National Service Hotline:
Business Scope
One-stop chemical compliance services, providing chemical compliance consulting services
National Export Compliance Services
Service Item
(I) Japan
Dangerous goods must meet the requirements of the Japanese Chemical Review Law, the full name of the Chemical Substances Review and Production Management Law (CSCL) and the Chemical Information Transmission Standard (JIS 7253) jointly implemented by the Ministry of Health, Labor and Welfare, the Ministry of Economy, Industry and the Ministry of the Environment.
(II) South Korea
It must meet the requirements of the South Korea Chemical Substances Registration and Evaluation Act (The Act on Registration and Evaluation of Chemical Substance) (K-REACH), also known as the Chemical Assessment Act, which came into effect on January 1, 2015.
The K-REACH adopts registration, evaluation, authorization and restriction requirements similar to those of the EU REACH regulation for new chemical substances, existing chemical substances and downstream products. For chemical suppliers South Korea outside the country, the law also requires registration to be completed through a unique representative (OR) in South Korea.
(III) Russian EAC Certification
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Service content: one-stop Russian EAC certification
Export to Russia with reference to TPTC009/2011 (Cosmetic Safety Regulations), hand sanitizer requires compulsory customs union certification, also known as customs union technical specification certification or customs union certification, abbreviated as EAC certification or CU-TR certification. |
Customs Union CU‐TR Technical Regulation Certification Certificate, Russian: технических регламентов Таможенного союза сертификатов соответствия/ деклараций о соответствии, abbreviated as TP TC. English: Technical Regulations of the Customs Union conformity Certificates / Declarations of Conformity (CU-TR certification for short), because the certification mark is EAC mark, it is also called EAC certification.
(IV) Canadian DIN certification
Service content:
Canada NPN certification, DIN certification and GMP certification application full set of services, including application evaluation, material preparation and follow-up, until the certification.
Chinese enterprises export more epidemic prevention materials to Canada, such as alcohol disinfectant spray, alcohol wet wipes, hands-free disinfection gel, etc., all need to obtain the natural product batch number (Natural Product Number, NPN) of Health Canada in order to obtain the sales qualification in the Canadian market with the highest technical threshold, the most mature market and relatively many technical barriers.
According to Health Canada (Health Canada) regulations, starting from September 1, 2014, all natural health products (Natural Health Products, NHPs) imported, produced and sold in Canada need to obtain Health Canada's Natural Product Batch Number (Natural Product Number, NPN) or Homeopathic Drug Batch Number (Homeopathic Medicine Number, DIN-HM).
In addition to the NPN and DIN-HM lot numbers, Health Canada also requires that all natural health products be produced, imported, labeled, packaged, transported and stored in locations that meet the Canadian Good Manufacturing Standards Canadian Good Manufacturing Practices (GMPs) for NHPs.
The regulations impose license requirements on packaging, label manufacturers and health care product importers. These units can only operate, sell, store and transport health products after obtaining the corresponding site license. The regulator requires that the site with the site license must have the health care product wholesale records, product recall records and detailed records of handling, storage and transport products for reference at any time. The regulations stipulate that if a serious adverse reaction occurs in or outside Canada, the distributor must notify the Federal Ministry of Health within 15 days of being aware of the reaction. The Ministry of Health should make a safety assessment as soon as possible and decide on the countermeasures to be taken, including Stop sales, mandatory recall, and revoke licenses. The public can make online inquiries or direct telephone inquiries. Concealing and not reporting or adding illegal drugs without permission will directly face the danger of being out.
News:Hand sanitizer spray wipes exported to Canada compliance small science:http://www.china-reach.net/index.php?id=949
(V) Australia TGA Certification
1.Introduction
(1) Name: Therapeutic Goods Administration, Australian Medical Supplies Authority, or TGA.
(2) Australian drug classification: according to the Australian therapeutic products act and therapeutic product registration management measures, drug registration classification for prescription drugs, OTC drugs, complementary drugs;
Drugs to get.ARTGThe registration number can be listed in Australia.
(3) The status of Chinese medicine in Australia: At present, almost all Chinese medicines listed by Chinese companies in Australia are applied for in accordance with supplementary drugs. Australia is one of only a few countries in the world to recognize traditional Chinese medicine, listed in Australia is generally in accordance with the complementary drug registration (Register) or registration (list).
Supplementary drugs refer to products containing ingredients that supplement drug ingredients. Such ingredients generally have traditional applications such as Chinese herbal medicines, vitamins and minerals, and the indications are also strictly limited. Words such as treatment cannot appear, generally improving/assisting, etc. This is a bit like Chinese health food. As for how to determine the claimed indications, manufacturers cannot compile them at will, and Australian officials have put forward detailed requirements.
(4)Drug application method: It can be through registration or registration. Distinguish according to the following requirements:
① Registration of new complementary medicines or components of complementary medicines.
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The registration process is actually a process of technical evaluation of the declared data, the technical framework of the new supplementary drug requirements is ICH's CTD format data, high requirements, high cost, domestic enterprises rarely involved. In comparison, the registration of new supplementary drug ingredients is simpler and the official Australian time frame is clearer.
② Registration of products containing supplementary drug ingredients (List)
Supplementary drug registration is a method that directly enters the electronic office system to register drugs, prescriptions, processes and indications through the platform provided by Australian officials to Australian agents (Sponsor), and then directly obtains the ARTG registration number through format review (the evaluation method of technical documents is to conduct spot checks on the classification of products after listing).
2. Application Procedure
GMP Clearance |
Before registering or registering a product, the Australian authorities must confirm that its production complies with Australia'sGMPrequirements, that is, the so-called“GMP clearance”Procedure(Simply put, it isGMPThe mutual recognition review process): Because China and Australia do notGMPThe mutual recognition process. Therefore, it is usually necessary to pass the Australian official first.-TGA-The site inspection to obtain its direct approval. |
Edit Registration File |
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Electronic registration by Sponsor
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Only through the Australian agent can apply (product and GMP inspection), the agent here has a proper noun called "Sponsor",For imported drugs is the importer. |
Fee |
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Get Registration Number |
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Receiving random and targeted inspections |
When registering supplementary drugs, after obtaining the registration number, the Australian authorities will review the quality and safety information of the products and conduct spot checks after the products are listed. The core of the document review is whether the product meets the basic requirements of supplementary medicine, whether it meets the detailed requirements of the Australian government on many aspects of quality, and whether the quality standards can effectively control the quality. |
3. OUR SERVICES
(1) Propose work assignments for the project.
(2) Preparation and provision of an outline for the preparation of registration documents in Chinese.
(3) Provide training and guidance to the preparation personnel of customer basic data.
(41) Review and confirm the basic information provided by the customer and prepare English documents.
(5) Cooperate with the customer's Australian registration applicant (SPONSOR) to apply.
(6) Be responsible for technical liaison with TGA during registration and GMP inspection, and answer relevant questions from TGA.
(V) compliance services such as KKDIK in Thailand, Cambodia, Vietnam and Turkey
National Service Hotline:
Beijing Headquarters: D10, Floor 4, Block A, Borui Building, No.26, Dongsanhuan North Road, Chaoyang District, Beijing, China
Tel: 86-010-6471 0683
Shanghai: Room D308, Zhongyi International Building, Puxing Highway 800, Minhang District, Shanghai
Tel: 86-021-3478 3993
Guangzhou: Room 201, Xinying Technology Park, No. 313 Jinxin Avenue, Panyu District, Guangzhou
Tel:400 660 1329
E-mail：nar@china-reach.net
Copyright: New Anrun (Beijing) Consulting Co., Ltd.
