Nghị định 89/2012/NĐ-CP sửa đổi Nghị định 79/2006/NĐ-CP hướng dẫn Luật dược

DECREE

AMENDING AND SUPPLEMENTING A NUMBER OF ARTICLES OF THE GOVERNMENT'S DECREE NO. 79/2006/NĐ-CP DATED AUGUST 09^TH 2006 DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE LAW ON PHARMACY

Pursuant to the Law on Government organization dated December 25^th 2001;

Pursuant to the Law on Pharmacy dated June 14^th 2005;

At the proposal of the Minister of Health;

The Government promulgates a Decree to amend and supplement a number of articles of the Government's Decree No. 79/2006/NĐ-CP dated August 09th 2006 detailing the implementation of a number of articles of the Law on Pharmacy,

Article 1. Amending and supplementing a number of articles of the Government's Decree No. 79/2006/NĐ-CP dated August 09th 2006 detailing the implementation of a number of articles of the Law on Pharmacy as follows:

1. Clause 2 Article 14 is amended as follows:

“Article 14. The pharmaceutical practice certificate

2. Each individual is only issued with one pharmaceutical practice certificate and  only allowed to manage one form of business at a location of medicine trading.”

2. Article 16 is amended and supplemented as follows:

“Article 16. The dossier of application for the issuance or reissuance of the pharmaceutical practice certificate

1. The dossier of application for the issuance or reissuance of the pharmaceutical practice certificate is made in one set.

2. A dossier of application for the issuance or reissuance of the pharmaceutical practice certificate, applicable to Vietnamese citizens, comprises:

a) The application for the pharmaceutical practice certificate made under the form provided the Ministry of Health;

b) The authenticated copies of professional qualifications;

c) The certificate of the internship in a legal pharmaceutical establishment made and issued by its leader under the form provided by the Ministry of Health, except for the bachelors of pharmacy graduated from a transferring program that registered for opening drug stores;

d) The authenticated copy of the ID card if the dossier is sent by post, or its photocopy and the original presented for comparison if the dossier is submitted directly;

dd) The certificate of health issued by a competent health agency within the previous 12 months;

e) 2 portrait pictures 4 cm x 6 cm taken within the previous 06 months as from the day of submitting the dossier.

3. A dossier of application for the pharmaceutical practice certificate in Vietnam, applicable to foreigners or Vietnamese residing overseas, comprises:

a) The papers prescribed in Point a, b, c, dd and e Clause 2 this Article;

b) The judicial résumé certified by the competent agency of the host country, or the work permit and the written certification of the membership of a the Board of Directors of the medicine-trading establishment;

c) The authenticated copy of the passport if the dossier is sent by post, or its photocopy and the original presented for comparison if the dossier is submitted directly;

The qualifications in pharmacy and other papers prescribed in Point c Clause 2 and Point b Clause 3 this Article issued, certified, or notarized by a foreign organization. Such papers must be consularly legalized and translated into Vietnamese; the Vietnamese translation must be notarized as prescribed by Vietnam’s law.

4. A dossier of application for the replacing the pharmaceutical practice certificate that has been lost, damaged, or expired (applicable to the issued certificates valid for 5 years); or the personal information of the individual registered for pharmaceutical practice on the pharmaceutical practice certificate is changed, comprises:

a) The application for the replacement of the pharmaceutical practice certificate made under the form provided the Ministry of Health;

b) The original of the issued pharmaceutical practice certificate, unless the pharmaceutical practice certificate is lost;

c) 2 portrait pictures 4 cm x 6 cm taken within the previous 06 months as from the day of submitting the application.”

3. Article 17 is amended and supplemented as follows:

“Article 17. Validity and expiry of pharmaceutical practice certificates

The pharmaceutical practice certificate is issued once and valid nationwide. When the pharmaceutical practice certificates valid for 5 years expire, the individuals must apply for reissuing the pharmaceutical practice certificate at competent State agencies”.

4. Article 18 is amended and supplemented as follows:

“Article 18. The procedures for and authority to issue and reissue pharmaceutical practice certificates

1. IF the dossier of application for the issuance or reissuance of the pharmaceutical practice certificate is not valid, the receiving agency must return it to the applicant within 03 working days as from receiving it.

2. If the dossier of application for the pharmaceutical practice certificate is valid, the receiving agency must appraise it and issue or reissue the pharmaceutical practice certificate within 10 working days. The refusal must be informed and explained in writing by the receiving agency.

3. The authority to issue and reissue pharmaceutical practice certificates are specified in Clause 3 Article 13 of the Law on Pharmacy. The pharmaceutical practice certificate is made in two copies: one copy is kept by the issuing agency, one copy is kept by the applicant.

4. The Ministry of Health shall provide the form of the pharmaceutical practice certificate .”

5. Article 19a is added after Article 19 as follows:

“Article 19a. Returning the pharmaceutical practice certificate

1. The State management agency that receives the dossier of application for the Certificate of fulfillment of conditions for trading medicines to the individual that registered for pharmaceutical practice in the following cases:

a) The pharmaceutical manager of the medicine-trading establishment is replaced;

b) The medicine-trading establishment shuts down;

c) The establishment applies for the Certificate of fulfillment of conditions for trading medicines but then receives the refusal from the receiving agency;

d) The applicant for the pharmaceutical practice certificate (applicable to the certificates valid for 5 years).

2. The Ministry of Health shall provide the procedures for returning the pharmaceutical practice certificate.”

6. Article 28 is amended and supplemented as follows:

“Article 28. The dossier of application for the issuance, adjustment, extension, or reissuance of the Certificate of fulfillment of conditions for trading medicines

1. The dossier of application for the issuance of the Certificate of fulfillment of conditions for trading medicines comprises:

a) The application for the issuance of the Certificate of fulfillment of conditions for trading medicines made under the form provided by the Ministry of Health;

b) The original of the pharmaceutical practice certificate of the pharmaceutical manager in accordance with the form of business, and the authenticated copy of the Certificate of business household registration, or the Certificate of Enterprise registration, signed and stamped by the establishment owner (applicable to enterprises);

c) The technical documents corresponding to the business conditions that need inspection as prescribed by the Ministry of Health in case the medicine-trading establishment must be assessed;

d) The agents of medicine-trading enterprises, and wholesale agents of vaccine and medicinal products must submit the authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) to certify the agent contract between the enterprise and the head of the agent, apart from the papers prescribed in Point a, b and c this Clause.

2. The dossier of application for expanding the business in the Certificate of fulfillment of conditions for trading medicines comprises:

a) The application for expanding the scale of medicine trading made under the form provided the Ministry of Health;

b) The authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) of the Certificate of fulfillment of conditions for trading medicines and the Certificate of Enterprise registration or the Certificate of business household registration;

c) The technical documents corresponding to the business conditions that need inspection as prescribed by the Ministry of Health in case the medicine-trading establishment must be assessed.

3. The dossier of application for the extension of the Certificate of fulfillment of conditions for trading medicines, applicable to the Certificates prescribed in Clause 4 Article 1 of this Decree, comprises:

a) The application for the extension of the Certificate of fulfillment of conditions for trading medicines made under the form provided by the Ministry of Health;

b) The authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) of the Certificate of fulfillment of conditions for trading medicines;

c) The original of the pharmaceutical practice certificate of the pharmaceutical manager in accordance with the form of business;

d) The technical documents corresponding to the business conditions that need inspection as prescribed by the Ministry of Health in case the medicine-trading establishment must be assessed.

4. The application for the reissuance of the Certificate of fulfillment of conditions for trading medicines that has been lost or damaged, for the replacement of the pharmaceutical manager; for the change of the name of the medicine-trading establishment without changing its location; for the change of the location in case it is not the location registered in the Certificate of fulfillment of conditions for trading medicines, comprises:

a) The application for the reissuance of the Certificate of fulfillment of conditions for trading medicines made under the form provided by the Ministry of Health;

b) The original of the pharmaceutical practice certificate of the pharmaceutical manager when replacing the pharmaceutical manager;

c) The authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) of the written approval for the change of the name of the medicine-trading establishment decided by the business registration agency when changing the name of the medicine-trading establishment;

d) The authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) of the written approval for the change of the location of the medicine-trading establishment decided by the business registration agency when changing the location of the medicine-trading establishment.”

7. Article 29 is amended and supplemented as follows:

“Article 29. Validity and expiry of the Certificate of fulfillment of conditions for trading medicines

1. The Certificate of fulfillment of conditions for trading medicines is issued to the medicine-trading establishment that satisfy the standards of Good practice in accordance with the form of medicine trading. When the certificate valid for 5 years expires, the trading establishment must follow the procedures for the reissuance at a competent State agency.

2. The medicine-trading establishments that are not required to satisfy the standards of Good practice, the Certificates of fulfillment of conditions for trading medicines are valid for 5 years as from the date of issue or until the commencement date of applying the standards of Good practice. If wishing to continue the business after the Certificate of fulfillment of conditions for trading medicines expires, the organization or individual must apply for the extension as prescribed in Clause 6 Article 1 of this Decree. The extension period is 05 years or until the time limit provided by the Ministry of Health.

3. The validity period of the new Certificate of fulfillment of conditions for trading medicines is equivalent to the remaining time of the lost or replaced certificate.”

8. The name of Article 30 and Clause 1, Clause 2 Article 30 are amended and supplemented as follows:

“Article 30. The procedures and authority to issue, reissue, extend, and expand the Certificate of fulfillment of conditions for trading medicines

1. The procedures for the issuance, reissuance, extension, and expansion of the Certificate of fulfillment of conditions for trading medicines are specified as follows:

a) If the medicine-trading establishment must be assessed, within 40 working days as from receiving the valid dossier of application for the issuance, expansion, or extension of the Certificate of fulfillment of conditions for trading medicines, the receiving agency must assess it and issue, expand, or extend the Certificate of fulfillment of conditions for trading medicines;

b) If assessment is not compulsory, the receiving agency must issue, reissue, expand, or extend the Certificate of fulfillment of conditions for trading medicines within 20 working days;

c) If the dossier of application for the issuance, expansion, or extension of the Certificate of fulfillment of conditions for trading medicines is not valid, the receiving agency must inform the applicant in writing within 10 working days so that they can supplement and complete the dossier.

2. The authority to issue, reissue, extend, and expand the Certificate of fulfillment of conditions for trading medicines is prescribed in Clause 3 Article 11 of the Law on Pharmacy. The Certificate of fulfillment of conditions for trading medicines is made in two copies: one copy is kept by the issuing agency, one copy is kept by the applicant.”

Article 2. Transitional provisions

The dossiers of application for the pharmaceutical practice certificate or Certificate of fulfillment of conditions for trading medicines being submitted before this Circular takes effect shall be assessed and issued with the pharmaceutical practice certificate or Certificate of fulfillment of conditions for trading medicines in accordance with the Government's Decree No. 79/2006/NĐ-CP dated August 09^th 2006 detailing the implementation of a number of articles of the Law on Pharmacy.

Article 3. Implementation provisions

1. This Decree takes effect on December 10^th 2012.

2. This Decree annuls Clause 2 Article 14, Article 16, Article 17, Article 18, Article 28, Article 29, the name of Article 30, Clause 1 and Clause 2 Article 30 of the Government's Decree No. 79/2006/NĐ-CP dated August 09th 2006 detailing the implementation of a number of articles of the Law on Pharmacy.

Article 5. Responsibility to organize the implementation

1. The Minister of Health shall guide and organize the implementation of this Decree.

2. The Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, the Presidents of People’s Committees of central-affiliated cities and provinces, and relevant organization are responsible for the implementation of this Decree./.

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