Decision No. 42/2013/QD-TTg stipulates the management of medicines for human use through export and non-commercial import, and amends and supplements certain provisions on the importation of medicines without registration numbers in Vietnam as issued by Decision No. 151/2007/QD-TTg dated September 12, 2007 of the Government.

Pursuant to …;

Regulations on the management of medicines for human use through export and non-commercial import,and amendments and supplements to certain provisions onthe importation of medicines not yet registered in Vietnam issued together with Decision No. 151/2007/QĐ-TTgSeptember 12, 2007Pursuant to Decree No. 58/2003/NĐ-CP dated May 29, 2003 of the Government on the control of export, import, and transit through the territory of Vietnam of narcotic drugs, precursor chemicals, addictive drugs, and psychotropic substances; of the Prime Minister

Based on the Law on the Organization of the Government dated December 25, 2001;

Pursuant to the Medicine Law dated June 14, 2005;

Pursuant to the Law on Prevention and Control of Narcotics dated December 9, 2000 and the Law Amending and Supplementing Some Articles of the Law on Prevention and Control of Narcotics dated June 3, 2008;

The Prime Minister promulgates regulations on the management of medicines for human use through export and non-commercial import, and amends and supplements certain provisions of the regulations on the importation of medicines not yet registered in Vietnam issued together with Decision No. 151/2007/QĐ-TTg dated September 12, 2007 of the Prime Minister.

At the proposal of the Minister of Health;

Article 1. Regulations on the management of medicines for human use through export and non-commercial import

1. Medicines for export and import through non-commercial channels as stipulated in this Decision include:

a) Gifts and presents from organizations and individuals abroad sent to organizations and individuals in Vietnam; from organizations and individuals in Vietnam sent to organizations and individuals abroad;

b) Goods of diplomatic missions, international organizations in Vietnam, and persons working at these agencies and organizations;

c) Personal luggage of persons exiting or entering the country carried according to the bill of lading, and goods carried by persons entering the country.

2. Medicines for export and import through non-commercial channels may only be permitted for export and import for personal use, family use, or for individuals working at organizations exporting and importing medicines through non-commercial channels as stipulated in Clause 1 of this Article.

3. Quantity limits for medicines allowed for export and import through non-commercial channels:

a) The quantity of finished addictive medicines carried by persons when exiting or entering the country shall not exceed the quantity stated in the prescription attached and shall not exceed the quantity prescribed for use within seven days;

b) The quantity of finished psychotropic medicines and precursors used for export and import through non-commercial channels shall not exceed the quantity stated in the prescription attached and shall not exceed the quantity prescribed for use within ten days;

c) Other finished medicines allowed for export through non-commercial channels are not subject to quantity limits or the number of times they can be sent or carried out of the country; allowed for import through non-commercial channels but the total value of imported medicines shall not exceed the equivalent of 100 US dollars (One hundred United States Dollars) per time, the maximum number of times receiving medicines for one individual or organization in a year shall not exceed three times;

d) In cases where the quantity of medicines exported or imported through non-commercial channels exceeds the limits specified in Points a, b, and c of this Clause, a permit for export or import must be obtained from the competent state agency.

4. The Ministry of Health shall specify the documentation for the export and import of medicines through non-commercial channels as stipulated in Points a, b, and c of Clause 3 of this Article, and shall specify the documentation, procedures, and formalities for issuing permits for the export and import of medicines through non-commercial channels as stipulated in Point d of Clause 3 of this Article.

5. Types of medicines prohibited from being exported or imported through non-commercial channels:

a) Raw materials for medicines;

b) Finished medicines containing active ingredients listed in the Catalogue of Prohibited Export and Import Active Ingredients issued by the Ministry of Health.

b) Finished pharmaceutical products containing active substances listed in the Prohibition of Export and Import Active Substances Catalog issued by the Ministry of Health.

Article 2. Amend and supplement some articles of the Regulations on the importation of medicines without registration numbers in Vietnam issued together with Decision No. 151/2007/QĐ-TTg dated September 12, 2007 of the Government Prime Minister as follows:

1. AMENDING AND SUPPLEMENTING ARTICLE 3 AS FOLLOWS:

"Article 3. Principles for managing medicines without registration numbers imported into Vietnam

1. Finished medicines without registration numbers shall only be allowed to be imported under an Import Permit. The Import Permit for finished medicines without registration numbers shall have a maximum validity of one year from the date of issuance.

2. Raw materials for medicines without registration numbers imported for the production of medicines with valid registration numbers, the Ministry of Health shall announce and regularly update the List of raw materials for medicines according to each type of medicine that has been granted registration numbers so that enterprises can import them based on their needs. The period for importing raw materials for medicines under the form of announcement shall be equal to the validity period of the registration number of the medicine produced from those raw materials.

3. Raw materials for medicines without registration numbers imported for the production of medicines with valid registration numbers but not yet announced in accordance with Clause 2 of this Article shall be allowed to be imported under an Import Permit. The Import Permit for raw materials for medicines without registration numbers shall have a maximum validity of two years from the date of issuance.

4. The Minister of Health shall guide the dossier, procedures, and formalities for issuing an Import Permit for medicines without registration numbers and the procedures and contents of announcing the List of raw materials for medicines permitted to be imported without requiring an Import Permit."

2. Supplement Clause 2 to Article 4 as follows:

"2. Enterprises that have not been granted a Certificate of Compliance for Medicine Production Conditions shall be allowed to import raw materials for medicines for trial production in quantities suitable for the expected scale of production. Products from the trial production process may only be used for research purposes and shall not be allowed to circulate or be used for people."

3. Supplement Point d to Clause 2 of Article 6 as follows:

"d) For rare medicines and medicines for hospital treatment in special cases with an expiration date of 24 months or more, the remaining expiration date of the medicine must be at least 12 months from the date of arrival at the Vietnamese port. In the case of medicines with an expiration date less than 24 months, the remaining expiration date of the medicine must be at least one-third of the expiration date of the medicine from the date of arrival at the Vietnamese port."

4. Amend and supplement Article 10 as follows:

"Article 10. Regarding raw materials for medicines without registration numbers

1. Raw materials for medicines without registration numbers that are allowed to be imported into Vietnam include:

a) Raw materials for medicines without registration numbers imported for the production of medicines with valid registration numbers of domestic medicine manufacturing facilities;

b) Raw materials for medicines without registration numbers for research and testing purposes, which can only be used for research and testing purposes in quantities suitable for the research and testing purposes;

c) Raw materials for medicines without registration numbers imported for the purpose of making samples for circulation registration in Vietnam, each type being imported in sufficient quantity for testing requirements.

2. Imported raw materials for medicines must meet quality standards and must ensure quality in accordance with the quality standards stated on the import order or registered in the drug registration dossier.

3. For raw materials for medicines belonging to the List of narcotic drugs, psychotropic substances, and precursor chemicals used in medicines without registration numbers, they must comply with the provisions of this Decision and the guidelines of the Ministry of Health on activities related to narcotic drugs, psychotropic substances, and precursor chemicals used in medicines, and other relevant laws."

Article 3. Transitional Provisions

1. Dossiers for non-commercial export and import of medicines submitted before this Decision takes effect shall be processed in accordance with Decision No. 71/2002/QĐ-TTg dated June 7, 2002 of the Government Prime Minister on the management of medicines for human treatment through non-commercial export and import channels.

2. Dossiers for applying for an Import Permit for medicines without registration numbers submitted before this Decision takes effect shall be processed in accordance with Decision No. 151/2007/QĐ-TTg dated September 12, 2007 of the Government Prime Minister promulgating the Regulations on the importation of medicines without registration numbers in Vietnam.

3. Import Permits for raw materials for medicines without registration numbers issued before this Decision takes effect shall remain valid until the expiry date stated on the permit.

Article 4. Responsibilities and Effectiveness of Enforcement

This Decision shall take effect from January 1, 2014.

Decision No. 71/2002/QĐ-TTg dated June 7, 2002, of the Government Chairman on the management of medicines for human treatment through non-trade export and import shall cease to be effective from the date this Decision takes effect.

The Ministry of Health shall be responsible for issuing guiding documents to implement this Decision.

THE MINISTERS, HEADS OF GOVERNMENT-LEVEL MINISTRIES, HEADS OF GOVERNMENT-LEVEL AGENCIES, AND CHAIRMEN OF PROVINCE AND CITY PEOPLE'S COMMITTEES DIRECTLY UNDER THE CENTRAL GOVERNMENT SHALL BE RESPONSIBLE FOR ENFORCING THIS DECISION./.