Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Simplified authorization for active substances used for ten years in the EU or EFTA (Art. 14 Abs. 1 Bst. abis HMG; Art. 17a-17b VAZV)

Switzerland · Swissmedic · New drugs

Well-established useHigh confidenceLast verified October 3, 2026

Review target

330 days

official guidance

Legal time limit

Not published

Steps

7 requirements

What is the Simplified authorization for active substances used for ten years in the EU or EFTA in Switzerland?

A medicine can be authorized in a simplified way when its active substances have been used for at least ten years in a medicine authorized in at least one EU or EFTA country, and the product is comparable in indication, dosage and route. Evidence on safety and efficacy can be bibliographic. The fee is 70 percent lower. Well-established medicines from EU or EFTA countries whose active substance is not yet authorized in Switzerland.

How long does the Simplified authorization for active substances used for ten years in the EU or EFTA take?

The official review target is 330 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.

What are the steps of the Simplified authorization for active substances used for ten years in the EU or EFTA?

1. Submit the application; 2. Review in standard time limits; 3. Official decision.

Does the Simplified authorization for active substances used for ten years in the EU or EFTA rely on other regulators?

Yes. It relies on approvals from European Union (reference approval required).

Outcome: Authorization for five years, renewable. Valid for 5 years.

Legal basis: Therapeutic Products Act (HMG) Articles 14 para. 1 let. abis and 14a; Ordinance on Simplified Authorisation (VAZV) Articles 17a and 17b; Fee Ordinance Article 10

Steps

In order, with the official target for each step

1. Submit the applicationThe dossier includes quality data, bibliographic evidence on safety and efficacy, and proof of the foreign authorizations.
2. Review in standard time limitsThe agency reviews the application. Safety and efficacy are checked only in summary form.
3. Official decisionThe agency issues the authorization.

Requirements

What the applicant must provide or meet

Eligibility

Comparable to the EU or EFTA productThe product must be comparable with the foreign product in indication, dosage and route of administration, with no expected change in the safety and efficacy assessment.

Clinical data

Bibliographic evidence allowedPharmacology, toxicology and clinical documentation can be bibliographic when published literature gives enough evidence of safety and efficacy.

Quality and manufacturing

Full quality dataData on manufacturing method, composition, quality and stability.

Reference approval

Proof of the foreign authorizationsThe application includes proof of the authorizations of the foreign comparator product.

Labeling

Product information taken from the foreign textKey sections of the product information are copied from the latest approved foreign text and translated. The leaflet states that the agency checked safety and efficacy only in summary form and names the foreign product.

After approval

Ongoing reporting of foreign safety signalsFor the whole life of the authorization, the holder sends all international safety signals and foreign authority reports on the comparator product without being asked.

Local presence

Applicant based in SwitzerlandThe applicant needs a domicile, registered office or branch in Switzerland. A foreign company usually acts through a Swiss company that holds the authorization.

Official time targets

Targets, not actual review times

Review targetofficial guidance. Official target for agency time only, counted in calendar days. Time the applicant takes to answer is not counted. Actual review times can differ. The standard time limits apply. The maximum total, including applicant time, is 540 days.

330 days

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Simplified authorization for active substances used for ten years in the EU or EFTA (Art. 14 Abs. 1 Bst. abis HMG; Art. 17a-17b VAZV)

What is the Simplified authorization for active substances used for ten years in the EU or EFTA in Switzerland?

How long does the Simplified authorization for active substances used for ten years in the EU or EFTA take?

What are the steps of the Simplified authorization for active substances used for ten years in the EU or EFTA?

Does the Simplified authorization for active substances used for ten years in the EU or EFTA rely on other regulators?

How the pathway works

Timeline with clock stops

Steps

Requirements

Eligibility

Clinical data

Quality and manufacturing

Reference approval

Labeling

After approval

Local presence

Official time targets

Fees

Reliance on other regulators