Chương I Thông tư 16/2023/TT-BYT: Quy định chung

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. This Circular prescribes marketing authorization registration of contract manufactured medicine, medicine of technology transfer in Vietnam; application and procedures for issuance, extension, revision, addition, and revocation of marketing authorization of contract manufactured medicine, medicine of technology transfer (pharmaceutics, vaccine, biologicals, herbal medicine) in Vietnam.

2. This Circular applies to domestic and foreign agencies, organizations, individuals relating to contract manufacturing of medicine and transfer of medicine technology in Vietnam.

Article 2. Definitions

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

1. Medicine contract manufacturing means to legally produce medicine under contract manufacturing contract where manufacturing facility performs one, several, or all stages in medicine production process at request of ordering facility for a payment.

2. Medicine manufacturing technology transfer means to transfer ownership or use right of medicine manufacturing technology from a sending facility to a receiving facility to perform one, several or all stages of medicine production under contract between the parties in a law-compliant manner.

3. Ordering facility (hereinafter referred to as “owner”) means the party that provides a part or all ingredients, materials, production process, technical instruments proving quality, safety, and efficacy to manufacturing facility in order to order medicine production under contract manufacturing contract between the parties.

4. Manufacturing facility (hereinafter referred to as “contract facility”) means the party that uses a part or all ingredients, materials, production process, and technical instruments of the owner to perform one, several, or all medicine manufacturing stages at request of the owner in exchange for a payment according to contract between the parties.

5. Facility sending medicine manufacturing technology (hereinafter referred to as “sending facility”) means the party that possesses technology ownership or use right of medicine manufacturing technology as per the law and transfers technology ownership or use right of medicine manufacturing technology to contract facility for application in one, several, or all medicine production process.

6. Facility receiving medicine production transfer (hereinafter referred to as “receiving facility”) means the party that receives technology ownership or use right of medicine manufacturing technology from the sending facility according to contract between the parties in order to apply in one, several, or all medicine production stages.

7. Medicine to be contract manufactured means a medicine whose marketing authorization in Vietnam has been/has not been granted and whose one, several, or all production stages executed by a contract facility have been requested by an owner in accordance with manufacturing contract between the parties.

8. Contract manufactured medicine means a medicine whose one, several, or all production stages are executed by a contract facility at request of an owner according to manufacturing contract between the parties.

9. Medicine for technology transfer means a medicine whose marketing authorization in Vietnam has been/has not been granted and whose technology ownership or use right is transferred by sending facility to receiving facility for application in one, several, or all drug production stages.

10. Medicine of technology transfer means a medicine whose one, several, or all production stages are executed by receiving facility on the basis of utilizing manufacturing technology transferred by sending facility in accordance with contract between the parties.