Unternavigation

Quality defect report

Recipient at Swissmedic: Division Market Control of Medicines

All fields marked * must be completed.

1. Origin of Report

1.1. Last name and first name of person reporting problem

1.2. Organisation (e.g. name of company, pharmacy, individual, etc.)

1.3. Adress

1.4. Telephone number

1.5. Facsimile number

1.6. E-mail address

1.7. Time of report

1.8. Date of report

(dd.mm.yyyy)

2. Product Details / Extent of the Problem

Note: for each product a separate form should be submitted

2.1. Name of product affected by the problem

2.2. Authorisation number or other reference number

2.3. Marketing Authorisation Holders or importers1) name and address (see package)

1) for medicinal products distributed in parallel

2.4. Pharmaceutical form

2.5. Active ingredient(s) (INN)

2.6. Manufacturer’s name and address (final product)

2.7. a) Process step that caused the quality problem (e.g. production of the active ingredient, packaging, quality control)

2.7. b) Name and address of the company in question

2.8. Concerned batches (Lot number(s), manufacturing date(s) / expiry date(s) / strength / batch size(s) / type(s) of packs / number of packs in stock)

If needed please attach separate list

2.9. Distribution of the lots concerned (countries / clients delivered e.g. wholesale distributors, hospitals, pharmacies, doctors [lot number(s), number of pack(s), date of delivery])

If needed please attach separate list

2.10. Other products involved (name / authorisation number or reference number)

Last modification 04.06.2026

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Quality defect report