFECTS OF COVID-19 VACCINES IN SWITZERLAND 2,701 reports of suspected adverse reactions to COVID-19 vaccines in Switzerland evaluated. Up to 2 June 2021, Swissmedic evaluated 2,701 reports on suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland.ANNUAL REPORT 2020
Schweizerisches Heilmittelinstitut Institut suisse des produits thérapeutiques Istituto svizzero per gli agenti terapeutici Swiss Agency for Therapeutic ProductsFEES - SWISSMEDIC
Procedural costs ; For administrative actions in the context of its supervisory duties, Swissmedic levies charges that are calculated either on the basis of the flat fees set out in Annexes 1 and 2 of the Ordinance on the fees charged by the Swiss Agency for Therapeutic Products (Fee Ordinance-Swissmedic; SR 812.214.5) or according to the actual work incurred (Art. 4 para. 1 FeeO-SwissmedicSWISSMEDIC 4.0
Swissmedic 4.0 Embarking on the digital journey . With its digital initiative Swissmedic 4.0, Switzerland’s therapeutic products agency has created a framework for exploiting the constantly changing requirements of the digital age as opportunities – an experimentation space for change and innovation in the years to come.DRUG SAFETY
Drug safety Finding out about pharmacovigilance . Pharmacovigilance covers all activities concerned with the identification and prevention of adverse drug reactions (ADRs). Any serious or previously unknown adverse reactions that occur must be reported as soon as possible.HOMEPAGE - VISIBLE
Minergie/sustainability “Certified green”: Swissmedic's building strategy . Swissmedic is committed to an ecological and resource-efficient approach to infrastructure management. Since 2019, all Swissmedic properties have been certified with the MINERGIE®quality label.
COMBINATION PRODUCTS A medicinal product with a medical device component is termed a “combination product”. One classic example is a prefilled syringe. Sebastian Fuchs (Medical Devices Surveillance Inspector in the Market Surveillance division) explains what the combination involves: "While the syringe, the "application container", is a medical device, the contents of the syringe are, for example, a vaccine orFOCUS ON SAFETY
First of all: arrival. The Clinical Trials Department is located on Freiburgstrasse in the west of Bern. Although most of the open-plan offices on the third floor are currently unoccupied, Alexander Mion was able to call upon the services of two team members: Verena Gafner and Simone Ferbitz accompanied us on a tour of the building and the subsequent interview. MINERGIE/SUSTAINABILITY Minergie/sustainability “Certified green”: Swissmedic's building strategy . Swissmedic is committed to an ecological and resource-efficient approach to infrastructure management. Since 2019, all Swissmedic properties have been certified with the MINERGIE®quality label.
OPERATION PANGEA XIV: CAMPAIGN AGAINST COUNTERFEIT AND The week from 18 to 25 May saw a coordinated worldwide campaign against the illegal online trade in medicines. For years, this market has been dominated by erectile stimulants.* Homepage
* Main navigation
* Content area
* Sitemap
* Search
DIREKTNAVIGATION NEWS, RECHTSGRUNDLAGEN, KONTAKT* News & Updates
* Allgemeine Mitteilungen * Mitteilungen zur Arzneimittelsicherheit (HPC/DHCP) * Arzneimittel > Out-of-Stock (Lieferengpässe) * Medizinprodukte > Sicherheitsmassnahmen/FSCA * Neu auf der Website * Aktualisierte Vorgabedokumente * Recht | Normen * Allgemeine Rechtsgrundlagen * Strafrecht – Strafverfolgung* Rechtsetzung
* Pharmakopöe
* Kontakt | Support & Hilfe * Allgemeine Anfragen * Fragen Medizinprodukte* Medienanfragen
* Zugang amtliche Dokumente* Feedback-Formular
* Support eGov ServicesHOMEPAGE
SPRACHWAHL
* DE
* FR
* IT
* EN
SERVICE NAVIGATION
* Medien
* Stellenangebote
* eGov-Portal (Fachanwendungen)* ElViS
SCHWEIZERISCHES HEILMITTELINSTITUT INSTITUT SUISSE DES PRODUITS THÉRAPEUTIQUES ISTITUTO SVIZZERO PER GLI AGENTI TERAPEUTICI SWISS AGENCY FOR THERAPEUTIC PRODUCTSSTANDARD-SUCHE
Eingabefenster für die Suche Eingabefenster für die SucheHAUPTNAVIGATION
SWISSMEDIC
* Aktuell
* Humanarzneimittel
* Tierarzneimittel
* Komplementär- und Phytoarzneimittel* Medizinprodukte
* Services und Listen* Über uns
STANDARD-SUCHE
Eingabefenster für die Suche Eingabefenster für die Suche* Aktuell
*
Schliessen
ALLLGEMEINE MITTEILUNGEN * Aktuelle Informationen zur Heilmittelsicherheit* Archiv
CORONAVIRUS-KRANKHEIT (COVID-19) PANDEMIENEU AUF DER WEBSITE
* Aktualisierte VorgabedokumenteNEWSLETTER
RSS FEEDS
* Humanarzneimittel
*
Schliessen
KLINISCHE VERSUCHE
* Klinische Versuche mit Arzneimitteln * Befristete Bewilligung zur Anwendung von Arzneimitteln* Gebühren
BEWILLIGUNGEN
* Betriebsbewilligungen * Sonderbewilligungen * Mikrobiologische LaboratorienZULASSUNGEN
* Informationen
* Neuzulassungen
* SwissPAR
* Human Medicines Expert Committee (HMEC) * Fachkommission Radiopharmazeutika (FKRP) * Roundtable Regulatory Affairs * Publikationsplattform BESONDERE ARZNEIMITTELGRUPPEN* Betäubungsmittel
* Blut und labile Blutprodukte * Kinderarzneimittel * Transplantatprodukte * Kontrollierte Substanzen nach Artikel 21 HMGMARKTÜBERWACHUNG
* Pharmacovigilance
* Themen
* Risk Management (Signalmanagement, PSURs, RMPs/RMP summaries) * DHPC/HPC – Info Arzneimittelrisiken* Haemovigilance
* Qualitätsmängel und Chargenrückrufe* Out-of-Stock
* Illegale Arzneimittel * ArzneimittelwerbungHUMANARZNEIMITTEL
------------------------- Arzneimittel dürfen in der Schweiz nur vertrieben werden, wenn sie vom Schweizerischen Heilmittelinstitut zugelassen sind. Swissmedic ist durch ihre Aufgaben in den Bereichen Bewilligung, Zulassung und Überwachung von Arzneimitteln in den gesamten Lebenszyklus eines Arzneimittels eingebunden.DIREKT ZU
Arzneimittelinformationen Dokumente & Formulare Listen und Verzeichnisse eGov Services/ApplikationenSubmissions
-------------------------* Tierarzneimittel
*
Schliessen
INFORMATIONEN
STRATEGIE
VETERINARY MEDICINES EXPERT COMMITTEE (VMEC)ROUNDTABLE TAM
NEUZULASSUNGEN
MARKTÜBERWACHUNG
* Health Professional Communication * Meldung unerwünschter Tierarzneimittelwirkungen* Chargenrückrufe
* Out-of-Stock
TIERARZNEIMITTEL
------------------------- Die Abteilung Tierarzneimittel ist nicht nur für die Zulassung von Arzneimitteln für Tiere zuständig, sondern ist auch die zentrale Anlaufstelle für die Sicherheit von Tierarzneimitteln.DIREKT ZU
Tierarzneimittelkompendium www.tierarzneimittel.ch Dokumente & Formulare Listen und VerzeichnisseeGov-Services
Submissions
* Komplementär- und Phytoarzneimittel*
Schliessen
KOMPLEMENTÄRARZNEIMITTEL * Aktuelle Informationen* Roundtable KPA
PHYTOARZNEIMITTEL
* Informationen
HOMANT
* Informationen
KOMPLEMENTÄR- UND PHYTOARZNEIMITTEL ------------------------- Komplementär- und Phytoarzneimittel sind in der Schweiz weit verbreitet und geniessen in der Bevölkerung eine hohe Akzeptanz. Swissmedic stellt für diese Produktgruppen sicher, dass die zentralen Zulassungsanforderungen eingehalten werden. Grundsätzlich können diese Arzneimittelkategorien nach den allgemeinen Bestimmungen der Komplementär- und Phytoarzneimittelverordnung vereinfacht zugelassen werden. Qualität, Sicherheit und Unbedenklichkeit müssen in jedem Fall gewährleistet sein.DIREKT ZU
Bitte auswählen… Marktüberwachung Dokumente & Formulare Listen und Verzeichnisse Informationsveranstaltung - Zulassung von asiatischen Arzneimittel ohne Indikation im Meldeverfahren (PDF, 524 kB, 06.06.2018)04.01.2018
KPA BREAKOUT SESSION – PRÄSENTATIONEN -------------------------* Medizinprodukte
*
Schliessen
LISTE RÜCKRUFE/FSCAAKTUELL
* Veranstaltungen über Medizinprodukte * Infos zu bestimmten Medizinprodukten* Archiv
REGULIERUNG MEDIZINPRODUKTE * Leitfaden Medizinprodukte-Regulierung * Konformitätsbewertungsstellen* Normen
* Fremdinspektionen
* Häufige PatientenfragenKLINISCHE VERSUCHE
* Bewilligungsverfahren * Meldepflichten im laufenden Versuch* Wie einreichen ?
MARKTZUGANG
* Einmalige Registriernummer (SRN) * Eindeutige Produktidentifikation (UDI) * Meldung Klasse I, Im & Is und Systeme * Meldung Sonderanfertigungen* Meldung IVD
* Meldung devitalisiertes menschliches Gewebe * Ausnahmebewilligungen für nicht konforme Medizinprodukte* Abgabe & Importe
* Häufige Fragen – FAQ VORKOMMNISSE & FSCA MELDEN (MATERIOVIGILANCE) * Anwender & Betreiber * Hersteller & Inverkehrbringer MARKTKONTROLLE MEDIZINPRODUKTE * Verdachtsmeldungen * Inspektionen bei Marktakteuren * Mitteilungen zu Marktkontrollthemen EXPORTZERTIFIKATE UND BESTÄTIGUNGEN * Exportzertifikate (Free Sales Certificates) und ManufacturingCertificates (MC)
* Sonstige Bescheinigungen * Information to third countries BESCHAFFUNG, WIEDERAUFBEREITUNG & INSTANDHALTUNG * Wiederaufbereitung* Instandhaltung
NEUE EU-VERORDNUNGEN (MDR, IVDR) * Informationen aus dem europäischen Umfeld * Häufige Fragen – FAQ* Meldung nach MDR
KONTAKTE / LINKS
MEDIZINPRODUKTE
------------------------- Anders als Arzneimittel durchlaufen Medizinprodukte keine behördliche Zulassung. Der Schwerpunkt von Swissmedic im Bereich Medizinprodukte liegt somit in einer effizienten Marktüberwachung. * Services und Listen*
Schliessen
ARZNEIMITTELINFORMATIONEN DOKUMENTE UND FORMULARE LISTEN UND VERZEICHNISSEEGOV-SERVICES
* Swissmedic Portal
* eSubmissions
* Safety communication* eMessage
* CPP
* GMP/GDP
* ElViS
* B2B Gateway
* MESA
* NDS-WEB
SUBMISSIONS
* Informationen
* Support
* Formale Anforderungen* eCTD
* eDok
* Papier
* Archiveinsicht
ABGRENZUNGSFRAGEN
* Humanpräparate
* Veterinärbereich
* Medizinprodukte
AGENDA/VERANSTALTUNGEN * ReferententätigkeitenLABOR (OMCL)
* Freigegebene ChargenBEWILLIGUNGSINHABER
SERVICES UND LISTEN
-------------------------DIREKT ZU
> Bewilligungen Betriebsbewilligungen Sonderbewilligungen Betäubungsmittel Blut und labile Blutprodukte TransplantatprodukteKlinische Versuche
> Marktüberwachung Pharmacovigilance Marktkontrolle Medizinprodukte* Über uns
*
Schliessen
INSTITUT
* Strategische Ziele* Leitbild
* Aufgaben
ORGANISATION
* Institutsrat
* Geschäftsleitung
NATIONALE ZUSAMMENARBEIT * Patienten- und Konsumentenorganisationen * Roundtable Regulatory Affairs* Roundtable TAM
* Roundtable KPA
* Roundtable GMP/GDP * Roundtable Medizintechnik (RTMT) * Roundtable Innovation (RTI) INTERNATIONALE ZUSAMMENARBEIT * Bilaterale Zusammenarbeit mit Partnerbehörden * Multilaterale Zusammenarbeit mit internationalen Organisationen /Initiativen
REGULATORY SYSTEMS STRENGTHENING* AMRH Programme
* Wissenschaftliche Beratung und Zulassung von Global HealthProducts (MAGHP)
* Schulungen
PUBLIKATIONEN
* Swissmedic Journal * Public Summary SwissPAR* Geschäftsbericht
* Heilmittelgesetz
* Videos
OFFENE STELLEN
* Lehrstellen
ÜBER SWISSMEDIC
------------------------- Swissmedic ist die Schweizerische Zulassungs- und Aufsichtsbehörde für Arzneimittel und Medizinprodukte. Das Institut gewährleistet, dass in der Schweiz nur qualitativ hochstehende, sichere und wirksame Heilmittel erhältlich sind – ein wichtiger Beitrag zum Schutz der Gesundheit von Mensch und Tier. WEITERFÜHRENDE LINKS Dokumente und FormulareRecht und Normen
Kontakt
AKTUELLES
Alle Updates anzeigen29.05.2020
MU500_00_014D_MB CORONAVIRUS COVID 2019 Merkblatt über die Zuständigkeiten für das Inverkehrbringen von Hygiene- und Atemschutzmasken, Einweghandschuhe, Händedesinfektionsmittel und Coronavirus-Tests28.05.2020
ANFORDERUNGEN AN KOMBINATIONSPRODUKTE (ARZNEIMITTEL MIT EINER MEDIZINPRODUKTKOMPONENTE) Verlängerung der Übergangsfrist27.05.2020
DHPC – HYDROXYCHLOROQUIN QT-Zeit-Verlängerung27.05.2020
PFINGSTEN 2020: GEPLANTER UNTERBRUCH DER SWISSMEDIC EGOV SERVICES WEGEN UMFANGREICHER WARTUNGSARBEITEN IM DATA CENTER BIT Netzwerkumstellung durch das Bundesamt für Informatik und Telekommunikation (BIT)26.05.2020
OUT-OF-STOCK – COVID-19 – BEWILLIGUNGEN ZUM BEFRISTETEN IMPORT UND VERTRIEB VON HUMANARZNEIMITTELN – UPDATE Bewilligungen gemäss Art. 4m Abs. 3 der COVID-19-Verordnung 2IM FOKUS
13.05.2020
CORONAVIRUS-KRANKHEIT (COVID-19) PANDEMIE Informationen in Zusammenhang mit dem neuen Coronavirus (SARS-CoV-2)Details
Copyright © 2024 ArchiveBay.com. All rights reserved. Terms of Use | Privacy Policy | DMCA | 2021 | Feedback | Advertising | RSS 2.0