Removing obstacles for enterprises to export and import drugs and medicinal ingredients

DNHN - During a recent dialogue with European businesses, the General Department of Customs highlighted several challenges faced by businesses, including paperwork for customs processes related to export. Import and export of pharmaceuticals.

There is a disconnect between the packer's power of attorney and the manufacturer's power of attorney, according to the European Business Association's Pharmaceutical Subcommittee (Pharma Group). Pharmacists define a drug producer as “an institution that produces or releases a batch of medications” (paragraph 6). Article 2, Circular 2 32/2018/TT-BYT dated 12/11/2018 regulating drug and medicinal ingredient registration.

So the packer's Power of Attorney suffices for customs clearance. The requirement to submit and not return the manufacturer's original Power of Attorney also causes issues for businesses because one original cannot be used for multiple shipments. 

The Pharma Group requested that the General Department of Customs make recommendations to expedite commodity clearance, particularly medication and vaccine import and export. Converse frequently with health-related businesses to develop solutions to practical challenges encountered during the customs clearance process. 

On the other hand, the General Department of Customs claims that current regulations on power of attorney for drugs and medicinal ingredients comply with Clause 15 of Decree No. 54/2017/ND-CP dated August 5, 2017 (amended and supplemented by Decree No. 155/2017/ND-CP December 11, 2018). If the supplier is a facility listed in Clause 15, Article 91, Points c, d, or h, it must be authorized in writing by the hospital.

Medication and medical substance providers must be members of one of the following organizations: For drugs approved for sale under the Pharmacy Law, manufacturers of imported drugs and medicinal ingredients are required to obtain a license from the Pharmaceutical Product Certification Board. Certificate of circulation in Vietnam

Article 92 of Decree No. 54/2017/ND-CP details a number of articles and procedures to implement the Pharmacy Law and related guiding documents. As a result, under Article 92, Point d, Clause 2, Point dd, Clause 4, the customs declarant must produce a copy of the permission letter or certificate of authorisation bearing the certification stamp of the importing business. A sales license or partnership certificate is required under Article 91, point DD, clause 15.

The Pharma Group questioned Customs' refusal to accept paperwork changes that did not affect pharmaceutical quality, safety, or efficacy (such as how to write expiration dates). Inconsistencies in the spelling or content of active ingredients between product labels, circulation registration papers, test sheets, and other accompanying documents, or between documents submitted for customs clearance procedures and information posted on the Drug Administration of Vietnam Portal.

The Customs Supervision and Administration Department states that the examination of customs dossiers must follow the rules of Article 32 of the Customs Law.

Because of this, the customs authority must examine both the contents of the customs declaration and their conformity with the management policy when analyzing the customs dossier.

Product management, export and import tax policies, and other key legal provisions. Imported drugs and medical substances are delicate items that directly affect customers' health. As a result, the customs authorities will use the information on the papers in the customs dossier to assess and manage the case.

The Customs Supervision and Administration Department reports that current restrictions on medicinal ingredient export and import are in accordance with Decree No. 54/ND-CP.

To this end, there are specific regulations on permits, official letters authorizing export and import, test sheets of imported batches of drugs and medicinal ingredients, authorization documents, and specialized papers that pharmaceutical business establishments, organizations, or individuals must present and submit upon customs clearance for drug export or import.

Based on the above regulations, businesses should compare them to the actual imported items and seek specific instructions from the customs sub-department where the operations are carried out.

If the issue persists, the company must send an official dispatch (accompanied by a set of customs dossiers containing complete product information, relevant documents, the customs sub-department where the procedures are carried out, recommendations, etc.)

Direction générale des douanes (via Direction générale de la supervision et de l'administration des douanes)

Phu Thanh