Removing problems for import and export businesses of medicines and medicinal ingredients

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Illustrative photo: Internet

Regarding the problem with the Power of Attorney from the packing unit and the Power of Attorney from the manufacturer, the Pharmaceutical Subcommittee of the European Chamber of Commerce in Vietnam (Pharma Group) said due to the difference in understanding and enforcement of a number of regulations in the field of pharmacy, a drug manufacturer is defined as a unit that performs one, several stages or the whole manufacturing process or releases a batch of drugs (according to Clause 6 of Article 2, Circular 32/2018/TT-BYT dated 12/11/2018 regulating the marketing authorization of drugs and medicinal ingredients).

Therefore, the Power of Attorney from the packing unit is eligible for customs clearance. In addition, the requirement on submitting the original Power of Attorney from the manufacturer is causing difficulties for businesses when one original cannot be used for many different batches.

Pharma Group proposed the General Department of Customs provide instructions to help quick clearance of goods, especially related to import and export of drugs and vaccines; and organize regular dialogues with businesses in the health sector to find solutions for problems that businesses are facing in customs clearance.

In order to promote inter-sectoral coordination and simplify procedures, Pharma Group also proposed the Ministry of Health and related ministries and agencies jointly organize this dialogue session.

In this regard, the Customs Control and Supervision Department said regulations on power of attorney for drugs and medicinal ingredients comply with Clause 15, Article 91, Article 92 of Decree 54/2017 dated 8/5/2017 (amended and supplemented in Decree 155/2017/ND-CP dated 12/11/2018).

Accordingly, if the supplier is a facility specified at Points c, d or h of Clause 15, Article 91, it must be authorized in writing by the unit specified at Points a or b of this Clause to supply drugs to Vietnam.

Specifically, an authorized supplier of drugs and medicinal ingredients must be one of the following establishments: Manufacturers of imported drugs and medicinal ingredients; the establishment that owns the imported drug or medicinal ingredients and owns the product license stated in the pharmaceutical product certification permit for drugs that have been granted the marketing certificate as described in Law of Pharmacy and drugs that have not yet been approved for sale in Vietnam.

Regarding customs clearance documents and dossiers, the Customs authority shall base on Article 92 of Decree 54/2017. Accordingly, according to Point d, Clause 2, Point dd, Clause 4, Article 92: For cases where a power of attorney must be submitted, the customs declarant shall submit a copy bearing the importer’s seal of the power of attorney or the seller’s license or certificate of partnership according to point dd Clause 15 of Article 91.

Pharma Group asked if the Customs authority did not accept differences in documents, most of which did not affect the truthfulness, safety or effectiveness of drugs (such as how to write expiration dates, the abbreviation of active ingredient name, presentation of active ingredient content format) between product labels, marketing certificates, testing certificates and other documents, or differences of documents submitted for customs clearance from the information posted on the Vietnam Drug Administration Portal.

For example, differences in typographical errors; different formats; abbreviation of the address of the manufacturer, trade name/ international common name of excipient materials; a small difference in the presentation of product names from the factory compared to the Certificate of Sale issued in Vietnam. Pharma Group believes that the above differences may be reasons for the Customs authority to transfer these shipments to the Red channel.

According to the Customs Control and Supervision Department, the inspection of customs dossiers shall comply with the provisions of Article 32 of the Law on Customs. Accordingly, upon examination of customs dossiers, the customs officer shall check the accuracy, completeness and conformity of the contents in customs declaration with the documents in the customs dossier, check the compliance with the management policy of goods, tax policies for exported and imported goods and other relevant provisions of law.

Imported drugs and medicinal ingredients are sensitive products that directly affect consumers' health. Therefore, if the information on the documents in the customs dossier is complete and appropriate, the customs authority will handle the procedures as prescribed.

Also related to export and import documents of medicinal ingredients, the Customs Control and Supervision Department said current regulations on the export and import of medicinal ingredients comply with Decree 54. Accordingly, the decree specifies permits, dispatch permitting export and import, testing certificates of imported batches of drugs and medicinal ingredients, power of attorney; regulations on specialized documents that pharmaceutical business establishments, organizations, and individuals need to present upon customs clearance for export or import of drugs and medicinal ingredients.

Instructions for inspecting shipments of medicines and medicinal ingredients

It is recommended that businesses should base on the above provisions and compare them with the actual imported goods for implementation, and contact the customs branch to receive specific instructions. If businesses still encounter problems, the businesses are requested to send a letter (with customs dossiers and relevant documents) to the General Department of Customs (via the Customs Control and Supervision Department) for guidance.