DECREE

ON ANNULLING A NUMBER OF PERMITS AND REPLACING SOME OTHERS WITH DIFFERENT MANAGEMENT MODES

THE GOVERNMENT

Pursuant to the Law on Organization of the Government of December 25, 2001;
Pursuant to Enterprise Law No. 13/1999/QH10 of June 12, 1999;
At the proposal of the Minister of Planning and Investment,

DECREES:

Article 1.- To annul the following permits:

1. Occasional publication permit for printing: Production technical instructions; product introductions; goods use directions; leaflets and folders for introduction of products, goods and enterprises, which were specified in the Government’s Decree No.79/CP of November 6, 1993 detailing the implementation of the Publication Law.

2. Occasional film production permit for Vietnamese organizations and individuals at home defined in the Government’s Decree No. 48/CP of July 17, 1995 on cinematographic organization and activities. For foreign organizations and individuals, including overseas Vietnamese, the current regulations shall apply.

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4. Sterilization practitioner’s card prescribed in the Agriculture and Rural Development Ministry’s Circular No.63/1999/TT-BNN-BVTV of April 9, 1999 guiding the domestic quarantine work.

Article 2.- To replace the certificate of satisfaction of criteria and conditions for setting up private pharmaceutical practice establishments (prescribed in the Health Ministry’s Circular No.01/1998/TT-BYT of January 21, 1998 guiding the implementation of the Ordinance on Private Medical and Pharmaceutical Practices and the Government’s Decree No.06/CP of January 29, 1994 detailing a number of provisions of the said Ordinance) and the certificate of satisfaction of conditions for dealing (trading) in pharmaceuticals (prescribed in the Health Ministry’s Circular No.02/2000/TT-BYT of February 21, 2000 guiding the trade in preventive and curative medicines for human use), with the certificate of eligibility for pharmaceutical practice applicable to all establishments practicing pharmacy, regardless of their economic sectors.

The Health Ministry shall, within 30 days after the signing of this Decree, guide the conditions and procedures for granting the certificate of eligibility for pharmaceutical practice.

Article 3.- To replace some following permits with the non-permit business conditions:

1. Plant quarantine practice permit (prescribed in Circular No.63/1999/TT-BNN-BVTV of April 9, 1999 of the Ministry of Agriculture and Rural Development guiding the domestic quarantine work).

The Ministry of Agriculture and Rural Development shall, within 30 days after the signing of this Decree, specify the conditions for plant quarantine business.

2. Certificate of eligibility for production of veterinary drugs (defined in the Regulation on management of veterinary drugs, promulgated together with the Government’s Decree No.93/CP of November 27, 1993 guiding the implementation of the Ordinance on Veterinary Medicine).

The Ministry of Agriculture and Rural Development shall, within 30 days after the signing of this Decree, specify the conditions for production of veterinary drugs.

3. Permit for setting up film-producing establishments (prescribed in the Government’s Decree No.48/CP of July 17, 1995 on cinematographic organization and activities).

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4. Certificate of eligibility for use of substances subject to strict labor hygiene requirements (prescribed in the Health Ministry’s Circular No.05/1999/TT-BYT of March 27, 1999 guiding the declaration, registration and granting of certificate of eligibility for use of substances subject to strict labor hygiene requirements).

The Health Ministry shall coordinate with the Ministry of Labor, War Invalids and Social Affairs in, within 30 days after the signing of this Decree, specifying the labor conditions, which must be met by business establishments that use substances subject to strict labor hygiene requirements, and the procedures for registering the use of the said substances.

5. Certificate of satisfaction of criteria and conditions for producing and trading in insecticidal and germicidal chemicals and preparations for domestic and medical use (prescribed in the Health Minister’s Decision No.1654/1999/QD-BYT of May 29, 1999 promulgating the Regulation on management of insecticidal and germicidal chemicals and preparations for domestic and medical use).

The Health Ministry shall, within 30 days after the signing of this Decree, specify the conditions for producing and trading in insecticidal and germicidal chemicals and preparations for domestic and medical use.

6. Certificate of eligibility for dealing (trading) in medical equipment and instruments (prescribed in the Health Ministry’s Circular No.03/2001/TT-BYT of February 16, 2001 guiding the trade in medical equipment and instruments).

The Health Ministry shall, within 30 days after the signing of this Decree, specify the conditions for trading in medical equipment and instruments.

Article 4.- To replace a number of permits with the registration of dossiers or contracts

1. To replace the following permits with the registration of dossiers or contracts:

a/ To replace medicine advertisement permit (prescribed in the Health Ministry’s Decision No.322/BYT-QD of February 28, 1997 promulgating the Regulation on information on and advertisement of medicines and cosmetics for human use) with the submission of all prescribed advertisement dossiers by the concerned organizations and individuals to the Health Ministry or provincial/municipal Health Services authorized by the Health Ministry. Within 15 working days after receiving the dossiers, if the Health Ministry or provincial/municipal Health Services do not request in writing amendments and/or supplements to such dossiers, the said organizations and individuals shall be allowed to make advertisements according to the contents in the submitted dossiers.

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b/ To replace the permit for advertisement of cosmetics directly affecting the human health (defined in the Health Ministry’s Decision No.322/BYT-QD of February 28, 1997 promulgating the Regulation on information on and advertisement of medicines and cosmetics for human use) with the submission of all prescribed advertisement dossiers by the concerned organizations and individuals to the Health Ministry or provincial/municipal Health Services authorized by the Health Ministry. Within 15 working days after receiving the dossiers, if the Health Ministry or provincial/municipal Health Services do not request in writing amendments and/or supplements to such dossiers, the said organizations and individuals shall be allowed to make advertisements according to the contents in the submitted dossiers.

In cases where the Health Ministry or provincial/municipal Health Services request in writing amendments and/or supplements to the dossiers, the concerned organizations and individuals shall have to make amendments and/or supplements and submit the amended and/or supplemented advertisement contents as requested to the Health Ministry or provincial/municipal Health Services. Within 5 working days after receiving the amended and/or supplemented advertisement contents, if the Health Ministry or provincial/municipal Health Services do not request in writing further amendments and/or supplements, the concerned organizations and individuals shall be allowed to make advertisements according to the amended and/or supplemented contents.

c/ To replace the permit for organizing workshops for introducing medicines (defined in the Health Ministry’s Decision No. 322/BYT-QD of February 28, 1997 promulgating the Regulation on information on and advertisement of medicines and cosmetics for human use) with the submission of all prescribed workshop dossiers by the concerned organizations and individuals to the Health Ministry or provincial/municipal Health Services authorized by the Health Ministry. Within 15 working days after receiving the dossiers, if the Health Ministry or provincial/municipal Health Services do not request in writing amendments and/or supplements to such dossiers, the said organizations and individuals shall be allowed to organize workshops according to the contents in the submitted dossiers.

In cases where the Health Ministry or provincial/municipal Health Services request in writing amendments and/or supplements to the dossiers, the concerned organizations and individuals shall have to make amendments and/or supplements and submit the amended and/or supplemented workshop contents as requested to the Health Ministry or provincial/municipal Health Services. Within 5 working days after receiving the amended and/or supplemented workshop contents, if the Health Ministry or provincial/municipal Health Services do not request in writing further amendments and/or supplements, the concerned organizations and individuals shall be allowed to organize workshops according to the amended and/or supplemented contents.

d/ To replace decisions on approval of contracts on transferring domestic technologies and contracts on transferring foreign technologies into Vietnam for investment projects not financed by the State and investment projects financed by the State with value equivalent to less than USD 30,000 (defined in the Government’s Decree No.45/1998/ND-CP of July 1, 1998 detailing the technology transfer) with the submission of technology transfer contracts (enclosed with annexes, if any) by the concerned enterprises to the Ministry of Science, Technology and Environment or provincial/municipal Services of Science, Technology and Environment authorized by the Ministry of Science, Technology and Environment. If within 15 working days after receiving the contracts, the Ministry or provincial/municipal Services do not request in writing amendments and/or supplements thereto, such contracts shall be automatically approved and valid.

In cases where the Ministry or provincial/municipal Services request in writing amendments and/or supplements to the contracts, the enterprises shall have to make amendments and/or supplements and submit to the Ministry or provincial/municipal Services the amended and/or supplemented contracts. If within 5 working days after receiving such amended and/or supplemented contracts, the Ministry or provincial/municipal Services do not request in writing further amendments and/or supplements, the enterprises shall be allowed to perform the amended and/or supplemented contracts.

2. The Ministry of Health and the Ministry of Science, Technology and Environment shall, within 30 days after the signing of this Decree, specify the order and procedures for and define the agencies which shall receive and carry out the registration of dossiers and contracts prescribed in Clause 1 of this Article, and assign responsibilities for managing and monitoring the implementation thereof.

Article 5.- This Decree takes effect 30 days after its signing for promulgation.

Article 6.- The ministers, the heads of the ministerial-level agencies, the heads of the agencies attached to the Government and the presidents of the People’s Committees of the provinces and centrally-run cities shall have to implement this Decree.

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ON BEHALF OF THE GOVERNMENT
PRIME MINISTER




Phan Van Khai