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. Lot number (s) concerned (Manufacturing date(s) / expiry date(s) / strength / batch size(s) / type(s) of packs / number of packs)

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)

3. Nature of defect(s)

3.1. Where was the product defect noticed

Patient

Hospital

Pharmacy

Manufacturer

Other

3.2. Details of defect or problem

3.3. Is the problem associated with any adverse event?

Yes

If so please specify

3.4. Is there any evidence or suspicion of a risk to public health (adverse effects or inefficacy)?

Yes

3.5. Classification of defect (I, II or III)*, please justify

^*refer to PI-010 "Procedure for handling rapid alerts and recalls arising from quality defects" of the Pharmaceutical Inspection Co-operation Scheme (PIC/S)

4. Action taken and proposed

4.1. Name and address of any regulatory authority notified of the problem

4.2. Action taken so far (if any)

4.3. Batch or product recall proposed?

Yes

If so please attach drafts for recall letter to clients and for publication in Schweizerische Apotheker Zeitung, Schweizerische Ärzte Zeitung, Schweizerische Drogisten Zeitung

4.4. Please indicate what happens to the pack(s) withdrawn

4.5. Further action planned or proposed

4.6. Other relevant information

List of attachments to this report

Are any documents / attachments available ?

Yes

List of attachments

Any documents/attachments are to be transmitted separately through the Federal Administration’s web transfer service. Upon receipt of the notification, the Department Market Monitoring of Medicines will contact you at the e-mail address provided under point 1.6 of the online form in order to arrange the transfer.

After you have sent the form, you will receive a confirmation e-mail recapitulating the content of the submitted form at the e-mail address specified under point 1.6.

Please send any questions regarding the notification to: market.surveillance@swissmedic.ch.

Last modification 28.03.2022

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Quality defect report