e-form

Medicinal Product Quality Defect Form

Completed form to be returned to: Inspectorate and Enforcement Division, Medicines Authority, Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann SĠN3000 or by e-mail at inspectorate.adm@gov.mt.

Shared areas to be completed by Medicines Authority Staff

Date:

Time:

Reference:
MDR

Initials:

Please complete sections 1 to 6 providing as much information as possible.

1. Report made by

Name:

Position/ Status:

Organisation:

Address:

Telephone No:

Email address:

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2. Product details:

Product name:

Supplier (from label):

Manufacturing Site:

Marketing Authorisation No:

Legal Status:

POM/ OTC:

Dosage forms:

Strength:

Container type/ size:

Batch/ Lot No:

Expiry date (if known):

First distributed (if known):

Is sample available for Medicines Authority arranged testing?

3. Reported defect and details of any associated clinical incident.

Do you consider the suspected defect to be:

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4. Contact that can give further information of any clinical incident:

Name:

Position/ Status:

Organisation:

Address:

Telephone No:

Email address:

5. Has manufacturer/ supplier been informed?

6. Other action taken by reporter:

7. Company Contact:

Name:

Position/ Status:

Company:

Address:

Telephone No:

Email address:

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8. The following details should be obtained/ confirmed with the licence holder:

Site of manufacture:

Date of distribution:

Batch size:

Distribution (including other countries):

Other similar defects:

Retained sample to be tested/ examined:

Name of QP(s) responsible for batch release:

9. Comments of Duty Medicine Inspector:

Initials:

Date:

Time:

10. Comments of Duty Medicinal Assessor (where applicable):

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11. The following details should completed when available:

Cross ref. to other file(s):

Ref no:

Defect confirmed?

Recall required?

Drug alert to be issued?

12. Drug Alert/ Recall Details:

Class:

Date:

Reference Number:

Level:

Distribution (In addition to miscellaneous list):

Rapid alert issued?

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13. Company Reports:

Initial report received:

Date:

Interim report received (if required):

Date:

Closing report received:

Date:

14. Administrative details:

Communication to Competent Authority in Country of Manufacture

Date:

File opened

Date:

Acknowledgement sent to reporter

Date:

Closing letter sent to:

Reporter:

Date:

Company

Date:

File closed

Date:

Database updated

Date:

15. Additional notes:

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