Decision No. 615/2005/QD-BYT on granting formal licenses to foreign enterprises for pharmaceutical activities, including drug manufacturing materials, in Vietnam issued by the Minister of Health.

Pursuant to …;

ON THE ISSUANCE OF LICENSES FOR FOREIGN ENTERPRISES TO OPERATE IN THE FIELD OF MEDICINES AND RAW MATERIALS FOR MEDICINES IN VIETNAM

THE MINISTER OF HEALTH

Pursuant to the Law on Health Care for the People dated July 11, 1989;
Pursuant to the Drug Regulation issued pursuant to Decree No. 23/HĐBT January 24, 1991 of the Council of Ministers (now the Government);
Pursuant to Circular No. 17/2001/TT-BYT August 1, 2001 of the Ministry of Health guiding foreign enterprises to register their activities related to medicines and raw materials for medicines in Vietnam;
Considering the minutes of the meeting of the Council for Reviewing Foreign Enterprises Operating in the Field of Medicines and Raw Materials for Medicines of the Ministry of Health;
At the proposal of the Director of the Vietnam Drug Administration Bureau,

Pursuant to …;

Article 1. Issuing a license for the enterprise Mega Products Ltd. to operate in the field of medicines and raw materials for medicines in Vietnam.

Address: 99/3-4 Ratanachart Bldg, Bangna Trad Rd. K2.7, Bangna, Prakonong, Bangkok 10260 Thailand

Telephone: +662 746 9652; Fax: +662 746 9651

Article 2. The specific fields of operation in Vietnam of the enterprise shall be recorded in the license.

Article 3. Foreign enterprises permitted to operate in the field of medicines and raw materials for medicines in Vietnam shall have rights and responsibilities as prescribed in Circular No. 17/2001/TT-BYT dated August 1, 2001 of the Ministry of Health guiding foreign enterprises to register their activities related to medicines and raw materials for medicines in Vietnam.

Article 4. Foreign enterprises must bear responsibility under Vietnamese law for any violations committed during their operations in Vietnam.

Article 5. This certificate shall be valid for 12 months from the date this Decision takes effect.

Article 6. This Decision takes effect from the date of issuance.

Article 7. The Heads of the Office, Inspectorate, Department Heads of relevant Departments of the Ministry of Health, Director of the Vietnam National Pharmaceutical Administration, Directors of Provincial Health Services, Directors of enterprises directly involved in importing and exporting medicines and raw materials for medicines, and the Director of the foreign company specified in Article 1 are responsible for implementing this Decision.