# Swiss Regulatory Guide

> Swiss pharmaceutical authorisation and regulatory planning for international manufacturers preparing market entry.

An independent information and enquiry brand for pharmaceutical businesses. Use the linked pages for context, dates and original sources. The website is not a regulator. Listing a company does not imply endorsement or a commercial relationship. Enquiries require email, phone, a message and consent; any external specialist introduction is agreed separately.

Links beginning with / are relative to this website's origin, including on preview hosts. This file is a content guide; crawling controls are in robots.txt.

## Agent guide

- [Business navigation guide](/agent-guide.md): Markdown overview of this site's audience, research workflow and enquiry process.
- [Resource index](/agent-resources.json): Localised page titles, descriptions and links for resource discovery.

## Key pages

- [Swiss pharmaceutical authorisation, explained](/en/): For international pharmaceutical businesses planning a Swiss launch: compare authorisation routes, dossier requirements and establishment…
- [Contact and specialist support enquiries](/en/kontakt/): Independent information site. Not affiliated with Swissmedic or the FOPH.
- [Medicinal Product Authorisation in Switzerland: Procedures, Timelines, Fees](/en/zulassung/): All Swissmedic marketing authorisation procedures: new authorisation, pre-notification, accelerated, Art. 13 TPA, temporary, generics, fees and timelines.
- [Establishment Licences from Swissmedic](/en/bewilligungen/): Swissmedic establishment licences: manufacturing, wholesale dealing, import and export, the Responsible Person, GMP and GDP inspections, and how to apply.
- [Legal Basis of Swiss Therapeutic Products Law](/en/gesetze/): The legal basis of Swiss therapeutic products law: the Therapeutic Products Act (TPA), Ordinance (TPO) and Medical Devices Ordinance (MedDO).
- [Swissmedic Explained: Mandate, Contact, Databases](/en/swissmedic/): Swissmedic explained: mandate and organisation, contact and address in Bern, databases and lists, the ELViS reporting portal.
- [Glossary: Swiss therapeutic products law from A to Z](/en/glossar/): Glossary of Swiss therapeutic products law: terms from the TPA, TPO and MPLO, each explained in two to four sentences.

## Languages

- [Deutsch](/de/): Localised pages and enquiries.
- [Français](/fr/): Localised pages and enquiries.
- [Italiano](/it/): Localised pages and enquiries.

## Optional

- [Legal notice](/en/impressum/): Website responsibility and legal contact.
- [Crawler directives](/robots.txt): Crawl rules and sitemap location.

## Additional website languages

- [简体中文](/zh-CN/): 简体中文 website and business enquiries.
- [日本語](/ja/): 日本語 website and business enquiries.
- [한국어](/ko/): 한국어 website and business enquiries.
- [עברית](/he/): עברית website and business enquiries.