Food supplement in Indonesia

Food Supplement Registration in Indonesia

  • InCorp Editorial Team
  • 16 July 2015
  • 4 reading time

The Overview of Food Supplement in Indonesia

Indonesia is one of the ASEAN member countries which decided to adopt the terminology in ASEAN harmonization regulations on Traditional Medicines and Health Supplements (TMHS). Under this regional harmonization framework, health supplement in Indonesia is registered to separate directorate named Directorate of Health Supplement Evaluation under BPOM.

food supplement registration in Indonesia CekindoBased on ASEAN Agreement on Traditional Medicines and Health Supplements (TMHS) article 2, product which is categorized as health supplement is any product that is used to supplement a diet and to maintain, enhance and improve the healthy function of human body and contains one or more or combination of vitamin, mineral, amino acids, fatty acids, enzymes, substance derived and synthetic sources of above ingredients.

However, Indonesia have its own definition for health supplement as complement the nutritional need, maintain, increase and improve health function, containing one or more ingredients in the form of vitamin, mineral, amino acid or other ingredient (originating from plant or non-plant) that have nutritional value and/or physiological effect, not intended as food.

However, this health supplement definition is not the single standard to categorize the product as health supplement or goes to another categorization. The categorization will instead depend on the ingredients in each product.



Health and Food Supplement Registration in Indonesia


In Indonesia, health supplement is regulated through Regulation of the Head of the Agency of Drug and Food Control Republic of Indonesia Number HK.00.05.41.1381 concern The Standard Procedure of Food Supplement Registration. Procedure to register health supplement in Indonesia is divided into 2 steps:


    

  • Pre-assessment as step for the evaluator to check the completeness of required documents and to determine the categorization of registration. The pre-assessment may take 20 working days to get the result.
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  • Assessment as the next step to conduct the evaluation based on documents and supporting data.
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In health supplement registration, one product with different size is considered as one registration only but if for example one product have 4 different flavors in different bottle, it is considered as one flavor as one product. During the registration, there is certain fee is charged in accordance with the prevailing statutory regulations.


Following pre-assessment and assessment is not the guarantee if the application is approved. In this case there is refusal possibility due to the incomplete documents or other factors and the payment term is non-refundable. The documents which are required as below:


Administration Documents



    

  • Letter of Authorization from manufacturer
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  • Certificate of Free Sale issued by the Government of country origin which legalized by Indonesian embassy/ Consulate General in that country origin
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  • Good Manufacturing Practice from the manufacturer
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  • Company Tax ID (NPWP)
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  • Trade Business License
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Technical Documents


    

  • Ingredients which includes details composition in matrix both active ingredients and additive, direction of usage (direction, dosage, warning, contraindication and other  necessary information )
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  • Manufacturing process from weighing of raw materials to finished products
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  • Method and result of stability study (Indonesia, zone IV, RH: 75% + 5%, T: 30oC +2oC, minimum 6 months  and 2 batch)
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Additional Documents


    

  • Certificate of safety test from laboratories appointed by BPOM for organoleptic, physical-chemical, microbial, heavy metal, chemical drug and psychotropic-narcotic contaminant.
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  • Data of toxicity test from laboratories appointed by BPOM or equivalent body in country of origin for health supplement which its safety is not yet known
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The assessment process approximately takes 6 months until 1 year to get the final result. The registration approval for food supplement is valid for five years as long as still meeting the prevailing provisions and can be extended through re-registration.


Cekindo Can Help You


You can register the food supplements directly under your own company.


Read: Company Registration in Indonesia


But if you are not ready yet to set up a company, you can register your products under Indonesian local company. Cekindo can help you to be the 3rd party so you can register the products safely under our company.




For further information about food supplement registration in Indonesia, simply just contact us by sending your email to sales@cekindo.com or put your comment below.

					

						
						

							

								

									

										

											
											
										

									

									

										

											

												
Daris Salam

												
COO Indonesia at InCorp Indonesia

												
With more than 10 years of expertise in accounting and finance, Daris Salam dedicates his knowledge to consistently improving the performance of InCorp Indonesia and maintaining clients and partnerships. 


											

										

									

								

							

						


									

			

		

	







	

		

						

				
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Frequent Asked Questions

				

					


						
							


								


								

								


								


								


									You can transfer the license as long as your current local distributor agrees to change the product license holder. The procedure will be different for each product category. We can only recommend you try to prevent these issues by setting cooperation with a trustworthy partner from the beginning
								


								


							


						
							


								


								

								


								


								


									Before you can distribute your products in Indonesia, you will have to register your product with the BPOM (National Agency of Food and Drugs) and MoH (Ministry of Health). Only an Indonesian legal entity can register the product. If you decide to distribute your product via a local distributor, they will register the product under their entity in Indonesia and become the product license holder. Cekindo can act as your local distributor and register the product under its name.
								


								


							


						
							


								


								

								


								


								


									There are three things business owners need to consider before setting up a business in Indonesia: the type of business entity, capital requirements, and regulations.
								


								


							


						
							


								


								

								


								


								


									Indonesian regulations separate local companies from foreign companies. Generally, foreign-owned companies (PT PMA) have more limitations than their local counterparts (Local PT). However, to pursue more foreign direct investment in the country, the government has taken several bold initiatives to increase the ease of doing business and provide numerous attractive incentives for foreign investors.
								


								


							


						
							


								


								

								


								


								


									There are two main types, namely, primary business licenses and non-primary business licenses. The primary ones commonly apply to various industries, such as general and industrial business licenses. Additional non-primary ones are included, depending on the operations of your business. Examples of non-primary business licenses are operational and commercial licenses.