The Decision 42/2013/qd-Ttg Dated: Regulations On The Management Of Medicines For People By Way Of Import, Export Africa Trade And Modification, Addition Of Some Articles Of The Regulation On The Import Of Drugs Qual. ..

Original Language Title: Quyết định 42/2013/QĐ-TTg: Quy định về quản lý thuốc dùng cho người theo đường xuất khẩu, nhập khẩu phi mậu dịch và sửa đổi, bổ sung một số điều của quy định về việc nhập khẩu thuốc ch...

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The DECISION rules on the management of medicines for people by way of import, export Africa trade and modification, addition of some articles of the regulation on the import of drugs yet to be registered in Vietnam attached to decision No 151/2007/QD-TTg dated 12 September 2007, the Prime Minister's _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ based on Government Organization Law of 25 December 2001;
Pharmaceutical Law base on June 14, 2005;
Pursuant to the law on drug prevention 9 December 2000 and the law on amendments and supplements to some articles of the law on drug prevention on June 3, 2008;
Pursuant to Decree No. 58/2003/ND-CP on 29 May 2003 by the Government export control regulations, import, transit the territory of Vietnam of drugs, precursors, addictive drugs, psychotropic drugs;
According to the recommendation of the Minister of health;
The Prime Minister issued the regulations on the management of medicines for people by way of import, export Africa trade and modification, addition of some articles of the regulation on the import of drugs yet to be registered in Vietnam attached to decision No 151/2007/QD-TTg dated September 12, 2007 by the Prime Minister.
Article 1. Regulations on the management of medicines for people by way of import, export Africa trade 1. Smoking export, import of the Africa trade provisions in this decision include: a) the gifts of the individual, organization abroad send individual organizations in Vietnam; of the Organization, individuals in Vietnam sent to organizations and individuals abroad;
b) of diplomatic missions, international organizations in Vietnam and those who work at the Agency, this organization;
c) personal baggage, the entry sent by invoices, goods carried by the entry.
2. export and import African Drug trade are only allowed to export, the importer to use for yourself, your family or for individuals working in the Organization of export/import non-drug trade in paragraph 1 of this article.
3. the level of smoking is allowed to export and import trade of Africa: a) the number of finished product addictive drugs bring people when exit, entry no longer than the number recorded in the application of the attached physician and should not exceed the number specified in 7 days;
b) the number of finished products of mental direction, drug precursors used to export and import the Africa trade not exceeding the amount stated in the accompanying physician's application and does not exceed the number specified in 10 days;
c) other products drugs allowed sugar export Africa trade norms and unlimited number of times to send or bring people abroad; imported by way of trade of Africa but of the value of imported medicine not too worth the equivalent of $ 100 (one hundred us dollars) once, the number receiving a maximum of no more than 3 times in a year for an individual, the Organization;
d) where exports, imports of non-drug trade in quantities exceeding the quota specified in point a, b and c of this paragraph must have a permit for export, import of the competent State bodies.
4. Ministry of health specifies the export profile, import the drug trade in Africa, a, b and c of Paragraph 3 of this article and profile, order and licensing procedures for the export and import of drugs Africa trade specified in point d of Paragraph 3 of this article.
5. The export/import non-trade: a) The type of raw material, do drugs;
b) drug products containing the active substances in the list of prohibited active substances imported by the Ministry of Health issued.
Article 2. Amendments and supplements to some articles of the regulation on the import of drugs yet to be registered in Vietnam attached to decision No 151/2007/QD-TTg dated September 12, 2007 by the Prime Minister as follows: 1. Amendments, supplements article 3 as follows: "article 3. Management principles for the registration number yet have drug imported into Vietnam 1. The drug product has not had the registration number to be imported in the form of import licenses. Drug import license and product number yet worth a maximum of 1 year from the date of signing.
2. The raw materials do not have the registration number of the drugs imported for the production of the drug has had the registration number is valid, the Ministry of health published and regularly updated list of ingredients as drugs in each drug items have been given the registration number to import business needs. The time limit for importing drug materials in the form published by the valid term of registration of the drug produced from raw materials.
3. Raw materials do not have the registration number of the drugs imported for the production of the drug has had the registration number is valid but not yet published the list of ingredients as drugs prescribed in paragraph 2 of this article, is allowed to import under the import permit form. Importing raw materials do not have the registration number drug worth a maximum of 2 years from the date of signing.
4. Minister of health guide to profiles, sequence, import licensing procedures yet has the registration number and sequence content, announced the list of ingredients as drugs imported are not required to have a license. "
2. additional item 2 in article 4 as follows: "2. The businesses not yet qualified certification of drug production are allowed to import raw materials for making the drug to produce suitable quantities test with the expected production scale. The products of the manufacturing process to try can be used only for research purposes, is not allowed to circulate and use for the people. "
3. additional Points DD on item 2 article 6 as follows: "rare, Drugs) drugs for the hospital's treatment needs in special cases are limited in use is greater than or equal to 24, the term used by the rest of the drug must be minimum 12 months from the day to the port of Vietnam. Limited use drug case under 24 month term used rest of smoking must be minimum 1/3 limit use of the drug since January to the port of Vietnam. "
4. additional amendments to article 10 as follows: "article 10. For the raw materials do not have drug registration number 1. The materials do not have the registration number drug imported into Vietnam include: a) the raw materials do not have the registration number of the drugs imported to produce the drug had valid registration of the drug manufacturing facility in the country;
b) ingredients for drugs not yet have registered to serve research, cum just to be used for research purposes, testing with the amount appropriated for the purpose of researching, testing;
c) raw materials do not have the registration number drug imports with the aim of making the registration form circulated in Vietnam, each type being imported in quantities sufficient for testing requirements.
2. The raw materials imported drugs must have quality standards and ensure the quality standard was recorded on import orders or have registered in the registration record.
3. for medicinal ingredients in drug addictive drug, mental direction and precursors used the medicine yet has the registration number must comply with the provisions of this decision and regulation of the Ministry of health to guide the activities related to the addictive drug, mental direction and drug precursors used and the provisions of relevant laws. "
Article 3. Transitional provisions 1. Records suggest that export, import of the drug trade on previous submission pilot decided to this effect made in accordance with decision No 71/2002/QD-TTg dated 7 June 2002 by the Prime Minister on the management of medicines for the people by way of import, export Africa trade.
2. The records suggest drug import license has not had the registration number filed prior to the date of this decision to that effect made in accordance with decision No 151/2007/QD-TTg dated 12 September 2007 Prime Minister's Government issued regulations on the import of drugs yet to be registered in Vietnam.
3. license to import raw materials do not have drug registration number be issued before the decision in effect allowed enforcement done by the end of the time limit stated in the license.
Article 4. Responsible and effective decision has effect from January 1, 2014.
Decision No 71/2002/QD-TTg dated 7 June 2002 by the Prime Minister on the management of medicines for the people by way of import, export Africa trade expired from the date of this decision to take effect.
The Health Ministry is responsible for issuing guidance documents made this decision.
The Ministers, heads of ministerial agencies, heads of government agencies, the Chairman of people's Committee of the central cities, is responsible for the implementation of this decision.