Memorandum of understanding
between the Government of the Republic of Uzbekistan and the Government of the Republic of Serbia
On Cooperation in the Pharmaceutical and Biotechnological Sectors
The Government of the Republic of Uzbekistan and the Government of the Republic of Serbia (hereinafter referred to as the “Participants”),
Reaffirming the friendly relations and expanding economic cooperation between the two States,
Recognizing the strategic importance of pharmaceutical production, biotechnology and life sciences for public health, innovation and sustainable economic development,
Taking into account international standards governing the development, manufacture and regulation of medicines, including the principles of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP),
Acknowledging the growing potential for cooperation between the pharmaceutical industries, regulatory authorities and research institutions of both countries,
Desiring to promote joint research, development and production of pharmaceuticals, biotechnology products and medical devices,
Have reached the following understanding:
Article 1
Purpose and Scope
Purpose and Scope
1. The purpose of this Memorandum is to establish a comprehensive framework for cooperation between the Participants in the fields of pharmaceuticals, biotechnology and medical technologies.
2. Cooperation under this Memorandum will aim to:
promote joint research, development and innovation in pharmaceutical and biotechnological fields;
strengthen the production capacities of pharmaceutical industries in both countries;
encourage investment and industrial partnerships in pharmaceutical manufacturing;
facilitate technology transfer and exchange of scientific knowledge;
enhance regulatory cooperation and alignment with internationally recognized quality and safety standards.
3. This Memorandum will apply to cooperation between competent governmental authorities, regulatory agencies, scientific institutions, universities and private-sector entities operating in the pharmaceutical and biotechnology sectors.
4. Implementation of cooperation under this Memorandum will be carried out in accordance with the national legislation of the Participants and applicable international obligations as well as in the case of the Republic of Serbia, obligations arising from the European Union accession process.
Article 2
Priority Areas of Cooperation
Priority Areas of Cooperation
1. The Participants will promote cooperation in the following priority areas:
a) research and development of pharmaceutical products, vaccines and biotechnology-based therapies;
b) development and production of generic medicines, biosimilars and biological products;
c) research and production of medical devices and diagnostic technologies;
d) pharmaceutical raw materials and active pharmaceutical ingredients (APIs);
e) biotechnology applications in medicine, public health and pharmaceutical manufacturing.
2. The Participants will encourage collaboration between universities, research institutes, biotechnology companies and pharmaceutical manufacturers to promote scientific and technological innovation.
3. The Participants may also cooperate in emerging fields of biotechnology, including genomic medicine, personalized medicine and advanced therapeutic technologies.
Article 3
Regulatory Cooperation and Quality Assurance
Regulatory Cooperation and Quality Assurance
1. The Participants will promote cooperation between their competent regulatory authorities responsible for the authorization, supervision and control of pharmaceutical products and medical devices.
2. Such cooperation may include:
exchange of regulatory information and best practices concerning pharmaceutical legislation;
cooperation in drug registration procedures;
exchange of data on safety monitoring and pharmacovigilance systems;
cooperation on laboratory testing and quality control mechanisms.
3. The Participants will encourage alignment of regulatory standards with internationally recognized guidelines, including:
Good Manufacturing Practices (GMP);
Good Clinical Practices (GCP);
Good Laboratory Practices (GLP);
relevant guidelines of the World Health Organization and other international bodies.
4. The Participants may consider establishing mechanisms for cooperation in:
inspection of pharmaceutical manufacturing facilities;
exchange of information on certification procedures;
mutual assistance in regulatory capacity building.
Article 4
Clinical Trials and Biomedical Research
Clinical Trials and Biomedical Research
1. The Participants will encourage cooperation in biomedical research and clinical trials related to pharmaceutical and biotechnology products.
2. Such cooperation may include:
joint research projects on vaccines, biologics and innovative therapies;
development of biosimilar medicines;
collaboration in epidemiological and biomedical research.
3. Clinical trials conducted under this Memorandum will comply with:
the national legislation of the Participants;
internationally recognized ethical standards;
applicable international guidelines on clinical research.
4. The Participants will encourage collaboration between hospitals, research institutes and pharmaceutical companies to facilitate the development and evaluation of new pharmaceutical products.
Article 5
Industrial Cooperation and Technology Transfer
Industrial Cooperation and Technology Transfer
1. The Participants will promote cooperation between pharmaceutical and biotechnology companies of the two countries with the aim of strengthening industrial production capacities.
2. Such cooperation may include:
establishment of joint ventures for the manufacturing of pharmaceutical and biotechnology products;
construction or modernization of pharmaceutical production facilities;
transfer of technologies and know-how related to pharmaceutical manufacturing.
3. The Participants will encourage cooperation in the production of:
generic medicines;
vaccines and biological products;
biosimilars;
medical diagnostic equipment and biotechnology products.
4. The Participants will facilitate industrial partnerships through appropriate mechanisms, including:
investment cooperation;
public-private partnerships;
collaboration between research institutions and industrial enterprises.
Cooperation in technology transfer will respect the protection of intellectual property rights in accordance with the national legislation of the Participants and relevant international agreements.
Article 6
Education, Training and Capacity Building
Education, Training and Capacity Building
The Participants will promote cooperation in education and professional training in pharmaceutical sciences and biotechnology, including:
exchange of researchers, scientists and experts;
joint academic programmes and training courses;
internships and professional development programmes for regulatory specialists and laboratory personnel.
Article 7
Financial Arrangements
Financial Arrangements
1. Implementation of cooperation activities under this Memorandum will be carried out in accordance with the national legislation of the Participants and subject to the availability of financial resources.
2. The Participants may encourage participation of international organizations, development banks and other financial institutions in projects carried out under this Memorandum.
Article 8
Status
Status
1. This Memorandum records the intentions of the Participants only. It is not an international treaty and does not create any rights or obligations under international or national law.
2. This Memorandum does not affect the rights and obligations of the Republic of Uzbekistan and the Republic of Serbia under other international agreements.
Article 9
Settlement of Disputes
Settlement of Disputes
Any dispute concerning the interpretation or implementation of this Memorandum will be resolved through consultations and negotiations between the Participants through diplomatic channels.
Article 10
Amendments
Amendments
This Memorandum may be amended by mutual written consent of the Participants. Amendments will come into effect in accordance with the procedure established in Article 11 of this Memorandum.
Article 11
Effect, Duration and Discontinuance
Effect, Duration and Discontinuance
1. This Memorandum will come into effect on the date of its signature.
2. This Memorandum will remain in effect for five (5) years and will be automatically extended for successive five-year periods unless one of the Participants notifies the other Participant in writing of its intention to discontinue this Memorandum at least six months before its expiration.
3. The discontinuance of this Memorandum will not affect the implementation of ongoing projects initiated under this Memorandum.
Done at Belgrade, on 8 September 2026, in two originals, in the Uzbek, Serbian and English languages, all texts being equally authentic. In case of divergence of interpretation, the English text will prevail.
(signatures)