Department for certification
Product Certification Body
Composition of the
Product Certification Body:
Hamidova Asel Anarbayevna – Head of department
Deputy Head - 1;
Chief Specialist-1;
Senior Specialist 1;
Specialist of the 1st category – 3.
General Information
SI “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 SI “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 SI “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 approval of the Regulations
on state registration of products and procedures for confirming conformity,” Resolution of the Cabinet of Ministers of the Republic
of Uzbekistan No. 502 dated 14 August 2025 and Resolution No. 318 dated 6 July 2004
under Scheme 7.
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
Cabinet of Ministers of the Republic of Uzbekistan No. 502 dated 14 August 2025
and Resolution No. 318 dated 6 July 2004 under Scheme 7 “On approval of the
Regulations on state registration of products and procedures for confirming conformity”
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 SI “DORI VOSITALARINI STANDARTLASH ILMIY MARKAZI”
applies certification schemes No. 7 and No. 2 in its activities, as established
in “On approval of the
Regulations on state registration of products and procedures for confirming conformity,” Resolution of the
Cabinet of Ministers of the Republic of Uzbekistan No. 502 dated 14 August 2025
and Resolution No. 318 dated 6 July 2004 under Scheme 7, 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.
Scheme No 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.
SI “DORI VOSITALARINI STANDARTLASH
ILMIY MARKAZI” considers complaints according to the procedure established in the
document DP QMS-06:2025 (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 SI “DORI VOSITALARINI STANDARTLASH ILMIY MARKAZI”.
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 "Karshi
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);
·
Contacts:
·
Tel .: 71 230-71-31
(internal number: 111)
·
33 102 48 88
Publicly available information in the field of product certification