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Registration

The company "ALIMOR Corporation" provides consultation and assistance to foreign and local companies in the issues related to the state registration of drug and herbal formulations, pharmaceutical substances, food supplements/Biological active additives (BAA), medical equipment and products of medical purpose in the Republic of Kazakhstan and in other CIS countries.
Marketing and introducing manufactured items of drug and herbal formulations, pharmaceutical substances, food supple-ments/Biological active additives (BAA), medical equipment and products of medical purpose into the market presuppose objective to necessity of their obligatory registration.
All drug formulations (original and generic) by any producer must be registered. Thus, the import of finished or in-bulk products require the safety, quality and efficiency approval by The Ministry of Healthcare, before their marketing and sale on the territory of the country. In case if the product matches with the required quality parameters, it is by the order of MOH will be registered and entered on the State register and to its manufacturer/applicant/ marketing authorization holder will be given the Registration certificate.

The Registration Certificate is the official document that verifies the admittance of the product's manufacture, import, sale and use on the territory of country where product is registered.

At stages of product registration or re-registration, the manufacturers, applicants or their representatives often have complications caused by labor-intensiveness and specific character of this procedure.

And for the purpose of simplifying the product registration procedures, starting from dossier preparation, obtaining of all the necessary documents from manufacturer to submission it for expertise, following registration process ‘till registration certificate and solving the problems connected with the registration process that the company "ALIMOR Corporation" Ltd., has been founded Product registration and consultation unit.
The goal of our work is not only execution of necessary documents, but also multifold coverage of any problems connected with it, complete and available consultation of the client and, certainly, timely informing him about the process of registration. The quality of rendered services is thoroughly supervised by us at the highest possible level.
Performance capabilities of our company are spread far beyond the procedure of registration. We take on ourselves all-round representation of the interests of the client in all registration stages, saving him from the settlement of disputable or nonstandard situations.

We offer our clients:
  1. Regulatory help, consultations in the field of registration of the pharmaceutical products We and you know that the adequate information access for applicants is another important component of the registration procedure. First, the manufacturer faces different problems like what the registration procedure starts with, what documents must be submitted, what way they are prepared in, what expert examinations should be taken, how much the registration procedure will cost and how much time the procedure or its certain stages will last etc.Such information can't be often found in normative documents or in the Internet. Please call or mail us and we will try to answer your questions as exhaustive as possible. If there are questions we find difficult in replying, we will consult together with the State Authorities on them and find the optimum solution.
  2. The complete service for the product registration from dossier evaluation for the completeness, dossier preparation (in accordance with Laws and requirements of MOH), the submission for expertise and following registration process ‘till the registration certificate and even more: pre-registration market survey, product selection for registration, responsibility for PV control and collection side effects of the product during 5 years after registration, assisting the manufacturer on PSUR preparation for re-registration period, implementing the modifications and changes to the registration certificate and dossier of the product at post- registration period;
  3. Cooperation with the State Authorities in the field of product registration (NATIONAL DRUG and MEDICAL EQUIPMENT EXPERTISE CENTER (NDMEEC), ACADEMY of Nutrition, Medical and Medical and Pharmaceutical control committee of MOH and Scientific-research institutions for the manufacturer/applicant and representation of interests in these institutions;
  4. Upon clients order to carry partially dossier preparation for the registration of the product on the manufacturer/applicant or representatives request, including document translation, AND (authorised normative document) and PI (pack insert), as well AWs (artworks) designing for the finished product in accordance with local Laws and requirements of MOH;
  5. Medical document translation.


Owing to our collaboration, you will certainly benefit from the following opportunities:
  1. Excellent quality dossier for the submission (the competent preparation of the registration dossier, including its scrupulous preliminary evaluation before submission, translations, AND,PI and AWs designing):
    • These all will speed up the registration process of your product because you and we will escape the rising queries from each stages of dossier expertise for product registration and rid up the dossier returns from the State Authorities for the correction of mistakes or for document deficiency.
  2. The highly professional pharmaceutical products' registration unit:
    • Entrusting product registration procedures to our company staff you will have a unique possibility to start the registration procedures immediately without drawing away your time for your own staff search.
  3. Little time needed for carrying-out the stages of the registration procedures:
    • We control and keep strictly the established terms of the every expertise procedure. This will let you plan the terms of your pharmaceutical product to be put up for sale and conduct the correct marketing studies, based on the real terms.
  4. We planning near time to have the account options at our web-site page (so called "the private office"):
    • Wherever in the world you will be, you will always have the opportunity to see the every stage of your order fulfillment. Our specialists will follow product registration process and send you monthly product registration progress report and in the future all stages will fix in your "private office". The "private office" option allows you to get the daily reports on our work.
  5. Experts' consultations:
    • Our qualified professionals will help and give consultations regarding to specific particularities of each registration procedure stage.
  6. The possibility of partial services:
    • Even, if your organization has its own registration unit you can employ us to hold some certain specific stages of the registration procedure (for example, professional medical translation of the required documents for the registration dossier, notary translation of the required documents (Power of Attorney etc.); preparation (localization) of the dossier and its parts for registration of the medicines.


Product registration/re- registration, change modifications to the product dossier in the republic of Kazakhstan

In accordance with law of the Republic of Kazakhstan the Registration certificate (has been valid for 5 (five). And product re-registration procedure must be performed to prolong product registration for next 5 years. The new requirements for the product dossier documents and their submission for the State registration were implemented in 2007. Currently we are following the laws, orders, rules, quidelines and references related to product registration of the Republic of Kazakhstan.

* Medical remedies Law of the Republic of Kazakhstan, 13.01.2004
* Government regulations No. 148 dated 14.11.2001 about rates of state registration charges
* Order of the Ministry of Health dated 25.08.2003 No. 635 for the registration, re-registration and variations of medicines and other medicals products, 25.08.2003
* Order No. 160 of the Ministry of Health, 17.02.2004 (PILs and package labeling requirements)
* Law of the Republic of Kazakhstan about State Language, 2005
* Order of National Drug Expertise Center dated 19.10.2004 No. 164–P «Improvement of registration procedure and expertise of the registration dossiers»
* Order of National Medicine Expertise Center dated 14.08.2007No. 500–P «Improvement of registration procedure and expertise of the registration dossiers»
* Kazakh state pharmacopeia (State Ph)
For additional information and for the requirements on the dossier for the product registration or re-registration refer to below or www.dari.kz or please send your question to us in written form by e-mail or call us and you'll give you the most comprehensive information in Russian, English or Kazakh (upon necessity.



General requirements for product dossier

2. The registration dossier is the complete set of the documents containing the whole information about specific pharmaceutical product. Set of documents and data must be submitted in folder type “Korona” in two copies with inprinted trade name of product, INN, form, strengths, applicant/manufacturer name on the label and covering page.
3. All the submitting documentations in dossier should be prepared in white colored paper with A4 format size, without threadening, clipsing and stapling (except notarized documentations).Do not allowed to put into dossier documentations in transparent file (transparent files- inserts, folder – insert and etc.) 4. The order is determined by the format of the documentation files installed NTSELS.
5. At the beginning of each section and paragraph dossier should be embedded color (red, yellow, green, etc., but not white, not black) of A4 paper sheet with the same density as the rest of the file lists.
Location leaf book, field 3 cm on all sides. On a sheet on top, aligned with the right side indicates the number of section 14 cpi font TimesNewRoman, bold (BOLD) syle. Line below indicates the section title font TimesNewRoman 14 point type, the usual faces. No other inscriptions or marks on this sheet is not allowed!
Note: The list of required documents, the order of placement in the file and in the file delimiters can download c http://www.alimor.kz or we kindly give at your request on 2 languages (English and Russian.
6. All sections must be present in the file. If information on a particular topic can not be represented, it is necessary in this section provide justification for failure to submit information.
7. In the file for changes, involving the examination of quality, efficacy and safety can be claimed only related changes. Ie if one change inevitably leads to another and separate introduction of these changes is not possible, such changes are interconnected (eg, changes in the composition of excipients, entails a decrease in the shelf life of the drug.
8. It is necessary for our future work with models of packages providing an electronic version of the packages in the layout format Corel Draw with the exact size and color approved.
9. Be sure to provide an electronic version. The electronic version of the file is permitted without the submission of documents scanned signature.
10. All documents, submitted for the State registration or re- registration or contributing the modification and changes, must be in English and translated into Russian. Documents (certificate of the pharmaceutical product; GMP, free sale, Manufacturing licence and marketing authorization certificates must be notary notarized and sealed with "apostyle" stamp.
11. All pages of the file should be signed by the authorised person of the applicant-organisation/ manufacturer.
12. First copy of product dossier- must include notary notorized original documents and other documents with translations into russian language ( all pages should be signed by authorized representative of applicant-organization), 3 copies of project AND, 3 copies of Pack insert project, 3 copies of packaging colored design;
13. The second copy – copy of 1st dossier must contain all documents, 1 copy of AND project, 3 copies of pack insert project, 3 copies of packaging colored design).
14. In a case if the dossier includes many folders, folders should be in one colour, and each folder must be numbered and on label must be shown total number of folders, for example «1 of 3; 2 of 3; 3 of 3»
Note: If you have any questions on how to prepare one or another part of the dossier please do not hesitate to contact our specialists for consultations on issues of your interest.