Are you seeking information on the registration certificate for the circulation of pharmaceutical raw materials? The following article by NPLaw provides detailed guidance on the relevant legal regulations, required dossiers, and procedures, helping you clearly understand the process and comply with the requirements of the competent authorities. We also address frequently asked questions and introduce professional legal consulting services to support your operations in the pharmaceutical sector with confidence.

I. Overview of the registration certificate for the circulation of pharmaceutical raw materials

In the context of an increasingly competitive pharmaceutical market and ever-stricter requirements for drug quality, possessing a registration certificate for the circulation of pharmaceutical raw materials is not only a mandatory legal requirement but also an essential document enabling pharmaceutical enterprises to establish credibility and enhance their competitive capacity.

The registration certificate certifies that the raw material has undergone rigorous evaluation and testing, meeting statutory standards on quality, safety, and efficacy under Vietnamese law. It ensures the quality of finished pharmaceutical products and safeguards public health.

II. Legal regulations on the registration certificate for the circulation of pharmaceutical raw materials

1. Definition of the registration certificate for the circulation of pharmaceutical raw materials

A registration certificate for the circulation of pharmaceutical raw materials is a legal instrument issued by a competent authority, certifying that the relevant raw material satisfies the standards of quality, safety, and efficacy as prescribed by Vietnamese law.

Such a certificate is a mandatory prerequisite for permitting the use of such raw materials in pharmaceutical manufacturing in Vietnam and serves as a legal basis for state authorities to supervise and control the quality of pharmaceuticals circulating on the market.

2. Dossier and procedures for applying for the registration certificate for the circulation of pharmaceutical raw materials

To obtain the registration certificate for the circulation of pharmaceutical raw materials, enterprises must prepare a complete dossier in accordance with the procedures specifically guided in Articles 32 and 36 of Circular No. 08/2022/TT-BYT. The dossier includes:

Administrative documents, including:

  • Application form using Form No. 5/TT promulgated together with Circular No. 08/2022/TT-BYT;
  • Letter of authorization (if any);
  • Samples of labels for drugs and pharmaceutical raw materials, and package inserts;
  • Certificate of eligibility for pharmaceutical business applicable to the Vietnamese registering entity;
  • Summary of product characteristics for new chemical drugs, vaccines, and biological products, using Form No. 6/TT issued together with this Circular;
  • Legal documents of the manufacturing establishment of active pharmaceutical ingredients, excipients, capsule shells, semi-finished pharmaceutical products, herbal materials, and medicinal materials;
  • Certificate of the testing establishment (if any);
  • Risk management plan (for vaccines) using Form No. 7/TT;
  • Samples of labels and package inserts currently circulated in the country of manufacture or the country issuing the Certificate of Pharmaceutical Product (for foreign drugs);
  • Certificate of Pharmaceutical Product (for foreign drugs);
  • Documents assessing compliance with Good Manufacturing Practices (GMP) (for foreign manufacturing facilities);
  • Certificate confirming that the pharmaceutical raw materials are permitted to be manufactured or circulated in the country of origin (for raw materials manufactured abroad).

Within a maximum period of 12 months (or up to 36 months in cases requiring additional clinical documentation), the Drug Administration of Vietnam shall issue the registration certificate for circulation, except for certain special cases.

3. Competent authority for issuing the registration certificate for the circulation of pharmaceutical raw materials

The Drug Administration of Vietnam under the Ministry of Health is the competent authority responsible for receiving, appraising, and issuing registration certificates for the circulation of pharmaceutical raw materials in Vietnam. Such an authority is responsible for ensuring that all raw materials permitted to circulate on the market comply with statutory standards of quality, safety, and efficacy.

III. Questions regarding the registration certificate for the circulation of pharmaceutical raw materials

1. Validity period of the registration certificate for the circulation of pharmaceutical raw materials

The validity period of the registration certificate for the circulation of pharmaceutical raw materials is stipulated in Clause 6, Article 56 of the Law on Pharmacy 2016. Accordingly, the certificate is valid for five (05) years from the date of issuance or renewal. For drugs subject to continued monitoring of safety and efficacy, the validity period is three (03) years from the date of issuance.

2. Is the registration certificate for the circulation of pharmaceutical raw materials renewable?

To ensure that pharmaceutical raw materials continuously meet the standards of quality, safety, and efficacy, the registration certificate may be renewed.

The dossier and procedures for renewal are specifically prescribed in Clause 2, Article 32 of Circular No. 08/2022/TT-BYT. Enterprises are required to proactively prepare the renewal dossier and complete the renewal procedures prior to the expiration of the certificate.

To ensure swift approval of the renewal dossier, enterprises should note the following:

  • Preparing all required documents in full compliance with regulatory requirements;
  • Updating the latest information on the quality, safety, and efficacy of the raw materials (if any);
  • Strictly adhering to the procedures and guidance issued by the competent authorities.

IV. Legal consulting services for registration certificates for the circulation of pharmaceutical raw materials

NPLaw takes pride in being a reputable legal consulting firm accompanying enterprises in their operations. We provide comprehensive legal services related to registration certificates for the circulation of pharmaceutical raw materials, including:

  • In-depth consultancy on the latest applicable legal regulations;
  • Assessment of the validity and likelihood of success of registration dossiers;
  • Drafting of dossiers for registration, renewal, and amendment of license information;
  • Representation of enterprises in working with the Drug Administration of Vietnam;
  • Resolution of disputes arising in the course of business operations.