Swissmedic Journal: The Official Publication
Short answer
The Swissmedic Journal is the Agency's official publication. It contains new authorisations, renewals, revocations, changes to the dispensing category, notices and decisions. For competitor monitoring and market access planning, it is the most reliable public source.
What is in the Journal?
New authorisations with product name, marketing authorisation holder, active substance and dispensing category, renewals, revocations and suspensions, changes to the dispensing category, removals under the sunset clause, procedural notices, and publications on market surveillance measures.
| Section | Content | Practical use |
|---|---|---|
| New authorisations | Product, holder, active substance, category | Competitor monitoring, generics planning |
| Renewals | Confirmed authorisations | Status checks before contracts |
| Revocations and suspensions | Ended or dormant authorisations | Identifying supply risks |
| Changes to the dispensing category | Switch from B to D and back | Range planning for pharmacies and drugstores |
| Lapses under the sunset clause | Authorisations with no market presence | Identifying gaps in the market |
| Notices | Procedural changes, guidelines, deadlines | Regulatory planning |
How do you analyse the Journal systematically?
A monthly routine works well: download the issue, filter new authorisations by ATC code and active substance, cross-check revocations against your own range, and log category switches for purchasing. Doing this over years reveals patent expiries and market entries earlier than press releases do.
- Retrieve and archive the issue monthly, with date and issue number.
- Add new authorisations to your own watch list by active substance and ATC code.
- Check revocations and suspensions against your own range and supply contracts.
- Pass category switches on to purchasing and sales.
- Add procedural notices to internal regulatory documentation.
- Cross-check anything notable against the authorisation list and AIPS.
What is not in the Journal?
No prices, no reimbursement status, no reasoning behind decisions, and no ongoing procedures. For prices, the FOPH's Specialities List applies; for reasoning on new active substances, the public assessment reports; for recalls, the Market Surveillance notices.
Which sources complement the Journal?
The authorisation lists for the current full inventory, AIPS for the information text, the Specialities List for prices, and the recall notices for quality events. In our network, swissmedicinesdirectory.com and swissreimbursement.com bring these views together for analysis.
Frequently asked questions
How often does the Swissmedic Journal appear?
Regularly, generally one issue a month with occasional combined issues. The issues are available on the website.
Is the Journal fee-based?
The electronic issues are publicly accessible. Fees can apply for printed versions or subscriptions.
Are refused applications listed there too?
No. Refusals are not published. Authorisations, renewals, revocations, suspensions and certain notices are published.
Can I find recalls there?
Recalls are primarily published as Market Surveillance notices. The Journal contains notices relating to measures but is not the fastest channel.
How far back do the archives go?
The electronic issues go back several years. For older years, a request to Swissmedic is needed.
Sources
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