Department for certification
Product Certification Body
Composition
of the Product Certification Body:
· Hamidova
Asel Anarbayevna – Head of department
· Deputy
Head - 1;
· Specialist
of the 1st category - 2;
· Specialist
of the 2nd category - 2;
· Specialist
– 2;
· Intern
– 2.
General Information
LLC
“DORI VOSITALARINI STANDARTLASH ILMIY MARKAZI”offers services for assessing the
conformity of products to the requirements of the National Certification System
of the Republic of Uzbekistan.
The
Product Certification Body of LLC “DORI VOSITALARINI STANDARTLASH ILMIY
MARKAZI”is an accredited conformity assessment body (registration number
O’ZAK.MS.0105 in the state register) and has independent legal status, as well
as financial and administrative independence from manufacturers (suppliers) and
consumers of products.
The
certification body operates on a full self-financing and self-sufficiency
basis. Certification services are provided based on contracts with applicants,
the legal force of which is conditioned by bilateral agreements, corresponding
to the requirements of the O’z DSt ISO/IEC 17065:2015 standard, in particular,
clause 4.1.2 "Certification Agreement."
The
Product Certification Body of LLC “DORI VOSITALARINI STANDARTLASH ILMIY
MARKAZI” is entitled to insure its activities to fulfill obligations arising in
the course of work.
The
applicant can apply for product certification through the "Single
Window" system (http://singlewindow.uz), attaching the necessary
documents.
In accordance with the Law of the Republic of
Uzbekistan "On Certification of Products and Services," certification
can be mandatory and voluntary.
1. Mandatory
certification:Confirms the safety of products in accordance with legislative
requirements in the field of
technical regulation.
2. Voluntary
certification is carried out at the initiative of the manufacturer.
Certification
work results in obtaining a certificate of conformity.
The resolution of the
Cabinet of Ministers of the Republic of Uzbekistan No. 43 “On the approval of
lists of conformity assessment objects subject to mandatory conformity
confirmation in the Republic of Uzbekistan” specifies the list of products
subject to mandatory certification.
The requirements for
regulatory documents used in product certification (excluding pharmaceutical
products), as well as the timelines for completing certification work, are
determined in “On Amendments and Additions to the Product Certification Rules,”
registered by the Ministry of Justice of the Republic of Uzbekistan on
15.05.2023 Reg. No. 1458-6.
The requirements for
regulatory documents used in the certification of pharmaceutical products, as
well as the timelines for completing certification work, are determined in “On
the Approval of Rules for the Certification of Pharmaceutical Products,” registered
by the Ministry of Justice of the Republic of Uzbekistan on 12.09.2022 Reg. No.
3386.
Certification Schemes
The product
certification body uses certification schemes corresponding to the following
regulatory documents:
Resolution of the
Ministry of Justice of the Republic of Uzbekistan dated 15.05.2023 Reg. No.
1458-6 “On Amendments and Additions to the Product Certification Rules.”
Resolution of the
Ministry of Justice of the Republic of Uzbekistan dated 12.09.2022 Reg. No.
3386 “On the Approval of Rules for the Certification of Pharmaceutical
Products.”
The product
certification body at LLC “DORI VOSITALARINI STANDARTLASH ILMIY
MARKAZI” applies certificationschemesNo. 7 andNo. 2 in its activities, as
established in “On Amendments and Additions to the Product Certification
Rules,”
Registered by the
Ministry of Justice of the Republic of Uzbekistan on 15.05.2023 Reg. No.
1458-6, and in “On the Approval of Rules for the Certification of
Pharmaceutical Products,” registered by the Ministry of Justice of the Republic
of Uzbekistan on 12.09.2022 Reg. No. 3386.
Certification schemes include:
Scheme
No.
7- is used for the certification of a batch of products and involves product
testing.
Scheme
No.
2- is used for the certification of a batch of medical products and involves
product testing.
SchemeNo
7: Product Certification Procedure (excluding pharmaceutical products):
In
its quality management system, product certification includes the following:
1. Submission
and review of the application.
2. Analysis
of regulatory documents and accompanying documents.
3. Decision
on the application.
4. Preparation
and approval of the testing program.
5. Identification,
sampling, and delivery of samples to the laboratory.
6. Testing
of samples in an accredited laboratory. ( ATL)
7. Analysis
of test results and issuance (or refusal) of the certificate of conformity.
8. Registration
of certificates of conformity in the state register.
Steps for certification under scheme 2
(for pharmaceutical products):
1. Acceptance
of the certification application.
2. Decision
on the application.
3. Approval
of the testing program.
4. Identification
and sampling of pharmaceutical products.
5. Testing
of samples in the laboratory.
6. Analysis
of documents (provided by the applicant and collected during the certification
process).
7. Issuance
of the certificate of conformity.
8. Registration
of the certificate of conformity in the state register.
For
the certification of imported products, the following documents must be
provided:
•
A sample label or product information.
To
obtain a certificate of conformity for manufactured products, the following
documents
must
be attached to the application:
•
A copy of the regulatory document for the manufactured product;
•
A sample product marking (product information).
Certificate
of conformity:• For imported products – valid for the shelf life of
the product.
Complaint
and Appeal Procedure:In case of disagreement with the
certification results, the interested party has the right to appeal to the
Appeals Council of the "Uzstandard" Agency or directly to the court.
LLC
“DORI VOSITALARINI STANDARTLASH ILMIY MARKAZI” considers complaints according
to the procedure established in the document DP QMS-06:2024 (Procedure for
Handling Complaints and Appeals).
Certification
Body must prepare and provide the following information upon request by the
applicant:
- A list
of types of products subject to mandatory certification, or an excerpt
from this list;
- Certification
rules for products in accordance with the certification body's scope of
accreditation;
- Price
list (tariffs) for certification services;
- Accreditation
certificate issued by the “DORI VOSITALARINI STANDARTLASH ILMIY MARKAZI”
LLC.
Rights and obligations of the customer:
-
• The Applicant is obliged to comply with the rules established by the National Certification System of the Republic of Uzbekistan, the requirements of "O’z DSt ISO/IEC 17065:2015," and the requirements of other regulatory and legislative documents.
• The Applicant determines the certification requirements in accordance with the scope of accreditation and type of product.
• The Applicant does not use product certification in a way that damages the reputation of the certification body and does not make any statements about product certification that the body considers incorrect or misleading.
• In the event of suspension, cancellation, or termination of certification, the Applicant ceases using all advertising materials containing references to certification and takes all actions required by the certification scheme (e.g., returning certification documents), as well as other necessary measures.
• Copies of certification documents provided to other parties must be complete or in the form specified by the certification scheme.
• When referring to product certification in the media, such as documents, brochures, or advertising materials, the Applicant must comply with the requirements established by the certification body or the certification scheme.
• The Applicant takes into account all known complaints concerning compliance with certification requirements and provides them upon official request to the certification body: - Takes appropriate measures regarding any deficiencies found in products that have impacted the fulfillment of certification requirements; - Documents their actions and, in the presence of complaints, provides reports to the certification body.
• The Applicant promptly informs the certification body of any changes that may affect their ability to meet certification requirements: - Changes in legal, commercial, or organizational status or ownership form; - Changes in organization and management (e.g., changes in top management, decision-makers, or technical personnel); - Changes in product or production methods; - Changes in contact information and production location.
• The Applicant is fully responsible for the accuracy and completeness of the information provided in the submitted documents and for ensuring that the documents comply with the current legislation of the Republic of Uzbekistan.
• The Applicant is responsible for the proper transportation and storage during the sale of certified products.
Sanctions:
• For failure to fulfill or properly execute obligations, the "Applicant" bears responsibility as provided by the Civil Code of the Republic of Uzbekistan and the law of the Republic of Uzbekistan "On the Contractual and Legal Framework for the Activities of Economic Entities."
• The applicant is responsible for providing falsified documents.
• In case of failure to comply with the contract terms, without prior notice to the applicant, the product certificate will be annulled, and relevant organizations will be notified accordingly.
Suspension, cancellation, or termination
of certification
The
certification body must make a decision on the application of appropriate
measures in case of non-compliance with certification requirements identified
during an audit or in other cases. The appropriate measures may include the
following:
a)
Ensuring the authenticity of certification in accordance with the conditions
established by the certification body (e.g., enhanced control);
b)
Reducing the scope of certification to exclude non-compliant products;
c)
Suspension of certification until the client eliminates non-compliance;
d)
Cancellation of certification.
If
certification is terminated (at the customer's request), the certificate of
conformity is suspended or canceled, the certification body must take
appropriate measures and make all necessary changes to the official
certification documents, public data, and agreements on the right to use the
conformity mark. In case of reducing the scope of the certificate, the
certification body must take appropriate measures and make all necessary
changes to the official certification documents, public data, and agreements on
the right to use the conformity mark.
The
certification body must clearly and accurately specify information about the
certificate in the certification documents and public data. If the certificate
is suspended, the certification body must notify the client and appoint one or
more individuals to perform the following actions:
- Ensure
the authenticity of the certificate in accordance with the certification
scheme;
- Perform
any other actions. These employees must be qualified in all aspects of
working with suspended certificates. If the validity period of the
certificate is resumed after suspension, the certification body must make
all necessary changes to the official certification documents, public
data, and agreements on the right to use the conformity mark to indicate
that the product in question continues to be certified. If the decision to
reduce the scope of the certificate is based on the condition of confirming
its authenticity, the certification body must make all necessary changes
to the official certification documents, public data, and agreements on
the right to use the conformity mark. It is necessary to clearly specify
information about the certificate in the certification documents and
public data. Examples of changes:
- Changes
in legal, commercial, organizational status, or ownership form;
- Changes
in organization and management (e.g., changes in top management,
decision-makers, or technical personnel);
- Changes
in the product or its production method;
- Changes
in contact information and production location;
- Significant
changes in the quality management system. List of laboratories involved in
conducting tests:
- State
Institution "Center for Pharmaceutical Product Safety";
- Branch
"Samarkand Center for Expertise and Standardization of
Pharmaceuticals, Medical Devices, and Medical Equipment";
- Branch
"Kashkadarya Center for Expertise and Standardization of
Pharmaceuticals, Medical Devices, and Medical Equipment";
- Branch
"Andijan Center for Expertise and Standardization of Pharmaceuticals,
Medical Devices, and Medical Equipment";
- LLC
"Tash-Lab Agency";
- LLC
"Center for Pharmaceutical Innovations";
- Committee
of Sanitary and Epidemiological Well-Being and Public Health of the
Ministry of Health of the Republic of Uzbekistan;
- Main
Department of Sanitary Control of the Administration of the President of
the Republic of Uzbekistan;
- LLC
"Alliance Standard Group".
Legislative and regulatory framework:
- Law of
the Republic of Uzbekistan "On Technical Regulation";
- Law of
the Republic of Uzbekistan "On Medicines and Pharmaceutical
Activities";
- Resolution
of the Cabinet of Ministers of the Republic of Uzbekistan No. 43 dated
January 30, 2021 "On approval of the lists of objects of conformity
assessment subject to mandatory confirmation of conformity in the Republic
of Uzbekistan";
- Resolution
of the Cabinet of Ministers of the Republic of Uzbekistan No. 318 dated
July 6, 2004 "On additional measures to simplify the procedures for
product certification";
- General
Technical Regulation "On the Safety of Medicines"
(UzTR.365-009:2016), approved by the Resolution of the Cabinet of
Ministers of the Republic of Uzbekistan No. 365 dated October 27, 2016;
- "Rules
for the certification of pharmaceutical products" (Registration AV
dated 12.09.2022 No. 3386);
- "On approval of the rules for the payment of works and services in the National Certification System of the Republic of Uzbekistan" (Registration AV dated 11.10.2013 No. 2516).
- Contacts:
- Tel .: 71 230-71-31 (internal number: 111)\
- 33 102 48 88
Publicly available information in the field of product certification