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Agreement of regulatory technical documentation and specifications for new and improved veterinary drugs and feed additives

Как получить услугу

Service provider

Legal entities

Documents required for submission to service provider:

An application.
A document confirming the authority of service recipient’s representative (when service recipient’s representative refers to).
Regulatory and technical documentation for new and improved veterinary drugs, feed additives (hereinafter, referred to as RTD) in 2 (two) counterparts in the state and Russian languages, which includes:

Veterinary drug and feed additive standardization document containing information on the structure in accordance with Annex 3 to the Rules.
Instructions for veterinary drug and feed additive manufacture and control signed/approved by the veterinary drug and feed additive developer or manufacturer containing information on the structure in accordance with Annex 4 to the Rules.
A manual (instructions) on the application (use) of a veterinary drug and feed additive developed by the manufacturer containing information on the structure in accordance with Annex 5 to the Rules.
A research study report on the veterinary drug and feed additive development, modification, improvement (hereinafter referred to as the research study report), as well as minutes (acts) of lab and production tests signed by the developer or manufacturer.
A research study report for veterinary drugs used in medical treatment including information on pharmacokinetics, pharmacodynamics, toxicity (acute and chronic), teratogenicity and other required active substance indicators, drug stability, as well as reports/minutes/acts on the veterinary drug efficacy and safety or bioequivalence study in the case of generic veterinary drugs.
A research study report including information on the vaccine safety, pathogenicity, biological activity, avirulence and other required indicators, drug stability as well as reports/minutes/acts on studying veterinary drug efficacy (immunity duration and intensity) and biological safety.
A research study report for veterinary drugs and feed additives used for disinfection, deratization and disinfestation including the efficacy test results.
A research study report for veterinary drugs used in the diagnosis of the diseases, including the specificity, sensitivity, reproducibility test results.
A passport for microbody production and test strains and for finite cell lines in the form in accordance with Annex 6 to the Rules (for veterinary drugs created using microorganisms, their cells components, life activity products of intended for the treatment, prevention and diagnosis of animal diseases).

A document confirming a veterinary drug and feed additive registration and/or inclusion in the state official pharmacopoeia of third countries, except for the member states of the Eurasian Economic Union (if any).
A notary certified counterpart of an agreement between veterinary drug and feed additive manufacturer and patent owner in the case of availability of patent (s) for composite veterinary drug and feed additives (microbody strains used for the veterinary drug and feed additive manufacture/control) or for the veterinary drug and feed additive manufacture technology/method or its use/application.
A document confirming permit to engage in activities for the production of veterinary drugs (for foreign manufacturers).

The service recipient, in addition to the documents, if available, shall submit documents certifying the production of veterinary drugs in accordance with international standard (good manufacturing practice (GMP)).

Documents drawn up in other languages shall be submitted along with notary certified translation into the state and Russian languages.

Service provider

Individuals

Documents required for submission to service provider:

An application.
A document confirming the authority of service recipient’s representative (when service recipient’s representative refers to).
Regulatory and technical documentation for new and improved veterinary drugs, feed additives (hereinafter, referred to as RTD) in 2 (two) counterparts in the state and Russian languages, which includes:

Veterinary drug and feed additive standardization document containing information on the structure in accordance with Annex 3 to the Rules.
Instructions for veterinary drug and feed additive manufacture and control signed/approved by the veterinary drug and feed additive developer or manufacturer containing information on the structure in accordance with Annex 4 to the Rules.
A manual (instructions) on the application (use) of a veterinary drug and feed additive developed by the manufacturer containing information on the structure in accordance with Annex 5 to the Rules.
A research study report on the veterinary drug and feed additive development, modification, improvement (hereinafter referred to as the research study report), as well as minutes (acts) of lab and production tests signed by the developer or manufacturer.
A research study report for veterinary drugs used in medical treatment including information on pharmacokinetics, pharmacodynamics, toxicity (acute and chronic), teratogenicity and other required active substance indicators, drug stability, as well as reports/minutes/acts on the veterinary drug efficacy and safety or bioequivalence study in the case of generic veterinary drugs.
A research study report including information on the vaccine safety, pathogenicity, biological activity, avirulence and other required indicators, drug stability as well as reports/minutes/acts on studying veterinary drug efficacy (immunity duration and intensity) and biological safety.
A research study report for veterinary drugs and feed additives used for disinfection, deratization and disinfestation including the efficacy test results.
A research study report for veterinary drugs used in the diagnosis of the diseases, including the specificity, sensitivity, reproducibility test results.
A passport for microbody production and test strains and for finite cell lines in the form in accordance with Annex 6 to the Rules (for veterinary drugs created using microorganisms, their cells components, life activity products of intended for the treatment, prevention and diagnosis of animal diseases).

A document confirming a veterinary drug and feed additive registration and/or inclusion in the state official pharmacopoeia of third countries, except for the member states of the Eurasian Economic Union (if any).
A notary certified counterpart of an agreement between veterinary drug and feed additive manufacturer and patent owner in the case of availability of patent (s) for composite veterinary drug and feed additives (microbody strains used for the veterinary drug and feed additive manufacture/control) or for the veterinary drug and feed additive manufacture technology/method or its use/application.
A document confirming permit to engage in activities for the production of veterinary drugs (for foreign manufacturers).

Documents drawn up in other languages shall be submitted along with notary certified translation into the state and Russian languages.

Результат оказания услуги

The agreement of regulatory and technical documentation for the new and improved veterinary drugs, feed additives, or a reasoned refusal to provide the public service.

Часто задаваемые вопросы

Grounds for refusal to provide the public service established by the laws of the Republic of Kazakhstan

1) the establishment of the inaccuracy of the documents submitted by the service recipient to receive the public service and (or) data (information) contained therein;

2) the non-compliance of the service recipient and (or) submitted materials, data and information necessary for the public service provision with the requirements established by the Rules;

3) a negative conclusion of veterinary drug, feed additive statutory and technical documentation of expert examination;

4) with respect to the service recipient, there is a court decision (sentence) that has entered into legal force prohibiting the activity or certain types of activity requiring the public service receipt;

5) the absence of consent of the service recipient, provided in accordance with Article 8 of the Law of the Republic of Kazakhstan "On Personal Data and Their Protection", to access sensitive personal data that are required to provide the public service.

Grounds for institution of an administrative procedure

appeal;
initiative of an administrative body or official.

General requirements for the appeal

The appeal submitted in hard copy or electronic form shall indicate:

Full name, IIN, postal address of a natural person, BIN of a legal entity;
name of administrative body, official to whom the appeal is submitted;
the essence of an appeal;
date of filing an appeal;
signature of the applicant or his representative;
other information provided for by legislation of the Republic of Kazakhstan.

If the administrative procedure is on a paid basis, the applicant must submit a document confirming the payment.

Receipt, registration, withdrawal and revoke of an appeal

! It is barred to reject the receipt of an appeal.

Once the appeal is submitted, the applicant is issued a receipt containing a unique number, indicating the date and time, last name and initials, and the position of the person who received the appeal.
In the case of non-compliance with the requirements established by Article 63 Code, the administrative body and the official shall indicate to the applicant the requirements the appeal does not comply with, and set a reasonable time limit for bringing it into compliance with the requirements.
Before a decision is made on the administrative case, the applicant may withdraw the appeal on the basis of his written application.

Referring the appeal to an authorized administrative body and official

An appeal received by an administrative body and official whose authority does not include the consideration of this appeal, within no later than 3 working days from the date of its receipt shall refer it to the authorized administrative body and official, with simultaneous notification of the participant in the administrative procedure.

Timeframe of administrative procedure that is under institution on the basis of an appeal

The timeframe of administrative procedure is 15 working days from the date of receipt of an appeal.

! The laws may set the other timeframe for consideration of appeals (For example, according to the Law “On Access to Information” a reply to a written enquiry is provided within fifteen calendar days from the date of receipt of the information by the owner).

The period of administrative procedure may be extended by a reasoned decision of the head of the administrative body for not more than 2 months, consistently the participant in the administrative procedure is notified within 3 working days from the date of extension.

Complaints procedure

A participant in the administrative procedure has the right to file a complaint the administrative action (inaction) related to the adoption of an administrative act.

If an administrative body and official within the timeframe has not adopted an administrative act or committed an administrative action, then commencing from the date of expiry it is considered that the administrative body and official rejected to adopt the administrative act or commit the administrative action.

The complaint is submitted to the administrative body and official whose administrative act and administrative action (inaction) is being appealed.

An appeal to the court is allowed after a pre-trial appeal. If the law provides for the possibility of going to court without the need to appeal to a higher authority, the administrative act, administrative action (inaction) of the administrative body and official is being disputed, along with the revoke, submit to the court a reasoned position of the head of the higher administrative body and official.

! The Administrative Procedure Code not always rules the procedure of complaint; the industry laws may contain statutes indicating the appeal of the decision in the court, without pre-trial appeal.

Deadline for filing a complaint

A complaint against an administrative act, administrative action (inaction) is submitted to the administrative body and official no later than 3 months from the day when the participant in the administrative procedure became aware of the adoption of the administrative act or the commitment of an administrative action (inaction).
If the deadline is missed for a good reason, at the request of the participant in the administrative procedure, it may be renewed by the body considering the complaint.
Missing the deadline for submitting the complaint is not a basis for rejection to receive the complaint by the body considering the complaint.

! Other laws may establish a special procedure and deadlines for appealing the decisions.

The period for consideration of the complaint is 5 working days from the date of receipt of the complaint.

! Other laws may establish a different period for appealing the decisions of administrative bodies.

Source: Administrative Procedural Code of Republic of Kazakhstan,
The Law of the RK "On Public services"

Полное название

Agreement of regulatory technical documentation and specifications for new and improved veterinary drugs and feed additives

Получатели услуги

Legal entities

Individuals

Стоимость услуги

Free of charge

Срок оказания услуги