English — reviewed original text

MEDICINES CONTROL AGENCY 54 Kairaba Avenue, Pipeline, The Gambia. Tel.No. +220 4380632, www.mca.gm RECALL INFORMATION FORM (PART 1) DETAIL OF THE PROBLEM Reporting Company / Entity Name of contact Position/ Occupation Organisation Address E-mail address Tel (office) (mobile) Fax Product problem occurred in The Gambia? If not, location of problem: Nature of the problem Date of receiving complaint □ Patient □ Customer □ Retailer □ Self-inspection Source of Complaint □ Other: Number of similar reports received Description of the problem (use separate sheet if space is inadequate) Results of tests/ investigation on suspect or other samples Has manufacturer/ distributor been contacted? □ No □ Yes (please write down their names) Other relevant information (attach photos, package insert and press release of oversea authority of the product if any) MCA-F-303/01, Version 2, 01 July 2020 Page 1 of 3

Recall Information Form MCA The Gambia DETAILS OF THE PRODUCT Name of the product (as in product registration certificate) MCA Registration number Active Ingredients & Strength Indications Dosage form Pack size Batch number Expiry date Distribution of products □ CMS □ Hospitals □ Private Pharmacies □ Private Clinics □ RMS □ Health Centres □ Others (specify) Manufacturer Name Address Tel Fax Manufacture date Quantity of the batch manufactured Date and quantity released Quantity on hold Quantity distributed: Importer Name Address Tel Fax Import date Quantity of the batch imported Date and quantity released Quantity on hold Quantity distributed: Local Distributors (please attach distribution list) No. of local distributors Name Address Contact Person Tel (office & mobile) Quantity on hold Quantity distributed: Exporter Has the product been exported outside The Gambia? □ Yes □ No If yes, specify the exported countries. Name of Reporter: Contact no. (mobile): Signature of Reporter: Date: MCA-F-303/01, Version 2, 01 July 2020 Page 2 of 3

Recall Information Form MCA The Gambia RECALL INFORMATION FORM (PART 2) RISK ASSESSMENT Type of hazard □ Safety □ Quality □ Labelling □ Compliance Issue □ Other (specify) Evaluation of Health Hazard to users (e.g. effects on users, possibility of occurrence) (attached expert advice if any) Proposed recall classification □ Class I □ Class II □ Class III PROPOSED ACTION (WITH AGREEMENT OF MCA PRIOR ACTION) Recall start date Proposed recall end date Hotline(s) for enquiry Hotline(s) operating hours: Mon- Fri Sat Sun & PH Responsible officer of recall Tel (office & mobile) Proposed recall level □ Wholesale □ Retail □ Consumer Location of recall spots (For Consumer level recall only) Operating hours and duration of the recall spots (For Consumer level recall only) Means of Refund at the recall spots □ Money □ Credit Note □ Replacement □ Other Conditions of Refund at the recall spots Proposed recall strategy (use separate sheet if space is inadequate) Name of Reporter: Contact no. (mobile): Signature of Reporter: Date: MCA-F-303/01, Version 2, 01 July 2020 Page 3 of 3