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THE GOVERNMENT.
Numbers: 89 /2012/NĐ-CP
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THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, October 24, 2012
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DECREE
S In exchange, some of the provisions of Protocol 79 /2006/NĐ-CP 9th Ah! 8 n What? 2006
c brew a Ch I'm The government rules out the details. i Some of the laws of the Law.
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The Law base. I Ch. I'm Twenty-five. Ah! - 1 2, 2001;
The School of Law. 1 June 4, 2005;
At the suggestion of Minister of Health What?
The government issued the revised decree, adding some of the provisions of the Protocol. 79 /2006/NĐ-CP 9th Ah! 8 n What? m 2006 c brew a Ch I'm The government rules out the details. i Some of the laws of the Law,
Number one. Modify, add some of the provisions of the Digital Protocol 79 /2006/NĐ-CP August 9, 2006, the government rules out some of the details. i The law is as follows:
1. Paragraph 2 Article 14 is modified as follows:
" Article 14. Pharmaceutical practice.
2. Each individual is issued only a pharmaceutical certificate and is only managed in a form of business organization at a drug business site. "
2. Article 16 is modified, adding as follows:
" Article 16. Grant file, grant certificate of drug practice
1. Profile of the grant, reissued the Certificate of Pharmacology as a 1-order.
2. The filing offers the Certificate of Occupational Certificate of Pharmacology to Vietnamese citizens, including:
a) The application of the Certificate of Occupation Certificate in the sample prescribed by the Ministry of Health;
b) Copy that there is a certificate of professional text;
c) The certificate of the time of practice in the legal pharmaceutical facility by the head of the facility is issued by the template issued by the Ministry of Health, except for the case of a graduate degree pharmacist who registers the type of pharmacy;
d) A copy of the certificate of the certificate of the people if the file sent by a postal or a photograph and the appearance of the original civil identity certificate for the reference if the file filed directly;
Certificate of health care obtained by medical authorities for a 12-month period;
e) 2 portraits of 4 cm x 6 cm taken in the last six (06) months as of the date of the filing of the Certificate of Certificate.
3. The filing recommended that the Certificate of Occupational Certificate in Vietnam for foreign individuals, the Vietnamese settled abroad, including:
a) The prescribed papers at the points a, b, c, e and e Section 2 This;
b) The judicial calendar is administered by the authority of the country at the confirmation or the employment permit and the confirmation paper as a Board Member or Board of Directors of the drug business facility;
c) A copy of the passport certificate if the file is sent by a postal or a passport photo and the original passport passport to the object if the file is filed directly.
The degree of expertise in pharmacy and other papers stipulated at Point 2 and B Point 3 This is due to the agency, foreign organization or the evidence, the confirmation must be legalised and translated into Vietnamese; the translation must be followed by the public. The regulations of Vietnamese law.
4. The filing offers to grant the Certificate of Pharmacy Certificate due to loss, failure, tear, and expiration (for the certificate issued for a period of five years); changes in the information of the individual who register the practice of pharmaceuticals in the Certificate of Occupational Medicine, including:
a) The application to grant the Certificate of Pharmacology by the template specified by the Ministry of Health;
b) The official Certificate of Pharmacology has been granted, except for the Certificate of Pharmaceutical Loss Certificate;
c) 2 images of 4 cm x 6 cm taken in the last six (06) months as of the date of the filing of the Certificate of Certificate. "
3. Article 17 is modified, adding as follows:
" Article 17. Value, duration of the Certificate of Pharmacology
The certificate of drug practice is granted once, valued within the country. For a five-year term, when the term expires, the individual has to do the procedure to reissue the Certificate of Pharmacy at the state authority. "
4. Article 18 is modified, adding as follows:
" Article 18. Order, authority, grant certificate of pharmacy
1. For the case is not valid, for a 3-day period of work since the date of receiving the recommended record, the application of the Certificate of Pharmacy, the agency receptions to the file sent back to the file for the individual file.
2. For the valid profile, for a 30-day period of work since the date of receiving a Certificate of Certificate of Occupation Certificate of Pharmacology or for a 10-day period of work since the date of receiving a proposed record of the Certificate of Pharmacology, the agency receives the right profile. the organization of the appraisal and rank, the reissue of the Certificate of Pharmacology; if not granted, the agency receives the document which must have a written answer and specify the reason.
3. Authority grants, reissued the Certificate of Pharmacology in accordance with provisions at paragraph 3 Article 13 of the Law of Pharmacy. The practice certificate is made into two copies: A circulation at the hierarchy, one for the individual to offer, reissued.
4. The Ministry of Health regulates the certificate of drug practice. "
5. Additional Article 19a following Article 19 as follows:
" 19a. Return the pharmacy Certificate
1. The state governing body receives a certificate of granting a Certificate of Certificate of Medication Return Certificate to the individual who register the practice of pharmaceuticals in the following circumstances:
a) The drug business facility changes the specialized manager of pharmacy;
b) The drug business is terminated in business;
c) The filing facility recommended a Certificate of Certificate of Sufficient Medicine, but received an unissued reply from the agency's application.
d) The individual applied for the Certificate of Pharmacology (for certificates issued for a period of five years).
2. The Ministry of Health rules the order, the procedure to return the Certificate of Occupational Medicine. "
6. Article 28 is modified, added as follows:
" Article 28. The profile of the offer, addition, extension, reissued the Certificate of Medication Business.
1. The filing offers a Certificate of Certificate of Drug Business, including:
a) The application to grant a Certificate of Certificate of Drug Business by the Ministry of Health Regulations;
b) The primary practice of administing the pharmacy of the professional manager in accordance with the form of business organization and the copy of the Certificate of Personal Business Registration or Certificate of Business Registration certificate or copy of a signed copy of the company. host and stamp stamp stamp (if business);
c) Technical documentation corresponding to business conditions recommend testing under the Ministry of Health ' s regulation on the case of having to specify a drug business basis;
d) For the wholesale agent of the drug business business, the wholesale dealer of vaccines, medical students, in addition to the prescribed papers at Point a, b and c This paragraph must have a copy of the certificate or copy of the base ' s signature and stamp confirmation. (if it is a business) contract between the open business and the head of the agent.
2. The filing offers to add the business scope in the Certificate of qualified drug business, including:
a) The application adds the scope of the drug business according to the sample provided by the Ministry of Health;
b) A copy of the certificate or copy with the signature of the base and stamp holder (if a business) A Certificate of Qualified Drug Business and a Business Registration Certificate or Business Registration Certificate;
c) Technical documentation corresponding to business conditions under the Ministry of Health's regulation on the case of having to specify a drug business basis.
3. A proposed filing to renew the Certificate of Medication Eligisum Certificate for Certification Documents with a specified deadline at paragraph 7 Article 1 This decree, including:
a) The proposed extension of the Certificate of Qualified drug business by the Ministry of Health;
b) The copy of the certificate or copy has the signature of the facility owner and stamped (if the business) the certificate of receiving sufficient drug business is granted;
c) The primary practice of administing the medicine of the specialized manager of pharmacy in accordance with the form of business organization;
d) Technical documentation corresponding to business conditions under the Ministry of Health's regulation on the case of having to specify a drug business basis.
4. The filing offers to re-issue the Certificate of Medication Business due to the loss, failure, tear, and change; changing the name of the drug business; change the name of the drug business base but does not change the business location; change the location of the registry headquarters. business in the case of business registration headquarters is not the location of business activity that has been granted a Certificate of Qualified Drug Business, including:
a) The application to regrant the Certificate of Qualified Drug Business by the Ministry of Health;
b) The official Certificate of Pharmacology of the new pharmacy of the new pharmacy for the case of change of specialist manager for pharmacy;
c) A copy of a certificate or a signed copy of the base and stamp of the facility (if a business) to the text of approval of changing the name of the business registry's drug business base to the business base name change case The medicine
d) A copy of a certificate or a signed copy of the base and stamp of the facility (if the business) the text approx the change of the location of the business registry headquarters to the case of business registration. The drug business registry. "
7. Article 29 is modified, added as follows:
" Article 29. Value, duration of the Certificate of Certificate of Drug Business
1. The certificate of qualifying for the drug business is granted once to the drug business base that reaches the principles, the practice of good Practice in accordance with the form of drug business. For a 5-year grant, at the end of the term, the business base is a reissued procedure at the state authority with jurisdiction.
2. For a drug-based business facility that has not yet been required to reach the principle, the standard of Good Practice, the Certificate of Qualified Drug business has a five-year term from the date of grade or to the deadline to implement the principle, the Practice Standards Good. When the certificate is eligible for a full drug business, if you wish to continue your business, the organization must make a proposal for a specified extension at the expense of 6 Article 1 of this decree. The duration of the extension is 05 years or to the deadline for the route specified by the Ministry of Health.
3. The shelf life of the Certificate in Certificate of Sufficient Business due to the loss, in exchange equivalent to the remaining deadline of the Certificate of Qualified Drug Business, in exchange. "
8. Name 30 and Clause 1, paragraph 2 Article 30 is modified, added as follows:
" Article 30. The order, the authority to grant, grant, renew, add business scope in the Certificate of qualified drug business.
1. Self-level, reorder, extension, the addition of business scope in the Certificate of qualified drug business is as follows:
a) For the case of having to specify a drug business basis (a federal level), in a maximum of 40 days of work since the date of receiving the proposed record, addition, extension of the Certificate of Qualified Drug Business, the agency recepts the case. having to hold appraisal and grade, supplement, renew the Certificate of Qualified Certificate Business;
b) For the absence of a business base appraisal, for a maximum of 20 working days, the agency recepts the case to grant, grant, supplement, renew the Certificate of Qualified Certificate Business;
c) The case of a proposed, radical, complementary, extension, extension of the certificate of receiving unvalid drug business is in the 10-day period of work, since the date received the case, the agency recepts to the case to have a written notice for the organization, the individual suggests. The grant, the addition, the supplement, renew the certificate of the drug business to replenel, complete the profile.
2. Authority grants, resupply, extension, addition of business scope in the Certificate of qualified drug business by regulation at paragraph 3 Article 11 of the Law of Pharmacy. The certificate of qualifying for the drug business is made up of two copies: A circulation at the agency, one for the individual, the organization offering the grant, the grant, the addition, the extension. "
Second. Fuck! i It's a transfer.
The filing of the Certificate of Occupational Certification, the Certificate of Occupational Drugs filed prior to the date of this decree was taken into effect and the certification level of the pharmacy, the Certificate of Occupational Medicine by the Digital Protocol. 79 /2006/NĐ-CP August 9, 2006 brew specifies the details of the laws of the Law.
Third. Execution clause
1. This decree has been in effect since 10 December 2012.
2. This decree repel paragraph 2 Articles 14, Article 16, Article 17, Article 18, Article 28, Article 29, Article 30, Clause 1 and Clause 2 Article 30 Decree No. 30 79 /2006/NĐ-CP August 9, 2006, the Government rules out certain conditions. brew A Law.
Article 4. Blame i The organization is organized.
1. The Minister of Health is responsible for the guidance of this decree.
2. Ministers, Prime Minister of the Ministry, Prime Minister c Uh ... Government, Chairman. Proxy The population of the provinces, the Central City, and the agencies, the relevant individual organization responsible for the implementation of this decree.
TM. THE GOVERNMENT. |
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Prime Minister |
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(signed) |
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Dao Dung |
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