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Regulations Of The Food And Drug Supervisory Agency Number Hk. 03.1.23.12.10.11983 In 2010

Original Language Title: Peraturan Badan Pengawas Obat dan Makanan Nomor HK.03.1.23.12.10.11983 Tahun 2010

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(2) The type of cosmetical supplies referred to in paragraph (1) is listed in Appendix 1 which is an inseparable part of this Regulation.

CHAPTER III OF THE NOTIFICATION SUBMISSION

Part 1 Registration of the Notification Request

Section 6 (1) The applicant who will apply for the notification must

register yourself to the Head of the Board. (2) The applicant as referred to in paragraph (1) consists of:

a. The cosmetics industry located in the region of Indonesia which has had a production permit;

b. Importers who move in the field of cosmetics conform to the provisions of the laws of the laws; or

c. Individual business/enterprise undertaking production contracts with the cosmetics industry which has a production permit.

(3) Importers as referred to in paragraph (2) the letter b must have an agency's letter of appointment from the industry in the country of origin.

Article 7 (1) Registration as the applicant as referred to in Section 6 of the paragraph

(1) is done by filling in template through an electronic system delivered to the Drug Supervising Agency website and Food with the http://www.pom.go.id address.

(2) Example template as referred to in paragraph (1) is listed in Annex 2 which is an inseparable part of this Regulation.

(3) After the data verification is done, Notification applicants will get a User ID and Password.

Section 8 (1) Registration as the applicant as referred to in Section 7 only

is done 1 (one) times, as long as there is no change of the applicant data. (2) The applicant must submit the applicant ' s data changes notice

the notification or submit the registration back if it changes

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as set forth in Appendix 3 which is an inseparable part of this Regulation.

(3) Notices of the notification of the notification applicant data as referred to in paragraph (2) must be accompanied by data supporting and relayed to the Head of the Agency via email to the address penilaian_kosmetik@pom.go.id.

(4) The reregistration as referred to in paragraph (2) is performed in accordance with the provisions referred to in Article 7.

Second Part Requests Notification

Section 9 (1) The notification applicant has listed as specified in

Section 7 may submit a notification request. (2) Notification Requests as referred to in paragraph (1) are submitted

by filling Template Notifications electronically which can be downloaded from website of the Drug and Drug Administration with the address http://www.pom.go.id.

(3) Example Template Notifications as set forth in Appendix 4 that are an inseparable part of this Regulation.

(4) Template The complete filled Notifications can be saved (save) and/or sent (submit) electronically.

Article 10 (1) the applicant has managed to send (submit) Template Notifications will

receive electronically Pay Orders via the applicant's email. (2) The applicant scores a Pay Warrant and makes the payment

through the designated Bank. (3) At least 10 (ten) days after the date of the Pay Order Letter,

the applicant must submit the original proof of payment through the Bank as referred to in paragraph (2) to the Food and Drug Administration or the Great Hall of the Drug Administration and Food/Food and Drug Control Hall.

(4) The original injection of payment evidence is delivered to the cosmetic notification locket.

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Article 11 (1) If within 10 (ten) days after the date of the pay command

as referred to in Article 10 of the paragraph (3) of the Food and Drug Administration or the Great Hall of the Drug and Food and Food/Hall The Food and Drug Administration has not received an original proof of payment, a cosmetic notification request was deemed to be rejected.

(2) Original evidence of payment received by the Board of Trustees of Drug and Food or the Great Hall of Drug and Food Supervisors/Supervisors Hall Drugs and Food will be verified the truth.

(3) If the original proof of payment is Received right, the applicant receives a product ID (ID of the product) as a receipt for the submission of the notification.

Section 12 If in the term of 14 (fourteen) days since the receipt of the application is received The notification as referred to in Article 11 of the paragraph (3), the Head of the Agency does not issue a rejection letter, against the cosmetics that are deemed to be approved and may circulate in the region of Indonesia.

The Third Part of the Notification Update

Article 13 (1) of the expired cosmetical Notifications of the expiring

as referred to in Section 4 of the paragraph (2) must be renewed. (2) Request renewal of the notification for expired cosmetics

the expiring term, submitted at least 1 (one) months prior to the expiration of the notification in accordance with the procedure referred to in Section 9 to Section 12.

The fourth part of the notification fee

section 14 (1) the request of the notification is charged as the State Reception Not

Tax under the provisions of the laws. (2) In the event of a notification request denied under the rejection letter

as referred to in Section 12, the fee payable is not retracted.

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CHAPTER IV OF OTHER PROVISIONS

Section 15 of the Head of the Agency may require the request of a notification to provide a cosmetical example when necessary.

CHAPTER V THE TRANSITION PROVISIONS

Article 16 (1) At the time of this Regulation start in force, a cosmetic edar permit that has been

issued under the Decree of the Head of the Drug and Food Supervisors Number HK.00.05.4.1745 Year 2003 on Cosmetics, declared to remain in effect for a term of 3 (three) years from the date This rule applies.

(2) Application of cosmetic edar permits that have been submitted before The enactment of this Regulation, processed under the Decree of the Head of the Drug and Drug Administration of HK.00.057.45 in 2003 on Cosmetics.

CHAPTER VI OF THE PROVISIONS

Article 17 At the time this Regulation is in effect, the Decision of the Head The Food and Drug Administration of HK.00.05.4.1745 In 2003 on Cosmetics as long as regulating the vacuum of cosmetics was revoked and stated to be void.

Article 18 of this Regulation came into force on 1 January 2011.

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For everyone to know it, ordering the invitational of this Regulation with its placement in the News of the Republic of Indonesia.

Specified in Jakarta on December 13, 2010 HEAD OF THE SUPERVISORS MEDICINE AND FOOD REPUBLIC OF INDONESIA, KUSTANTINAH

PROMULRED IN JAKARTA ON 13 DECEMBER 2010 MINISTER OF LAW AND HUMAN RIGHTS REPUBLIC OF INDONESIA, PATRIALIST AKBAR

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ctory; c. the name of the industri/impor/body of the venture that performs

the notification; or d. size and type of packaging; must be made notification of change.

(4) In addition to the changes referred to in paragraph (3), the industri/import/entity must renew the notification.

Section 5

(1) The Cosmetics is justified must conform to the type of cosmetic supply.

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