Components and the Results

PROJECT COMPONENTS

Component 1: Approximation of the legal framework and strengthening of the MMDA’s institutional and organisational capacities

Activity 1.1 Approximation of the legal framework;
Activity 1.2 Training of staff on the EU regulatory framework for medicines and medical devices;
Activity 1.3 Benchmark of functions of the MMDA with the EU competent authorities and services;
Activity 1.4 Analysis of the decision making procedures;
Activity 1.5 Study visit to Lithuania and Poland.

Component 2: Strengthening of the MMDA’s regulatory functioning with respect to medicinal products

Activity 2.1 Development of an SOP (Standard Operating System) for the authorization of medicinal products including building the infrastructure for risk benefit assessment and robust and independent decision making;
Activity 2.2 Training of the MMDA staff responsible for carrying out marketing authorization procedures;
Activity 2.3 Development of a risk-based enforcement system of medicines quality rules as well as other GMP, GDP and GVP;
Activity 2.4 Strengthening of pharmacovigilance by establishing a better functioning pharmacovigilance unit;
Activity 2.5 Improving pharmacovigilance by reaching out to the medical and pharmaceutical community;
Activity 2.6 Drafting SOP Clinical Trial authorization procedure;
Activity 2.7 Strengthening the functioning of the MMDA with respect to clinical trials;
Activity 2.8 Study visits to Lithuania and Poland.

Component 3: Strengthening of the MMDA’s regulatory functioning with respect to medical devices

Activity 3.1 Development of a SOP for the supervision of the medical devices market;
Activity 3.2 Training of the MMDA staff in respect of medical devices;
Activity 3.3 Strengthening of vigilance and strengthening enforcement;
Activity 3.4 Design of IT infrastructure and procedures for medical devices register;
Activity 3.5 Study visit to Poland.

Component 4: Improvement of rational use of medicines and medical devices

Activity 4.1 Expert mission about improving mechanisms to ensure availability and access;
Activity 4.2 Strengthening of Compliance / Training of GMP, GDP and GCP inspectors;
Activity 4.3 Enforcement of legislation about promotion of medicinal products;
Activity 4.4 Development communication strategy on rational use medicinal products;
Activity 4.5 Strengthening of supervision of pharmacies and enforcement of GPP;
Activity 4.6 Study visits to Lithuania and Poland.

Component 5: Transition of the MDDA to full compliance with the EU requirements

Activity 5.1 Strengthening assessment capacity;
Activity 5.2 Development of Good Governance Practice;
Activity 5.3 Developing new tasks for the Quality Control laboratory;
Activity 5.4 Management of the medical products market during the transition;
Activity 5.5 Study visits to Lithuania and Poland.