ANNEX I.Logical framework matrix in standard format

LOGFRAME PLANNING MATRIX for Project Fiche / Programme name and number: IPA 2008 II part
Strengthening the institutional capacity of the Agency for Medicines and Medical Devices of BiH
Total budget: / IPA budget (max):
500,000 EUR
Overall objective / Objectively verifiable indicators / Sources of Verification
To provide safe and effective pharmaceuticals and medical devices to the health care services and patients in BiH / Single internal market of drugs and unique registration procedure for drugs in Bosnia and Herzegovina established / EC Progress Report
The Agency for Medicines and Medical Devices of BiH
annual reports
WHO reports
BiH Ministerial Health Conference reports
Project purpose / Objectively verifiable indicators / Sources of Verification / Assumptions
To assist the Agency for Medicines and Medical Devices of BiH in becoming a fully functional institution in accordance with EU standards. / The Agency for Medicines and Medical Devices of BiH member of the EU network of Pharmaceutical agencies / Annual pharmaceuticals register
Register of relevant drug certificates and authorizations issued
List of essential drugs / Core structuresof the Agency for Medicines and Medical Devices of BiH established and operative according to the Law on Medicines and Medical Devices of BiH.
Results / Objectively verifiable indicators / Sources of Verification / Assumptions
R1. In the areas of licensing, post-licensing and inspection to assist technical staff to became competent in the type of work listed below and to produce relevant documentation:
R2.Competent staff members trained to be able to deal with following areas:
R3. Development and implementation of relevant bylaws and other legal acts arising from the Law on Pharmaceuticals and Medicinal Devices drafted in line with EU legislation
R4. A clearly defined and implemented organigramme of the Agency
R5. Two study visits to EU member states partner Agencies organised
R6. Recommendation Report for future work of the Agency prepared / Key expert staff (40) from all Agency units (Drug Agency, Control Laboratory and Pharmacovigilance) trained.
Set of the Agency for Medicines and Medical Devices of BiH bylaws relevant for drugs import, marketing authorisations, authorisations for clinical trials of pharmaceuticals, monitors adverse reaction of pharmaceuticals etc. published in BiH Official Gazette.
Recommendations report drafted including all elements of further Agency’s development.
Laboratories operate in accordance with ISO standards. / Training agenda, list of participants at workshops and seminars
BiH Official Gazette
Agency’s report
Specification of laboratory equipment
OMCL certificate
OMCL network’s report/database / Enough number of trained expert staff to cover all organizational units of Agency
Registers of certificates and authorizations established and run in accordance with bylaws.
Budget funds for implementation of project recommendations provided.
Activities / Means / Costs / Assumptions
A1. Institutional building
- Define the vision, mission and short- and long-term strategy and business plan for the Agency,
- Further develop the detailed organisational structure of the Agency
- Establish a long-term budget planning system
- Develop a quality management system of internal operations, including reporting and specific standard operational procedures (SOPs)
- Develop a recruitment policy for key staff
- Develop training programmes for staff
- Organise and perform "training on the job" programmes
- Introduce EU-rules and international guidelines in practice in all relevant fields
- Establish working relations with its advisory bodies and external experts
- Establish international links with EU, EMEA, WHO, etc.
- Establish communication channels with the pharmaceutical industry,
- distributors and pharmacy organisations,
- Establish a Medicines Information Service on medicines marketing,
- Establish cooperation with other Governmental bodies (MoCA, Council of Ministers, entity ministries of health),
- Introduce system of data collection and reporting on statistics on medicines according to WHO requirements,
- Establishment of an information service for public,
- Designing legal acts that are arising/deriving from the Law on Pharmaceuticals and Medical Devices (bylaws).
A.2 Staff capacity building
Organise and perform in-house training to build capacity in the following areas:
  • Good Regulatory Practice (GRP) and internal quality management programmes
  • EU rules and local legislation for medicines
  • Cooperation with international organisations in the field of legislation for medicines
  • Quality control of medicines (quality / safety / efficacy)
  • Pharmaceutical quality control of biological products (blood products, vaccines, sera)
  • Good Manufacturing Practice (GMP) in cooperation with industries
  • Good Clinical Trial Practice (GCP) in cooperation with academic institutions
  • Good Distribution Practice (GDP) and Good Storage Practice( GSP) for Pharmaceutical Products
  • Pharmaco-vigilance in cooperation with regional adverse drug reaction centres
  • Expert training of the staff from all Agency units in relevant fields
A.3. Organise study programme in the twinning EU Member State:
A.4. Preparation of Recommendation Report for further improvement of Agency’s work (human recourse development, infrastructure etc.) to became prepared for membership in EU / Twinning contract / 500,000EUR

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