Thông tư 31/2017/TT-BYT về Danh mục sản phẩm, hàng hóa có khả năng gây mất an toàn thuộc phạm vi được phân công quản lý của Bộ Y tế

CIRCULAR

ON THE LIST OF POTENTIALLY UNSAFE GOODS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

Pursuant to the Law on Goods Quality dated November 21, 2007;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 specifying the implementation of certain articles of the Law on Goods Quality;

At the request of the Director of the Administration of Science Technology and Training affiliated to the Ministry of Health, the Minister of Health promulgates a Circular on the list of potentially unsafe goods under the management of the Ministry of Health,

Article 1. Promulgation of the list

This Circular shall enclose the list of potentially unsafe goods under the management of the Ministry of Health (hereinafter referred to as “list of group 2 goods ") including 6 categories of goods as follows:

1. Commercial medicines, vaccines, biological products for disease treatment.

2. Medicine ingredients, primary packages of medicines.

3. Type B, C and D medical equipment specified in the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on the management of medical equipment.

4. Contraceptives.

5. Insecticides and germicides for domestic use (housing, schools, public works, office buildings or airplanes) and medical use.

6. Traditional medical equipment.

Article 2. Management of goods quality

1. The management of quality of group 2 goods specified herein shall be published in line with the national technical regulation promulgated by the Ministry of Health.

2. The management of goods on the list of group 2 specified herein that have not applied the corresponding national technical regulation shall be published according to regulations of law on standards of producers.

3. Quality of group 2 medical equipment stipulated herein shall be managed in accordance with the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical equipment.

4. Quality of group 2 insecticides and germicides for domestic use (housing, schools, public works, office buildings or airplanes) and medical use prescribed herein shall be managed according to provisions of the Government’s Decree No. 91/2016/ND-CP dated July 01, 2016 on management of chemicals, insecticides and germicides for domestic and medical uses.

Article 3. Effect

This Circular comes into force from September 15, 2017.

The Circular No. 44/2011/TT-BYT dated December 06, 2011 by the Ministry of Health on the list of potentially unsafe goods under the management of the Ministry of Health shall be replaced by this Circular from the date of its entry into force.

Any issues arising in the course of implementation shall be promptly reported to the Ministry of Health.

LIST

OF POTENTIALLY UNSAFE GOODS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH(Attached to the Circular No. 31/2017/TT-BYT dated July 25, 2017 by the Ministry of Health)

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