Registration of medical products
MEDREG’s experience and professionalism will provide smooth and fast registration of medicine in the Republic of Armenia, including assessment of applications for registration certification, preparation of regulatory documents, medical application instructions, general characteristics of medicines, and translation of all necessary documents.
- Primary expert evaluation of application and consultation with the customer
- Estimation and compliance assessment of provided materials for medicals, subject to RA state registration
- Registration cost estimate, coordination with custome
MEDREG offers to its customers the following services:
- Consultation regarding medical products registration and preparation of a list of necessary documents;
- Review and assurance of correctness of all documents required for the registration application in compliance with legislation of the Republic of Armenia;
- Translation of all necessary documents;
- Assistance in pre-approval expert quality report procedure for the medical product in an independent laboratory;
- Setting up registration application and further support in accordance with regulatory requirements;
- Submission of registration application to the authorized agency of executive department, receiving official inquiries, consultation for additional materials preparation in compliance, and customer advocacy;
- Receipt and delivery of registration certificate for the medical product;
- Amendments to registration application documents and further support to ensure compliance with regulatory requirements;
- Confirmation of state registration (and/or re-registration) of medical product.
The estimated duration of expert evaluation for medical product state registration in the Republic of Armenia is 180 days, except for medical products already registered in one of the EU member-countries, USA, or Japan, which takes only 30 days as per a simplified procedure. The issued registration certificate is valid for five years.