Quyết định 1545/QĐ-BYT của Bộ Y tế về việc sửa đổi, bổ sung Quyết định 2962/QĐ-BYT ngày 22/08/2012 của Bộ Y tế về việc ban hành Quy định tạm thời về các tài liệu cần cung cấp để công bố các danh mục thuốc biệt dược gốc, thuốc tương đương điều trị với thuốc biệt dược gốc, thuốc có tài liệu chứng minh tương đương sinh học

THE MINISTRY OF HEALTH

Decision No.  1545/QD-BYT of the Ministry of Health amending and supplementing the Decision No. 2962/QD-BYT dated August 22, 2012 of the Ministry of Finance on promulgating temporary regulation on documents need supply in order to announce lists of original proprietary medicines, medicines used for treatment similar with original proprietary medicines, medicines with documents proving bioequivalence

Pursuant to the Pharmacy Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;  

Pursuant to the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding bidding of drugs procurement in the medical facilities

At the proposal of Director of Drug administration of Vietnam,

DECIDES:

Article 1.To amend and supplement Clause 2, Section I of temporary regulation on documents need supply in order to announce lists of original proprietary medicines, medicines used for treatment similar with original proprietary medicines, medicines with documents proving bioequivalence issued with the Decision No. 2962/QD-BYT dated August 22, 2012 of the Ministry of Health as follows:

“2. Patent granted by one of competent intellectual property agencies (in the List specified in section V of this Regulation) for:

(i) Active ingredient of medicine containing an active ingredient; or

(ii) Mixture of active ingredients if medicine contains many active ingredients; or

(iii) Pharmacy or preparations for injections, infusions, drugs used for eyes, sprays, implants,  transversal patch, drugs in gel form.

The patent must enclose part referencing point requiring protection, determining scope of protection for corresponding medicine (original has consular legalized as prescribed; or a valid notarized copy as prescribed; or a copy certified by the seal of facility if the patent may search, define at websites supplying database of intellectual property agencies – in this case, it should indicate clearly address for search, name of intellectual property agency and search code)”.

Article 2.To supplement two below agencies to the list of intellectual property agencies granting patent approved for consideration of announce lists of original proprietary medicines at section V of temporary regulation on documents  need supply in order to announce lists of original proprietary medicines, medicines used for treatment similar with original proprietary medicines, medicines with documents proving bioequivalence promulgated together with the Decision No. 2962/QD-BYT dated August 22, 2012 of the Ministry of Health:   

“15. German Patent and Trade Mark Office (national code: DE);

16. United Kingdom Intellectual Property Office (national code: GB)."

Article 3.Chief of Ministerial office, directors of  Pharmacy Administration, Administration of medical examination and treatment, Department  of Science and training, Department of traditional medicine and pharmacy; and heads of:  Legal Department, Department of Health Insurance, Department of Planning and Finance and heads of relevant units shall implement this Decision.

For the Minister of Health

Deputy Minister

Nguyen Thi Xuyen