Pharmacovigilance is a system for monitoring, analyzing and evaluating information on the safety of registered medicines.
Registration of medicines is a prerequisite for the introduction of new medicines into the pharmaceutical market of the Republic of Azerbaijan.
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All types of pharmaceutical services are carried out
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MAKROMED LLC is one of the best and leading qualified consulting companies in Azerbaijan established in 2013. Now it’s a part of the Makromedicine worldwide webportal (www.makromedicine.com).We are currently cooperating with many leading pharmaceutical companies around the world, as well as CIS countries.Through its professional team of experts with an excellent reputation in Azerbaijan pharmaceutical market, Makromed LLC offers the highest level of services available and an excellent understanding of the specifics of the pharmaceutical market and regulators.We consider each problem objectively from our largest to our most focused engagement, based on rigorous and thorough research. We follow the data relentlessly and deliver not just the conventional wisdom but also deeper and sharper insights that are actionable and give our clie
Parmacovigilance
According to the legislation of the Republic of Azerbaijan, the state registration expertise of the medicinal product consists of two stages: initial and specialized expertise.
In the territory of the Republic of Azerbaijan, the license holder must appoint a person responsible for pharmacovigilance with the qualifications outlined in subsection 2.1.5 of the Regulation. The license holder is required to inform the Agency of the name and contact information of the person responsible for pharmacovigilance.
When applying for state registration of a medicinal product, the permit holder shall submit a brief summary of the pharmacovigilance system. A summary of the pharmacovigilance system consists of:
- A document on the appointment of the license holder as a person responsible for pharmacovigilance.
- Contact information of the person responsible for pharmacovigilance (address, telephone, fax, e-mail, etc.).
- Certificate certified by signature and seal, attesting that the license holder possesses the necessary equipment to fulfill their duties and obligations related to pharmacovigilance.
- Certificate, certified by signature and seal, confirming the existence of the main dossier of the pharmacocontrol system of the medicinal product.
Pharmacovigilance in the postmarketing phase supports drug development by identifying safety issues and guiding corrections in use.
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Call us: Mob: +91-9157010011
Call us:
E-mail: Pharmacovigilance: pv1@makromed.in CIS - Registration Services and Business Development: office@makromed.in
Address: C-02, Elanza Crest, Near Sigma House, Snidhu Bhavan Road, Bodakdev, Ahmedabad-380059, Gujarat, India.
Call us: Mob: +91-9157010011
Call us:
E-mail: Pharmacovigilance: pv1@makromed.in CIS - Registration Services and Business Development: office@makromed.in
Address: C-02, Elanza Crest, Near Sigma House, Snidhu Bhavan Road, Bodakdev, Ahmedabad-380059, Gujarat, India.
Mob: +91-9157010011
Pharmacovigilance: pv1@makromed.in CIS - Registration Services and Business Development: office@makromed.in
