Recommendations on some problems regarding the Notice No. 1234 / TB-ATTP dated April 19, 2019 and the Draft Circular guiding Good Manufacturing Practices (GMP) in the production and trading of health supplement

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Name of recommendations: Recommendations on some problems regarding the Notice No. 1234 / TB-ATTP dated April 19, 2019 and the Draft Circular guiding Good Manufacturing Practices (GMP) in the production and trading of health supplement

Status: Responded

Recommended by units: The American Trade Association in Vietnam (AmCham Vietnam) Address: New World Hotel, Rm. 323, Fl.3, 76 Le Lai Str., Dist. 1, HCMC

Official letter: No 1336/PTM - V, dated: 2019-06-18

Recommended contents:

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. "

Article

Current contents

Recommended contents for adjustment

Reason

Point a, Clause 2, Article 2

Only recognizes 2 types of paper:

1.   Certificate GPM for TPBVSK

2.   Certificatefor pharmaceuticals with corresponding production lines

 

1.Requires GPM certificate or equivalent GPM (HACCP, ISO 22000, IFS, BRC, FSSC 22000) for normal food

2.Certificatefor pharmaceuticals with corresponding production lines. We agree with this request and recommend keeping it as in the draft

Currently, because the ASEAN harmony agreement on health supplements not been signed, the requirement for GMP for TBVSK is not required. For example, Singapore does not require GMP for TVBSK.

Some countries (for example the US) only issue GMP certificates for common food or GMP products without separate GMP certificates for VSK.

Many other certificates considered to be equivalent to GMP such as HACCP, ISO 23000, IFS, BRC, FSSC22000 have been recognized in the Decree 15, so they must be accepted in Vietnam.

Point b, clause 2, Article 2

Hasn’t got addresses of establishments issued certificates yet

Add the addresses of the establishments   granted certificates

Clearer

 

Name of authority issues certificate

Adds the addresses of the GMP establishments   granted certificates for third party.

Many countries have GMP certificates of food issued by a third party that verifies production conditions, not state agencies.


Article 3,enforcement effect

 

Hadn’t got yet

At least one year from the date of signing

This circular affects many importing enterprises, many countries will not meet the requirements of Vietnam. Therefore, it takes a minimum of 1 year for the enterprise to prepare

Point b, Clause 1, Article 4

 

If manufacturing since July 1, 2019, additional certificates of satisfaction of food safety requirements for good manufacturing practice (GMP) and health supplements must be supplemented according to Clause 1 and 2 of Article 2 of this Circular before production.

Abolishment of this rule

- Does not comply with the Decree 15 because Decree 15 only provides:

1. From July 1, 2019, enterprises must submit additional GMP in the registration dossier of imported T1.

- From July 1, 2019, enterprises must submit additional GMP in TPBVDK registration dossier issued by the Ministry of Health.

- Causing great risks to production and business, issuing instructions in such a short time, making it impossible for enterprises to comply.

- Unreasonable in chronological order: The Ministry of Health posted the agreement on the website with the comment deadline dated  July 17, 2019, after that, it must be submitted for evaluation.

 

 

Responded by units: TheMinistry of Health

Official letter: No 2233/ATTP - SP; 2443/ATTP - NĐTT, dated: 2019-07-15

Responded contents:

On February 2, 2018, the Government of the Socialist Republic of Vietnam issued a Decree No. 15/2018 / ND-CP detailing the implementation of a number of articles of the Law on Food Safety. Accordingly, Point d Clause 1, Point dd Clause 2 Article 7 prescribed in the dossier of registration of product declaration for imported and home-made health protection foods that must have a sufficient base certificate of food safety conditions that meet Good Manufacturing Practices (GMP) applied from July 1, 2019. Earlier, on August 8, 2016, the Ministry of Health issued a Decision No. 4288 / QD - BYT issuing guidelines for good manufacturing practices (GMP) for health supplements. The application of good manufacturing practices (GMP) to health protection foods is to ensure the quality of the product as well as the rights of consumers.

2. The Department of Food Safety issued a Notice No. 1234 / TB-ATTP dated April 19, 2019 providing additional guidance on supplementation of the certificate of satisfaction of food safety requirements to Good Manufacturing Practices. (GMP) in the manufacturing, trading and registration of health food products declarations are based on Point d Clause 1 Point Clause 2 Article 7 and Clause 3 Article- 28 of Decree No. 15/2018 / The above ND-CP aims to urge and guide organizations and individuals to strictly comply with the provisions of law,

In practice, on August 8, 2016, the Decision No. 4288 / QD-BYT above was issued, organizations and individuals have spent 2 years and 9 months in order to access information on technical content of real estate Export good (GMP) health protection foods. Next, from February 2, 2018, the Decree No. 15/2018 / ND - CP that has been taken effect so far is 1 year 4 months for organizations and individuals to have time to prepare for the implementation of mandatory regulations of Good Manufacturing Practices (GMP) for health care. With the above preparation time schedule, the implementation of the Government's regulations does not hinder production and business activities.

Legally based on Clause 3, Article 28 of the Decree No. 15/2018 / ND-CP, starting from July 01, 2019, real facilities that are against health protection must apply Good Manufacturing Practices. (GMP) health-protecting foods under the guidance of the Ministry of Health. This provision will be applied equally between domestic production and import to ensure the principle of non-discrimination of WTO.

Regarding the conditions for transiting and biting according to Article 42 of the Decree No. 15/2018 / ND-CP, the products have been issued with Receipt of Announcement of Conformity to regulated technical standards and Certification of Announcement of Compliance with Food Safety Regulations in advance February 2, 2018, will continue to be used until the expiry date stated on the paper and the expiry date of the product.At the same time, according to Clause 3, Article 28, from July 1, 2019 to produce food for health protection, it is required to apply Good Manufacturing Practices (GMP) for health food according to the guidance of the Ministry of Health. Thus, health food products have been capped. receive regulation conformity announcement and confirmation. receive a declaration of compliance with the current food safety regulations, which is not required to be re-announced, but only needs to supplement the certificate of good manufacturing practice (GMP) if the product (manufactured after July 1, 2019) It is allowed to continue importing into Vietnam. For manufacturers that do not meet GMP, Notice 1234 / TB-ATTP has specific guidance on changing manufacturers.

Specific provisions on the certificate of GMP equivalent for health protection products are specifically provided by the Ministry of Health in the Circular guiding Good Manufacturing Practices (GMP) in health supplement production and trading.

3. For the draft circular guiding good manufacturing practices (GMP) 'in the health supplements production and trading published in May 2019, it is included in the plan to review and develop regulations. In the reviewing of the law of the Ministry of Health, the Department of Food Safety will synthesize the Association's comments and recommendations related to the revision of the Decree No. 15/20 Ti8 / ND-CP, report to the Ministry of Health leaders and the Government to make appropriate decisions.

·         According to the Official Letter 2443 / ATTP - NDTT of Department of Food Safety - Ministry of Health dated August 2, 2019

Comments of the American Trade Association in Vietnam to the development of a Circular guiding Good Manufacturing Practices (GMP) in health supplementsproduction and trading:

1 Comments on the process of issuing Circular:

+ The process of developing a Circular guiding Good Manufacturing Practices (GMP) in the health supplements production and trading as prescribed in the Circular No. 22/2014 / TT-BYT dated June 30. The Ministry of Health / 2014 stipulates the drafting, promulgation and organization of the implementation of the examination into legal documents on health. The public comment of the draft circular has been conducted from May 16, 2019 and the Ministry of Health issued the Circular No. 18/2019 / TT-BYT dated July 17, 2019 on guidelines for Good Manufacturing Practices(GMP) in health supplements manufacturing and trading. Thus, the time for giving comments is 61 days.

+ For implementation effect: The Decree No. 15/2018 / ND-CP takes effect from February 2, 2018 to present is 01 year and 4 months that give organizations and individuals time to prepare. Currently, there is a compulsory regulation of good manufacturing practice (GMP) for health supplements. With the above preparation time schedule, the implementation of the Government's regulations does not hinder production and business activities of enterprises and the promulgation of the Circular No. 18/2019 / TT-BYT takes effect immediately to facilitate businesses to apply and implement.

Comments on the draft content of the Circular:

+ For the equivalent certificate and content of the certificate of satisfaction of food safety requirements with GMP requirements for imported health supplements specified in Clause 1 and Clause 2 Article 4 of Circular No. 18/2019 / TT-BYT.

+ For comments on the addition of certified copies of establishments for the certificate of establishment meeting food safety requirements meeting good manufacturing practice (GMP) standards for health-protecting foods since July 1, 2019, as prescribed in Clause 3, Article 28 of Decree No. 15/2018 / ND-CP of the Government and specified in Point b, Clause 1, Article 6 of Circular No. 18/2019 / TT- BYT of the Ministry of Health.

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