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Rapid Alerts

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Report via the Below Form

Rapid Alert Notification Form
Rapid Alert Follow-up Form

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Report via the Below Form

Rapid Alert Notification Form

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Rapid Alert Notification Form

Reporter*

Recall Number as Assigned: (when applicable)

Product; Brand/Trade Name*

Details of Defect

Product Photo (attach copy):*

Accepted file types: jpg, png, pdf, Max. file size: 200 MB.

A clear visible photo of the product with clear (attach copy); a. Labelling b. Product name c. Stated manufacturer d. Batch number e. Manufacturing date f. Expiry date g. Place of identification

INN or Generic Name

Dosage Form*

Batch Number*

Marketing Authorization Holder Name and Address*

Strength*

Expiry Date*

Date Manufactured*

Pack Size and Presentation*

State Information On Distribution Including Exports (specify type of customer, e.g. hospitals)*

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OFFICIAL USE ONLY: FOR BoMRA OFFICE

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BoMRA Office (Name of AMC/Head Office):

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Type of Rapid alert e.g. SF, Fraud (specify)

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Product Recall Class of Defect: (circle one)

III

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Action taken by BoMRA:

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Reporter’s Contact Details:

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Name:

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Address (Physical and Postal):

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Telephone and Cell no:

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Signature

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Date

Edit Content

Report via the Below Form

"*" indicates required fields

Rapid Alert Follow Up Form

REPORTER (Issuing stakeholder in full with addresses)*

To Stakeholders: (see list attached, if more than one)*

Stakeholder Contact Person

Product; Brand/Trade Name*

Marketing Authorization Holder

Dosage Form*

Marketing Authorization Contact Details

Strength*

Distributor Contact Details

Batch Number (and bulk, if different):*

INN or Generic Name

Subject Title*

Add Bulk Message Here On Action Taken*

Signed

Date

Time

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OFFICIAL USE ONLY: FOR BoMRA OFFICE

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Rapid alert Number reference number as assigned: (AS PER THE INITIAL RAPID ALERT NOTIFICATION)

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Frequently Asked Questions

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BoMRA Background

The Botswana Medicines Regulatory Authority (BoMRA) Was established through the Medicines and Related Substances Act of 2013. The MRSA Authorises BoMRA to perform functions given by the shareholder – The Government of Botswana. The MRSA of 2013 replaced the repealed Drugs and Related Substances Act No.

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Corporate Governance

PEOPLE

STRATEGIC PARTNERSHIP

REGULATIONS

ACT

PUBLICATIONS

EVENTS

GALLERY

NEWS

Tenders

Careers

Report-an-Issue

Register

Repositories

ABOUT US

Corporate Governance

PEOPLE

STRATEGIC PARTNERSHIP

REGULATIONS

ACT

PUBLICATIONS

EVENTS

GALLERY

NEWS

Tenders

Careers

Report-an-Issue

Register

Repositories

Rapid Alerts

SAVE A LIFE

Report via the Below Form

Report via the Below Form

Rapid Alert Notification Form

Rapid Alert Notification Form

OFFICIAL USE ONLY: FOR BoMRA OFFICE

Reporter’s Contact Details:

Report via the Below Form

Rapid Alert Follow Up Form

OFFICIAL USE ONLY: FOR BoMRA OFFICE

Frequently Asked Questions

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