According to the … MS DOS programs originally use PIF files and they serve as executable file shortcuts like an .LNK file. The main objective of this ASEAN Product Information File (PIF) Guideline* is to provide companies placing a cosmetic product in the market recommendations on how to organize and compile the PIF based on a recommended PIF format. What Is TPD (Therapeutic Product Directorate)? Further guidance from Cosmetics Europe – Guidelines on Product Information File (PIF) Requirement. What is Reference Safety Information (RSI)? What Is Identification of Medicinal Products (IDMP)? La documentazione informativa (o Product Information File) sul prodotto cosmetico dovrà essere conservata per un periodo di dieci anni dopo la data in cui l’ultimo lotto del prodotto cosmetico è stato immesso sul mercato.» Assessor’s credentials and approval – name, address, proof of qualification, date and signature. The Product Information File (PIF) must contain five parts. L’articolo 10 e 11 del nuovo regolamento CE 1223/2009 sui prodotti cosmetici inseriscono, per la prima volta nella terminologia cosmetica, termini quali Documentazione informativa sul Prodotto (P.I.F. Sacha Baïzet – Moderator, Hi I need to set up a pig fif file how do I do this can I pay a company to do this, Hello Shabina, Cosmetics Product Information File (PIF)? PIF – PRODUCT INFORMATION FILE NAPKIN GO 09 ‐ MAKE UP REMOVER CODICE FORMULA CH09 Rev 00 Data: 20/01/2015 Pagina 4 di 31 PROVE ed EFFETTI ATTRIBUITI AL PRODOTTO COSMETICO È stato eseguito il patch test occlusivo, singola applicazione. Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. The P.I.F. Introduction and Objective The ASEAN Cosmetic Directive (ACD) requires persons or companies placing a product on the market to keep a product information file “readily Under the rules, … Product Information File (PIF) Each cosmetic product must have its own Product Information File (though the term 'file' includes virtual records) containing a great deal of information about the product. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was pla ced on the market. The PIF must include the product description, the Cosmetic Product Safety Report, details of methods of … It needs to be established before you start selling your products, as it is basically a record of how you made them. Therefore, it is crucial for cosmetic product manufacturers to file it compliantly by … Readily accessible: The P.I.F. What Are IND (Investigational New Drug) and NDA (New Drug Application) Applications? Our content is informative and does not constitute legal advice. What is a Product Information File (PIF)? The Product Information Form (PIF) allows companies to include a variety of information about food products and ingredients in a single document that meets information needs for legal and regulatory compliance in Australia and New Zealand, in a standardised manner. However we work with regulatory partners when a customer project requires it. Below the list of documents that composed the PIF: If it appears that a cosmetic product placed on the market presents a risk to human health, the person responsible for placing it on the market must immediately inform the authorities and specify the preventive and corrective measures to be adopted. The main objective of this ASEAN Product Information File (PIF) Guideline* is to provide companies placing a cosmetic product in the market recommendations on how to organize and compile the PIF based on a recommended PIF format. It contains the … According to regulation 1223/2009 article 2.11, the product information file shall be kept at the disposal of the competent authorities at least ten years after the last product batch has … What is Regulated Product Submission (RPS)? The Product Information File (PIF) is the mandatory compilation of technical documentation required for each cosmetic product to be placed on the EU market. We provide a PIF authoring and review service to help producers comply with the PIF requirements as part of the EU regulations for cosmetic products. What is a Voluntary Cosmetic Registration Program (VCRP)? The PIF must be maintained by the Responsible person for at least 10 years post the date, on which the last batch of the product was distributed in the market. These instructions can include the amount of memory to use, the path to the executable file, and what type of window to use. I am interested in a PIF document for lip gloss online business which I intend to start up in the UK and ship to Europe. Hi, Compiling a Product Information File (PIF) is one of the key steps you need to comply with when it comes down to putting your cosmetic products on the European market. What is A Cosmetic Product Safety Report (CPSR)? It also needs to contain company information including the street address of all distributors and the details of the ‘Responsible Person’. What is the Product Information File (PIF)? The person responsible placing the cosmetic product on the market have to submit to competent authorities (ANSM, the Directorate General of Health or the DGCCRF) the PIF, as well as the Risk assessment of the product and keep those documents updated for at least 10 years. European Authorized Representative (EC REP), Local Authorized Representative Support – ROW, Cosmetic Product Formulation And Ingredient Review, Cosmetic Safety Assessment and Toxicology Services, Go-To-Market and Local Representation Services. 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Cosmetic Product Information File (PIF) The responsible person must keep a Product Information File (PIF) at their address indicated on the label and make it available to supervisory authorities. Express your needs and expectations; we will do our best to organize a meeting with our sales team. The Product Information File (PIF) is one of the key elements for ensuring successful market entry of a cosmetic product in the European market. Each cosmetic product is required to have a PIF of its own containing information about the product such as CPSR (Cosmetic Product Safety Report), product description, methods of manufacture etc. Short for Program Information file, a type of file that holds information about how Windows should run a non-Windows application. P.I.F. The health authorities can review the PIF at any time, and if they notice that a cosmetic product presents any non-conformity, they will require the immediate withdrawal of the product. We apologize for the late response. This tool provides you with the an indication of the key steps you will need to follow, without having to go through the whole Cosmetic Regulation 1223/2009. Data on Animal Testing. The Product Information File (PIF) is a mandatory document that is necessary for every cosmetic product placed in the Association of Southeast Asian Nations (ASEAN) and European markets. What Is A Product Information File (PIF)? Though it’s not needed to submit complete PIF to health authority for approval, but all the documents need to be in place as health authority may request any time for information. Ask questions about Lascom products to our team of experts; we will be glad to answer you as soon as possible. We develop PLM (Product Lifecycle Management) software covering, among others, regulatory challenges. The Regulation goes further with the introduction, for the first time, of the wording ^Product Information File (the P.I.F shall be accessible to the competent authority of the Member State where the P.I.F. and is open for inspection by the Regulatory authority. ASEAN PIF Guidelines 13 June, 2007 Page 3 of 7 1. In case any changes are made to the product, the PIF must be updated immediately. What is a Marketing Authorization Application (MAA)? Need help to write one? Sincerely, Product Information File (PIF) – All You Need to Know. According to the Cosmetic Regulation (EC) No 1223/2009, when a cosmetic product is placed in the European market, the Responsible person for the product is required to maintain a Product Information File (PIF). It needs to be established before you start selling your products, as it is basically a record of how you made them. The Product Information File (PIF) is kept by Responsible Person for 10 years for each product placed on to the market, at the address specified on the product label, readily accessible for the competent authority. We maintain the PIF including all required documents and information for you! According to EU Cosmetics Regulation 1223/2009/EC, the product information file should contain at The product information file does need to have a structure. This document also provides guidance on who is responsible to keep the PIF and some guiding points for PIF audits. Product Information File The Product Information File (PIF) is the mandatory compilation of technical documentation required for each cosmetic product to be placed on the EU market. However, the Regulation 1223/2009, which is fully enforced since 11 July 2013 in lieu of the Directive, goes farther, by detailing the content of the Product Information File (PIF). According to the EU Cosmetics Regulation 1223/2009/EC, the elements of the PIF include but are not limited to: Proof of the effect claimed (where justified) Proof of the effect claimed (where justified) Data on Animal Testing. Name and address of the responsible person, The country of origin if the product is imported from countries outside of the EU, Nominal content of the product, given by weight or volume, Date of minimum durability or period after opening. What Is Active Substance Master File (ASMF)? Since the application of the new European Cosmetics Regulation 1223/2009 article 11 on cosmetic products sold in the European Union, industry professionals have to provide a Product Information File (PIF) for each of the product placed on the market and destined for consumption. What is the Product Information File (PIF)? Reach out to us at sales@freyrsolutions.com. What are National, Mutual Recognition, Decentralized and Centralized Procedures? The product information file (PIF) is a collection of technical documentation for each cosmetic product to be introduced to the market. To learn more about how can Lascom CPG software help you to manage your product development and be compliant with EU regulations : https://www.lascom.com/solutions/plm-software-cosmetics/, Share the post "Product Information File (PIF) – All You Need to Know", Hello Mr. Camlek, You will be able to automatically create the product information file and manage all the information related to your cosmetic products: physico-chemical specifications, microbiological, control plans, product formulation, constrained formulation (regulations and customers), nonconformity management, etc. where the Product Information File (PIF) is kept details of a named contact for urgent enquiries details of any nanomaterials the cosmetic product contains details of … A Product Information File (PIF) is one of the most important legal requirements for placing a product in the market. CHIC TRADING s.r.l. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance. Product Information File (PIF) Content . What is The Center for Drug Evaluation and Research (CDER)? EU REGULATION 1223/2009© CE.way Regulatory Consultants Ltd 2. The responsible person must make the PIF readily accessible in electronic or other format at the physical address indicated on the product label to the competent authority of … Sacha Baïzet – Moderator. PIF – PRODUCT INFORMATION FILE NAPKIN GO 09 ‐ MAKE UP REMOVER CODICE FORMULA CH09 Rev 00 Data: 20/01/2015 Pagina 5 di 31 Dopo un periodo di … Quando un prodotto cosmetico è immesso sul mercato, la persona responsabile deve mantenere una accurata documentazione (PIF) informativa su di esso. Product Information File (P.I.F. and is open for inspection by the Regulatory authority. Part A – Safety Information. PIF (Product Information File) Regulation (EC) No 1223/2009 – PIF requirements. Think of it like a big file that you just keep adding to. Sacha Baïzet – Moderator. According to the EU Cosmetics Regulation 1223/2009/EC , the elements of the PIF include but are not limited to: Sincerely, The Product Information File (PIF), which shall come along with any cosmetic product placed on the market, has been tremendously modified by the new Cosmetics Regulation, which is mandatory since July 2013. If you are selling your cosmetic products then one of the requirements is that you produce a Product Information File (PIF) for each recipe/product that you make. What is EU General Data Protection Regulation (EU GDPR), What is European Database on Medical Devices (EUDAMED). Under the rules, producers are required to have a Product Information File – or PIF. PIF structure Regulation (EC) No 1223/2009 does not specify in what format the product information file is stored. To talk to one of our PLM (Product Lifecycle Management) experts, please fill in a contact request and our teams will come back to you shortly! Each cosmetic product is required to have a PIF of its own containing information about the product such as CPSR (Cosmetic Product Safety Report), product description, methods of manufacture etc. ´Vaatimattomasti sanottuna Product Information File sisältää aivan kaiken kosmetiikkatuotteeseen liittyvän. Regulation (EC) No 1223/2009 requires that a product information file (PIF) is kept for ten years for every cosmetic product placed onto the market within the European Union (EU). Panaracer No. Nel PIF, in particolare, il valutatore della sicurezza dovrà effettuare e documentare verifiche su: about the cosmetics product information file (pif) The product information file is a cosmetic product dossier containing all the most important information about the finished product, ingredients which the product is made from, packaging in which the product is sold, manufacturing process and product labelling, which shows the product characteristics, its safety and efficacy. The Product Information File (PIF) is the mandatory set of technical documentation required for each cosmetic product to be placed on the EU market. and is open for inspection by the Regulatory authority. What is A Certified Product Information Document-Chemical Entities (CPID-CE)? Lascom CPG solution helps you to manage all your product data and information. Since the application of the new European Cosmetics Regulation 1223/2009 article 11 on cosmetic products sold in the European Union, industry professionals have to provide a Product Information File (PIF) for each of the product placed on the market and destined for consumption. Via a simple procedure, during which the user is required to specify different elements that compose the dossier (namely the information about finished product, producer and distributor, microbiological control tests, evaluations … ): the information needed to meet the requirements of Article 11 of the EC Regulation. For example, a PIF file can contain instructions for executing a DOS application in the Windows environment. should be available to control officers at the … Our content is informative and does not constitute legal advice. What is A Pharmacovigilance System Master File (PSMF)? In order to compile the PIF, product information has to be gathered from several stakeholder: suppliers, laboratories, safety assessor, and internal product information system. It is a legal document containing: a clear description of your cosmetic product a CPSR (Cosmetic Product Safety Report) for your cosmetic proof of any claim of effect (it is not possible to make claims without quantified proof) the cosmetic’s ingredients (using INCI names and assembled in the right order) information on the manufacturing process (including … The PIF must also include the “Physical and chemical characteristics of the substances or mixtures, as well as of the cosmetic product.” which is covered in the raw materials’ MSDS sheets. What is CFR (Code of Federal Regulations)? The Product Information File (PIF) is one of the key elements for ensuring successful market entry of a cosmetic product in the European market. What is a Clinical Evaluation Report (CER)? Cosmetics Product Information File (PIF) is compiled documentation with information about the cosmetic product. Article 11.1 of the EC regulation states: “When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it.” A compliant product information file (PIF) therefore must be created from the date the cosmetic product is first sold and for a duration of 10 years from the date when the … A compliant product information file (PIF) therefore must be created from the date the cosmetic product is first sold and for a duration of 10 years from the date when the product is last sold. Legal objective and justification related to animal testing, It should be kept in electronic or any other (example: paper) format as long as it is maintained, The information included should be easily understood by the verifier of the PIF, It should be in the national language of the country it is kept in, Any supporting documents such as laboratory reports, letters or publications should be retained in the original language they are written in. Further guidance from Cosmetics Europe – Guidelines on Product Information File (PIF) Requirement. The PIF must be made available by the responsible person (RP) at the address displayed on the label of the cosmetic product in accordance with the Regulation. *This is not a legal document and as such, … EU Regulation No 1223/2009 as amended lays down the rules for cosmetic products on the EU market. The PIF should include all the elements considered to be of primary importance to the consumer and its health: namely the identity of the product, the precaution of use, the list of ingredients and the possible negative effects. The product information file does need to have a … Who Is A Marketing Authorization Holder (MAH)? The Legal basis . #1: Finished Product Information A PIF needs to start with the product name, its description and intended uses. The product information file (PIF) demonstrates the safety of a cosmetic product for reasonably foreseeable use and must be in place before placing a cosmetic product on the market. further by requiring a product information file to be kept for 10 years for each product placed on to the market.1 The product information file builds on the product information required under the directive but requires a cosmetic product ... PIF structure Regulation (EC) No 1223/2009 does not specify in what format the product information file is stored. For cosmetics manufactured in the European Union, the person who sells the product under their brand is the responsible person. Cosmetics product information file (PIF) 1. Product Information File (PIF) Each cosmetic product must have its own Product Information File (though the term 'file' includes virtual records) containing a great deal of information about the product. Who is A Mexican Registration Holder (MRH)? Every product that falls under the definition of a cosmetic product and is placed in the European market, requires a PIF. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label. Our blog authors combine information freely available on the web with our teams’ experience to provide related best manufacturing practices. Consult our experts regarding authoring, compiling and submitting PIFs. 製品情報ファイルは化粧品を説明する書類であり、相応の資質を有する専門家がサインした安全性評価も含みます。 我々は、あなたの製品情報の設定ファイルが、我々の保護されたデータベースにセットアップし、毎日更新されています。 What we will do: This is a requirement of Cosmetic Regulation (EC) No 1223/2009 and thus applies to any cosmetic or personal product sold within the EU. so I am looking for help to complete this if you can help. is kept, in electronic or other format and in a language which can be easily understood by the competent authority.. The Product Information File (PIF) is the mandatory set of technical documentation required for each cosmetic product to be placed on the EU market. PIF software for cosmetics products PIF software from cosmetri, enables fast generation and therefore easy maintenance of your product information file, also known as the PIF. The Regulation (EC) N° 1223/2009 on cosmetic products is implemented in full from July … What is the Office of Generic Drugs (OGD)? However we work with regulatory partners when a customer project requires it. The bases that lead to the PIF already existed in the Directive 76/768. What is Certification of Suitability (CEP) and Sister CEP submissions? Mitä Product Information File sisältää? What is Medical Device Single Audit Program (MDSAP)? Each cosmetic product is required to have a PIF of its own containing information about the product such as CPSR (Cosmetic Product Safety Report), product description, methods of manufacture etc. We set up your Product Information File (PIF) in our protected database, we daily keep it updated, and in case of inspection by Authorities, we can send it in a few minutes. Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. What Is A Periodic Safety Update Report (PSUR)? Our aim is to assist you in the creation of innovative and effective products which are in line with european regulation, and safe for both human health and the environment. Nel PIF, in particolare, il valutatore della sicurezza dovrà effettuare e documentare verifiche su: The product information file (PIF) is a collection of technical documentation for each cosmetic product to be introduced to the market. According to EU Cosmetics Regulation 1223/2009/EC, the product information file should contain at least the followings: • Product description and categories • Safety assessment report . What Is Post-Authorisation Safety Study (PASS)? - Product Information File ... PIF in TECHNICS is nothing more than the collection and organization of all informations memorized previously through research and development. This is a legal requirement and According to the EU Cosmetics Regulation 1223/2009/EC, the elements of the PIF include but are not limited to: Product Description; Safety Report: Part A: Cosmetic Product Safety Information. PIF – Product Information File Il dossier cosmetico viene sostituito dal PIF ( Product Information File ) documento molto più articolato e meglio definito rispetto al passato. Product Information / Technical File Compilation Product information file or technical file is type of cosmetic dossier and need to be in place before the product is placed in the market. These information could be the exe file path, the amount of memory used, as ell as the program window size. https://www.lascom.com/solutions/plm-software-cosmetics/, Quantitive and qualitive composition of the product – exact percentage, Physical/chemical characteristics and stability of the product, Impurities, traces, information about the packaging, Statement on the safety of the cosmetic product, Statement on the need to label any particular warnings and instructions of use, Explanation of the scientific reasoning of the substances contained in the cosmetic product and on the Safety Information documentation, Justification of the consideration and non-consideration of the raw materials’ toxicological profiles.