CIRCULAR additional amendments to some articles of the circular No. 47/2009/TT-BYT on 29th December 2010 French social psychologist of the Minister of health guide export activities, importing the drug and packaging direct in with _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Pharmacy pursuant to the law No. 34/2005-QH-11 on June 14, 2005;
Pursuant to Decree No. 63/2012/ND-CP on August 31, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
Pursuant to decision No. 42/2013/QD-TTg dated 15 July 2013 of Prime Government 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 12 September 2007 of Prime The Government;
At the suggestion of the Director of the drug administration;
The Minister of Health issued a circular amending and supplementing some articles of circular No. 47/2009/TT-BYT on 29th December 2010 guide export activities, importing the drug and packaging in direct contact with the drug.
Article 1. Amendments and supplements to some articles of the circular No. 47/2009/TT-BYT on December 29, 2010 by the Health Minister instructed export activities, importing the drug and packaging in direct contact with the drug (hereinafter referred to as the circular 47/2009/TT-BYT) as follows: 1. Amend paragraph 3 to article 4 as follows "3. Requests for test votes: When do the customs, the import business of drugs, the packaging in direct contact with the drug are required to present the Customs gate a test vote of major production facilities quality standard certification for each batch of imported medicine manufacturers except medicinal herbs and drugs prescribed in articles 12, 13, 14, 15, 17 and 18 of this circular.
Case from 10 upwards basis involved drug production shall accept a test vote of major production facilities or a major test vote of the final packing facility or the facility's responsibility.
The Customs gate to save a copy of the slip testing has the stamp of confirmation of import business ".
2. Modify Article 19 as follows: "article 19. Ingredients for medicines, medicinal herbs have not got the registration number in circulation, the packaging in direct contact with the drug 1. Smoking materials are allowed to import under the list of ingredients as drugs imported by drug administration publication (do not require import licenses) as defined in paragraph 2 of this Article or in the form of import license under the provisions of Paragraph 3 of this article.
2. Imports under the category medicinal raw materials imported by drug administration announced (no license required) a) category of drug materials imported (no license required) due to drug administration announced includes, except the raw materials in the addictive drug the mental substance, money, used as medicine. The base case produced changes in origin or quality standards of raw materials, the manufacturing facility must apply to register the changes as specified in annex II attached to circular No. 03/2009/TT-BYT on November 24, 2009 by the Minister of health of drug registration regulation and can only be imported after the writing of the Drug Administration Council Note the content changes, the addition of drug administration. b) announced procedure-Drug Administration announced the category medicinal materials imported (no license required) in electronic information page of drug administration (www.dav.gov.vn) in the form of 16 attached to this circular.
-Within 30 working days from the date the drug was granted registration number, drug administration announced the list of ingredients as drugs are imported.
c) import business-drug manufacturing facility is granted registration number are only allowed to import raw materials under the category have been published.
-Enterprise business functions to import raw materials for making the drug are allowed to import raw materials belonging to the category of drug materials imported (no license required) due to drug administration announced.
d) record and import procedures-production facilities have the need to import raw materials for the production of the drug, raw material importer to do business directly with the Customs gate to import raw materials under the category have been drug administration announced;
-Drug manufacturing facility must present a certificate of qualified drug production or the certificate of good manufacturing practice (GMP) prescribed in points c, d paragraph 1 of article 3 of this circular.
-Import business to business must present the certificate of eligible drug business (form of wholesale or import and export of drugs) and certificate of good storage practice (GSP) with the proper business scope as defined in point a of paragraph 1 of article 3 of this circular.
-The time limit for importing drug materials in the form of publication has the time limit by the effect of registration of the drug produced from raw materials;
-Foreign enterprises provide the raw materials for making the drug in Vietnam must have active licenses on medicines and raw materials for making the drug in Vietnam is also in force in accordance with paragraph 12 of article 3 of this circular.
3. Importing drug materials in the form of import license a) drugs imported materials in the form of import license include:-raw materials for making the drug not be allowed to import under the form of publication prescribed in clause 2 of this Thing;
-Material list addictive drugs, mental direction, amount of substance use as drugs;
-The material is excipients, capsule shell, the packaging in direct contact with the drug;
-Raw materials used for research, testing;
b) importer of raw materials in the form of import licenses and foreign enterprises provide the raw materials for making the drug in Vietnam are specified in article 3 of this circular.
c) profile of import licensing proposal-Singles imported under model number 12a, 12b, 12 c, 12d, 13 DD issued herewith.
-A standard of quality and a method of testing raw materials, pharmaceutical chemicals, packaging in direct contact with the drug for the raw materials, packaging and quality standards of testing method of manufacturer or photocopy of the treatise the quality standards of Pharmacopoeia except applying the standards of the European Pharmacopeia , Uk, us, international, Japan.-for ingredients for smoking is addictive drugs, mental direction, doing drugs precursors must submit inventory report form No. 3 issued herewith.
d) licensing procedures import businesses send to Drug Administration – Department of health. Within a period of 7 working days as from the receipt of a valid profile, drug administration-Ministry of health consider the import license.
As for the ingredients for the drug's addictive drugs, mental direction, doing drugs, precursors within 15 working days, from receipt of valid records, drug administration-Ministry of health consider the import license.
Case no license, drug administration – the Ministry of health have written business reply and stating the reason.
DD) importing raw materials do not have the registration number drug worth a maximum of 2 years from the date signed. "
3. additional changes and issued the following form: a) issued the model No. 1 attached to this circular added Appendix to circular 47/2009/TT-BYT (Supplement 16).
b) issued a model No. 2a, 2b, 2 c, 2d, 2 DD replaced the model No. 12a, 12b, 12 c, 12d issued circular 47/2009/TT-BYT.
c) issued the No. 3 Sample replacement model No. 1a issued circular 47/2009/TT-BYT.
d) issued a model No. 4 No. 3 Sample replacement issued circular 47/2009/TT-BYT.
DD) issued a model No. 5 replace model No. 6a issued circular 47/2009/TT-BYT.
e) issued the model No. 6 replacement model No. 7a issued circular 47/2009/TT-BYT.
f) model No. 7 replacement model No. 7 c issued circular 47/2009/TT-BYT.
g) enacted 8 replacement model No. 11a issued circular 47/2009/TT-BYT.
Article 2. Transitional provisions 1. Records suggest drug import license not yet have registered before January 1, 2014 to comply with the provisions of circular No. 47/2009/TT-BYT on December 29, 2010 by the Health Minister instructed export activities, importing the drug and packaging directly with smoking.
2. license to import raw materials do not have drug identification number was issued before the date of this circular in force are allowed to perform for the rest of the time limit stated in the license.
Article 3. Terms of implementation 1. Drug Administration published before 31 December 2014 for all drugs have been granted registered before 1 July 2014.
2. Since 1 July 2014, Drug Administration published the material in the category medicinal materials imported (no license required) within 30 working days from the date the drug was granted registration number.
Article 4. Effective enforcement of this circular are effective since January 1, 2014.
Paragraph 3 article 4, article 19 circular 47/2009/TT-BYT, model No. 1a, model No. 12a, 12b, 12 c, 12d, model No. 3, model No. 6a, 7a, 7 c denominator the denominator and model No. 11 c issued circular 47/2009/TT-BYT most effective from the date of this circular effect.
In the process, if there are difficulties and obstacles, suggest the Organization, personal reflections about timely Health Ministry (Drug Administration) to be guided or modified, supplemented as appropriate./.