2.
In these guidelines, unless the context otherwise requires - “Active substance” means a biologically or chemically active substance or compound that is used or intended to be used in the manufacture of a product as an active compound (ingredient); “Applicant” means a person who submits an application for renewal of marketing authorisation; who may be a manufacturer, patent holder or a person responsible for placing the product on the market with Power of Attorney from, or in contract with, the manufacturer or patent holder; “Authority” means the Zambia Medicines Regulatory Authority; “Marketing Authorisation” means the authorisation granted under section thirty-nine of the Medicines and Allied Substances Act No. 3 of 2013, for the placement of a medicine or allied substance on the market. Synonymous to product registration; “Market Authorisation Holder” means any person who may either be the trademark owner or authorized person, who has rights to sell the product and is responsible for placing the product on the Zambian market; SECTION 1: GENERAL REQUIREMENTS 1.1 An application for Renewal of Marketing Authorisation (MA) of a medicine or an allied substance shall be submitted by a Marketing Authorisation Holder (MAH) for quality review 5 years from the date of grant of marketing authorisation or when requested to do so by the Authority. 1.2 The MAH shall submit an application to the Authority before 30th June 2020. 1.3 The application should be sent to the following address: The Director General P.O. Box 31890 Plot 6903, Tuleteka Road Off Makishi Road Rhodes Park Zambia SECTION 2: HOW TO SUBMIT AN APPLICATION FOR RENEWAL 1.4 Payment of Renewal Fees should be done before the deadline of 31st March 2020. 1.5 A separate application and payment of fees shall be required for each marketing authorisation (MA). Both hard and electronic copies of the application will be required. 1.6 Hard copies of the application should be filed in a spring A4 size file with collapsible edge made of biodegradable material. Data shall be presented on A4 and 80g/m2 paper with readily readable letters of at least Times New Roman 12 font size. Every page shall be numbered sequentially. Extension sheets, tables, diagrams and other supporting documents shall as far as possible be of the same size, well annotated, numbered and appropriately cross-referenced. SECTION 3: TECHNICAL REQUIREMENTS FOR RENEWAL OF MARKETING AUTHORISATION 1.7 The MAH shall submit hard as well as electronic copies (in PDF or WinWord format, on CD-ROM or Flash Drive) of the following documents, where specified:
(i) A covering letter, which should contain a clear statement by the responsible person submitting the quality review, indicating that the information submitted is true and correct;
(ii) A duly completed application form for renewal of MA, in searchable PDF format (as per Annex 1);
(iii) Proof of payment of the prescribed fees;
(iv) Summary of key product information, in Microsoft Word format (as per Annex 2);
(v) Two (2) samples of smallest commercial pack of the product;
(vi) Approved product information i.e. Summary of Product Characteristics (SmPC) and/or Patient Information Leaflet (PIL), in PDF and Microsoft Word format;
(vii) Attestation notifying the Authority that no further amendments have occurred to information provided in the initial application, other than those already submitted to ZAMRA as applications for amendments. A consolidated report of all amendments made to the product should be submitted, in PDF format (as per Annex 3);
(viii) A pharmacovigilance plan and a consolidated report on adverse drug reaction reports, as well as other safety updates, in PDF format; and
(ix) Product quality review report, in PDF format. SECTION 4: REQUIREMENT FOR LOCAL RESPONSIBLE PERSON FOR FOREIGN- BASED MARKETING AUTHORISATION HOLDERS 1.8 Pursuant to Section 17 of S.I. No. 79 of 2019, all foreign-based MAH are also required to submit copies of letter of appointment of a Local Responsible together with Power of Attorney, stating that the appointee shall be responsible for submitting the application on behalf of the MAH, receive the decision of the Authority on behalf of the MAH and shall implement the pharmacovigilance plan on behalf of the MAH. SECTION 5: HOW TO MAKE PAYMENTS 1.9 The Renewal of Marketing Authorisation Fees for each may be paid to one of the following account:- Name of Account holder: Zambia Medicines Regulatory Authority Name of Bank: Standard Chartered Bank, North-End Branch, Cairo Road, Lusaka, Zambia ZMK Bank Account No. 0100122033800 US Dollar Account No. 8700211468100 Swift Code: SCBLZMLX Payment of any applicable bank transfer charges shall be borne by the MAH. The MAH shall ensure that an advice note is sent to the Authority giving details of the payment, in particular the name of the applicant, the products paid for and amount paid. SECTION 6: PROCESSING OF APPLICATIONS 1.10 The Authority may during assessment of applications request for additional samples, documents, information or clarifications. The application may be rejected, resulting in lapse of MA, if the MAH fails to satisfactorily address the issues within thirty (30) days from the date of request. 1.11 Notwithstanding Section 1.9, the Authority may reject an application for renewal if:
(i) It is found that a product and/or specified manufacturing site no longer complies with the our recommended standards;
(ii) The MAH fails to submit an application for renewal of MA; or
(iii) Any fraud or omissions by the applicant, manufacturer(s) of a finished pharmaceutical product (FPP) or active pharmaceutical ingredient (API) or clinical research organisation (CROs) in the initial application, becomes evident; and
(iv) The Authority considers that a batch (or batches) of the supplied approved product is (were) not in compliance with the approved specifications. 1.12 Where the Authority refuses to renew the marketing authorisation, it shall notify the MAH in writing of such a decision and the reason(s) thereof.