Re-issue of a biosafety certificate is an important step that ensures that your products or processes continue to comply with applicable biosecurity regulations. This helps businesses or organizations not only maintain legitimacy in production and research activities but also enhance reputation and competitiveness in the market. The following article will provide detailed instructions on the steps to re-issue a biosafety certificate.

The competent authority re-issues the Biosafety Certificate

According to Article 10 of Decree 103/2016/ND-CP amended and supplemented by Point d, Clause 1, Article 15 of Decree 155/2018/ND-CP:

• The Minister of Health shall appraise and re-issue the Certificate of testing facilities meeting biosafety standards for level III testing facilities (called Biosafety Certificate), except for testing facilities. under the management authority of the Ministry of National Defense.
• For testing facilities under the Ministry of National Defense, the Minister of National Defense will organize the appraisal, new issuance, re-issuance and revocation of the Biosafety Certificate. This regulation is intended to ensure specificity and security in the defense sector.

Procedures for re-issuance of biosafety certificate

Application for re-issuance

Article 11 of Decree 103/2016/ND-CP amended and supplemented by Article 15 of Decree 155/2018/ND-CP stipulates that there are 3 cases of re-issuance of a Biosafety Certificate, each case requires documents. different profiles:

1. In case the Certificate expires:

• Application for re-issuance according to Form No. 05 issued with Decree 103/2016/ND-CP;
• Copy of old Certificate;
• Report changes related to personnel (if any);
• Report equipment changes;
• Report changes related to facilities;
• Report biosecurity incidents (if any).

2. In case the Certificate is damaged or lost:

• Just submit an application for re-issuance according to Form No. 05 issued with Decree 103/2016/ND-CP;

3. In case of changing the name of the testing facility:

• Application for re-issuance according to Form No. 05 issued with Decree 103/2016/ND-CP;
• Documents proving name change: State facility: Certified copy of establishment decision for state medical facility or certified copy of Business Registration Certificate for private medical facility or Investment Certificate for foreign-invested medical facilities.

Full and accurate preparation of the above documents is the first important step in the process of reissuing the Biosafety Certificate.

Procedures for reissuing the biosafety certificate

According to the provisions of Clause 3, Article 12 of Decree 103/2016/ND-CP, the process of reissuing the Biosafety Certificate includes the following steps:

Step 1: Submit application: The testing facility must send the application to the permanent unit at least 60 days before the Certificate expires. If this deadline is exceeded, the facility must carry out new issuance procedures.

Step 2: Receiving dossiers: The standing unit issues a receiving slip when receiving a valid dossier.

Step 3: Appraise the dossier: Within 10 days from the date of receiving the dossier, the standing unit will appraise the dossier and check the previously issued appraisal dossier.

Step 4: Additional request (if necessary): If the dossier is incomplete, the standing unit will notify you in writing within 5 working days from the date of appraisal, clearly stating the content that needs to be supplemented or amended. .

Step 5: On-site appraisal and issuance of certificate:

• If necessary, conduct evaluation at the laboratory within 10 days from the date of evaluation of the dossier.
• If the dossier is complete and does not require on-site appraisal, reissue the Certificate within 10 days from the date of dossier appraisal.

Time limit for processing applications for reissue

Pursuant to Points c, d, dd, Clause 3 and Clause 5, Article 12 of Decree 103/2016/ND-CP, the time limit for processing applications for re-issuance is prescribed as follows:

1. Appraisal and inspection of documents: 10 days from date of receipt.
2. Laboratory appraisal (if necessary): 10 days from the date of document appraisal.
3. Re-issue of Certificate (if the dossier is complete and does not require on-site appraisal): 10 days from the date of dossier appraisal.
4. Notify the Provincial People’s Committee and Department of Health: 15 days from the date of new or re-issued issue.

Follow the deadline regulations to ensure the process of reissuing the Biosafety Certificate is carried out effectively and in accordance with the law.

Consulting and support services for reissuing biosafety certificates at Long Phan

Long Phan provides support services for applying for a biosafety certificate with a scope of work including:

1. Instructions for preparing documents according to regulations:

• Consulting on necessary documents in the application for re-issuance.
• Support in drafting the application for re-issuance according to Form No. 05.
• Check the completeness and validity of the documents in the file.

2. Explanation of implementation procedures:

• Provide detailed information about the Certificate re-issuance process.
• Advice on time and steps to take during the re-issue process.
• Answer questions related to legal regulations and technical requirements.

3. Instructions for submitting documents according to regulations:

• Advice on how to submit applications to the permanent unit.
• Assist in tracking application processing progress.
• Advise on how to respond when there is a request to add or edit records.

4. Representing customers in working with competent authorities.

5. Receive results and hand over to customers

Long Phan’s services aim to ensure that the process of applying for a biosafety certificate goes smoothly, in accordance with regulations and in a timely manner.

Re-issuance of biosafety certificates is an important legal process for testing facilities. Customers need to strictly comply with the regulations and deadlines to ensure the re-issuance process goes smoothly. For professional support on procedures to re-issue biosafety certificates, please contact Long Phan via hotline. 0906735386.