Decree No. 59/2002/ND-CP abolishes certain licenses and replaces them with other management methods, applicable to enterprises and individual organizations. The new provisions aim to simplify administrative procedures and reduce burdens on enterprises.
Đối tượng áp dụng
Enterprises, organizations, and individuals operating in various fields such as publishing, film, pharmaceuticals, plant quarantine, veterinary drug production, films, advertising, and technology transfer.
Các điểm cốt lõi
- Enterprises and organizations no longer need a temporary publication license for printing technical production guides, product introductions, flyers, brochures introducing goods, and enterprises.
- Replacing the Certificate of Meeting Standards and Conditions for Establishing Private Pharmaceutical Practices with the Certificate of Meeting Conditions for Pharmaceutical Practice.
- Replacing certain licenses such as the Plant Quarantine Practice License, the Certificate of Meeting Conditions for Veterinary Drug Production Practice, the Film Production Establishment License, and the License for Using Substances with Strict Health and Safety Requirements with business conditions that do not require licenses.
- Replacing certain licenses such as the Drug Advertising License, the Cosmetic Advertising License affecting human health directly, and the Seminar Introduction Drug License with registration of files and contracts.
- The Ministries of Health, Science and Technology, and Environment will specify the procedures, formalities, and agencies responsible for receiving registration files and contracts.
🌐 Tác động xã hội từ văn bản này
- Facilitating businesses in their operations by reducing administrative burdens.
- Simplifying the management process for cultural, health, pharmaceutical, film, plant quarantine, and technology transfer activities.
- There needs to be time for relevant agencies to develop and perfect business conditions without licenses.
❓ Câu hỏi thường gặp
How will the temporary publication license for printing technical production guides, product introductions, flyers, brochures introducing goods, and enterprises continue to be implemented?
Enterprises no longer need this license. They only need to submit all required documents to the Ministry of Health or authorized provincial health departments according to regulations.
How long after signing and promulgating the new Decree does it take effect?
This Decree takes effect thirty days from the date of signature and promulgation.
What must enterprises do to obtain permission to advertise drugs and cosmetics that directly affect human health?
Enterprises must submit all advertising documents as prescribed to the Ministry of Health or authorized provincial health departments. After fifteen working days, if there are no requests for amendments, enterprises may proceed with advertising as submitted.
In replacing the plant quarantine practice license with business conditions that do not require licenses, what conditions must enterprises meet?
The Ministries of Agriculture and Rural Development will specify the business conditions for plant quarantine within thirty days from the effective date of this Decree.
How long does it take for enterprises to receive feedback after submitting files and contracts?
After fifteen working days, if the Ministry or provincial department does not request amendments or supplements, enterprises may proceed as submitted. If amendments or supplements are required, the period is five working days.
Toàn văn
DECREE
Regarding the abolition of certain permits and the replacement of some permits with other management methods
Abolish the following permits:
____________________________
THE GOVERNMENT
Pursuant to the Law on Organization of the Government dated December 25, 2001;
Pursuant to the Enterprise Law No. 13/1999/QH10 dated June 12, 1999;
At the proposal of the Minister of Planning and Investment.
DECREE:
Article 1. 1. The temporary publication permit for printing technical production guides; product introductions; instructions on the use of goods; brochures and leaflets introducing products, goods, and enterprises as stipulated in Decree No. 79/CP dated November 6, 1993 of the Government detailing the implementation of the Law on Publishing.
2. The temporary film production permit for domestic organizations and individuals as stipulated in Decree No. 48/CP dated July 17, 1995 of the Government on the organization and operation of the film industry. For foreign organizations and individuals, including overseas Vietnamese, the current regulations shall apply.
3. The performing arts practice permit (issued to artists) as stipulated in Decree No. 87/CP dated December 12, 1995 of the Government on strengthening the management of cultural activities and cultural services and intensifying the eradication of serious social evils and Decision No. 32/1999/QĐ-BVHTT dated April 29, 1999 of the Minister of Culture and Information promulgating the Regulations on Professional Performing Arts Activities.
4. The disinfection practice card as stipulated in Circular No. 63/1999/TT-BNN-BVTV dated April 9, 1999 of the Ministry of Agriculture and Rural Development guiding the implementation of domestic quarantine work.
Replace the Certificate of Meeting Standards and Conditions for Establishing Private Pharmaceutical Practices (as stipulated in Circular No. 01/1998/TT-BYT dated January 21, 1998 of the Ministry of Health guiding the implementation of the Ordinance on Private Medical and Pharmaceutical Practices and Decree No. 06/CP dated January 29, 1994 of the Government detailing certain provisions of the Ordinance on Private Medical and Pharmaceutical Practices) and the Business Operation Permit (selling pharmaceuticals) (as stipulated in Circular No. 02/2000/TT-BYT dated February 21, 2000 of the Ministry of Health guiding the sale of medicines for disease prevention and treatment) with a Practice Certificate of Meeting Conditions for Pharmaceutical Practices applicable to all pharmaceutical practices regardless of economic component.
Article 2.
The Ministry of Health shall guide the conditions and procedures for issuing the Practice Certificate of Meeting Conditions for Pharmaceutical Practices within thirty days from the date of issuance of this Decree.
Replace the following permits with business conditions that do not require permits:
Article 3. 1. Replace the Plant Quarantine Practice Permit (as stipulated in Circular No. 63/1999/TT-BNN-BVTV dated April 9, 1999 of the Ministry of Agriculture and Rural Development guiding the implementation of domestic quarantine work) with business conditions that do not require permits.
The Ministry of Agriculture and Rural Development shall specify the detailed business conditions for plant quarantine within thirty days from the date of issuance of this Decree.
2. Replace the Certificate of Meeting Conditions for Producing Veterinary Medicines (as stipulated in the Management Regulation for Veterinary Medicines issued together with Decree No. 93/CP dated November 27, 1993 of the Government guiding the implementation of the Ordinance on Veterinary Medicine) with business conditions that do not require permits.
The Ministry of Agriculture and Rural Development shall specify the detailed conditions for producing veterinary medicines within thirty days from the date of issuance of this Decree.
3. Replace the Permit for Establishing Film Production Facilities (as stipulated in Decree No. 48/CP dated July 17, 1995 of the Government on the organization and operation of the film industry) with business conditions that do not require permits.
The Ministry of Culture and Information shall specify the detailed conditions for film production within thirty days from the date of issuance of this Decree.
4. Replace the Certificate of Permission to Use Substances with Strict Requirements for Occupational Hygiene (as stipulated in Circular No. 05/1999/TT-BYT dated March 27, 1999 of the Ministry of Health guiding the declaration, registration, and issuance of certificates for the use of substances with strict requirements for occupational hygiene) with business conditions that do not require permits.
The Ministry of Health shall coordinate with the Ministry of Labor, Invalids, and Social Affairs to specify the detailed labor conditions for businesses using substances with strict requirements for occupational hygiene and the procedures for registering the use of such substances within thirty days from the date of issuance of this Decree.
5. Replace the Certificate of Meeting Standards and Conditions for Producing and Trading Chemicals and Insecticides, Disinfectants Used in Household and Medical Fields (as stipulated in Decision No. 1654/1999/QĐ-BYT dated May 29, 1999 of the Minister of Health promulgating the Management Regulations for Chemicals and Insecticides, Disinfectants Used in Household and Medical Fields) with business conditions that do not require permits.
The Ministry of Health shall specify the detailed conditions for producing and trading chemicals and insecticides, disinfectants used in household and medical fields within thirty days from the date of issuance of this Decree.
6. Replace the Certificate of Meeting Conditions for Trading Medical Equipment and Devices (as stipulated in Circular No. 03/2001/TT-BYT dated February 16, 2001 of the Ministry of Health guiding the trade of medical equipment and devices) with business conditions that do not require permits.
The Ministry of Health shall specify the detailed conditions for trading medical equipment and devices within thirty days from the date of issuance of this Decree.
Replace certain permits with filing applications and contracts
Article 4. 1. Replace certain permits with filing applications and contracts:
a) Replace the Drug Advertising Permit (as stipulated in Decision No. 322/BYT-QĐ dated February 28, 1997 of the Ministry of Health promulgating the Regulations on Information and Advertising of Drugs and Cosmetics for Human Use) with the requirement for organizations and individuals to submit all advertising files according to regulations to the Ministry of Health or the People's Committee of Health authorized by the Ministry of Health. After fifteen working days from the date of receipt of the file, if the Ministry of Health or the People's Committee of Health does not issue a document requesting amendments or supplements, the organization or individual may advertise according to the submitted content.
a) Replace the Advertising Permit for Medicines (as stipulated in Decision No. 322/BYT-QD dated February 28, 1997, issued by the Ministry of Health on Information and Advertising Regulations for Medicines and Cosmetics for Human Use) with the requirement that organizations and individuals must submit all advertising files in accordance with regulations to the Ministry of Health or the People's Committee Department of Health authorized by the Ministry of Health. Within fifteen working days from the date of receipt of the file, if the Ministry of Health or the People's Committee Department of Health does not issue a document requesting amendments or supplements, the organization or individual shall be entitled to advertise according to the content submitted.
In case the Ministry of Health or the Department of Health issues a document requesting amendments or supplements, organizations and individuals must make such amendments or supplements and submit to the Ministry of Health or the Department of Health the amended and supplemented advertisement content as required. Within five working days from the date of receipt of the amended and supplemented advertisement content, if the Ministry of Health or the Department of Health does not issue a document requesting amendments or supplements, organizations and individuals are entitled to advertise according to the amended and supplemented content.
b) Replacing the Drug Advertisement Permit affecting human health (as stipulated in Decision No. 322/BYT-QĐ dated February 28, 1997 issued by the Ministry of Health on Information and Advertising Regulations for Drugs and Cosmetics for Human Use) with the requirement that organizations and individuals must submit all advertising files as prescribed to the Ministry of Health or the Department of Health authorized by the Ministry of Health. Within fifteen working days from the date of receipt of the files, if the Ministry of Health or the Department of Health does not issue a document requesting amendments or supplements, organizations and individuals are entitled to advertise according to the submitted content.
In case the Ministry of Health or the Department of Health issues a document requesting amendments or supplements, organizations and individuals must make such amendments or supplements and submit to the Ministry of Health or the Department of Health the amended and supplemented advertisement content as required. Within five working days from the date of receipt of the amended and supplemented advertisement content, if the Ministry of Health or the Department of Health does not issue a document requesting amendments or supplements, organizations and individuals are entitled to advertise according to the amended and supplemented content.
c) Replacing the Drug Seminar Permit (as stipulated in Decision No. 322/BYT-QĐ dated February 28, 1997 issued by the Ministry of Health on Information and Advertising Regulations for Drugs and Cosmetics for Human Use) with the requirement that organizations and individuals must submit all seminar files as prescribed to the Ministry of Health or the Department of Health authorized by the Ministry of Health. Within fifteen working days from the date of receipt of the files, if the Ministry of Health or the Department of Health does not issue a document requesting amendments or supplements, organizations and individuals are entitled to organize seminars according to the submitted content.
In case the Ministry of Health or the Department of Health issues a document requesting amendments or supplements, organizations and individuals must make such amendments or supplements and submit to the Ministry of Health or the Department of Health the amended and supplemented seminar content as required. Within five working days from the date of receipt of the amended and supplemented seminar content, if the Ministry of Health or the Department of Health does not issue a document requesting amendments or supplements, organizations and individuals are entitled to organize seminars according to the amended and supplemented content.
d) Replacing the Approval Decision for Domestic Technology Transfer Contracts, Foreign Technology Transfer Contracts into Vietnam for investment projects not using state capital and investment projects using state capital with a value equivalent to less than thirty thousand US dollars (as stipulated in Decree No. 45/1998/NĐ-CP dated July 1, 1998 issued by the Government detailing technology transfer) with the requirement that enterprises must submit technology transfer contracts (including attached appendices if any) to the Ministry of Science and Technology or the Department of Science and Technology authorized by the Ministry. Within fifteen working days from the date of receipt of the contract, if the Ministry or the Department does not issue a document requesting amendments or supplements, the contract is automatically approved and becomes effective.
In case the Ministry or the Department issues a document requesting amendments or supplements, enterprises must make such amendments or supplements as required and submit to the Ministry or the Department of Science and Technology the amended and supplemented contract. Within five working days from the date of receipt of the amended and supplemented contract, if the Ministry or the Department does not issue a document requesting amendments or supplements, enterprises are entitled to implement the amended and supplemented contract.
2. The Ministries of Health, Science and Technology, within thirty days from the date of signing this Decree, shall specify the detailed procedures, formalities, agencies receiving registration of the files and contracts as stipulated in Clause 1 of this Article and decentralize management and supervision of implementation.
Article 5. This Decree takes effect thirty days from the date of issuance.
Article 6. Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairpersons of provincial and municipal People's Committees directly under the Central Government are responsible for implementing this Decree./.
PRIME MINISTER
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