Kontrollü Makine İthalatı için DEA Lisansınızı Nasıl Güvence Altına Alırsınız?

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Gibi ekipmanların ithalatı Kapsül dolum makineleri, Tablet preslerive ilgili paketleme sistemlerinin Amerika Birleşik Devletleri'ne girişi geçerli bir DEA Lisansı. Uyuşturucuyla Mücadele Dairesi'nden (DEA) yetki alınmadan, kontrollü makine sevkiyatları ABD Gümrüklerinden geçemez. Başvurunuzu kolaylaştırmak için DEA'nın resmi portalından (apps.deadiversion.usdoj.gov/tem/spri spring/login) ve bir hesap için kayıt olun.

Do health supplement companies in the United States need a DEA license to purchase capsule filling machines from Chinese manufacturers?
Answer: Yes, they do！

To be more precise, instead of requiring a long-term DEA registration license like a pharmacy, you must declare to the DEA and obtain a one-time import permit before importing the machine.

The specific explanation is as follows:

Why you need a permit: In the United States, capsule filling machines and tablet presses are classified as "regulated machines" by the DEA, regardless of what you use them to produce. This is because such equipment may be abused to illegally manufacture drugs or counterfeit drugs. Therefore, the DEA strictly controls the import of such machines.

The key lies in the "import" behavior: The focus of supervision is on the "import" link. Even if your final product is a completely legal health product (such as cellulose), as long as you buy it from China and ship it to the United States, you must comply with DEA regulations.

Specific process:

Before the machine is shipped from China, your US company must submit an application form called Form 452 (Machine Import Application) to the DEA.

You need to fill in your company information, Chinese seller information, and detailed specifications of the machine in the form.

The most important step is that you must prove on the form that you are purchasing this machine for "legitimate commercial use", such as producing health supplements.

Only after the DEA reviews and approves your application can the machine be cleared by the US Customs and Border Protection (CBP). Without this pre-approval, the machine is likely to be seized or destroyed by customs after it arrives in the United States.

Regardless of machine size and power, this regulation applies to all types and sizes of capsule filling machines, whether small, low-power, manual, or fully automatic, and must be declared.

Pharmaceutical Sciences Dergisi'nde yayınlanan 2019 tarihli bir çalışmada araştırmacılar, iyi yapılandırılmış ithalat uyumluluk programlarına sahip kuruluşların onay sürelerini %'ye kadar azalttığını gözlemlediler.¹ Net, aktif sesli adımlarımızı izleyerek, DEA Form 452'yi ("Kontrollü Makinelerin İthalatı") nasıl dolduracağınızı ve DEA Lisansınızı alana kadar işleminizi nasıl takip edeceğinizi öğreneceksiniz.