Circular 39/2013/tt-Byt: Regulations On The Management Of Medicines For The People By Way Of Import, Export Africa Trade

Original Language Title: Thông tư 39/2013/TT-BYT: Quy định về quản lí thuốc chữa bệnh cho người theo đường xuất khẩu, nhập khẩu phi mậu dịch

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MINISTRY OF HEALTH
Number: 39 /2013/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, November 1, 2013

IT ' S SMART

Q It ' s about the management of medicines for people with export, importing and importing.

__________________________

The Code of Pharmacy. 34 /2005/QH11 June 14, 2005;

Department of Defense, Anti-Drug Code 23 /2000-QH10 December 9, 2000;

Base of Protocol 58 /2003/NĐ-CP May 29, 2003 The government regulates the import, export, transportation of the territory of Vietnam, drug, drug, drug, and drug.

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government stipulated the function, mandate, jurisdiction and organizational structure of the Ministry of Health;

Base Decision Base 42 /2013/QĐ-TTg July 15, 2013 by the Prime Minister of the Government of the Government of the Government of the Government of the Government of the Government of the Government of the United States of the Government of the Government of the Government of the Government of the Government of the Government of the United States of the United States of the United States of the United States of the United States of the United States, on 15 July 2013, on the management of the drug Number Decision 151 /2007/QĐ-TTg September 12, 2007 of Prime Minister;

On the recommendation of the Director of the Bureau of Pharmacology,

The Minister of Health has issued a regulatory provision for the management of medicines for people on the export route, importing the non-trade.

What? 1. The adjustment range

1. This information specifies whether the operation is involved in the export, importing the drug used to the person (later called the drug) according to the non-trade route.

2. Drug treatment for people in the export route, importing the prescribed non-trade at this Smart Line include:

a) The drug is a gift, a gift of the organization, the individual in Vietnam to the organization, the individual abroad; the organization, the overseas individual sent to the organization, the individual in Vietnam;

b) The drugs of the goods of the diplomatic representative body, the international organization in Vietnam or the diplomatic representative body, the organization of Vietnam abroad and those who work in the agencies, the organization. The case is preferable, with the exception of the Customs procedure, according to the International Convention in which Vietnam is a member.

c) The drug's personal luggage, the entry of a single transport, is carried by the person of the landscape, entry.

3. The export forms, importing other non-commercial drugs (imported drugs, imported to model registrants, samples, and experimental substances, research, aid medicines, humanitarian aid) are not part of the scope of this information.

What? 2. Joint regulation on imported medicine, imported by non-trade route

1. The export medication, imported by the non-trade route only to treat the disease for themselves and the individual family to offer export, importing drugs on non-trade routes, the individual working in the organization offering export, importing non-trade drugs. Non-trade imported drugs are not marketed or used for any other illegal purposes.

2. Personally, the organization recommends exporting, importing the drug on the non-trade route responsible for the origin and quality of the export drug, importing the drug according to the non-trade route.

3. Import by non-trade routes must have a label that records the name of the drug, the name of the material, the concentration, the content, the shelf life.

4. In addition to the prescribed implementation at this message, the arrival of the arrival is required to implement the law of entry.

What? 3. The export ban, imported by non-trade route

1. Drug-making ingredients.

2. The drugs that contain the activity in the category of prohibited export, import used as the prescribed medication at the Digital Information 47 /2010/TT-BYT On December 21, 2010, the Minister of Health directed the export, importing, and revised documents of the Ministry of Health, the Department of Health's announcement of the cessation of use, importation.

What? 4. The drug level is allowed to export, export non-trade

1. The number of drug-based drug-based medications, the entry is not overtaken by the prescription of the physician and cannot exceed the number of applications used for 7 days.

2. The number of psychochemicals, prescriptions for non-commercial imported drugs, is not overtaken by the number of applications of the physician and cannot exceed the number of designated users for 10 days.

3. Other food drugs are allowed to export by non-trade routes that do not restrict the number and number of sending or carrying people abroad; are allowed to import by non-trade routes but the total value of imported drugs is not too much equivalent. US$ 100USD (equivalent to the interbank rate) once, the maximum number of receiving the drug is no more than 3 times per year for an individual, organization.

4. The case of the number of exported drugs, imported by non-trade routes beyond the stipulation rate at 1, 2 and 3 This, must be allowed by the regulatory authority to have jurisdiction under regulation at this Article 6.

What? 5. export records, import drug on non-trade routes

1. An export profile, importing the drug according to the non-trade route stipulated at paragraph 1, paragraph 2 Article 4 This message consists of:

a) The prescription, the medical examination: The prescription of the Vietnamese physician, the outpatient examination of the Foreign Tuberculosis Examination at Appendix I issued by Decision No. 04 /2008/QĐ-BYT February 1, 2008, of the Minister of Health on the issue of the Code of Health prescribation in Foreign Affairs, the Drug Order, a medical doctor, is required to be recorded in English or Vietnamese, if in other languages, it must be translated into English. You or the Vietnamese and you have to have the following:

-Name, the patient's age.

-The drug, the content or the concentration and the volume.

-The number of drugs (or the number of days of medication)

-A dose.

-The name, the physician's signature.

-The address of the healer (the address where the healer practice: hospital, clinic).

b) Individuals with export procedures, importing non-trade drugs must have full prescribation and prescription applications with Customs.

2. export records, import of drugs according to the non-trade route stipulated at the 4 Article 4 This message consists of:

a) (Form 1a/PMD or 1b/PMD)

b) A photograph of the People's Certificate or passport of the export or import of the drug according to the non-trade route (when the Customs procedure must first publish the identity of the people, passport)

c) The following documents: The prescription or medical records or medical records or the corresponding documents.

d) The prescription of the Vietnamese medicine teacher, the outpatient examination for the prescribed pattern at Annex I issued by Decision No. 1. 04 /2008/QĐ-BYT 01/02/2008 of the Minister of Health for the promulonation of the Drug Prescribed Procedure in outpatient treatment. The foreign physician's application, the medical records, the medical records must have the prescribed content at this one.

What? 6. Presentation, jurisdiction allows export, import of drug on non-trade routes

1. Drug export, non-trade by non-commercial individuals who meet valuation in paragraph 1, 2, and 3 Article 4 This information, personally making the export procedure, imported at the store customs.

2. The case of exporting, importing the drug according to the individual ' s non-trade route, or the number of receiving drugs for greater treatment of regulation at paragraph 2, paragraph 3 Article 4 This information, based on the medical treatment of medical and pharmaceutical regulations. relevant, the Local Health Department will consider allowing the drug to be taken for treatment as follows:

a) For individual drugs that appear, legal entry carries out or into Vietnam, the local Department of Health where the store is a procedure, entry, or the Health Department where the person is living or temporarily legally residing as a review agency.

b) For the medicines taken by the individual from abroad, the Department of Health where the person is residing or temporarily legally residing is the subject of the review.

3. The case of exporting, importing the drug according to the organization ' s non-trade route, the Ministry of Health (Department of Pharmacy) based on the medical treatment of medical and regulatory practices is relevant for the permit.

4. The case of export, import of drug on non-trade routes, or the number of receiving larger drugs than the prescribed rate at 1 Article 4 This information, the Ministry of Health (Bureau of Pharmacology) based on the medical treatment of medical and drug-related medicine. Yes, I do.

5. During the 7-day period of work, the agency has the authority to answer the results, granting the export license, importing or answering a written statement stating the reasons for not granting.

6. For the export case, import of non-trade drugs exceeds the stipulation rate at paragraph 4 Article 4 This Smart, while waiting for a written permit of the regulatory authority under the prescribed jurisdiction at paragraph 2, 3 and paragraph 4 Articles 4. Now, personally, the organization is allowed to take the drug with the correct number of regulations at paragraph 1, 2 and paragraph 3 Article 4 of this.

What? 7. Waste Processing

1. The export drugs, imported by non-trade routes with regulation at this Smart, will be processed as export drugs, unauthorized imports, seized and processed by regulation at the United States Digital Protocol. 176 /2013/NĐ-CP November 14, 2013 of the Government of the United States Regulation of sanctions in the field of health and other provisions of the law are involved.

2. organizations, shipping individuals, export drug business, import of drug on non-trade routes with the regulation of this Smart are considered to be transported, unauthorized drug business and regulated by regulation at the International Protocol. 176 /2013/NĐ-CP November 14, 2013 of the Government of the United States Regulation of sanctions in the field of health and other provisions of the law are involved.

What? 8. The transition clause

1. Prescriptions for export, import of drug on non-trade by the Ministry of Health (Bureau of Pharmacology), the Department of Health of the Provinces, the central central city to the individual, the prescribed organization at No. 01 /2007/TT-BYT On January 17, 2007, the Minister of Health guidelines for the management of medicines for people with sugar, exports, importing non-trade, to be allowed to perform at the end of the process of writing in writing.

2. The case of a law that rules the reference law at this message is modified, complemated or replaced, according to the revised text law of amendment, addition or replacement,

What? 9. organizational responsibility

The Director of the Bureau of Pharmacology, Director of the Department of Health, the Central City of the Central Committee is responsible for the organization's implementation of this information.

What? 10. The effect of execution

1. This message has been in effect since 1 January 2014.

2. Digital News 01 /2007/TT-BYT January 17, 2007, of the Minister of Health, which governs the management of the drug for a person on the export route, importing the non-commercial non-commercial since this date is effective.

In the course of execution, if there is difficulty, entangrium, agency recommendation, organization, individual feedback on the Ministry of Health (Bureau of Pharmacology) to be guided or modified, supplements the ./.

KT. MINISTER.
Captain.

(signed)

Mr. Lê Tuan