PharmExpert LLC

• Set up and implementation of Pharmacovigilance System
• Development and maintenance of Pharmacovigilance System Master File (PSMF)
• 24/7 availability as of Qualified Person for Pharmacovigilance (QPPV) and Local contact person for Pharmacovigilance (Local QPPV)
• International and Local Literature Review
• Regulatory Intelligence Services
• Authority Website Monitoring
• Product Complaints Management & Reporting
• Adverse Events case Processing & Reporting
• Signal detection and Management
• Aggregate reports (PSUR/ PBRER/ PADERs)
• Preparation/maintenance of Risk Management System (RMS), Risk Management Plan (RMP) and Risk Minimisation Activities
• Direct Healthcare Professional Communication (DHPC) management
• Safety Data Exchange Agreements (SDEA) preparation and maintenance
• Training
• Supporting of Expertise process of PV System by NCA
• Audit and inspection readiness

• Appointment of Local Contact Person for Food Supplement Vigilance
• Comprehensive management of adverse events of food supplements reported by consumers, health professionals or authorities
• Submission of serious adverse reactions to the manufacturer
• Periodic search of safety information of food supplement products in scientific literature
• Food supplement Product Safety Report
• Signal Detection and Management

• Appointment of Local Contact Person for Cosmetovigilance
• Comprehensive management of adverse events of cosmetic reported by consumers, health professionals or authorities
• Submission of serious adverse reactions to the manufacturer
Periodic literature search in scientific literature to identify safety information and adverse events of cosmetic products
• Cosmetic Product Safety Report
• Signal Detection and Management

Under development

• Collection, investigation, and assessment of Adverse Device Effects (ADE) / Medical Device Incidents (MDI)
• Submission of Adverse Device Effects (ADE) / Medical Device Incidents (MDI) to manufacturer
• Monthly compliance and status reporting
• ADE and MDI Reconciliation
• Preparation of Periodic Summary Reporting
• Preparation of Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)
• Writing and/or reviewing Standard Operating Procedures
• Periodic literature search in scientific literature to identify safety information and adverse reactions of food supplement products

• Individual Case Safety Report (ICSR) Processing (Medical Evaluation of Cases)
• Safety Database
• Serious Adverse Event (SAE) Reconciliation (Necessary for Regulatory Authorities (RA) Submission)
• Serious Adverse Event (SAE) Narratives Preparation
• Case Report Form (CRF) and line-listings safety review (To address any site concerns regarding health state of participants)

• Study Abstracts
• Clinical Protocols
• Informed Consent Forms
• Patient Information Sheets
• Case Report Form
• Clinical Study Reports
• Risk Management Plan /Risk Evaluation and Mitigation Strategy (RMP/REMS)

• MedDRA Terms Coding (using the latest version of MedDRA dictionary)
• WHO Drug Terms Coding
• Coding Consistency Review (in accordance with MedDRA, WHO Drug and other specific recommendations)

State registration of medicines is a prerequisite for the introduction of new products on the pharmaceutical market of the Republic of Azerbaijan.

PHARMEXPERT CRO offers you professional services for registration of medicines in the Azerbaijani Republic. State registration, re-registration, and changes in the registration dossier of the medicines is performed by the Analytical Examination Center under the Ministry of Health of the AR.
Medicine categories SUBJECT to state registration:

Medicine categories NOT SUBJECT to state registration:
• original medicines
• generic medicines
• effective combinations of medicines that have been previously registered
• already registered medicines that have changed the pharmaceutical form and dosage
• medicines prepared by pharmacies according to the appropriate recipe and with the fulfillment of all the requirements of medical organizations
• medicines purchased outside the territory of the Republic of Azerbaijan and intended for personal use

Changes that require expertise:

• if necessary, change the instructions for use of the medicine
• replacing of excipients to the composition of the medicines
• when changes are made to data on the manufacturer of a medicine;
• when changing indicators that characterize the quality of the drug, as well as the replacement of methods for controlling the quality of the drug;
• at change of the expiration date established for the registered medicine.

All of the above changes must be introduced within a maximum of 3 months from the date of the decision being made about the change by manufacturers.

Refusal of Registration
The Ministry of Health refuses state registration of medicines in the following cases:

• If the information provided in the submitted documents is not true;
• The medicine contains a prohibited substance in the territory of the Republic of Azerbaijan;
• If the quantitative and qualitative indicators specified in the submitted documents do not correspond to reality;
• If therapeutic efficacy is not proven;
• Clinical trials and other studies evaluating the safety, efficacy, and quality of a drug are unsatisfactory.
• If serious side effects are detected during the registration process;
• Negative opinion on the results of the manufacturer’s verification;
• Negative opinion on the results of specialized expertise and (or) on the results of additional specialized expertise conducted by the Expert Council on Pharmacology and Pharmacopoeia of the Ministry of Health of the Azerbaijan Republic.

When making a decision to refuse the state registration of a medicinE, the applicant is provided with a written reasoned response.

Terms of re-registration
According to the law, for state re-registration of the drug, the applicant should contact the Agency at least 210 (two hundred and ten) calendar days before the expiry of the previous state registration period.