The Decree 89/2012/nd-Cp: Modifying, Supplementing A Number Of Articles Of Decree No. 79/2006/nd-Cp Dated 9 August 2006 From The Government Detailing The Implementation Of A Number Of Articles Of The Law On Pharmacy

Original Language Title: Nghị định 89/2012/NĐ-CP: Sửa đổi, bổ sung một số điều của Nghị định số 79/2006/NĐ-CP ngày 09 tháng 8 năm 2006 của Chính phủ quy định chi tiết thi hành một số điều của Luật Dược

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DECREE amending and supplementing a number of articles of Decree No. 79/2006/ND-Cp of August 9, 2006 detailing the Government's implementation of some articles of the law on Pharmacy _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ based on Government Organization Law of 25 December 2001;
Pharmaceutical Law base on June 14, 2005;
According to the recommendation of the Minister of health;
The Government issued the decree amending and supplementing a number of articles of Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of some articles of the law, article 1. Modifying, supplementing a number of articles of Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of some articles of the law as follows: 1. Item 2 article 14 is amended as follows: "article 14. Practice medicine 2. Each individual was only granted a certificate to practice Pharmacy and managed only a specialized form of business organization in a business location. "
2. Article 16 is amended and supplemented as follows: "article 16. The records suggest, again practice medicine 1. The records suggest, again practice medicine are made into 1.
2. The records suggest practising pharmacy certificate for Vietnam citizens, including: a) certificate application to practice medicine according to the template specified by the Ministry of health;
b) authenticated copies of professional qualifications;
c) certificate of practice time in legitimate pharmaceutical facility due to the head of that base level according to the template specified by the Ministry of health, except in the case of University graduate pharmacists professional system tu register type of Pharmacy;
d) copies are authenticated identity Paper if the record sent by post or snapshot and original identity to compare if the submission directly;
DD) health certificate by the competent health authorities granted within a period of 12 months;
e) 2 photo portrait size 4 cm x 6 cm, taken within six (6) months as of submission of the proposal to grant the certificate.
3. recommended records issued the certificate of practice of pharmacy in Vietnam for individual foreigners, Vietnam people settled abroad, including: a) the papers specified at points a, b, c, e and e Account 2 things;
b) criminal record be competent authority of the country or work permits and certifications are Board members or the Board of Directors of the business establishments, smoking;
c) certified copies of passport applications sent by post or passport copy and produce original passport to engineer if the record filed directly.
Professional diploma in Pharmacy and other documents specified in point c of Paragraph 2 and point b Paragraph 3 of this article by the Agency, foreign organization or notary, confirmed to be legalized and translated into Vietnamese Consulate; the translation must be notarized in accordance with the law of Vietnam.
4. recommended records reissued a certificate of practice medicine due to loss, damage, torn; expired (for the certificate was granted five years); change your personal information registered to practice medicine on the practice of pharmacy, including: a) petition to practice medicine according to the template specified by the Ministry of health;
b) A practising certificate in pharmacy administration was granted, unless the certificate of practice of Pharmacy;
c) 2 photo portrait size 4 cm x 6 cm, taken within six (6) months as of submission of the proposal to grant the certificate. "
3. Article 17 is amended and supplemented as follows: "article 17. Value, the duration of the practice of pharmacy practice pharmacy is granted once, there is value in nationwide. For the practice of Pharmacy was granted with the 5-year period, when expired, the individual must do the procedures to practice pharmacy in the State competent bodies ".
4. Article 18 is amended and supplemented as follows: "article 18. The order, issued, again practice medicine 1. For the record is not valid, within 3 working days from receipt of the records suggest, again practice medicine, the agency receiving records return records for the individual applicants.
2. for documents, within 30 working days from the date of the proposed profile certificate of practice or pharmacy within 10 working days of receiving the recommended records reissued a certificate of practice, the agency receiving records to organize the evaluation and issue again, the practice of Pharmacy; If not level, level again, the receiver records must have a written reply stating the reason.
3. The authority granted, again practice medicine made according to the provisions in clause 3 of the article 13 of the law on Pharmacy. Practice of Pharmacy was made into both a save at the agency level, a personal grant proposals, level again.
4. The Ministry of health regulation of pharmacy practice certificate template. "
5. Supplement Article 19a after article 19 as follows: "article 19a. Return the practice of Pharmacy 1. State agency receiving the certification proposal eligible drug business to pay back the certificate of practice for pharmacy practice pharmacy registered individual in the following cases: a) drug business change manager specializing in pharmacy;
b) drug business establishments cease operations;
c) proposal submission facility certification eligible drug business but received no answer text issued by the agency receiving the record;
d the personal level) back to the practice of Pharmacy (for the certificate was issued has a time limit of 5 years).
2. The Ministry of health regulation sequence, the procedure returns the certificate to practice medicine. "
6. Article 28 is amended and supplemented as follows: "article 28. Records request, additional, renewal, reissuance of certificates of qualified business smoking 1. Records suggest that certification of eligible drug business, including: a) the certification application is eligible to form business due to health regulations;
b) A practising certificate in pharmacy administration of professional pharmacy manager match the form of business organization and a copy of the certificate of registration of individual business households or business registration certificate has a certificate or a copy signed by home base and stamped validation (if business);
c) technical documentation corresponding to business conditions suggest checking according to the regulations of the Ministry of health for cases to assess drug business establishments;
d) for resellers of drug trading business dealer wholesale, vaccine, medical products, in addition to the documents specified in point a, b and c Account have to have authenticated copies or copies signed by home base and stamped validation (if business) agent contract between the enterprise and the head of the agent.
2. the additional proposal profile and business scope of the certificate of eligible drug business, including: a) additional form of business scope of drugs according to the template specified by the Ministry of health;
b) authenticated copies or copies signed by home base and seal (if business) certificate of eligibility issued drug business and business registration certificate or certificate of registration of business households;
c) technical documentation corresponding to business conditions as stipulated by the Ministry of health for cases to assess drug businesses.
3. The records suggest the extension of the certificate of eligibility for the drugs business certificate has the time limit prescribed in paragraph 7 article 1 of this Decree, including: a) renewal application for certificate of eligibility form drug business by the Ministry of health regulation;
b) authenticated copies or copies signed by home base and seal (if business) certificate of eligibility issued drug business;
c) A practising certificate in pharmacy administration of professional pharmacy manager match the form of business organization;
d) technical documentation corresponding to business conditions as stipulated by the Ministry of health for cases to assess drug businesses.
4. recommended records reissued certificate eligible drug business because of lost, damaged, torn; change the Manager specializing in pharmacy; change the name of the drug business but do not change the location of business; change location to the business registration office in the case of the business registration office is not the location of business activity has been certified eligible drug business, including: a) petition reissued certificate of eligible drugs business model by the Ministry of health regulation;
b) A practising certificate in pharmacy administration of professional managers about a new drug for cases of change of professional managers of Pharmacy;
c) certified copies or copies signed by home base and seal of the base (if business) for the text approved the name change to the drug business establishments of the business registration agency for name change to the drug business establishments;
d) certified copies or copies signed by home base and seal of the base (if business) text approved the change of location to the business registration office of the business registration agency for relocating the business registration office of drugs. "
7. Article 29 is amended and supplemented as follows: "article 29. Value, the duration of the certificate of eligible drug business 1. Certificate of eligible drug business be granted once for business establishments, smoking reached the principles, standards of good practice consistent with the form of the drug business. For certificates issued with the 5-year period, when expired, the business base reissuing procedures in the competent State bodies.
2. for business establishments, smoking by the roadmap are not yet required to reach the standards, principles of good practice, the certificate of eligible drug business has a time limit of 5 years from the date of issue or due to implementation guidelines, good practice standards. When certificate of eligibility expired drugs business, if want to continue business, the individual, the organisation must make records suggest renewed according to the provisions in paragraph 6 article 1 of this Decree. Every time grace period is 5 years or to the time limit according to the roadmap by the Health Ministry regulations.

3. The time limit for use of the certificate of eligibility of business level again due to loss, equivalent to the remaining term of the certificate of eligible drug business has been lost, changed. "
8. The name and article 30 paragraph 1, paragraph 2 article 30 be amended and supplemented as follows: "article 30. The order, issued, reissued, extend, complement the range of trading in certificates of qualified business smoking 1. The order issued, reissued, extend, supplement the business scope of the certificate of eligible drug business are defined as follows: a) for cases to appraise base business (Associate level), within a maximum of 30 working days from the date of the grant proposal profile , addition, extension of eligibility certificate valid drug business, the agency receiving records are held and additional grants, evaluation, renewal of the certificate of eligible drug business;
b) for cases not verified business establishments, within a maximum of 20 working days, the agency receiving records are issued, reissued, complement, renew the certificate of eligible drug business;
c) case records suggest, again, additional, renewal of the certificate of eligible drug business is not yet valid, then within 10 working days from the date of receiving the application, the Agency receives the record must have the text notified to the Organization, the individual grant proposal Refresh, replenish, renew the certificate of eligible drug business to supplement, complete the profile.
2. The authority level, level back, extend, supplement the business scope of the certificate of eligible business follow medication prescribed in paragraph 3 article 11 of the law on Pharmacy. Certificate of eligible drug trading is made in two copies: one copy saved at the agency level, a personal organizer, a grant proposal, again, additional, extended. "2. The transitional provision of records suggest practising certificate, the certificate of eligible drug business, filed before the date of this Decree in effect was the evaluation and certification of pharmacy practice, qualified certificate trading according to Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of some articles of the law.
Article 3. Terms of implementation 1. The Decree has effect from the date of 10 December 2012.
2. This decree repealed the clause 2 article 14, article 16, article 17, article 18, article 27, article 29, article 30, paragraph 1 name and item 2 article 30 of Decree 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of some articles of the law.
Article 4. Responsible for implementation 1. The Minister of health is responsible for guiding, organizing the implementation of this Decree.
2. Ministers, heads of ministerial agencies, heads of government agencies, the Chairman of people's Committee of the province, central cities and agencies, individual organization concerned is responsible for the implementation of this Decree.