MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 07/2018/TT-BYT | Hanoi, April 12, 2018 |
CIRCULAR
ON GUIDELINES FOR SOME ARTICLES ON PHARMACY BUSINESS OF THE LAW ON PHARMACY AND THE DECREE NO. 54/2017/ND-CP DATED MAY 08, 2017 OF THE GOVERNMENT.
Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;
Pursuant to the Decree No. 54/2017/ND-CP dated May 08, 2017 of the Government on guidelines for implementation of some articles of the Law on Pharmacy.
Pursuant to the Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on defining functions, tasks, powers and organizational structure of the Ministry of Health.
At the request of Director General of the Drug Administration.
The Minister of Health promulgates the Circular on guidelines for some articles on pharmacy business of the Law on Pharmacy and the Decree No. 54/2017/ND-CP dated May 08, 2017 of the Government.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulations:
This Circular provides guidelines for pharmacy business including:
1. Pharmacy language requirements for foreigners in Vietnam and for Vietnamese expatriates stipulated in Clause 2, Article 14 of the Law on Pharmacy.
2. Disclosure of the list of holders of pharmacy practice certificates working for the pharmacy business establishments stipulated in point g, Clause 2, Article 42 of the Law on Pharmacy.
3. Operation of establishments having pharmacy-related activities that are not required to obtain the certificate of eligibility for pharmacy business as stipulated in Article 35 of the Law on Pharmacy.
4. Retailing drugs on the List of drugs restricted from retailing stipulated in point k, Clause 2, Article 42 of the Law on Pharmacy.
5. Retailing drugs at the drug counters in ethnic minority areas, highlands, islands or extremely disadvantaged areas as stipulated in point b, Clause 1, Article 48 of the Law on Pharmacy.
6. The pharmaceutical sale representatives (hereinafter referred to as “sale representatives”) of pharmacy business establishments who introduce drug to medical practitioners as stipulated in point b, Clause 6, Article 76 of the Law on Pharmacy.
7. Organization and operation of the Advisory Council for issuance of pharmacy practice certificates as stipulated in Clause 11, Article 6, Decree No. 54/2017/ND-CP dated May 08, 2017 of the Government.
Article 2. Regulated entities.
This Circular is applicable to Vietnamese organizations, individuals and expatriates; any foreign organization and individual who practice pharmacy and/or run a pharmacy business without obtaining the Certificate of eligibility for pharmacy business in Vietnam.
Chapter II
PHARMACY LANGUAGE REQUIREMENTS FOR FOREIGNERS IN VIETNAM AND FOR VIETNAMESE EXPATRIATES.
Article 3. Pharmacy language requirements.
1. The head of the drug retailer and the person in charge of clinical pharmacology of the health facility who are foreigners or Vietnamese expatriates shall obtain a certification of fluency in Vietnamese language, otherwise they shall register the language they use and have a qualified interpreter according to Article 5 of this Circular.
2. A foreigner or Vietnamese expatriate who has not obtained such certification shall have a statement written on his/her certificate as “interpreter is required.” When apply for the Certificate of eligibility for pharmacy business, he/she shall provide his/her contract with the interpreter as stipulated in Clause 1, Clause 2, Article 5 of this Circular.
Article 4. Criteria for issuing the certificates of fluency in Vietnamese language or other languages used in practicing pharmacy for foreigners and Vietnamese expatriates.
1. The pharmacy practitioner shall obtain a certificate of fluency in Vietnamese language from the educational institution stipulated in Article 6 hereof; except some cases stipulated in Clause 4 of this Article.
2. If the practitioner registers for another language different from his/her mother language to practice pharmacy, he/she shall be tested for that language and later be certified by the legal educational institution stipulated in Article 6 hereof. The language which the pharmacy practitioner uses to practice pharmacy shall be: English, French, Russian, Chinese, Japanese and Korean.
3. The practitioner who obtains a certificate of fluency in Vietnamese language or in the language which he/she uses to practice pharmacy but is not required to do the test if he/she:
a. Has an associate degree or higher in medicine or pharmacy or in traditional medicine which is issued by a Vietnamese or foreign legal educational institution where the teaching language is Vietnamese or the language which the practitioner uses to practice pharmacy as stipulated in Clause 2 of this Article.
b. Has a certificate of training in medicine or pharmacy or in traditional medicine with a duration for at least 12 (twelve) months which is issued by the educational institution where the teaching language is Vietnamese or the language that the practitioner uses to practice pharmacy as stipulated in Clause 2 of this Article.
c. Has a college degree in medicine or pharmacy or in traditional medicine which is issued by a Vietnamese or foreign legal educational institution where the teaching language is Vietnamese or the language which the practitioner uses to practice pharmacy as stipulated in Clause 2 of this Article.
The certificates which are stipulated in point (a) and (b) of this Clause must be issued within 05 (five) years before the date of submission of the application
Article 5. Criteria for certifying pharmaceutical interpreters.
1. The pharmaceutical interpreter who satisfies the translation standards will be certified by the legal educational institution stipulated in Article 6 of this Circular; except the cases stipulated in Clause 2 of this Article.
2. The interpreter will be certified as a qualified pharmaceutical interpreter if he/she:
a. Has an associate degree or higher in medicine or pharmacy which is issued by a Vietnamese or foreign legal educational institution where the teaching language is the one that the interpreter uses for his/her job.
b. Has a training certificate in medicine or pharmacy with a duration for at least 12 (twelve) months from the institution where the teaching language is the one that the interpreter uses for his/her job.
c. Has an associate degree or higher in medicine or pharmacy or in traditional medicine, and a college degree in foreign language which is appropriate with the language that the interpreter uses for his/her job.
The certificates which are stipulated in point (a) and (b) of Clause 2 of this Article shall be issued within 05 (five) years before the date of submission of the application.
3. A pharmaceutical interpreter shall work for only one pharmacy practitioner during the latter’s practice.
Article 6. The educational institution permitted to issue certificates of fluency in Vietnamese language or other languages, or qualifications for interpretation in the field of pharmacy.
An educational institution will be permitted to test and certify pharmacy practitioners or pharmaceutical interpreters for their language proficiency (hereinafter referred to as testing institution) if it:
1. Is a university of medicine or of pharmacy in Vietnam.
2. Has a faculty of one of the foreign languages stipulated in Clause 2, Article 4 of this Circular and satisfy the requirements for testing Vietnamese as language used in a professionas stipulated in Circular No. 17/2015/TT-BGDDT dated September 01, 2015 of the Minister of Education and Training; and.
3. Has a question bank serving testing on proficiency in Vietnamese language or other languages or qualification for interpretation in the field of pharmacy.
Article 7. Procedures for listing the testing institution.
1. Application documents:
a. An application form using the form No. 01 in Appendix I hereto.
b. A certified true copy of the documents as proofs of establishment and operation of the institution.
c. Documents proving there is one faculty or course of the foreign language stipulated in Clause 2, Article 6 hereof, and a list of lecturers of this faculty or course who work full time.
d. A question bank serving testing on proficiency in Vietnamese language or other languages or qualification for interpretation in the field of pharmacy, using one of the main languages stipulated in Clause 2, Article 4 of this Circular.
2. In case the testing institution registers for another language stipulated in Clause 2, Article 4 hereof to be used in their testing program, the application shall be submitted in accordance with point a, c, d in Clause 1 of this Article.
3. Procedures:
a. The educational institution shall send 01 set of documents, stipulated in Clause 1, Clause 2 of this Article, to the Ministry of Health (Department of Science and Technology and Training) to request for the listing.
b. The Ministry of Health (Department of Science and Technology and Training) shall return to the educational institution the paper proof of delivery using form No. 02 in Appendix I hereto.
c. Within 05 (five) working days from the date written on the Paper proof of delivery, the Ministry of Health (Department of Science and Technology and Training) shall post on its website the information regarding the testing institution. If the aforesaid institution can’t be listed, the Ministry of Health shall provide explanation in writing.
Article 8. Delisting of testing institution.
1. The institution no longer provides tests or issues certificates or qualifications.
2. Any of the requirements stipulated in Article 6 of this Circular is not satisfied.
3. Falsifying application documents for listing of testing institution.
Article 9. Procedures for delisting of testing institution.
1. Within 05 (five) working days from the date receiving the results from the competent authority for delisting of testing institutions stipulated in Article 8 hereof, the Ministry of Health (Department of Science and Technology and Training) shall delist the institutions under its control; otherwise it shall provide explanation in writing to the organizations or individuals that request the delisting.
2. Within 05 (five) working days from the date on which the decision on delisting is promulgated, the Ministry shall:
a. Post the decision on delisting on its website and send this decision to the Departments of Health nationwide.
b. Update information regarding the delisting of testing institution on its website
Article 10. Procedures for requesting the test and certificate of fluency in Vietnamese language or other languages or the qualification for interpretation in the field of pharmacy.
1. The application documents for requesting the test and certificate include:
a. A written application for the test and certificate using form No. 03 in Appendix I hereto.
b. A certified true copy of the ID card or citizen identity card or passport or equivalent valid documents.
c. 02 (two) photos of 04 cm x 06 cm with a white background behind taken within 06 months before the date of submission of the application.
2. Procedures for providing the test and issuing the certificate:
a. The applicant shall submit 01 set of documents stipulated in Clause 1 hereof to the educational institution stipulated in point c, Clause 3, Article 7 hereof.
b. Within 30 days from the date receiving the legal documents, the educational institution shall test and certify those who satisfy the requirements stipulated in Clause 1 and Clause 2, Article 4, and Clause 1, Article 5 hereof using form No. 04 in Appendix hereto. If the education institution does not issue the certificate, it shall provide explanation in writing.
Within 03 (three) working days from the date receiving the testing results, the educational institution shall post up the results.
3. The application documents for the certificate of fluency in Vietnamese language or other languages or the qualification for interpretation in the field of pharmacy include:
a. An application form using form No. 05 in Appendix I hereto.
b. Documents and photos stipulated in point b and c, Clause 1 of this Article.
c. A certified true copy of the certificate stipulated in Clause 3, Article 4 of this Circular for those who satisfy the requirements of fluency; a certified true copy of certificate stipulated in Clause 2, Article 5 hereof for those who satisfy the requirements of interpretation.
4. Certifying procedures:
a. The applicant shall submit 01 set of documents stipulated in Clause 3 hereof to the testing institution mentioned in point c, Clause 3, Article 7 of this Circular.
b. Within 10 working days from the date receiving the sufficient legal documents, the legal educational institution shall issue the certificate using form No. 04 in Appendix hereto to those that satisfy the requirements stipulated in Clause 3, Article 4 and Clause 2, Article 5 hereof. If the institution does not issue the certificate or qualification, it shall provide explanation in writing.
Within 03 (three) working days from the date receiving the approving results, the educational institution shall publicly post these results up.
Chapter III
NOTIFICATION AND PUBLISHING OF THE LIST OF PHARMACY PRACTITIONERS.
Article 11. Notification of the list of practitioners who have pharmacy practice certificates shall be sent to the competent authority.
Within 30 (thirty) days from the date starting the business or having changes of holders of pharmacy practice certificates, the pharmacy business establishment shall notify the Department of Health of province or central-affiliated city (hereinafter referred to as Department of Health) about the list of these holders using form No. 06 in Appendix I hereto, and also attach the file or update online as guided by Department of Health.
Article 12. Publishing of the list of holders of pharmacy practice certificates.
Within 05 (five) working days from the date receiving the list of holders of pharmacy practice certificates who are currently working at the pharmacy business establishment within the area, the Department of Health shall post this list on its website as stipulated in Clause 11 of this Circular.
Chapter IV
ESTABLISHMENT HAVING PHARMACY-RELATED ACTIVITIES WITHOUT HAVING TO OBTAIN A CERTIFICATE OF ELIGIBILITY FOR PHARMACY BUSINESS.
Article 13. General provisions for the non-profit establishments having pharmacy-related activities.
1. Non-profit establishments having pharmacy-related activities are establishments that do not apply for business registration according to the Law on Enterprises; however, they do practice pharmacy as stipulated in Clause 2 of this Article. These pharmacies include:
a. Public Sector Entities.
b. Military pharmacies that provide services with financial autonomy mechanism or price their drugs according to the provisions of the Government do not fall into the cases stipulated in point d, Clause 1, Article 35 of the Law on Pharmacy.
c. The pharmacy of the clinical units; storages of vaccines and/or drugs of the expanded immunization centers.
2. Activities of non-profit establishments include: manufacture, storage, transportation and distribution of drugs and of medicinal ingredients, testingof drugs and medicinal ingredients, bioequivalent evaluationand clinical trial.
3. The evaluation of Good Practice of the non-profit establishment is to be carried out in accordance with the Good Practice requirements promulgated by the Minister of Health. The aforesaid establishment shall satisfy the Good Practice requirements stipulated in Article 142 of the Decree No. 54/2017/ND-CP.
Article 14. Procedures for listing of pharmacy business establishment that has a drug cabinet.
1. Application for listing of pharmacy business establishment that has a drug cabinet.
a. An application form of business establishment that has a drug cabinet, using form No. 07 in Appendix I hereto.
b. A copy of the Decision of establishment or the Investment License or the Certificate of Business Registration that has the establishment’s signature and stamp.
c. A certified true copy of the basic degree or higher in pharmacy of the head of the business establishment.
d. A list of drugs in the cabinet expected to be sold. This list shall be included in the list of permissible cabinet drugs stipulated in the Appendix II hereto.
dd. A photo of the drugs cabinet.
e. Procedures for evaluating and supervising the drugs qualities and for importing and exporting drugs of the establishment.
2. Procedures for listing of the business establishment that has a drug cabinet:
a. Before operation, the business establishment that has a drug cabinet shall send 01 set of application documents via the post office to the Department of Health within its area according to Clause 1 of this Article.
b. Once the application is received, the Department of Health shall provide a paper proof of delivery for the establishment using form No. 02 in the Appendix I hereto.
c. Within 05 (five) working days from the date written on the paper proof of delivery, the Department of Health shall post the list of the approved business establishments that have drug cabinets on its website. If a business establishment can’t be listed, the Department of Health shall provide explanation in writing.
Article 15. The business establishment that has a drug cabinet shall be delisted if:
1. The business establishment is shut down or stops selling drugs from the drug cabinet.
2. Any of conditions for business establishment that has a drug cabinet stipulated in point b, Clause 2, Article 35 of the Law on Pharmacy is not satisfied.
3. The contents for listing the business establishment that has a drug cabinet are ultra vires or against the law.
4. The establishment falsifies the application documents.
5. The establishment suspends for 12 (twelve) consecutive months without notifying the Department of Health within its area.
Article 16. Procedures for delisting of business establishment that has a drug cabinet.
1. Within 05 (five) working days from the date receiving the results from the competent authority to delist the establishment stipulated in Article 15 hereof, the Department of Health shall delist the establishment under its control; otherwise it shall provide explanation in writing for the organizations and individuals that request the delisting.
2. Within 05 (five) working days from the date on which the decision on delisting is promulgated, the Department of Health shall:
a. Post the decision on delisting on its website and send this decision to the Ministry of Health and other Departments of Health nationwide.
b. Update the information regarding the delisting on its website.
Article 17. Responsibilities of the establishment having pharmacy-related activities without having to obtain the certificate of eligibility for pharmacy business.
1. Make a signboard with full name and address of the head of the pharmacy business establishment, the procedures and scope and area of practice written on it.
2. Take full responsibilities for providing and maintaining the establishment’s operating conditions and the origin and quality of drugs.
Chapter V
RETAILING DRUGS ON THE LIST OF DRUGS RESTRICTED FROM RETAILING AND RETAILING EXTRA DRUGS AT THE DRUGS COUNTERS.
Article 18. The List of drugs restricted from retailing.
1. Drugs restricted from retailing include those that lead to dependence or make people unable to use other drugs. The prescription, sale and use of these drugs are required to be supervised carefully.
2. List of drugs restricted from retailing is provided in Appendix III hereto.
Article 19. Retailing drugs which are restricted from retailing.
The Department of Health, based on the epidemiology in the province, grants a permit for retiling some drugs on the list of drugs restricted from retailing stipulated in Article 55, Decree No. 54/2017/ND-CP. The epidemiology of the province is defined according to the medical statistics yearbook, surveys and the published scientific researches.
Article 20. Receptions in ethnic minority areas, highlands, islands and extremely disadvantaged areas.
Based on the disease situation in the province as stipulated in Article 19 of this Circular, the pharmacies in the ethnic minority areas, highlands, islands and extremely disadvantages areas are permitted by the Department of Health to retail prescription drugs which are not on the List of essential drugs.
Chapter VI
THE SALE REPRESENTATIVE OF THE PHARMACY
Article 21. Requirements for the sale representative.
1. The sale representative of the pharmacy is granted a sale representative card by the head of the pharmacy business establishment to introduce drugs to medicine practitioners.
2. The sale representative shall satisfy the following requirements:
a. Having a college degree or higher in medicine or pharmacy.
b. Being recruited and trained by the pharmacy business establishment for professional skills related to introducing drugs and understanding the legislative documents on Pharmacy.
3. Cases where the sale representative is not recruited include:
a. Be facing a criminal prosecution, serving a court’s sentence or ruling; be suspended from practice or doing works related to pharmacy under the court’s sentence or ruling.
b. Having limited legal capacity.
Article 22. Responsibilities of the sale representative.
1. Wear the sale representative card issued by the establishment and follow the regulations promulgated by the health facilities while working as stipulated in Clause 2, Article 24 hereof. The sale representative shall only introduce drugs if permitted by the medical practitioners.
2. Only introduce drugs on the List of drugs which is assigned by the pharmacy business establishment, and shall only provide information from the registered medication guides or any drugs information that is verified by the competent authority of the Ministry of Health.
3. When required by the head of health facility or the medical practitioner, provide legal documents proving the legality of the drug information according to the regulations.
4. Collect the reports on the drugs’ adverse effects and reports related to the quality of drugs, then send them to the competent authority of the Ministry of Health according to the National guidelines on Pharmacovigilance promulgated by the Ministry of Health.
5. Prohibited acts:
a. Informing drugs information that is not as accurate as the applied information or the information verified by the regulatory authority. Publishing the drugs information or documents that are not verified by the regulatory authority.
b. Introducing drugs that are not assigned to introduce by the pharmacy business establishment.
c. Using material benefits to affect the medical practitioner or drugs user to make them give more prescriptions or purchase more drugs.
d. Introducing or providing drugs information that is not appropriate according to Clause 3, Article 76 of the Law on Pharmacy.
dd. Comparing and/or introducing the drugs from his/her establishment with another establishment without providing scientific proof documents which are approved by the competent authority.
e. Introducing products other than drugs.
g. Having activities related to selling and purchasing drugs with the medical practitioners.
h. Approaching the patient, collecting information regarding the medical records and drugs prescriptions of the patient; discussing or requiring information related to the patient.
i. Providing documents and/or information of drugs to the entities that are not permitted by the competent authority of Ministry of Health.
Article 23. Responsibilities of the heads of pharmacy business establishments that employ pharmaceutical sale representatives.
1. Take full responsibilities for the sale representative’s practice and drug information they provide.
2. Provide training for the sale representative in accordance with Clause 2, Article 21 hereof.
3. Provide adequate information regarding the legal and technical documents for the sale representative to make sure the introducing process is carried out legally as stipulated in this Circular.
4. Issue the sale representative card using form No. 08 in Appendix hereto for the sale representative who satisfies the requirements stipulated in Clause 2, Article 21 hereof.
5. No later than 07 (seven) working days from the date issuing the sale representative cards, the head of the establishment shall send the list of holders of the cards using form No. 09 in Appendix I hereto, or update that list online and send it to the Department of Health where the sale representative introduces drugs.
If there are amendments to the list of sale representatives, the head of the establishment shall issue or change the cards, and update these changes in accordance with the procedures for first time issuing the cards.
6. Revoke the sale representative card from the representative that:
a. Has his/her labor contract terminated.
b. Stops introducing drugs.
c. Falls into the cases stipulated in Clause 3, Article 21 of this Circular.
d. Violates one of the regulations stipulated in Clause 5, Article 22 of this Circular.
7. Within 07 (seven) working days from the date revoking the sale representative card, the head of the establishment shall send the list of those who have their cards revoked using form No. 10 in Appendix I hereto, or update that list online and send it to the Department of Health where the sale representative introduces drugs.
8. The head of the establishment shall not issue the sale representative card within 12 (twelve) months from the date on which he/she revoked the card from those that fall into the cases stipulated in point d, Clause 6 of this Article.
Article 24. Responsibilities of the head of health facility where the sale representative introduces drugs.
1. Allow only holders of the sale representative cards to introduce drugs and publish information about drugs that are permitted and certified by the regulatory authority of the Ministry of Health.
2. Promulgate and implement the regulations on organizing location and time for the sale representative to introduce drugs to the medical practitioners, and other related regulations stipulated in this Circular that the sale representative shall comply with.
3. Implement measures for prohibiting the medical practitioner’s acts of prescribing drugs and providing medication instructions with profits purposes due to being materially or financially affected by the sale representative.
4. Suspend any sale representative that fails to fulfill his/her duties stipulated in Article 22 of this Circular.
Article 25. Responsibilities of the Department of Health where the sale representative introduces drugs.
1. Post up or remove the list of holders of the sale representative cards on its website within 07 (seven) working days from the date receiving that list and another list of those who have their sale representative cards revoked according to Clause 5 or Clause 7, Article 23 hereof
2. Direct the health facilities in their areas and take full responsibility for doing their job as stipulated in Clause 24 of this Circular.
3. Evaluate and inspect the activities of providing drugs information; Take actions against the sale representative and the establishment where he/she works within the area where they are required to comply with the regulations stipulated in this Circular.
Chapter VII
ORGANIZATION AND OPERATION OF THE ADVISORY COUNCIL FOR ISSUANCE OF PHARMACY PRACTICE CERTIFICATE.
Article 26. Establishment of the Advisory Council.
1. Minister of Health makes a decision to establish the Advisory Council for issuance of pharmacy practice certificate requiring an examination (hereinafter referred to as Ministry of Health's Advisory Council for issuance of pharmacy practice certificate)
2. The director of the Department of Health makes a decision to establish the Advisory Council for issuance of pharmacy practice certificate requiring an application (hereinafter referred to as Department of Health's Advisory Council for issuance of pharmacy practice certificate)
Article 27. Members of the Advisory Council.
1. The Department of Health’s Advisory Council shall be composed of 05 (five) members include: Chairperson, Deputy Chairperson, Secretary and other members, to be specific: Head of Department of Health, senior representatives from the following agencies: related departments, pharmacy association, regulatory agency of education, educational institution and public college as stipulated in Clause 3 of this Article, and other cadres from related units of the Ministry of Health.
2. The Ministry of Health’s Advisory Council for issuance of pharmacy practice certificate shall be composed of 05 (five) members include: Chairperson, Deputy Chairperson, Secretary and other members, to be specific: Head of Ministry of Health, Head of Drug Administration, Head of Traditional Medicine Administration for issuing certificates of private practice of traditional medicine, Head of Department of Science and Technology and Training, Head of Department of Legal Affairs, representatives from the following agencies: pharmacy association, regulatory agency of education, educational institution and public college as stipulated in Clause 3 of this Article and other cadres from related units of the Ministry of Health.
3. In case where the practitioner’s title and profession are not confirmed and written on the certificate as stipulated in Article 17, Decree No. 54/2017/ND-CP, the Advisory Council shall also include representatives from the following agencies: regulatory agency of education, higher educational institution and public college.
4. In case where the Advisory Council’s members are representatives of units and organizations, they shall be the heads of these units and organizations or nominated by them.
Operation of the Advisory Council for issuance of pharmacy practice certificate.
1. The Advisory Council has the responsibility to develop its operation regulation and report it to the Minister of Health or the Director of Department of Health to approve and implement after that.
2. The Advisory Council has the responsibility to advise the issuing authority in issuing, replacing, and revoking the pharmacy practice certificate.
Chapter VIII
IMPLEMENTATION
Article 29. Entry into force and implementation.
1. This Circular comes into force from June 01, 2018
2. Circular No. 13/2009/TT-BYT dated September 01, 2009 of the Minister of Health shall be expired from the date on which this Circular comes into force.
Article 30. Terms of reference.
In cases where the legislative documents and regulations of this Circular are amended or replaced, the new legislative documents shall apply.
Article 31. Transition
1. From January 01, 2019, the pharmacy practitioners stipulated in Clause 1, Article 3 of this Circular who are already issued with pharmacy practice certificates before this Circular comes into force, while practicing, shall have interpreters or shall satisfy the pharmacy language requirements stipulated in this Circular.
2. Those who are issued with the sale representative cards according to the Circular No. 13/2009/TT-BYT dated September 01, 2009 of the Minister of Health shall be able to introduce drugs until the expiration date on the cards.
3. In cases where the practitioners who submit applications for the certificates of eligibility for pharmacy business, as stipulated in Article 28, Decree No. 89/2012/ND-CP dated October 24, 2012 of the Government, already submit the original of the pharmacy practice certificate of the head of the establishment, the agency that receives the applications shall return the original to the head of the establishment if:
a. The head of the pharmacy business establishment is changed.
b. The establishment is shut down.
c. The establishment submits application for the Certificate of eligibility for pharmacy business but receives the reply in writing not to issue from the issuing agency.
d. The individual who has his/her name written on the certificate requests the agency to return the certificate to him/her.
When return the original of the Certificate, the issuing agency shall save the certified true copies of the applications and shall write hand-over reports using form No. 11 in the Appendix I hereto. The issuing agency shall save 01 report, the receiver shall save 01 report.
Article 32. Implementation responsibilities:
The Drug Administration, Traditional Medicine Administration, Department of Science and Technology and Training, units under the Ministry of Health and Department of Health, related agencies, organizations and individuals shall implement this Circular.
The Department of Health shall check and keep track of the drug retailers within the areas that sell drugs included in the list of drugs restricted from retailing stipulated in this Circular.
During the implementation process, if there is any problem, the agencies, organizations and individuals shall notify the Ministry of Health (Drug Administration, Traditional Medicine Administration, Department of Science and Technology and Training) to solve them.
| PP. MINISTER |
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