Country · Europe
Pharmaceutical exports to Switzerland, ready for Swissmedic authorisation
Progene Pharma supplies Swiss marketing authorisation holders, importers and wholesalers with generic medicines we manufacture in an EU-GMP and WHO-GMP certified facility. We prepare the dossier, the stability data and the GMP evidence Swissmedic asks for, label in German, French and Italian, and ship via Rotterdam and Basel.
- Regulator
- Swissmedic
- Labels
- German, French and Italian
- Stability
- Zone II, 25 °C / 60% RH
- Route in
- Rotterdam, Basel
The Swiss medicines market in brief
Switzerland is a small, wealthy market with some of the highest medicine prices in Europe and a lower generics share than its neighbours. Swissmedic runs its own system, separate from the EU, and has a reputation for thorough assessment.
The Federal Office of Public Health decides which medicines are reimbursed, and sets prices partly by comparison with other countries. Pharmacies buy from wholesalers, and doctors and pharmacists have been encouraged to prescribe and dispense generics, which makes room for good-quality equivalents.
The authorisation is held by a company established in Switzerland, and labels and leaflets carry the national languages, German, French and Italian, so artwork needs planning. Switzerland has no seaport, so cargo arrives by river, rail and road, usually via Rotterdam and Basel.
Medicines we supply to Switzerland
These are the medicines Swiss distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Generic prescription medicines
Metformin, amlodipine, atorvastatin, losartan and similar generics in tablets and capsules made to the European Pharmacopoeia, for marketing authorisation holders.
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Generics for pharmacy dispensing
High-volume active substances such as metformin, amlodipine and atorvastatin, in the packs pharmacies dispense.
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Antibiotics and anti-infectives
Amoxicillin, amoxicillin and clavulanic acid, azithromycin and ciprofloxacin, and injectable antibiotics for hospitals.
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Stomach and allergy
Omeprazole, pantoprazole, cetirizine and montelukast, for prescription and pharmacy sale.
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Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
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Food supplements
Vitamins, minerals, omega-3, probiotics and protein products for brands selling supplements.
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Traditional herbal products
Herbal tablets, capsules and powders for the traditional herbal route or for sale as supplements.
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Cosmetics
Creams, washes, soaps and shampoos with INCI ingredient lists and the data your responsible person needs.
Swissmedic registration, step by step
A medicine cannot be sold in Switzerland until it has been authorised. This is the usual route for a generic medicine made outside Europe, and the page explains it step by step.
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01
A local company applies
The authorisation is held by a company established in Switzerland, usually the importer or distributor, acting as the marketing authorisation holder. It applies to Swissmedic.
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02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
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03
The dossier goes in
The applicant submits the CTD dossier with stability data at Zone II conditions, bioequivalence data where required, the GMP certificate and the product information, in the format the route requires. We prepare the manufacturer's documents.
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04
Swissmedic reviews it
Swissmedic assesses the dossier and may ask questions, which we answer with you. Where a medicine is already authorised by a recognised regulator, Swissmedic can take that into account.
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05
GMP and batch release
The authority relies on the manufacturer's GMP certificate or inspects the site, and a Qualified Person at the importing site in Europe tests and certifies each batch before it goes on sale.
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06
Registration and renewal
On approval Swissmedic issues an authorisation with a number, which goes on every pack. The product can then be listed for reimbursement, and the authorisation is renewed as the rules require.
Registration takes from several months to more than a year, and Swissmedic updates its requirements from time to time, so check the current guidelines with Swissmedic or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Switzerland
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The Swissmedic application, as the marketing authorisation holder
- The import and wholesale authorisations your business needs
- Bioequivalence studies for generics, where the route requires them
- The responsible person who releases each batch
- Listing and price applications
Progene Pharma handles
- The CTD dossier, stability data and bioequivalence data where required
- The EU GMP certificate and the manufacturing details
- The information the Qualified Person needs to certify each batch
- A Certificate of Analysis for every batch
- Labels and leaflets in the product information template, ready for your authorisation number
- Answers to Swissmedic's questions during assessment
Made for Swiss conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
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Labels in the national languages
Cartons and patient leaflets in German, French and Italian, with the authorisation number, batch number and expiry date, and an approved proof before printing.
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Stability for Europe
Stability studies at 25 °C and 60% relative humidity (Zone II), the condition Swissmedic asks for, so the shelf life on the pack is valid.
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A thorough dossier
A complete, well-organised file with the stability data and the GMP evidence Swissmedic expects, because gaps slow review.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities pharmacies and hospitals buy.
Shipping to Switzerland
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
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Rotterdam
The usual sea gateway, with onward freight by Rhine barge, rail or road
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Basel
Switzerland's river port on the Rhine, close to the pharmaceutical industry
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Zurich
By air to Zurich Airport for urgent orders and samples
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import documents and customs declaration from your side
Where Swiss distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Pharmacies and wholesalers
Pharmacies buy from wholesalers, which stock the registered packs.
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Hospitals
Hospitals buy through purchasing groups and ask for the full document set.
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Dispensing doctors
In some cantons doctors dispense medicines directly and buy from wholesalers.
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Importers and distributors
Importers hold the authorisations and supply the market.
Questions about supplying Switzerland
Something else? Email [email protected].
Do you export medicines to Switzerland?
Yes. Progene Pharma manufactures generic medicines in an EU-GMP and WHO-GMP certified facility and supplies them to marketing authorisation holders, importers, wholesalers and tender suppliers in Switzerland.
Can you help us obtain an authorisation from Swissmedic?
Yes. Progene Pharma prepares the manufacturing and quality documents an application needs: the CTD dossier, stability data, the GMP certificate and the manufacturing details. Your Swiss company files the application, and we answer Swissmedic's questions with you.
Do I need a local company to hold the authorisation?
Yes. The authorisation is held by a company established in Switzerland, usually the importer or distributor. Check the current requirements with Swissmedic.
Is an EU authorisation valid in Switzerland?
No. Switzerland runs its own system under Swissmedic, so a medicine needs a Swiss authorisation. Documents prepared for an EU dossier can often be reused, and Swissmedic can take approval by a recognised regulator into account. Check the current requirements with Swissmedic.
Which documents does Swissmedic ask for?
The usual set is the CTD dossier, stability data at European conditions, the manufacturer's GMP certificate and manufacturing details, bioequivalence data for most generics, the active substance master file details and product information. Swissmedic updates its requirements from time to time, so confirm the current list with Swissmedic or your regulatory consultant. We tell you what we can provide with your quotation.
Who releases each batch in Switzerland?
A responsible person at an authorised importing site tests and releases each batch before it goes on sale. Your importer normally holds that authorisation, and we supply the batch documents the responsible person needs.
Which languages must the packs carry?
Swiss packs carry German, French and Italian, as the rules require. We prepare the artwork to match your authorisation, and you approve a proof before printing.
How does a Swiss shipment arrive?
Switzerland has no seaport, so goods arrive by sea at Rotterdam and then by Rhine barge, rail or road to Basel and onward. Your customs broker handles import, and we confirm the schedule with your quotation.
What must the packs carry for Switzerland?
German, French and Italian text, the Swissmedic authorisation number, batch number, expiry date, storage conditions and the other details Swissmedic requires. We prepare the artwork to match your authorisation and you approve a proof before printing.
Are your medicines tested for European conditions?
Yes. Progene Pharma tests products at 25 °C and 60% relative humidity (climate Zone II), the condition European authorities ask for, and packs them in moisture-resistant blisters or bottles, so the shelf life on the pack is valid.
Can you supply tenders in Switzerland?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.
How are orders shipped to Switzerland?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Rotterdam, with onward Rhine, rail or road freight to Basel, or by air to Zurich for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.
What is the minimum order quantity?
It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.
Related pages
Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494