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Tel: +387 33 771 700 | Fax: +387 33 771 707 | apomedical@apomedical.ba | BHS | EN

„Apomedical d.o.o." department for regulatory affairs and pharmacovigilance provides registration services for medicines, medical devices, food supplements and cosmetic products as well as services for  pharmacovigilance.“

 

Product Registration

Product registration is a process of performig a set of activities in order to obtain marketing autorization. This process could be related to the renewal of the licence and making corrections to the previous one.

The registration Associate reviews all the incoming documents and controls its completeness in accordance with the requirements prescribed by the Law on Medicinal Products and Medical Devices BIH.

At the completion of the registration dossier for a medicinal product / medical device, the Associate communicates and coordinates any possible shortcomings and ambiguities with the foreign partner and also provides the necessary documentation from the competent institutions of BiH.

 Services included in the registration process are following:

Support and monitoring during the application procedure for obtaining marketing authorization for a medicinal product

Consultation and planning during the implementation procedure applications

Creation of text packaging material, Patient Leaflet and Summary Product Characteristics of the medical product

Respond to comments / additional requirements of relevant institutions

Maintenance of marketing authorisation approval

Variations of marketing authorisation for the medicinal product

Support Programme for import of samples of medicinal products (consultation and support to import samples

 

 The required documents for registration of medicinal product / medical device and more information: www.almbih.gov.ba 

Note:

The duration of the registration process, according to the Law on Medicinal Products and Medical Devices BIH is 210 days, and 90 days for medical devices from the verification date of the completeness of submitted documents. Renewal of registration for every medicinal product is done after 5 years from the grant of marketing authorization.

 

 

Pharmacovigilance

 

Pharmacovigilance (PV OR PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Adverse drug reaction:

an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product

harmful and unintentional response to the drug.

This includes the side effects that result from:
• use of the drug in terms of approval,

• the use of a medicinal product outside approved conditions, including overdose, non-authorized use of the drug, drug misuse, misuse,
• professional exposure.

Serious undesirable drug interactions are a harmful and inadequately induced reaction to a drug that results in death, immediate life threat, disability, hospital treatment (if not needed before), extension of hospital treatment or congenital anomaly, or defect detected by birth.

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Associate for pharmacovigilance performs activities to establish and maintain a system of pharmacovigilance * / materiovigilance **.

Those activities are performed in order to protect the health and safety of patients or other users of medical devices and to reduce the risk and likelihood of recurrence of adverse events.

Services included in the pharmacovigilance process are following:

Monitoring daily incoming communication (e.g., e-mail, telephone, and fax) for ICSRs to report to GPE.

Handling of ICSRs and other PV data received locally in line with GPE Global SOPs and local regulatory PV requirements.

Handling of periodic reports including PSURs, DSURs and Product safety alerts in line with GPE global SOPs and local regulatory PV Requirements.

Tracking of reporting activities

Managing of quarterly reporting to GPE

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* Pharmacovigilance - way to report, collect and evaluate adverse reactions of medicines used in human medicine.
** Materiovilance - monitoring adverse events related to medical devices.