Chapter VI
IMPLEMENTATION
Article 37. Effect
1. This Circular shall come into force from January 15, 2015.
2. The major, minor, other variation applying to the registered drugs prescribed in Appendix II issued herewith shall be applied from April 1, 2015.
3. The Circular No.22/2009/TT-BYT dated November 24, 2009 of the Minister of Health on drug registration, the Article 6 of the Circular No.45/2011/TT-BYT dated December 21, 2011 of the Minister of Health on amendments to the Decision No.1570/2000/QD-BYT dated May 22, 2000 of the Minister of Health on implementation of GMP requirements for drug testing; the Decision No.2701/2001/QD-BYT dated June 29, 2001 of the Minister of Health on implementation of GMP requirements for drug storation; the Decision No.06/2004/TT-BYT dated May 28, 2004 on guidance on drug processing; the Decision No. 3886/2004/QD-BYT dated November 13, 2004 of the Ministry of Health on implementation of GMP requirements for drug manufacturing recommended by WHO; the Circular No.13/2009/TT-BYT dated September 1, 2009 of the Ministry of Health on drug advertisement; the Circular No.22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration; the Circular No. 47/2010/TT-BYT dated December 29, 2010 on importation and exportation of drugs and packages in physical contact with medicinal products shall be annulled from the effective date of this Circular.
Article 38. Transitional provisions
1. The application for registration submitted before the effective date of this Circular shall be processed and granted as prescribed in the Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration.
2. The foreign applicant may use the License for operating in drugs or medicinal materials in Vietnam which is granted before the effective date of this Circular to apply for drug registration until the Certificate expires.
Article 39. Reference provisions
In case legislative documents and regulations in this Circular is amended or replaced, they shall apply to new legislative documents.
Article 40. Implementation
1. The Drug Administration of Vietnam or Department of Medical Equipment and Health Works within their competence of roadmap of ASEAN harmonization in drug registration shall:
a) Provide guidance and implementation of this Circular.
b) Update, edit and issue the ACTD, technical requirements and guidance on registration of ASEAN
c) Update the list of drugs granted drug registration numbers periodically by the Ministry of Health and other registration information about drugs on website of the Drug Administration of Vietnam or website of the Ministry of Health about IVD products.
d) Formulate and implement SOPs, QM, and reduced process of verification and issuance of drug registration numbers certified by WHO;
2. Services of Health of central-affiliated cities and provinces shall inspect the implementation of this Circular applied to pharmacy enterprises within their competence.
3. The Ministry of Health affiliated units, Vinapharm, other drug-trading establishments, foreign enterprises obtaining operation license in the pharmacy field shall implement this Circular.
Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (the Drug Administration of Vietnam and the Department of Medical Equipment and Health Works regarding IVD products) for consideration./.
Tìm kiếm
Thông tư 44/2014/TT-BYT (Bản Word)