Decision No. 1417/2003/QÐ-BYT On the issuance of the Regulation on the operation of the Council for Reviewing Foreign Enterprises Registering to Operate in Pharmaceuticals and Medicinal Ingredients in Vietnam

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of the Rules on the Operation of the Council

for reviewing foreign enterprises registering to operate in pharmaceuticals

and medicinal ingredients in Vietnam

___________________________

THE MINISTER OF HEALTH

Based on the Law on Health Care for the People dated July 11, 1989;

Pursuant to Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decision No. 3010/QÐ-BYT dated August 7, 2002 of the Minister of Health establishing the Council for reviewing foreign enterprises registering to operate in pharmaceuticals and medicinal ingredients in Vietnam;

At the proposal of the Director of the Vietnam Drug Administration Bureau,

DECISION:

Article 1. Now hereby promulgated pursuant to this Decision "The Rules on the Operation of the Council for reviewing foreign enterprises registering to operate in pharmaceuticals and medicinal ingredients in Vietnam".

Article 2. This Decision takes effect from the date of issuance. All previous regulations that conflict with the provisions of these rules shall be abolished.

Article 3. The following individuals are responsible for implementing this Decision: Director of the Office, Inspector General, Heads of relevant Departments under the Ministry of Health, Director of the Drug Administration of Vietnam, members of the Council established by Decision No. 3010/QÐ-BYT dated August 7, 2002 of the Minister of Health.

REGULATIONS ON THE OPERATION

Of the Council for Reviewing Foreign Enterprises Registering to Operate in Pharmaceuticals and Medicinal Ingredients in Vietnam (Issued together with Decision No. 1417/2003/QÐ-BYT dated April 28, 2003 of the Minister of Health)

Article 1. The Council for reviewing foreign enterprises registering to operate in pharmaceuticals and medicinal ingredients in Vietnam is established and its tasks are stipulated in Decision No. 3010/QÐ-BYT dated August 7, 2002 of the Minister of Health.

Article 2. Principles of operation of the Council:

Clause 2.1. The Council operates according to the principle of democratic centralism.

Clause 2.2. The Chairman of the Council is the person who chairs meetings; when the Chairman is absent, he may delegate authority to the Vice-Chairman to chair the meeting. The Vice-Chairman must report back to the Chairman after chairing the meeting.

Clause 2.3. The Council meets 2-3 times a year. The Chairman or the Vice-Chairman (delegated) may convene an extraordinary meeting to seek opinions from members when necessary.

Clause 2.4. At least two-thirds of the members must be present at the Council's meetings. The conclusions of the Council must be agreed upon by at least two-thirds of the members.

Clause 2.5. Members of the Council have the responsibility to carry out the common tasks of the Council and bear primary responsibility for the areas they oversee.

Clause 2.6. Issues related to the Council's tasks discussed in meetings must be collectively deliberated. Minutes must be signed by all participating members of the Council. The minutes of the Council's meetings must be submitted to the Minister as a basis for issuing directives.

Article 3. Procedures for the Council's operations:

Clause 3.1. The Drug Administration of Vietnam sends the review records, annotated by experts, to the Council members at least three days before the Council meeting.

Clause 3.2. Council members are responsible for reading each record and providing their opinions during the meeting on whether to grant or deny permission, stating the reasons. Council members have the right to request the Drug Administration to provide additional materials or to verify additional information about the enterprise.

Clause 3.3. In cases where Council members require clarification on certain points, the Drug Administration must provide the requested materials and has the responsibility to explain and elaborate on related issues. Council members must provide written responses within five days of receiving the supplementary materials.

Clause 3.4. In cases where it is not possible to organize a Council meeting, the Drug Administration may send the dossier and review records to individual Council members for comments before submitting them to the Minister. Members receiving the dossiers must provide their responses within three days of receipt.

Clause 3.5. After obtaining the Minister's opinion, the Drug Administration of Vietnam must formalize the Council's conclusions in writing for implementation and guidance on implementation.

Article 4. The Vietnam Medicine Administration shall be responsible for preparing matters related to the Decision on issuing licenses, managing such licenses, and monitoring the operations of foreign enterprises that have been granted licenses for pharmaceutical activities in Vietnam.

Article 5. The Council reviewing foreign enterprises registering for pharmaceutical activities and raw materials for medicines in Vietnam shall have a permanent office and an expert team assisting the Council, designated and directed by the Director of the Vietnam Medicine Administration.