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

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: http://peraturan.go.id/inc/view/11e44c50b7a3c360a6e5313233303239.html

BN 598-2010 .doc REPUBLIC INDONESIA No. 598, 2010 FDA. Cosmetic Notification. The procedure. Filing. REGULATION of the HEAD of the FOOD and DRUG SUPERVISORY AGENCY of the REPUBLIC of INDONESIA NUMBER HK. 03.1.23.12.10.11983 in 2010 ABOUT the CRITERIA and the PROCEDURES for FILING a NOTIFICATION COSMETICS with the GRACE GOD ALMIGHTY HEAD of FOOD and DRUG WATCHDOG AGENCY of the Republic of INDONESIA, Considering: that in order to implement the provisions of article 7 regulation of the Minister of health the number 1165/Menkes/Per/VIII/2010 2010 Notification of Cosmetics need to set rules of the head of the food and drug Watchdog Agency about the criteria and the procedures for Filing a notification Cosmetics; Remember: 1. Act No. 8 of 1999 on the protection of the consumer (State Gazette of the Republic of Indonesia Number 42 in 1999, an additional Sheet of the Republic of Indonesia Number 3821); 2. Law number 11 Year 2008 of the information and electronic transactions (State Gazette of the Republic of Indonesia Number 58 in 2008, an additional Sheet of the Republic of Indonesia Number 4928); www.djpp.depkumham.go.id 2010, no. 598 2 3. Act No. 36 of 2009 about health (State Gazette of the Republic of Indonesia Number 144 in 2009. An additional Sheet of the Republic of Indonesia Number 5063); 4. Government Regulation Number 72 in 1998 about Security Preparations pharmaceutical and health equipment (State Gazette of the Republic of Indonesia Number 138 in 1998, an additional Sheet of the Republic of Indonesia Number 3781); 5. Presidential Decree Number 103 in 2001 about the position, duties, functions, authorities, Organization of work and the Non Governmental Departments as it has several times changed the last presidential regulation Number 64 in 2005; 6. Presidential Decree Number 110 in 2001 about the Task and Organizational Unit Echelons of Non Government agencies I Department as it has several times changed the last presidential regulation Number 52 in 2005; 7. Regulation of the Minister of health the number 1175/Menkes/Per/VIII/2010 2010 about Permits the production of Cosmetics; 8. Regulation of the Minister of health the number 1165/Menkes/Per/VIII/2010 2010 about Cosmetic Notification; 9. The decision of the head of the food and drug Supervisory Agency Number 02001/SK/KBPOM 2001 about the Organization and the Work of drug and food Supervisory Agency as last amended by decision of the head of the food and drug Supervisory Agency Number HK. 00.05.21.4231 2004; 10. The decision of the head of the food and drug Supervisory Agency Number HK. 00.05.4.3870 in 2003 about the guidelines of how to Manufacture Cosmetics; www.djpp.depkumham.go.id 2010, no. 598 3 11. Regulation of the head of the food and drug Supervisory Agency Number HK. 00.05.42.1018 in 2008 about cosmetic ingredients; DECIDED: Setting: RULE The HEAD Of FOOD And DRUG WATCHDOG AGENCY ABOUT The CRITERIA And The PROCEDURES For FILING A NOTIFICATION COSMETICS. CHAPTER I GENERAL PROVISIONS article 1 in this rule is: 1. Cosmetics is material or preparations intended to be used on the outside of the human body (epidermis, hair, nails, lips and external genital organs) or the teeth and the mucous membranes of the mouth especially to clean, mewangikan, changing appearance and/or fixing the body odor or protect or maintain the body in good condition. 2. Domestic Cosmetics cosmetics are made and packaged by the cosmetics industry within the country or made overseas but packed in primary packaging cosmetics industry within the country. 3. The import of Cosmetics is the cosmetics made by the overseas cosmetics industry, at least in the primary packaging. 4. Primary Packaging is the packaging/containers which come into contact with the contents. 5. Cosmetics Contract manufacturing cosmetics that are delegated to other cosmetic industry based on the contract. 6. Cosmetic cosmetics license is made in the region of Indonesia on the basis of the appointment or the written consent of the cosmetics industry in the country of origin. 7. Making a good Cosmetic, hereinafter abbreviated CPKB, are all aspects of the activities of the making of cosmetics which aims to ensure that the resulting product always meets the requirements of the quality specified in accordance with the purpose of its use. www.djpp.depkumham.go.id 2010, no. 598 4 8. The notification template is the form-filling application notification via electronic systems. 9. Pay Warrant is an order to pay a fee as an acceptance of cosmetic notification State is not a tax. 10. The day is a working day. 11. Product information document, hereinafter abbreviated DIP, is data about quality, security, and benefit cosmetics. 12. The head of the Agency is the head of the Agency's tasks and responsibilities in the field of supervision of food and drug. CHAPTER II the CRITERIA of article 2 (1) Cosmetics that were released in the territory of Indonesia must meet the criteria: a. the safety of cosmetic ingredients is assessed are used in accordance with the provisions of the regulations and cosmetics generated do not interfere with or endanger human health, both used in normal as well as on the conditions of use have been estimated; b. benefit which is rated from conformance with the purpose of use and claims that are listed; c. quality assessed from eligibility according CPKB cosmetic ingredients and used in accordance with the Codex standard Indonesia, other Cosmetics that are recognized, and the provisions of the legislation; and d. the tagging that contains complete information, objectively, and not misleading. (2) a claim referred to in subsection (1) letter b in accordance with the provisions of the legislation. (3) a Designation as referred to in paragraph (1) letter d should use the language of Indonesia for information: a. Description of uses; b. how to use; and c. the warning and other information required. www.djpp.depkumham.go.id 2010, no. 598 5 (4) be excluded from the provisions referred to in paragraph (2) letter a and letter b to the obvious cosmetic uses or usage. (5) in addition to the labelling as referred to in paragraph (3) and subsection (4), labelling requirements in accordance with other provisions of the legislation. Article 3 (1) the criteria referred to in article 2 must be documented in the DIP. (2) the DIP as referred to in subsection (1) must be already available before making such notification. Article 4 (1) Cosmetics that will be circulated in the region of Indonesia to do the notification to the head of the Agency. (2) the notification referred to in subsection (1) apply for a period of three (3) years. (3) If during the period referred to in subsection (2) do the changes above: a. the name of the importer/industry/business entity that does change without notification of the right to circulate or ownership status; b. industry address/importer/business entities that do not occur with notification of changes the location of the plant; c. the name of the leadership of the industry/importer/business entity that does notifications; or d. the size and type of packaging; notification of changes should be done. (4) in addition to the changes referred to in paragraph (3), industrial/importer/business entity must renew notification. Article 5 (1) Cosmetics that dinotifikasi should match the types of material of cosmetics. www.djpp.depkumham.go.id 2010, no. 6 598 (2) types of cosmetic preparations as referred to in paragraph (1) are listed in annex 1 that are part an integral part of this regulation. CHAPTER III PROCEDURES of FILING a NOTIFICATION the first part of the applicant's Notification of registration article 6 (1) the Applicant shall submit an application must register the notification to the head of the Agency. (2) an applicant referred to in subsection (1) consists of: a. the cosmetics industry in Indonesia that has possess permits production; b. importers engaged in cosmetics in accordance with provisions of laws and regulations; or c. the efforts of individuals/businesses that do production contract with the cosmetics industry has had a production permit. (3) the importer referred to in paragraph (2) letter b must have a designation of agents of industry in the country of origin. Article 7 (1) the registration of the applicant as referred to in article 6 paragraph (1) is carried out by means of filling in the template via electronic systems delivered to the website food and drug Watchdog Agency with address http://www.pom.go.id. (2) Sample template as intended in paragraph (1) are listed in Appendix 2 that is part an integral part of this regulation. (3) After verification of the data the notification, the applicant will get a User ID and Password. Article 8 (1) the registration of the applicant as referred to in article 7 is only done one (1) time, all data changes are not the applicant. (2) the claimant must deliver notice of the change of data of the applicant a notification or filing a registration back if there is a change www.djpp.depkumham.go.id


2010, no. 598 7 as listed in Appendix 3 that is part an integral part of this regulation. (3) a notice of change of the data of the applicant a notification referred to in subsection (2) must be accompanied with supporting data and submitted to the head of the Agency by email to the address penilaian_kosmetik@pom.go.id. (4) the registration of the return referred to in subsection (2) is conducted in accordance with the provisions referred to in article 7. The second part of the application for Notification of article 9 (1) Applicants who have registered for notifications as referred to in article 7 may apply for such notification. (2) the application for a notification as referred to in paragraph (1) be filed by filling out the electronic Notification Templates that can be downloaded from the website of the food and drug Watchdog Agency with address http://www.pom.go.id. (3) the notification Template Examples as listed in Appendix 4 that is part an integral part of this regulation. (4) the notification Template that already completed can be stored (save) and/or sent (submit) electronically. Article 10 (1) an applicant who has managed to send the notification Template (submit) will receive Warrants to pay electronically via email of the applicant. (2) the appellant scored a warrant and make payments through the designated Banks. (3) the longest 10 (ten) days after the date of the Warrant, the applicant must submit an original proof of payment by the Bank as referred to in paragraph (2) to the food and drug Supervisory Agency or a large Hall Watchdog food and drug/food and drug Watchdog Hall. (4) the submission of the original receipts are submitted to cosmetic notification counters. www.djpp.depkumham.go.id 2010, no. 598 8 article 11 (1) if within 10 (ten) days after the date of the orders pay as stipulated in article 10 paragraph (3) of the food and drug Supervisory Agency or a large Hall Watchdog food and drug/food and drug Watchdog Hall had not yet received the original payment receipt notification, requests for cosmetics is considered rejected. (2) original proof of payment accepted Drug and food Supervisory Agency or a large Hall Watchdog food and drug/food and drug Watchdog Hall will be verified truth. (3) if the original receipt is received properly, the applicant receives a product ID (product ID) as a receipt of filing the notification application. Article 12 when within a period of fourteen (14) days from the filing of the petition receipt obtained the notification referred to in article 11 paragraph (3), the head of the Agency did not issue a denial letter, against the dinotifikasi cosmetics is considered approved and can be marketed in the territory of Indonesia. The third part of renewal Notification Article 13 (1) the cosmetic Notification had expired period of validity period as referred to in article 4 paragraph (2) should be updated. (2) the application for a renewal notification for cosmetics that have been submitted, expires the longest one (1) month prior to the expiration of the notification in accordance with the procedure referred to in Article 9 and article 12. The fourth part of article 14 Notification Fees (1) the notification Application is charged as an acceptance of the State is not in accordance with Tax legislation. (2) in the event the notification application is denied based on the letter of refusal referred to in article 12, the cost of which has been paid can not be pulled back. www.djpp.depkumham.go.id 2010, no. 598 9 CHAPTER IV MISCELLANEOUS PROVISIONS Article 15 Chiefs can require the applicant to provide the notification sample cosmetics when needed. Chapter V TRANSITIONAL PROVISIONS article 16 (1) at the time these regulations come into force, the permission path cosmetics that have been issued on the basis of the decision of the head of the food and drug Supervisory Agency Number HK. 00.05.4.1745 in 2003 about cosmetics, stated remains valid for a period of three (3) years from the date this Regulation applies. (2) the application for the permit issued on cosmetics which have been filed before the entry into force of this regulation, are processed based on the decision of the head of the food and drug Supervisory Agency Number HK. 00.05.4.1745 in 2003 about cosmetics. CHAPTER VI CLOSING PROVISIONS article 17 at the time these regulations come into force, the decision of the head of the food and drug Supervisory Agency Number HK. 00.05.4.1745 in 2003 about the Cosmetics along that path cosmetics set permission revoked and declared inapplicable. Article 18 this Regulation comes into force on January 1, 2011. www.djpp.depkumham.go.id 2010, no. 598 10 so that everyone knows it, ordered the enactment of this regulation with its placement in the news of the Republic of Indonesia. Established in Jakarta on December 13, 2010 the HEAD of the FOOD and DRUG SUPERVISORY AGENCY of the Republic of INDONESIA, KUSTANTINAH Enacted in Jakarta on December 13, 2010 the MINISTER of LAW and HUMAN RIGHTS Republic of INDONESIA, PATRIALIS AKBAR www.djpp.depkumham.go.id