Chương IV Thông tư 05/2010/TT-BYT: Thực hiện bảo mật dữ liệu

Chapter IV

KEEPING OF DATA CONFIDENTIALITY

Article 9. Acceptance of data confidentiality keeping requests

1. For accepted medicine registration dossiers subject to data confidentiality keeping requests (except for those specified in Article 10 of this Circular), the Vietnam Drug Administration shall also accept data confidentiality keeping requests and take confidentiality-keeping measures specified in Article 12 of this Circular.

2. Decisions on acceptance of data confidentiality keeping requests shall be notified by the Vietnam Drug Administration to medicine-registering establishments and published on the Vietnam Drug Administration's website together with notices of decisions on grant of medicine circulation registration numbers.

Article 10. Refusal to keep data confidentiality

1. In the following cases, the Vietnam Drug Administration shall refuse to keep data confidentiality:

a/ Data requested to be kept confidential are not those specified in Article 5 of this Circular;

b/ Medicine in the medicine registration dossier subject to data confidentiality keeping request is not permitted for circulation in Vietnam:

c/ There is a ground to believe that the data requested to be kept confidential fail to satisfy at least one of the confidentiality keeping conditions specified in Article 6 of this Circular;

d/ Keeping data confidentiality might cause serious impacts on human health.

2. Notices of refusal to keep data confidentiality shall be sent by the Vietnam Drug Administration to medicine-registering establishments together with notices of decisions to grant or on refusal to grant medicine circulation registration numbers, clearly stating the reasons for refusal.

Article 11. Opinions of a third party on keeping data confidentiality

1. From the date a decision on acceptance of a data confidentiality keeping request is announced, all organizations and individuals may request the Vietnam Drug Administration to terminate the keeping of data confidentiality under Article 14 of this Circular.

2. A request for termination of the keeping of data confidentiality must be made in writing, according to a set form provided in this Circular (not printed herein), and enclosed with documents or quotations of information sources to support the request.

3. Within 15 working days after receiving a request for termination of the keeping of data confidentiality, the Vietnam Drug Administration shall notify such in writing to the medicine-registering establishment whose data are kept confidential. Within 3 working months after the Vietnam Drug Administration signs a written notice, the medicine-registering establishment shall send a written reply to explain the reason(s) for keeping, and supply necessary documents and evidence as requested in the notice.

4. Based on results of consideration of a request for termination of the keeping of data confidentiality and opinions of concerned parties, if finding such a request well-grounded, the Vietnam Drug Administration shall issue a decision to terminate the keeping of data confidentiality and post such decision on its website; or issue a decision on refusal to terminate the keeping of data confidentiality and notify such to organizations/individuals that request the termination if finding the such request groundless.

Article 12. Data confidentiality keeping measures

In case a request for data confidentiality is accepted, the Vietnam Drug Administration shall take the following measures:

1. Archiving and managing documents showing data requested to be kept confidential under regulations on management of secret documents.

2. Preventing any third party from accessing confidential data unless the access to these data by a competent management agency aims to verify results of a clinical trial, safety and effect of a medicine or to meet requirements of public health care.

3. Abstaining from disclosing data, unless the disclosure is necessary to protect the public.

4. Temporarily refusing to consider and grant permits to medicine-registering establishments that file their registration dossiers later than a dossier with confidential data, in case dossiers of establishments with later application dates refer to data currently kept confidential without the consent of the medicine-registering establishment whose data is kept confidential and establishments with later application dates cannot prove that data referred to in their dossiers are created independently from confidential data.

Article 13. Duration of keeping data confidentiality

1. The data confidentiality keeping measures specified in Clauses 1,2 and 3 of Article 12 shall be applied from the date the data are filed to the date the data are disclosed. However, the duration of keeping data confidentiality must not exceed the duration of management of secret documents prescribed in current regulations.

2. The data confidentiality keeping measure specified in Clause 4, Article 12 shall be applied from the date the data are filed to the date of expiration of the 5-year validity of a medicine circulation permit granted to a medicine-registering establishment having confidential data.

Article 14. Termination of keeping of data confidentiality

The keeping of data confidentiality shall be partially or wholly terminated in the following cases:

1. Data no longer satisfy the confidentiality keeping conditions specified in Article 6 of this Circular.

2. A competent agency has grounds to believe that the medicine-registering establishment having data currently kept confidential has no lawful right to use these data.

3. A decision to grant a circulation permit for a medicine with confidential data is no longer valid or the medicine registration number is revoked or the medicine-registering establishment voluntarily requests revocation of the registration number.

4. A competent agency issues a decision to compel the licensing of a patent on the medicine with confidential data.

5. An agency competent to settle complaints issues a decision to invalidate a decision on acceptance of a data confidentiality keeping request.

6. Termination of the keeping of data confidentiality is needed to protect public health and meet the society's urgent needs.

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