Chương V Thông tư 19/2019/TT-BYT: Điều khoản thi hành

Chapter V

IMPLEMENTATION PROVISIONS

Article 20. Entry into force

1. This Circular comes into force from September 27, 2019.

2. Circular No. 14/2009/TT-BYT dated September 03, 2009 of the Minister of Health expires from the effective date of this Circular.

Article 21. Transition clauses

1. The documents submitted before the effective date of this Circular shall be process as prescribed in the Circular No. 14/2009/TT-BYT dated September 03, 2009 of the Minister of Health on guidelines for application of “Good agricultural and collection practices of medicinal plants” principles and standards according to recommendation of the World Health Organization.

2. With respect to the facilities issued with notice of receipt of declaration of compliance with GACP – WHO before the effective date of this Circular:

a) The notice of receipt of declaration of compliance with GACP – WHO shall remain effective until its expiry;

b) From the effective date of this Circular, in case the facility applies for the Certificate of compliance with GACP for herbal materials instead of the valid notice of receipt of declaration of compliance with GACP – WHO, it shall apply for re-issuance of the Certificate of compliance with GACP for herbal materials as specified in Article 17 of this Circular. The Certificate of compliance with GACP for herbal materials is valid until the expiration date of the previous declaration of GACP – WHO manufactured herbal material acceptance form.

Article 22. Terms of reference

In the cases where any of the legislative documents and regulations referred to in this Circular is amended or replaced, the newest one shall prevail.

Article 23. Responsibility for implementation

1. The Traditional Medicine Administration of Vietnam shall have the responsibilities to:

a) organize the implementation, examine and inspect the implementation of this Circular on a nationwide scale;

b) issue the GACP herbal material qualification;

c) update the list of GACP-qualified facility on the website of the Ministry of Health or the website of the Traditional Medicine Administration of Vietnam;

d) handle complaints about inspection of compliance with GACP for herbal materials as per law;

dd) take actions violations committed by GACP-compliant herbal material cultivation and collection facilities nationwide as per law.

2. The Departments of Health of provinces and central-affiliated cities shall have the responsibilities to:

a) organize the implementation, examine and inspect the implementation of this Circular within their provinces;

b) participate in the GACP inspectorate to assess the local facilities at the request of the receiving authority.

3. The herbal material cultivation and collection facilities, must submit annual reports on the yield of collected herbal materials that have undergone inspection of GACP compliance and have been declared compliant with GACP.

4. Chief of the Ministry Office, Ministry Inspectorates, Directors General of Departments, General Departments affiliated to the Ministry of Health, Directors of Health Departments of provinces and central-affiliated cities and other relevant agencies, organizations, units and persons shall implement this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Traditional Medicine Administration of Vietnam - Ministry of Health.