On April 19, 2019, the Department of Food Safety - the Ministry of Health issued a Document No. 1234 / TB-ATTP providing additional guidance on GMP Certificates in production, business and registration of TPBVSK products and by May 2019, announced the draft Circular of GMP Guidelines in the production and business of TPBVSK with the deadline for comment dated July 17, 2019. Both of these documents have a lot of practical and legal inadequacies, which can greatly affect the activities of SCB businesses in Vietnam, specifically as follows:

1. The Notice No. 1234 / TB-ATTP guiding the supplementation of GMP Certificate in production, business and registration of TPBVSK product declarations is an unreasonable hindrance to business activities and contrary to the Decree. 15/2018 / ND-CP:

This notice provides: For imported TPBVSK, which has been granted a certificate of declaration of conformity to food safety regulations or a valid receipt of registration of product declaration

“2.1. Products manufactured before July 1, 2019, may continue to be imported and circulated to the expiry date of their products

2.2. For products manufactured after July 1, 2019, organizations and individuals must add the GMP certificate of the manufacturer to the dossier and notify the Food Safety Department before importing the product. "

Thus, with the Notice No. 1234 / TB-ATTP, TPBVSK products, even though the licenses issued by the Food Safety Department are still valid, if they are manufactured from July 1, 2019 onwards, they will not continue.imported into Vietnam if not promptly supplemented certificate of GMP. Moreover, this must be a GMP certificate for TPBVSK, a certificate that very few countries around the world have, as most countries around the world only issue GMP certificates for general food or pharmaceuticals.

In practice, this Notice will cause a huge barrier in trade, many products are imported and normal business will not be imported from July 1, 2019, because 1) the exporting country do not issue GMP certificate for TPBVSK, only GMP certificate or equivalent for food or pharmaceutical products; and 2) for some countries that have issued GMP certificates for TPGVSK, the time from now until July 1, 2019 is too short for businesses to complete the procedures for adding GMP certificates to the TPSVSK.

Legally, this Notice is also contrary to the provisions of Decree 15/2018 / ND-CP, because:

- Announcement No. 1234 / TB-ATTP states that “Legal basis of Point d Clause 1, Point dd Clause 2 Article 7 and Clause 3, Article 28 of the Decree No. 15/2018 / ND-CP”. Point d, Clause 1, Article 7 stipulates “a registration dossier of product declaration announcement for imported food needs ... d) A certificate of satisfaction of food safety requirements with production practice (GMP) or equivalent certification in case the imported product is TPBVSK applied from July 1, 2019 ”. Point d, Clause 2, Article 7 provides for the dossier of registration for publication of product announcements for domestically manufactured foods, so we do not mention them here. Clause 3, Article 28 stipulates that “From July 1, 2019, health food manufacturing facilities must apply Good Manufacturing Practices (GMP) for health supplements according to the guidance of the Ministry of Health. ".

- Therefore, Point dd, Clause 1, Article 7 of the Decree 15 is a regulation for the composition of the registration dossier for imported foods, and only applies to products submitted from July 1, 2019 onwards. Do not apply to previously registered products. Article 28 refers to "production" establishments, does not mention about the "import" and "business" establishments. However, the Notice No. 1234 / TB-ATTP will automatically apply to imported food consignments that have been issued with a valid product registration certificate, which will not be imported from July 1, 2019 if there is no additional GMP certificate for TPBVSK. This is without a legal basis and interferes with the normal business activities of the business.

- Article 42 of the Decree 15 states that “Products that have been issued with a certificate of conformity announcement and a certificate of compliance with food safety regulations before the effective date of this Decree may continue to be used until the expiry date indicated on the paper and the expiry date of the product. ”Thus, with products registered under the Decree 38, the Government in Decree 15 also allows the import and storage of products. When the license is still valid, there is no reason that the Notice No. 1234 / TB-ATTP ban import from July 1, 2019 foriems with a valid license, including a license issued under Decree 38, or newly issued under Decree 15, just because it is unable to supplement the GMP certificate for the TPBVSK, but until now the Circular guiding the certification of this certificate has not been issuedby the Ministry of Health (new in draft form).

Therefore, Amcham respectfully requests that the Ministry of Health consider revising Notice No. 1234 / TB-ATTP as follows to ensure compliance with the Decree 15/2018 / ND-CP and not hinder business activities. Usually the business:

1. For imported health supplements that have been issued with a Certificate of Announcement of Compliance with Food Safety Regulations or Registration of product announcement before July 1, 2019: will be imported until the expiry date of the registration certificate. The imported products will be circulated until the expiry date of the products.

2. Recognizing GMP certificates or GMP equivalents for foodstuff in general or pharmaceuticals used for registration of product declarations for countries certified by food management agencies not granting GMP certificates to TPBVSK, which only grants GMP or GMP equivalent certificates for general food or pharmaceuticals.

3. Comments on the Draft Circular upon Good Manufacturing Practices (GMP) in the production and business of SSCs

General comments:

Regarding the process of issuing the Circular: Because there are timelines in the draft that are not in compliance with the provisions of the law, we are very worried about the issuance process. Proposing the Ministry of Health to strictly apply the regulations on promulgating legal documents in the Law on Promulgation of Legal Documents 2015 No. 80/2015 / QH13, Article 101 “In the process of drafting a circular, a ministerial-level officials in charge of drafting must consult the subjects directly affected by the document; states issues to be consulted suitable to each object of the opinion collection and specify the address for receiving opinions; publishes the full text of the draft on the Government's website and the portal of the ministry or ministerial-level agency for at least 60 days ”and Article 151“ Effective date of the whole or a part of a legal document is specified in that document but not earlier than 45 days from the date of adoption or signing for promulgation of legal documents of the central state agency. "