KAZAKHSTAN REGISTRATION/RE-REGISTRATION OF PHARMACEUTICAL PRODUCTS, BULK PRODUCTS
Shang Hai SEC  company provides services for the realization cycle of the registration / re-registration of the pharmaceutical products from the preparation of the registration dossier in accordance with the requirements of the Republic of Kazakhstan to obtain a registration certificate.


Yu must fill out and send us the form for the initial evaluation to take opinion on the possibility of registering your product: gost@gost.org.cn (specify in the subject line " Pharmaceutical products for evaluation").


The term of preparation of the registration dossier for submission depends on the quality of the source documents and conditions are negotiated with the client.

If you have any questions, we are happy to answer call on them:

SCHEME OF OUR COOPERATION
1 Signing a confidentiality agreement
2 Examination of the submitted documents, giving to the applicant the status of documents, request the missing documents; calculation of the number of samples and standards for analytical examination, calculation of the cost of our services, inclusive of all the additional work to prepare the registration dossier (IDA development, translations, etc.); calculation of the overall preparation of the dossier and aggregate term of registration.
3 Conclusion of a contract for services
4 Formation of the registration dossier. Development of analytical-normative document (IDA), the drafring of instructions for medical use, the development of labeling in Russian and Kazakh languages.
5 Execution of the contract between the Applicant and the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan.
6 Obtaining of permits to import samples of the pharmaceutical products and the organization of import procedures and customs clearance.
7 Filing of documents for the registration dossier, samples and standards to the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan.
8 Receipt of invoice for payment of examination in the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan.
9 Maintenance and monitoring at all stages of registration, compliance with comments;
10 Agreed with the customer IDA projects, instructions for medical use, layout packages
11 Obtaining the original registration certificates and normative documents and send them to the Customer;
The term of the initial examination of the documents submitted - 1-3 days.
The term of preparation of documentation for submission to the Government authorities 7- 15 working days.

В.I Administrative documents
В.I.1 Inventory of documents and date with the number of pages and copies being stated
В.I.2 Application for the state registration of a drug or for amendments to be made into the registration documents
В.I.3 Documents supporting the competence of an application for state registration (warrant for submission of documents and data for state registration (amendments), a letter about no misuse of intellectual property subjects)
В.I.4 Receipt for the state registration payment of the drug
В.I.5 Original payment order on state charge for the state registration of the drug
В.I.6 Application to the Russian Committee of Health Care Control for the registration of the drug (amendments)
В.I.7 The name of the drug, including international nonproprietary name, scientific name in Latin, basic synonyms
В.I.8 The original name of the drug, if it is registered as a trademark in accordance with the legislation of the on trademarks, service trademarks and the name of the manufacturer, its city and country (trademark certificate)
В.I.9 List of the components of the drug, their amount
В.I.10 Instruction for use of the drug, drawn up in compliance with the requirements laid down in Article 16 of the Federal Law No. 86-ФЗ “On Drugs” dated June 22, 1998
В.I.11 Drug quality certificate (attested copy attached by its translation signed by the authorized person of the applicant)
В.I.12 Drug price offer
В.I.13 Documents supporting the registration of the drug, if it registered outside
В.II Description of pharmaceutical properties
В.II.14 Components of the drug
В.II.15 Active substance(s) (manufacturer’s certificate)
В.II.16 Excipients (manufacturer’s certificate)
В.II.17 Ready-made dosage form (the contents of active ingredients; limits of tolerance; physicochemical and biological properties); rationale for choosing a method of production and (primary and secondary) package; microbiological properties
В.III Data on drug manufacture
В.III.18 Legal address of the manufacturer of the drug (confirmation of the manufacturer’s country)
В.III.19 Site(s) of manufacture (confirmation of the compliance with good manufacturing practice)
В.III.20 Material balance sheet
В.III.21 Brief sheet scheme of a process and its controlling methods
В.III.22 Control of manufacture stages and intermediates
В.III.23 Validation and/or qualification of the process
В.IV Data on drug quality control

В.IV.24 Original pharmacopoeial article of the enterprise (that of the normative document)
В.IV.25 Methods for controlling the quality of the drug; specifications; analytical procedures; validation of analytical procedures; series analysis; characteristics of impurities; rationale for specifications
В.IV.26 Standards or reference materials (a reference to the manufacturer in case of standards; a copy of the manufacturer’s certificate with the attested translation being attached in case of reference substances)
В.IV.27 Samples of the drug for testing its quality (confirmation of the readiness of making examination for quality)
В.IV.28 Primary and secondary package of the drug (confirmation of permission for its use in the manufacturer’s country)
В.IV.29 Models of labels for the primary and secondary packages of all claimed dosages
В.IV.30 Results of testing for stability in the claimed types of primary package
В.V Information on the results of preclinical pharmacological and toxicological studies of the drug

В.V.31 Introductory brief overview of performed preclinical trials
В.V.32 Reports on performed trials
В.V.33 Pharmacology: results of the trials confirming the pharmacological activity of the drug
В.V.34 Pharmacokinetics: absorption; distribution; metabolism; excretion; drug interactions
В.V.35 Toxicology: systemic toxicity, specific toxicity
В.V.36 List of references
В.VI Information on the results of clinical trials of the drug

В.VI.37 Pooled analysis of the study results of the effectiveness and safety of the drug. Summarized results of individual studies; comparative analysis of the results of individual studies; populations to be studied; comparison of the results obtained in different efficacy studies; comparison of the results in individual groups of patients; analysis of the results of recommended dosage studies.
В.VI.38 Pooled analysis of the results of safety. Safety evaluation methods; pattern and frequency of adverse reactions; clinically significant changes in laboratory parameters; drug interactions; development of the withdrawal syndrome.
В.VI.39 List of references

上海经合工业设备检查有限公司

021-36411223  021-36411293

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