Moldova Medicines Authorization Procedures 2021-2022 Overview

Moldova Medicines authorization procedures

Authorization process development 2021 2022 General (210 days) General (210 days) Simplified procedure (60 days) Simplified procedure (60 days) Accelerated procedure (10 days) Emergency use & conditional procedure (10 days) Collaborative procedure (WHO prequalified products) 45 days

General procedure Category of products All products registered in the manufacturer s or MAH country Length of procedures 210 days 5 Modules in CTD format for first authorization 3 Modules (1 - 3) in CTD format + PSUR for renewal Structure of dossier In sufficient quantity to ensure 3 full analyzes in accordance with the quality parameters for manufacturers that have not been inspected by a PIC/S the member state Samples and standards All the documents (GMP, ML) must be presented in certified copies Submission of administrative data Assessment Full assessment

Simplified procedure Available for medicines authorized in European Economic Area countries, including through national procedure and mutual recognition or Switzerland, USA, Canada, Japan, Australia Category of products Length of procedures 60 working days 5 Modules in CTD format for first authorization Module 1 + PSUR for renewal Structure of dossier Samples and standards Not required Submission of administrative data A reference to EudraGMDP database is sufficient Assessment Comparative assessment The applicant's declaration/commitment that the dossier submitted is identical to the one accepted by the EMA or by the competent national regulatory authorities from the countries of the European Economic Area or Switzerland, USA, Canada, Japan, Australia. Additional requirements

Emergency use & conditional procedure Medicines authorized through the emergency procedure by WHO, EMA, USA, Switzerland, Canada, Japan, Australia, UK Category of products Length of procedures 10 working days MMDA signs a confidentiality agreement with WHO in order to access to the dossier included by WHO in the EUL The conditional procedure is applied on the basis of less complete documentation of clinical data, if the risk/benefit ratio is positive and if it concerns the protection of public health Structure of dossier Samples and standards Not required Submission of administrative data Copies of GMPs are considered sufficient Assessment Comparative assessment Additional requirements To carry out post-authorization safety and efficacy studies

Collaborative procedure Category of products Medicines prequalified by the WHO Length of procedures 45 working days 5 Modules in CTD format for first authorization 3 Modules (1 - 3) in CTD format + PSUR for renewal Structure of dossier Samples and standards Not required Submission of administrative data All the documents (GMP, ML) must be presented in certified copies Assessment Comparative assessment Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the Procedure Expression of interest to national regulatory authority (NRA) in the assessment and accelerated national registration, acceptance by NRA and notification of Procedure outcomes Additional requirements

Accelerated procedure Medicines approved by regulatory authorities: EMA (centralized procedure), competent authorities of EU member states (decentralized procedure), USA, Switzerland, Canada, Japan, Australia, UK Category of products Length of procedures 10 working days Abridged Module 1 (application, copy of CPP, Copies of GMP certificates, SPC, Labelling, Package Leaflet, CV of qualified person responsible for pharmacovigilance on the territory of the Republic of Moldova) Module 2 Structure of dossier Samples and standards Not required Submission of administrative data A reference to EudraGMDP database is sufficient Assessment Comparative assessment A declaration of the owner's own responsibility, as if the documentation submitted in support of the authorization request reflected the same conditions for the quality, safety and efficacy of the product submitted for authorization as a document approved by one of the bodies: EMA (centralized procedure), competent authorities of the EU Member States (decentralized procedure), USA, Switzerland, Canada, Japan, Australia, UK Additional requirements

Frequent Questions Answers The language of submitted documents Dossier - English or Romanian SmPC and PIL - Romanian mock-ups English, French, Spanish, Romanian 26983 MDL ( 1400 EUR) for innovative 1 dose/strength Fees 9137 MDL ( 460 EUR) for innovative 2nd and further doses/strengths 24078 MDL ( 1200 EUR) for other types of application 1 dose/strength 8295 MDL ( 420 EUR) for other types of application 2nd and further doses/strengths Format of dossier Only CTD Does it apply to all medicinal products regardless of the active substance? Yes. It is important that in EU member-states it is authorized according to the centralized or decentralized procedure Does the legal basis for the approval of the medicine in the EU matter (well established use, generic, hybrid, etc.)? No. All application types can afford accelerated procedure For long ago authorized medicinal products, is it necessary to update the reviews that are part of Module 2 (clinical, non-clinical, qualitative)? Through the accelerated procedure, the Holder submits to MMDA the last dossier accepted by EU regulatory authorities, including all variations Are there any other conditions for the product to undergo the procedure? A declaration of the owner's own responsibility, as if the documentation submitted in support of the authorization request reflected the same conditions for the quality, safety and efficacy of the product submitted for authorization as a document approved by one of the bodies: EMA (centralized procedure), competent authorities of the EU Member States (decentralized procedure), USA, Switzerland, Canada, Japan, Australia, UK