Standard Operating Procedure for Screening New Applications
颁布于 2021-04-08 · 文本截至 2026-10-01
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研究内容本身以英文撰写。标题和标签已翻译，调查结果和引文未翻译。
关于这部法律
- 语言
- English
- 类型
- 其他
- 国家
- 津巴布韦
- 主题
- Livestock, General
- 关键词
- public health, drugs, authorization/permit, procedural matters, animal health
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1.0 PURPOSE To establish a procedure for conducting the screening of new applications for registration.
2.0 SCOPE Applies to the procedure of screening new applications for completeness.
3.0 FREQUENCY The procedure is applied to each new application for registration before evaluation as determined by EVR Guidance document on screening, EVG03. 4
4.0 LOCATION
4.1. The Master Copy of this SOP is kept by the Quality Manager’s office.
4.2 Controlled copies are kept by the Head of Evaluations & Registration Division and Evaluations & Registration Division staff.
4.3. Controlled copies issued to staff will be kept at points of use in the division
5.0 DEFINITIONS ial A Book: A register of all new applications for registration of human allopathic products which have been submitted to the MCAZ.
5.2. H Book: A register of all new applications for registration of veterinary product which have been submitted to the MCAZ. ° TITLE: Standard Operating Procedure for Screening New Applications SOP Number: EVR 09 | Revision Number: 4 Page 2 of 5 Se CM book: A register of all new applications for registration of human complementary products which have been submitted to the MCAZ.
6.0 RESPONSIBILITY
6.1 It is the responsibility of the Regulatory Officer/Screening Officer to ensure that all applications are screened before they proceed to evaluation.
6.2 The Head of the Division is accountable for the implementation of this procedure.
7.00 PROCEDURE Tl Using the A-Book (EVRB01), H Book (EVRB16) or CM book (EVRB10) extract new application for registration that is yet to be screened. re In the appropriate book, under the “motivation” column, enter the phrase “Screened” PS Fill in the product information into the appropriate screening checklist template, using the application form for the product located in Volume 1 of the product dossier. Also, enter the appropriate GMP status of the product manufacturer.
7.4 Go through the entire screening form and product dossier, entering into the screening form whether the required information has been submitted or not. ys) Upon completing the form, send the report to a second reviewer for second review
7.6 The second reviewer shall make comments and an overall recommendation based on the decision tree appended as Appendix 1 of this Standard Operating Procedure. The following are possible recommendations:
7.6.1 Ifthere are 3 or more critical deficiencies, then the recommendation should be “intend to refuse to register”
7.6.2 If there are 2 or fewer deficiencies, then the recommendation should be “proceed to evaluate”
7.6.3 If any one of the noted deficiencies is clinical data for human allopathic medicines, then the recommendation should be “intend to refuse to register” 1 The second reviewer returns the reviewed report to the screener to make the necessary changes oe
7.8 The screener enters the outcome of the screening in the appropriate book under motivation as either “passed” or “failed” ree, When an application has failed screening, the report is tabled in the following Registration Committee meeting, with the recommendation of “intend to refuse to register”.
7.10 Should the Committee uphold the recommendation a letter of intent to refuse to register together should then be sent to the applicant. Pek The screening report and letter should be uploaded onto SharePoint.
8.0 APPENDICES/ATTACHMENTS
8.1 Appendix I: Decision tree table Reviewed by: Approved by HoU/HoD: Authoris ea by QM: L. T. Makhurane Motde G.R. Matimba __ fj > Date:08/04/2021 Date: 09/04/2021 Date: “101 61, lg) TITLE: Standard Operating Procedure for Screening New Applications SOP Number: EVR 09 | Revision Number: 4 L Page 3 of 5
9.0 RECORDS Document Title of Record Retention Period Number N/A Screening report Infinity N/A Letter of intent to refuse to register Infinity EVRBO1 A-Book Infinity EVRB16 H Book Infinity EVRB10 CM book Infinity
10.0 REFERENCES
10.1 EVG03: Guidance document on screening
10.2. SOP MR 4.0 Writing Standard Operating Procedure
10.3. SOP MR 4.13 Control of Records
11.0 HISTORY DOCUMENT HISTORY Revision | Date Reason for Change Number | Approved 0 April 2010 Rolling review 1 January 2012 System Improvement Z October 2014 System Improvement 3 April 2018 Rolling review and System Improvement Reviewed by: Approved by HoU/HoD: L. T. Makhurane @\gicl-e | G. R. Matimba ‘ul : Date:08/04/2021 Date: 09/04/2021 TITLE: Standard Operating Procedure for Screening New Applications SOP Number: EVR 09 | Revision Number: 4 | Page 4 of 5
APPENDIX I: Decision Tree: Recommendations for Screened New Applications ee Critical deficiencies Yes > 3 Critical as | RSI deficiencies INTENT TO | REFUSE | — NN No No Yes a 7 <— PROCEEDTO >) If noted : EVALUATE i deficiencies is “YR, ae —_ caren clinical data No Yes Gara apn ae ELLY oe) <2 Critical deficiencies Reviewed by: Approved by HoU/HoD: een QM L. T. Makhurane @\oO\-2. | G. R. Matimba (inal: =X: a Date:08/04/2021 Date: 09/04/2021 Date: olBh Wav TITLE: Standard Operating Procedure for Screening New Applications SOP Number: EVR09 —_| Revision Number: 4 Page 5 of 5 Reviewed by: Approved by HoU/HoD: ate i ugé by QM: L.T. Makhurane_ @boic\-2 | G.R.Matimba (jw : Date:08/04/2021 Date: 09/04/2021 Date: waa Fo Z|