Swissmedic Updates Information Sheet on Notification of Quality Defects

Swissmedic has updated its information sheet “Notification of Quality Defects” to version 4.0, valid from 1 July 2026.

The document, identified as MU102_10_001, summarizes key points relating to the mandatory notification of quality defects of medicinal products and active pharmaceutical ingredients.

What Is Considered a Quality Defect?

Swissmedic explains that the quality of a ready-to-use medicinal product is considered inadequate if the specifications authorised by Swissmedic are not fulfilled, if there are deviations from Good Manufacturing Practices, or if formerly unknown quality issues are identified that could endanger human or animal health.

Quality defects may be discovered during use by patients or doctors, in pharmacies, in distribution channels, during quality or stability analyses by the marketing authorisation holder, through Swissmedic market surveillance or as a result of pharmacovigilance reports.

Swissmedic also notes that counterfeit medicinal products are an increasing concern and should be considered when evaluating a quality defect.

Why Quality Defects Must Be Reported

Swissmedic highlights that only high-quality, safe and effective medicinal products may be placed on the market.

For this reason, all quality defects that affect the established use, efficacy or safety of a medicine must be reported to Swissmedic under the Therapeutic Products Act.

Which Quality Defects Must Be Reported?

The information sheet states that quality defects must be reported for batches of medicinal products marketed in Switzerland and/or the Principality of Liechtenstein.

Reporting also applies to quality defects in batches manufactured in Switzerland or Liechtenstein, even if the products are manufactured for export only.

Swissmedic also requires notification of quality defects for authorised Swiss products marketed only abroad when the defect concerns the general basis for assessing the product, such as pharmaceutical properties, safety or effectiveness. All Class I and Class II quality defects must be reported.

Quality defects involving active ingredients used in medicinal products manufactured or authorised in Switzerland and/or Liechtenstein must also be reported, as must quality defects of active ingredients manufactured in Switzerland.

Minor Defects

Swissmedic clarifies that isolated, minor defects that clearly do not affect the specified use, safety or efficacy of the medicinal product do not necessarily have to be reported to Swissmedic.

Examples include a few slightly damaged secondary packages. Such defects only need to be reported to the marketing authorisation holder. In case of doubt, Swissmedic’s Market Monitoring of Medicines Division should be contacted.

Who Must Report?

Swissmedic states that anyone may notify a quality defect relating to a medicinal product.

However, reporting is mandatory for companies manufacturing or distributing medicinal products in Switzerland, including marketing authorisation holders, manufacturers and wholesalers. It is also mandatory for professionals who administer or supply medicinal products, such as doctors, pharmacists and chemists.

For companies holding Swissmedic operating licences, the Qualified Person is responsible for the quality of medicinal products manufactured or distributed and for submitting notifications of quality defects and taking necessary measures, including emergency measures.

Reporting Timelines

Swissmedic states that quality defects must generally be reported if the medicinal product concerned has been released for distribution.

The maximum timeframe for notification after identification is 15 days, depending on the defect classification and risk category.

The information sheet classifies defects into three categories:

• Class I: potentially life-threatening or could cause serious risk to health — report within 24 hours;

• Class II: could cause illness or incorrect treatment, but is not Class I — report within 3 calendar days;

• Class III: no significant hazard to health is expected — report within 15 calendar days.

For all quality defects where the marketing authorisation holder intends to initiate a batch recall, Swissmedic must be informed in advance.

How to Report

Quality defects must be notified to the Swissmedic Market Monitoring of Medicines Division.

Reports can be submitted using the defective product report form or the online form available through Swissmedic’s quality defects and batch recalls reporting page. For Class I defects, the Swissmedic contact point should first be contacted by telephone so that the notification can be handled within the short timeframe for serious defects.

Fees

Version 4.0 adds a paragraph on fees.

Swissmedic states that, from 1 July 2026, the fee amounts to CHF 270.00 per working hour. For work carried out up to and including 30 June 2026, the previous hourly rate of CHF 200.00 per working hour applies.

Swissmedic Measures After Notification

After a defect is reported, Swissmedic’s Market Monitoring of Medicines Division contacts the Qualified Person of the marketing authorisation holder as quickly as possible and specifies the next steps.

Quality defects may lead to batch recalls or communication letters to affected persons. Where appropriate, international therapeutic product authorities may also be informed through the EMA Rapid Alert System, PIC/S member states, partner authorities and international organisations such as EDQM, WHO and the European Commission.

Defects linked to GMP or GDP violations may be referred to Swissmedic’s Inspectorates and Licences Division and can lead to for-cause inspections or other measures under Swiss therapeutic products legislation.

Impact on Marketing Authorisation Holders and Manufacturers

For marketing authorisation holders, manufacturers, wholesalers and Qualified Persons, the updated information sheet reinforces the importance of timely quality defect assessment, classification and reporting.

Stakeholders should pay particular attention to:

• quality defect identification and internal escalation;

• defect classification into Class I, II or III;

• reporting timelines of 24 hours, 3 calendar days or 15 calendar days;

• advance notification before batch recalls;

• reporting obligations for Switzerland, Liechtenstein and export-only batches;

• active ingredient quality defects;

• counterfeit product considerations;

• Qualified Person responsibilities;

• documentation of GMP or GDP-related issues;

• Swissmedic contact procedures;

• updated hourly fee from 1 July 2026.

For companies operating in Switzerland, the key message is that quality defect reporting must be risk-based, timely and well documented, with urgent escalation for defects that may present serious risks to health.