Regulations Governing Good Storage and Good Distribution Practices of Medical products.
Country
Type of law
Regulation
Abstract
These regulations govern Good Distribution Practices of Medical Products. As stated in Chapter 1, they apply to all regulatory controls related to good storage and distribution practices for medical products and to all persons and companies involved in any aspect of the distribution of medical products from the manufacturing site to the point of use.
The Regulations begin by setting, in Chapter 2, general provisions concerning the requirements for application for GDP inspections, the donations of medical Products, the distribution of Medical Products within and outside Rwanda. This Part also sets rules on the organization, management and personnel involved in distribution activities as well as on the need of a quality assurance system. There are also detailed provisions on the premises, Warehousing and Storage conditions for different types of products.
Chapter 3 continues by deepening all aspects related to personnel employed in activities related to the storage and distribution of medical products (training, hygiene, conditions of employment).
Chapter 4 is dedicated to all aspects concerning transportation and distribution.
Chapter 5 set provisions on the handling of substandard and falsified products and establishes that the owner of premises shall have a quality system which includes procedures to assist in preventing, identifying, responding or handling products that are suspected to be substandard and or falsified.
Chapter 6 regulates the handling of complaints; Chapter 7 regulates the returns and the recalls of products; Chapter 8 covers inspections and enforcement; Chapter 9 disposes on the documentation requirements and records keeping; Chapter 10 foresees the refusal of the validity of a certificate; Chapter 11 categorizes the inspection findings and, finally, Chapter 12 provides for administrative sanctions.
The Regulations begin by setting, in Chapter 2, general provisions concerning the requirements for application for GDP inspections, the donations of medical Products, the distribution of Medical Products within and outside Rwanda. This Part also sets rules on the organization, management and personnel involved in distribution activities as well as on the need of a quality assurance system. There are also detailed provisions on the premises, Warehousing and Storage conditions for different types of products.
Chapter 3 continues by deepening all aspects related to personnel employed in activities related to the storage and distribution of medical products (training, hygiene, conditions of employment).
Chapter 4 is dedicated to all aspects concerning transportation and distribution.
Chapter 5 set provisions on the handling of substandard and falsified products and establishes that the owner of premises shall have a quality system which includes procedures to assist in preventing, identifying, responding or handling products that are suspected to be substandard and or falsified.
Chapter 6 regulates the handling of complaints; Chapter 7 regulates the returns and the recalls of products; Chapter 8 covers inspections and enforcement; Chapter 9 disposes on the documentation requirements and records keeping; Chapter 10 foresees the refusal of the validity of a certificate; Chapter 11 categorizes the inspection findings and, finally, Chapter 12 provides for administrative sanctions.
Attached files
Long title of text
Regulations Governing Good Storage and Good Distribution Practices of Medical products. (Rwanda FDA law No 003/2018 of 09/02/2018, Article 8).
Date of text
Repealed
No
Publication reference
Doc Ref N⁰.: CBD/TRG/027 Rev. N⁰ 0
Source language
English
Legislation Amendment
No