Regulations for Analysis of Products regulated by Rwanda FDA.
Country
Type of law
Regulation
Abstract
The purpose of these Regulations, organized in 9 Chapters is, as per Chapter 1, to provide a legal framework for the effective and efficient laboratory analysis of products regulated by Rwanda Food and Drugs Authority.
Chapter 2 describes the powers of which the Rwanda Foods and Drugs Authority dispose of to analyze the regulated products: they include the taking of samples of such regulated products, the sub-contracting of testing of regulated product samples when need arise, the validation of methods of analysis of products, the offer of training services on laboratory analytic techniques to industry experts, students, institutions and other stakeholders from within or outside Rwanda, the issuance of certificate of Analysis. The QCL Division of the Authority has responsibilities related to the testing function, which are detailed by article 8. The QCL Division also contributes to other regulatory functions.as per article 9.
Chapter 3 describes the categories of samples while Chapter 4 covers the procedures to be followed in order to submit and test samples.
Chapter 5 is about the sub-contracting of testing which the Authority can opt for if need arise. It covers the relevant procedure and the responsibilities of Rwanda FDA during sub contraction of testing service.
Chapter 6 regulates the disposal of samples and waste. Chapter 7 regards national and international collaborations and partnership. Chapter 8 treats the confidentiality of data and the record keeping while Chapter 9 brings a sole final provision concerning commencement of the Regulation.
Chapter 2 describes the powers of which the Rwanda Foods and Drugs Authority dispose of to analyze the regulated products: they include the taking of samples of such regulated products, the sub-contracting of testing of regulated product samples when need arise, the validation of methods of analysis of products, the offer of training services on laboratory analytic techniques to industry experts, students, institutions and other stakeholders from within or outside Rwanda, the issuance of certificate of Analysis. The QCL Division of the Authority has responsibilities related to the testing function, which are detailed by article 8. The QCL Division also contributes to other regulatory functions.as per article 9.
Chapter 3 describes the categories of samples while Chapter 4 covers the procedures to be followed in order to submit and test samples.
Chapter 5 is about the sub-contracting of testing which the Authority can opt for if need arise. It covers the relevant procedure and the responsibilities of Rwanda FDA during sub contraction of testing service.
Chapter 6 regulates the disposal of samples and waste. Chapter 7 regards national and international collaborations and partnership. Chapter 8 treats the confidentiality of data and the record keeping while Chapter 9 brings a sole final provision concerning commencement of the Regulation.
Attached files
Long title of text
Regulations for Analysis of Products regulated by Rwanda FDA. (Rwanda FDA Law N° 003/2018 of 09/02/2018, Article 9).
Date of text
Repealed
No
Publication reference
Doc. Ref. No.: CBD/TRG/022 Rev_0
Source language
English
Legislation Amendment
No