Pharmacovigilance

Priorities of JV “Remedy Group” LTD are high quality and safety of products.

In accordance with the current regulatory documents (Order No. 13 of the Ministry of Health of the Republic of Uzbekistan, 5-, 6-, 10-, 15- Law of the Republic of Uzbekistan “On Medicines”, Articles 5-, 15- “On the Protection of Citizens’ Health”) and international recommendations: ICH (E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting) (E2E Pharmacovigilance Planning) (E2F Development Safety Update Report); Volume 9a of The Rules Governing Medicinal Products in the European Union Sept 2008, The International Society for Pharmacoepidemiology (ISPE): Guidelines for Good Pharmacoepidemiology Practices (GPP), a drug manufacturer must objectively and appropriately monitor the safety of its medicines. In this regard, the company operates a pharmacovigilance system.

The system includes the collection of information from all subjects of drug circulation (patients, pharmacists, doctors, etc.) in real clinical practice.

Dear colleagues and consumers!

If you have information regarding adverse reactions or lack of effectiveness of drugs produced by JV Remedy Group LLC, we suggest you fill out a message about a suspected adverse reaction or lack of effectiveness of a drug or provide the necessary information in any way convenient for you:

  • Form for medical / pharmaceutical worker: FILL
  • Form for the consumer: FILL

Authorized person responsible for pharmacovigilance at JV Remedy Group LLC:

Radjabova Munisa Akmalovna

e-mail: munisa.radjabova.90@bk.ru
Phone number: (99871) 226 54 65, (99890) 788 62 36

Adress: 51, Yangi Almazar str, Yangi Almazar dist., Tashkent city, Uzbekistan

All information that you provide to us is confidential and not subject to disclosure, except as otherwise provided by law.

Before starting to fill out a report on a suspected adverse reaction or lack of effectiveness of the drug, we ask you to familiarize yourself with the basic concepts and terms in the field of pharmacovigilance.

Terms and Definitions

Pharmacovigilance is scientific research and activities related to the identification, assessment, understanding and prevention of adverse reactions or any other problems associated with the use of drugs.

Adverse (side) reaction is any unwanted adverse reaction that occurs when using drugs in the usual doses recommended for the prevention, diagnosis and treatment of diseases.

An expected adverse reaction of a medicinal product is an adverse reaction, the nature or severity of which is consistent with the available information about the medicinal product (for example, with the Instruction / Package leaflet for the medical use of the medicinal product).

An unexpected adverse drug reaction is an adverse reaction, the nature or severity of which is not consistent with the available information on the drug (e.g., the Instructions for Use/Assignment Sheet for medical use of the drug).

A serious adverse drug reaction is any adverse reaction resulting in:

  • death;
  • a condition requiring emergency hospitalization or prolonged hospitalization;
  • A life-threatening condition;
  • Disability or significant and permanent disability;
  • Development of congenital anomalies or malformations.

A non-serious adverse drug reaction is any adverse reaction that does not meet the criteria for a serious adverse reaction.

Lack of effectiveness of the drug – lack of therapeutic effect of the drug on the course and duration of the disease.

Interaction reactions – reactions occurring against the background of taking several drugs, which are a consequence of their mutual influence on the pharmacodynamics and pharmacokinetics of each other.

Manufacturer of a drug – a legal entity that carries out at least one of the stages of production of a drug, including packaging.

A suspected drug is a drug for which there is a causal relationship between the clinical manifestations of any adverse reaction and its medical use.

The series number is a characteristic combination of numbers (or numbers and letters) that specifically identifies the series. Applied to all types of packaging.