Circular No. 38/2013/TT-BYT Amending and Supplementing Certain Provisions of Circular No. 47/2010/TT-BYT dated December 29, 2010, of the Minister of Health guiding the export and import of medicines and direct contact packaging materials

CIRCULAR

Amending and supplementing certain Articles of Circular No. 47/2010/TT-BYT dated December 29, 2010, issued by the Minister of Health guiding the export and import activities of medicines and direct contact pharmaceutical packaging

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Pursuant to the Medicine Law No. 34/2005-QH-11 dated June 14, 2005;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

Pursuant to Decision No. 42/2013/QĐ-TTg dated July 15, 2013, of the Prime Minister on the management of medicines for human use through non-commercial export and import activities and amending and supplementing certain provisions of the Regulation on the Importation of Medicines Not Yet Registered in Vietnam promulgated together with Decision No. 151/2007/QĐ-TTg dated September 12, 2007, of the Prime Minister;

At the proposal of the Director of the Drug Administration Department;

The Minister of Health issues this Circular to amend and supplement certain Articles of Circular No. 47/2010/TT-BYT dated December 29, 2010, guiding the export and import activities of medicines and direct contact pharmaceutical packaging.

Article 1. Amending and supplementing certain Articles of Circular No. 47/2010/TT-BYT dated December 29, 2010, of the Minister of Health guiding the export and import activities of medicines and direct contact pharmaceutical packaging (hereinafter referred to as Circular No. 47/2010/TT-BYT) as follows:

1. Amending Clause 3 of Article 4 as follows:

“3. Requirements for test certificates:

When handling customs clearance procedures, enterprises importing medicines and direct contact pharmaceutical packaging must present to the customs office the original test certificate issued by the production facility certifying that each batch of imported medicines meets quality standards, except for medicinal herbs and medicines specified in Articles 12, 13, 14, 15, 17, and 18 of this Circular.

In cases where two or more facilities participate in the production of medicines, the customs office will accept either the original test certificate from the production facility or the original test certificate from the final packaging facility or the facility responsible for releasing the product.

The customs office shall retain a copy of the test certificate stamped with the confirmation seal of the importing enterprise.”

1. Vehicles that have reached their service life before December 31, 2018: Allowed to operate until December 31, 2023.

“Article 19. Raw materials for medicines, unregistered medicinal herbs, and direct contact pharmaceutical packaging

1. Raw materials for medicines permitted to be imported according to the List of Permitted Imported Raw Materials for Medicines published by the Drug Administration Department (no import permit required) as stipulated in Clause 2 of this Article or under the form of an import permit as stipulated in Clause 3 of this Article.

2. Importing according to the List of Permitted Imported Raw Materials for Medicines published by the Drug Administration Department (no import permit required)

a) The List of Permitted Imported Raw Materials for Medicines (no import permit required), published by the Drug Administration Department, includes drug substances, excluding raw materials listed in the controlled substances, psychotropic substances, and precursor substances used in medicines. If a production facility changes the source or quality standard of the raw material, the facility must submit a change registration dossier in accordance with Appendix II issued together with Circular No. 22/2009/TT-BYT dated November 24, 2009, of the Minister of Health on the registration of medicines and may only import after receiving a written agreement from the Drug Administration Department regarding the content of the change and supplementation.

b) Publication procedure

- The Drug Administration Department publishes the List of Permitted Imported Raw Materials for Medicines (no import permit required) on its electronic information website (www.dav.gov.vn) using Form No. 16 issued together with this Circular.

- Within thirty working days from the date of issuance of the registration number for the medicine, the Drug Administration Department publishes the List of Permitted Imported Raw Materials for Medicines.

c) Importing enterprises

- A production facility that has been granted a registration number is only allowed to import raw materials according to the published List.

- Enterprises engaged in the business of importing raw materials for medicines are permitted to import raw materials included in the List of Permitted Imported Raw Materials for Medicines (no import permit required) published by the Drug Administration Department.

d) Importation documents and procedures

- Production facilities requiring the importation of raw materials for the production of medicines and enterprises importing raw materials for business purposes shall directly handle customs clearance procedures to import raw materials according to the published List;

- Production facilities of medicines must present a Certificate of Compliance with Conditions for Medicine Production or Good Manufacturing Practice (GMP) Certificate in accordance with point c and point d of Clause 1 of Article 3 of this Circular.

- Enterprises importing raw materials for business purposes must present a Certificate of Compliance with Conditions for Pharmaceutical Business (wholesale or import-export) and a Good Storage Practice (GSP) Certificate with a scope of business consistent with the requirements set out in point a of Clause 1 of Article 3 of this Circular.

- The validity period for importing raw materials for medicines under the publication method is equal to the validity period of the registration number of the medicine produced from those raw materials;

- Foreign enterprises supplying raw materials for medicines to Vietnam must have a valid Pharmaceutical and Raw Material Operation Permit in Vietnam in accordance with Clause 12 of Article 3 of this Circular.

3. Importing raw materials for medicines under the form of an import permit

a) Raw materials for medicines imported under the form of an import permit include:

- Raw materials for medicines not permitted to be imported under the publication method as stipulated in Clause 2 of this Article;

- Raw materials listed in the controlled substances, psychotropic substances, and precursor substances used in medicines;

- Raw materials such as excipients, capsule shells, and direct contact pharmaceutical packaging;

- Raw materials used for research and testing;

b) Enterprises importing raw materials under the form of an import permit and foreign enterprises supplying raw materials for medicines to Vietnam as stipulated in Article 3 of this Circular.

c) Documents for applying for an import permit

- Import order forms according to Forms No. 12a, 12b, 12c, 12d, and 12đ issued under this Circular.

- Quality standards and testing methods for raw materials, herbal medicines, and direct contact pharmaceutical packaging, provided by the manufacturer, or a photocopy of the monograph on quality standards from the pharmacopoeia, except when European, British, American, International, or Japanese pharmacopoeia standards are applied.

- For raw materials for drugs that are addictive substances, psychotropic substances, or precursors for drugs, a Stock Report according to Form No. 3 issued under this Circular must be submitted together.

d) Import permit issuance procedures

The enterprise submits the dossier to the Drug Administration Department - Ministry of Health. Within seven working days from the date of receipt of a valid dossier, the Drug Administration Department - Ministry of Health will consider issuing the import permit.

For raw materials for drugs that are addictive substances, psychotropic substances, or precursors for drugs, within fifteen working days from the date of receipt of a valid dossier, the Drug Administration Department - Ministry of Health will consider issuing the import permit.

In case the import permit is not granted, the Drug Administration Department - Ministry of Health shall notify the enterprise in writing and specify the reasons.

đ) An import permit for raw materials for drugs without registration number has a maximum validity of two years from the date of issuance.

3. Amend and promulgate additional forms as follows:

a) Issue Form No. 1 attached to this Circular to supplement the Appendix of Circular No. 47/2010/TT-BYT (supplementing Form No. 16).

b) Issue Forms No. 2a, 2b, 2c, 2d, 2đ to replace Forms No. 12a, 12b, 12c, 12d issued under Circular No. 47/2010/TT-BYT.

c) Issue Form No. 3 to replace Form No. 1a issued under Circular No. 47/2010/TT-BYT.

d) Issue Form No. 4 to replace Form No. 3 issued under Circular No. 47/2010/TT-BYT.

đ) Issue Form No. 5 to replace Form No. 6a issued under Circular No. 47/2010/TT-BYT.

e) Issue Form No. 6 to replace Form No. 7a issued under Circular No. 47/2010/TT-BYT.

f) Issue Form No. 7 to replace Form No. 7c issued under Circular No. 47/2010/TT-BYT.

g) Issue Form No. 8 to replace Form No. 11a issued under Circular No. 47/2010/TT-BYT.

Article 2. Transitional Provisions

1. Applications for import permits for drugs without registration numbers submitted before January 1, 2014, shall be processed in accordance with the provisions of Circular No. 47/2010/TT-BYT dated December 29, 2010, guiding the export and import activities of drugs and direct drug packaging.

2. Import permits for raw materials for drugs without registration numbers issued before the effective date of this Circular are permitted to continue until their expiration date as stated on the permit.

Article 3. Implementation Provisions

1. By December 31, 2014, the Drug Administration Department shall announce all drugs that have been registered before July 1, 2014.

2. From July 1, 2014, the Drug Administration Department shall announce raw materials included in the list of raw materials for drugs allowed to be imported (without requiring an import permit) within thirty working days from the date of drug registration.

Article 4. Effective date

This Circular takes effect from January 1, 2014.

Clause 3 of Article 4, Article 19 of Circular No. 47/2010/TT-BYT, Form No. 1a, Form No. 12a, 12b, 12c, 12d, Form No. 3, Form No. 6a, Form No. 7a, Form No. 7c, and Form No. 11c issued under Circular No. 47/2010/TT-BYT cease to be effective from the date this Circular takes effect.

During implementation, if there are difficulties or obstacles, organizations and individuals are requested to promptly report to the Ministry of Health (Drug Administration Department) for guidance or amendments to ensure compliance./.