タイFDAワンストップサービスセンター

先週、ワークパーミットを貰ったその足で、タイFDA(食品医薬品局)のワンストップサービスセンターに行ってきた。 

医薬品、食品、医療機器、化粧品の輸入・販売には、FDAのライセンスを得ないといけないので、そのためだ。

すぐさまそれらを取り扱うとは限らないが、いずれ取り扱う可能性が高いので、個々の製品の許可申請の前に、まずは会社の登録を行う必要がある。個々の製品の許可取得には、膨大な資料と非常に長い審査時間が必要で、かなりの確率で断念せざるを得なくなる可能性があるが、業のライセンスまたは登録だけならそれほど難しくないと聞いていた。ワークパーミットの再申請時には最低限これが必要となる。

タクシーで行ったので、ワンストップサービスセンターの場所がイマイチよく分からないのだが、それはノンタブリにあり、ワークパーミットを貰った市役所からタクシーで70バーツほどのところだった。ここが一番肝心のお役所であって、それが僕の会社からとても近いのは非常にラッキーだった(そんなことは知らずにここにオフィスを構えた)。

FDAは保健省(クラサーン・サーターラナスックกระทรวงสาธารณสุข)通称 スートสธ の中にある巨大な組織だ。

僕はモンに何をしないといけないかを告げただけ。具体的な団取りは申請資料作成はモンに頼らざるを得ない。

IMG 8194

ワンストップサービスセンターの受付。ここで整理番号を貰う。

ワンストップサービスセンターも、クーデターなんか全く関係ないといった感じで業務が行われていた。そのことは僕に大きな安心感を与えた。この政変で全てが止まるということはなさそうだ。

次のステップは、ライセンスをどのように取得するのかを相談する。

受付のすぐ近くに相談窓口があった。

相談窓口はFDA内の組織と同じように、6つに分類されていた。

  • 医薬品
  • 医療機器
  • 危険物
  • 化粧品
  • 食品(健康食品、食品添加物を含む)
  • 食品の製造
FDA内には、この他に麻薬部門があるが、ワンストップサービスセンターにはその窓口ななかった。

IMG 8197

IMG 8198

最初は一番簡単そうな化粧品の窓口に行った。(ちなみに、一番難しのは医薬品、次が食品)

前の相談者を見ると、背広族はあまりいなくて、普通のおばちゃん風だったり、若い二人連れだったりして、描いていた怖いイメージとは異なった。相談コーナーでは、標準的な方法を教えるだけのようだったが、割と和やかなムードだったように思う。

順番が来たので、

「新しく作った会社で化粧品の輸入販売をしたいのですが、どうしたら良いですか?」というような具合に、とにかく一から聞く。

すると、申請書セットが手渡され、

「これに必要事項を記載して申請してください。」となる。

そんなことはホームページを見てもう分かっていたので、モンは用意してきた書類の束を出して、

「これでいいかどうか見てくれますか?」

だいたい良さそうだった。

申請は上記の分類ごとに独立して行うので、書類のコピー1セットでは足りなかったので、FDA内のコピーコーナーでコピーを取り、下の写真の左奥にある申請場所に書類を提出した。ワークパーミットを取ってから1時間後のこと。非常に速いペースだ。

IMG 8201

しかし、残念ながら足りないものがあった。権限委譲書のためのモンの身分証明書のセットだ。モンは結婚、死別離婚の過程で複数回姓名とも変えているので、揃えるべき書類が非常に多く足りないものがあったのだ。

ここには何度も何度も何度も足を運ばなくてはならないことは確実で、その全てに僕が来ることは出来ないので、モンを代理人とする権限移譲書を提出しなくてはいけない。権限移譲書の有効期間は1年間。奇異に感じたのは、その権限移譲書からして上記の6分野でそれぞれ異なっていた。どうも、ここも縦割り社会のようだ。

申請は午前中のみので、しかも一回何かを申請すると3業務日は他の申請が出来ないことになっているらしい。業のライセンス登録だけで何度も来なくてはいけないことが分かった。

モンがセンター内のポスターを見て教えてくれた。

「エージェントに頼む必要はありません。あなたが直接申請出来ます。」と書いてあったそうだ。

外国人のみならず、タイ人でもこのFDAの許可取得は難物で、その難しさはワークパーミットの比ではない。そのため、専門家に依頼するケースが多いのだが、FDAはその必要はないと言っている。日本の大手企業が専門のコンサルを使って挑戦しても、ダメなものはダメ、いいものはいいということで、誰がやっても結果は同じということか。

その言葉に勇気づけられて、僕らもどうにもならなくなるまでは自分たちでやってみるつもりだ。ややこしかったワークパーミットだって、そうして切り抜けてきたのだから。

 

 

Related Entries

Topic : タイ・バンコク
Genre : ForeignCountries

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Only the administrator may view.

Only the administrator may read this comment.

初めまして

初めまして、まっくと申します。
まさしく私もFDA申請をしようと思っていたばかりでして
すごくこの記事がためになりました!

私も化粧品の輸入のためにFDAを取得したいと思っていますが、
FDAのページに申請書セットをダウンロードするようなところは
ありましたでしょうか?
小生、英語サイトしかみていませんが、見つけることが
出来ませんでした。

お手数ですが、ご返答頂ければありがたく存じます。
いきなりのコメントで大変失礼とは思いますが、
何卒よろしくお願い申し上げます。





Only the administrator may view.

Only the administrator may read this comment.

Re: WP取得おめでとう

> >「エージェントに頼む必要はありません。あなたが直接申請出来ます。」と書いてあったそうだ。
> 食い物にされている例が多いからではないでしょうか。
賄賂防止なのかもしれませんね。エージェントと担当者が仲良くなると、グルで賄賂を分け合うようになりますから。

WP取得おめでとう

遅ればせながら、WP取得おめでとうございます。

>「エージェントに頼む必要はありません。あなたが直接申請出来ます。」と書いてあったそうだ。

食い物にされている例が多いからではないでしょうか。
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サラリーマンはもう飽きた。気がつけば人生の残りも僅か。ここはひとつ、窮屈な日本を抜け出し、活力あるのにどこかゆる~いタイを舞台に、自分らしい第二の人生に旅立つことを決めてしまった50代親父。

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