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Sectors: Co-op & Development, Education - Training, Health, New technologies, Research, Services

Beneficiaries: Administrations States, Local and Regional authorities, Research centres

Regions: Candidate countries, European Union

Category: Call for proposals

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We funding – IPA – Harmonise…
Funds for: Harmonising the legislation for medicinal products with EU legislation
Main beneficiaries: Public bodies

Responsible: European commission

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Amorce:

Funds for: Harmonising the legislation for medicinal products with EU legislation
Main beneficiaries: Public bodies

Priorities and funded actions:

Objectives: 
* Supporting the Agency for medicines and medical devices (MALMED) in accordance with the international standards and good pharmaceutical practices, as well as adoption, implementation, and enforcement of the national pharmaceutical legislation in accordance to the EU acquis;

Priorities:
* Improvement and harmonisation of the legal framework on medicines and medical devices;
* Recommendations for the development of the MALMED administrative capacity for implementation of regulation according to EU practices drafted;
* Recommendation for the establishment of a drug utilisation system

Among financed actions: 
* Recommendations on the revision of the current law (by chapters) and the current procedures framework to define weaknesses and omissions;
* Conduct and develop a comparative analysis of the organisational structure, functions, and responsibilities of the relevant units in MALMED, taking into consideration best EU practices in Member States and a report with recommendations for improvement;
* Carry out strategic training needs analysis (TNA) covering the whole system, in order to elaborate a National Training Plan;
* Organisation of workshops related to best practices from MS of:
– Marketing authorisation of medicines;
– Marketing authorisation of medical devices;
– Good practices for inspection and licensing
* Organise 3 joint inspections with experts from MS and MALMED inspectors regarding GMP, GDP, GPv and GCP in the beneficiary country;
* Organise and carry out 1 study visit (max 5 participants for 5 days) focussed on functioning and methodology of database of drug utilisation system as well as supporting IT system, in a Member State;
* Draft a proposal for Guidelines for drug utilisation and a pilot version of a database