THE MINISTRY OF HEALTH

Circular No. 23/2013/TT-BYT of August 13, 2013, guiding drug processing

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

Pursuant to June 14, 2005 Commercial Law No. 36/2005/QH11;

Pursuant to the Governments Decree No. 12/2006/ND-CP of January 23, 2006, detailing the Commercial Law regarding international goods trading and agency, and purchase, sale, processing and transit of goods with foreign countries;

Pursuant to the Governments Decree No. 79/2006/ND-CP of August 9, 2006, detailing a number of articles of the Law on Pharmacy;

Pursuant to the Governments Decree No. 89/2012/ND-CP of October 24, 2012, amending and supplementing a number of articles of Decree No. 79/2006/ND-CP of August 9, 2006;

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

At the proposal of the director of the Drug Administration of Vietnam;

The Minister of Health promulgates the Circular guiding drug processing.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1.   This Circular provides drug processing, dossiers for registration of drug processing, order and procedures for registration, suspension and withdrawal of registration numbers of processed drugs.

2.   This Circular applies to domestic and foreign organizations and individuals engaged in drug processing and registration for circulation of processed drugs in Vietnam.

Article 2. Interpretation of terms

In this Circular, the terms below are construed as follows:

1.   Drug processing means that the processing party performs work to make products at the request of the ordering party and the ordering party receives products and pays remuneration under the agreement reached in accordance with law.

The processing party’s work is to perform one, several or all of stages of the drug manufacturing process (receipt of raw materials, processing and packaging including packaging in the final packing and labeling).

2.   Drug ordered for processing means a drug that has a circulation or export permit granted by the pharmaceutical management agency; has a patent, or has been researched by the very ordering party, for drugs without circulation registration number in Vietnam.

3.   Ordering party means the party submitting the application for a permit for circulation of processed drug.

4.   Processing party means the party manufacturing and receiving remuneration for manufacturing from the ordering party. The processing party may consist of more than one manufacturer, with each manufacturer involved in one, several or all of stages of manufacturing.

5.   Processing contract means the agreement between the parties, under which the processing party performs work to make products at the request of the ordering party while the ordering party receives products and pays processing remuneration.

6.   Transitional processing means the drug processing in which there are more than one processing party, whereby:

-   The processed products of one processing contract are used as processing materials for another processing contract in Vietnam;

-   The processed products of the processing contract of the previous stage are delivered to another manufacturer designated by the ordering party for the processing contract of the subsequent stage.

Chapter II

PROVISIONS ON DRUG PROCESSING

Article 3. Conditions for drug processing

1.   Conditions for acting as the ordering party

Lawful Vietnamese drug trading establishments, foreign drug trading and manufacturing establishments that possess operation licenses of foreign enterprises for drugs and drug materials in Vietnam and have drugs with registration numbers granted by the Vietnamese Ministry of Health and still valid, or that are owners of patents or research subjects already accepted in accordance with Vietnamese law or product research documents at the very processing-ordering establishments, for drugs without circulation registration number in Vietnam ordered for manufacturing and processing.

2.   Conditions for acting as the processing party

a/ For pharma-chemical drugs, herbal drugs (except oriental drugs), vaccines, antibody- containing sera, and medical biologicals: Manufacturing establishments in Vietnam with certificates of eligibility for drug trading and certificates of satisfaction of “Good Manufacturing Practices” (GMP) standards with preparation forms suitable to drugs intended for processing.

 b/ For in-vitro diagnostic biologicals: Manufacturing establishments in Vietnam with certificates of eligibility for drug trading and certificates of satisfaction of “Good Manufacturing Practices” (GMP) standards or Vietnam standard TCVN ISO 13485 or other equivalent] standards with preparation forms suitable to drugs intended for processing.

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