Decision No. 42/2013/QD-TTg of July 15, 2013, providing the management of drugs for human use which are imported and exported through non-commercial channel, and amending and supplementing a number of articles of the Regulation on import of drugs without registration numbers in Vietnam promulgated together wi........

DECISION

PROVIDING THE MANAGEMENT OF DRUGS FOR HUMAN USE WHICH ARE IMPORTED AND EXPORTED THROUGH NON-COMMERCIAL CHANNEL, AND AMENDING AND SUPPLEMENTING A NUMBER OF ARTICLES OF THE REGULATION ON IMPORT OF DRUGS WITHOUT REGISTRATION NUMBERS IN VIETNAM PROMULGATED TOGETHER WITH THE PRIME MINISTER’S DECISION NO. 151/2007/QD-TTG OF SEPTEMBER 12, 2007

Pursuant to the December 25, 2001 Law on Organization of the Government;

Pursuant to the June 14, 2005 Law on Pharmacy;

Pursuant to the December 9, 2000 Law on Drug Prevention and Control and the June 3, 2008 Law Amending and Supplementing a Number of Articles of the Law on Drug Prevention and Control;

Pursuant to the Government’s Decree No. 58/2003/ND-CP of May 29, 2003, prescribing the control of import, export and transit via Vietnamese territory of narcotic substances, pre-substances, addictive drugs and psychotropic drugs;

At the proposal of the Minister of Health,

The Prime Minister prescribes the management of drugs for human use which are imported and exported through non-commercial channel, and amendments and supplementations to a number of articles of the Regulation on import of drugs without registration numbers in Vietnam promulgated together with the Prime Minister’s Decision No. 151/2007/QD-TTg of September 12, 2007.

Article 1. Regulations on management of drugs for human use which are imported and exported through non-commercial channel

1. Drugs imported and exported through non-commercial channel prescribed in this Decision include:

a/ Donations and gifts which are given by overseas organizations and individuals to organizations and individuals in Vietnam, or by organizations and individuals in Vietnam to overseas organizations and individuals;

b/ Goods of diplomatic missions and international organizations in Vietnam and employees of these missions and organizations;

c/ Personal luggage of persons on entry or exit which are consigned with bills of lading and carry-on baggage of persons on entry.

2. Drugs eligible for non-commercial import and export may be imported and exported only for use by persons on entry or exit, their families or employees of organizations importing and exporting drugs through non-commercial channel as specified in Clause 1 of this Article.

3. Quotas of drugs permitted for non-commercial import and export:

a/ The quantities of finished addictive drugs being carry-on baggage of persons on entry or exit must not exceed the quantities written in enclosed doctor prescriptions or the dose indicated for 7 days;

b/ The quantities of finished psychotropic drugs and pre-substances used for drug production which are imported and exported through non-commercial channel must not exceed the quantities written in the enclosed doctor prescriptions or the dose indicated for 10 days;

c/ Other finished drugs are permitted for non-commercial export in unlimited quantities and consignments or carry-on baggage; are permitted for non-commercial import provided that the total import value does not exceed USD 100 (one hundred US dollars) each time and that each individual or organization receives drugs no more than 3 times a year;

d/ Competent state agencies’ import or export licenses are required for non-commercial import or export of drugs with quantities exceeding the limits specified at Points a, b and c of this Clause.

4. The Ministry of Health shall specify dossiers for non-commercial import or export of drugs specified at Points a, b and c, Clause 3 of this Article, and dossiers, order and procedures for grant of licenses for non-commercial import or export of drugs specified at Point d, Clause 3 of this Article.

5. Drugs banned from non-commercial import and export include:

a/ Materials used for drug production;

b/ Finished drugs containing active ingredients which are on the Ministry of

Health’s list of active ingredients banned from import and export.

Article 2. To amend and supplement a number of articles of the Regulation on import of drugs without registration numbers in Vietnam promulgated together with the Prime Minister’s Decision No. 151/2007/QD-TTg of September 12, 2007, as follows:

1. To amend and supplement Article 3 as follows:

“Article 3. Principles of managing drugs without registration numbers which are imported into Vietnam

1. Finished drugs without registration numbers may be imported under import license. Such a license is valid for one year at most after its signing.

2. For materials used for drug production without registration numbers imported for production of drugs with valid registration numbers, the Ministry of Health shall publicize and regularly update the list of materials used for drug production detailed to each drug item already granted registration numbers for enterprises to import materials to meet their demands. The time limit for import of materials used for drug production under publicized demands equals the validity duration of registration numbers of drugs produced from such materials.

3. Materials used for drug production without registration numbers which are imported for production of drugs with valid registration numbers while the list of materials used for drug production prescribed in Clause 2 of this Article has not yet been publicized may be imported under import licenses. Such a license is valid for 2 years at most after its signing.

4. The Minister of Health shall guide the dossiers, order and procedures for grant of import licenses for drugs without registration numbers, and the order and contents of publicization of the list of materials used for drug production which are permitted for import without licenses.”

2. To add the following Clause 2 to Article 4:

“2. Enterprises not yet granted drug production eligibility certificates may import materials used for drug production in order to produce drugs on a trial basis with quantities suitable to the expected production scale. Trial products may be used for research purpose only and may not be circulated and used for humans.”

3. To add the following Point dd to Clause 2, Article 6:

“dd/ For rare drugs and drugs for therapeutic demands of hospitals in special cases and with a use duration of 24 months or more, their remaining use duration must be at least 12 months counting from the date they arrive at a Vietnamese port. For drugs with a use duration of less than 24 months, their remaining use duration must equal at least one third of their use duration counting from the date they arrive at a Vietnamese port.”

4. To amend and supplement Article 10 as follows:

“Article 10. For materials used for drug production without registration numbers

1. Materials used for drug production without registration numbers permitted for import into Vietnam include:

a/ Materials used for drug production without registration numbers which are imported for production of drugs with valid registration numbers by domestic drug producers;

b/ Materials used for drug production without registration numbers for research and testing purposes which are used only for research and testing purposes with quantities sufficient for such purposes;

c/ Materials used for drug production without registration numbers which are imported for use as samples registered for circulation in Vietnam with quantities of each kind sufficient for testing purpose.

2. Imported materials used for drug production must be subject to quality standards and have quality according to the standards written in import orders or registered in drug registration dossiers.

3. Materials used for drug production on the list of addictive drugs, psychotropic drugs and pre-substances used for drug production without registration numbers must comply with this Decision and the Ministry of Health’s regulations guiding activities relating to addictive drugs, psychotropic drugs and pre-substances used for drug production, and other relevant regulations.

Article 3. Transitional provisions

1. Dossiers of request for non-commercial import and export of drugs which are submitted before the effective date of this Decision comply with the Prime Minister’s Decision No. 71/2002/QD-TTg of June 7, 2002, on management of curative drugs for human use imported and exported through non-commercial channel.

2. Dossiers of application for import licenses for drugs without registration numbers which are submitted before the effective date of this Decision comply with the Prime Minister’s Decision No. 151/2007/QD-TTg of September 12, 2007, promulgating the Regulation on import of drugs without registration numbers in Vietnam.

3. Import licenses for materials used for drug production without registration numbers which are granted before the effective date of this Decision will be valid till their expiration date.

Article 4. Implementation responsibility and effect

This Decision takes effect on January 1, 2014.

The Prime Minister’s Decision No. 71/2002/QD-TTg of June 7, 2002, on management of curative drugs for human use imported and exported through non-commercial channel, ceases to be effective on the effective date of this Decision.

The Ministry of Health shall promulgate documents guiding the implementation of this Decision.

Ministers, heads of ministerial-level agencies, heads of government-attached agencies and chairpersons of provincial-level People’s Committees shall implement this Decision.-