Medicine Registration
Apomedical LLC’s registration and pharmacovigilance department provides registration services for drugs, medical devices, nutritional supplements and cosmetic products as well as pharmacovigilance services.
Drug registration is a formal and legal procedure that includes the collection, preparation and submission of complex documentation to the regulatory body of a country or region in order to obtain approval for placing the drug on the market. The goal of drug registration is to ensure that the drug is safe, effective and of high quality and that it is produced in accordance with applicable regulations and guidelines, ensuring access to safe and effective drugs for patients.
Apomedical is your real partner when it comes to the registration of medicines in Bosnia and Herzegovina.
Medicine registration service includes:
- Preparation and submission of documentation for obtaining, renewing and amending approval for marketing the drug
- Registration in the Register of Medical Devices, including the renewal of registration in the Register as well as the request to change the certificate
- Preparation and submission of documentation for obtaining a permit for the import and placing on the market of dietary preparations in the territory of the Federation of BiH/RS
- Support program for the import of drug samples and reference standards in registration procedures - consultation and support during the import of samples
- Support and monitoring in the course of the application procedure for obtaining/renewing/amendment of approval for putting the preparation on the market
Get in touch with us
The first step is to contact Apomedical as your trusted partner for drug registration. Our expert team will guide you through the entire process and provide all the necessary information.
Preparation of documentation
Based on the collected information about your product, our team will prepare all the necessary documents and harmonize them with the Law on Medicines and Medical Devices in Bosnia and Herzegovina.
Application and assessment
We submit a request for drug registration to the BiH regulatory body, which will conduct an assessment and make a decision on approval for placing your drug on the market.
Pharmacovigilance/Materiovigilance
Pharmacovigilance is a procedure that is applied to identify, collect, monitor, analyse and react to new data related to the safety of the drug and the assessment of the relationship between risk and benefit when using the drug or interacting with other drugs.
As an expert associate for pharmacovigilance, we are dedicated to the activities of establishing and maintaining the pharmacovigilance system, to ensure the protection of the health and safety of our patients and users of medical devices. Our goal is to reduce the risk and likelihood of recurrence of adverse events, setting high standards in the monitoring and evaluation of data on side effects. Your safety and well-being are our priority concerns, therefore the expert pharmacovigilance team is constantly engaged to ensure the highest level of quality and safety of our products.
The pharmacovigilance service includes:
- Application of local and foreign Individual Case Safety Report (ICSR) to ALMBIH*** and company headquarters
- Reporting of adverse events from post-marketing clinical trials to ALMBIH and company headquarters
- Monitoring of Periodic Reports (PSUR, DSUR) and Product Safety Alerts in accordance with SOPs and applicable regulatory requirements
- Monitoring of local scientific literature to analyze articles and possibly report information
- Conducting appropriate training for employees on the basics of pharmacovigilance, in accordance with business needs
- Quality system maintenance and relevant reporting
Good to know:
• is any harmful and unintentionally induced reaction that can occur at a therapeutic dose of the drug (definition according to the Rulebook on the manner of reporting, collecting and monitoring adverse drug reactions);
• is an adverse and unintended response to the drug.
These include side effects resulting from:
• use of the drug under approval conditions;
• use of the drug outside the approved conditions, including overdose, off-label use of the drug, abuse of the drug, wrong use;
• professional exposures
(definition according to European Directive DIR 2001/83/EC Art1(11)).
A serious side effect of the drug is a harmful and unintentionally caused reaction to the drug that results in death, immediate threat to life, disability, hospital treatment (if it was not necessary before), extension of hospital treatment or congenital anomalies, i.e. a defect discovered at birth.
Glossary
*Pharmacovigilance – method of reporting, collecting and evaluating adverse reactions to drugs used in human medicine;
**Materiovilanca – monitoring of unwanted events related to medical devices.
***ALMBIH – Agency for Medicines and Medical Devices of Bosnia and Herzegovina www.almbih.gov.ba