Programme for Reimbursement of 50% of Expenses Related to Pharmaceutical Circulation Regulatory Examinations
BENEFICIARIES
A legal entity or individual entrepreneur holding a license for the production of medicines who has submitted an application to the Ministry of Economy of the Republic of Armenia for reimbursement and signed an agreement with the Ministry on the provision of reimbursement.
CONTENT
The goal of the programme is to reimburse 50% of the costs of examinations related to regulatory procedures in the field of pharmaceutical circulation, for medicines produced in the Republic of Armenia by resident companies or registered individual entrepreneurs, including:
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Registration, re-registration, or extension of the marketing authorization of a medicine in the Republic of Armenia;
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Examination of post-registration amendments to dossier alignment or mutual recognition of a medicine registered in Armenia in accordance with EAEU (Eurasian Economic Union) regulations;
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Re-examination for mutual recognition in other countries of a medicine registered or dossier aligned under EAEU regulations solely in Armenia;
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Examination for the purpose of registration or re-registration under the EAEU procedure, extension of marketing authorization, post-registration amendments, registration of a new indication or new production site;
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Laboratory fees (duties) in cases of making changes to a specification indicator;