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Call key data
Strengthening the administrative capacity of the Institute for Medicines and Medical Devices of Montenegro regarding the requirements of the EU accession process
Funding Program
Instrument for Pre-accession Assistance
Call number
EuropeAid/180627/DD/ACT/ME
deadlines
Opening
04.03.2024
Deadline
10.05.2024 14:30
Call budget
€ 250,000.00
Estimated EU contribution per project
€ 250,000.00
Link to the call
Link to the submission
Call content
short description
This call focusses on the provision of quality, safe and effective medicines and medical devices of appropriate performances on the Montenegrin market and supporting the development of the pharmaceutical market.
Call objectives
Projects should focus on strengthening the administrative capacity and internal competences of the Institute for Medicines and Medical Devices of Montenegro with a focus on meeting the requirements of the EU accession process and harmonization of Montenegro's legal framework to align closely with the EU acquis.
Expected effects and impacts
Component 1: Strengthening administrative capacity and internal competences of the CInMED
- Result 1 - Strengthened administrative capacity and internal competences of the CInMED in the field of Medicines
- Sub - result 1.1: Strengthened the internal capabilities of CInMED for conducting independent administrative and substantive assessments of documentation and improvement of the national medicines database. This includes different types of applications for issuing marketing authorizations for human medicines, specifically focusing on quality, safety, and efficacy documentation.
- Sub - result 1.2: Strengthened CInMED's internal expert competencies for assessing variations, ensuring that medicines on the market are consistently accompanied by the most updated information.
- Sub - result 1.3: Strengthened CInMED's internal expert competencies for dealing with medicines shortages
- Result 2 - Strengthened administrative capacity and internal competences of the CInMED in the field of Medical Devices
- Sub - result 2.1: Increased internal competencies in medical device vigilance and market surveillance, encompassing the management of quality defects and the protocol for withdrawing medicinal products from the market.
- Result 3 - Strengthened administrative capacity and internal competences of the CInMED in the field of GxP inspections
- Sub - result 3.1: Increased CInMED's internal competencies in conducting GxP inspections, ensuring compliance with EU guidelines on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
- Sub - result 3.2: Increased CInMED's internal capabilities to monitor rapid alerts and evaluate quality defects in medicines.
- Result 4 - Strengthened internal competences of CInMED for public relations and international cooperation
- Sub - result 4.1: Increased CInMED's internal competencies for public relations and international cooperation through training sessions, exchange of experience and joint participation in EC and EMA working groups.
Component 2: Recommendations for further harmonization of legal framework in Montenegro to achieve alignment with EU acquis
- Result 5 - Set of recommendations for alignment with EU acquis and further harmonization of legal framework in Montenegro
- Sub - result 5.1: Set of recommendations to align the Law on medicines with the most recent EU acquis.
- Sub - result 5.2: Set of recommendations to align the Law on medical devices with the most recent EU acquis.
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Expected results
Result 1 -: Strengthened administrative capacity and internal competences of the CInMED in the field of Medicines
- Sub - result 1.1
- A.1.1.1: Joint review of assessments of medicines quality documentation, using practical examples from applications submitted in the Member State.
- A.1.1.2: Conducted joint review of assessments of safety and efficacy documentation for different legal basis applications, utilizing practical examples from applications submitted in the Member State.
- A.1.1.3: Conducted joint review of assessments of administrative and regional documentation for different application types, addressing major challenges. This activity should be conducted through a three - day study visit, involving five participants from CInMED in the Member State.
- A.1.1.4: Organized training sessions on the national registry of medicines, mode and type of data on medicines imported into the national medicines database. This activity should be conducted during a two - day study visit involving three participants from CInMED in the Member State.
- Sub - result 1.2
- A.1.2.1 Joint review of the assessments of variations documentation, using practical examples from variations submitted in the Member State. This activity should be conducted through a three - day study visit involving five participants from CInMED in the Member State.
- Sub - result 1.3
- A.1.3.1: Organized workshop on medicines shortages actions in European Union
Result 2 - Component 1: Strengthened administrative capacity and internal competences of the CInMED in the field of Medical Devices
- Sub - result 2.1
- A.2.1.1: Training sessions on European medical devices vigilance system and market surveillance, encompassing the management of quality defects and the protocol for withdrawing medicinal products from the market.
Result 3 - Component 1: Strengthened administrative capacity and internal competences of the CInMED in the field of GxP inspections
- Sub - result 3.1
- A.3.1.1 Perform joint and/or mock up GMP - (practical training – joint/mock up inspection) in the Member State or some other country, depending on inspection plans
- A.3.1.2 Perform joint and/or mock up GDP - (practical training, joint/mock up inspection) in Montenegro or Member State, depending on inspection plans. Plan and location of joint inspections depend on the annual plan of inspections in the Member State and CInMED. Inspectors from CInMED would join inspection team from the MS in their already planned and scheduled inspections, as observers and vice versa. Also mock up inspection could be planed.
- Sub - result 3.2
- A.3.2.1 Training sessions on monitoring rapid alerts and evaluate quality defects of medicines using practical examples from the Member State.
Result 4 - Component 1: Strengthened internal competences of CInMED for public relations and international cooperation
- Sub - result 4.1
- A.4.1.1. Training sessions for public relations and international cooperation – practical examples and exercises to help achieve good communication and collaboration with future EU regulatory partners.
- A.4.1.2. Training sessions for social media visibility enhancement, digital marketing skills and crisis management PR
Result 5 - Component 2: Recommendations for alignment with EU acquis and further harmonization of legal framework in Montenegro
- Sub - result 5.1:
- A.5.1.1 Perform joint analysis of legal framework in Montenegro and suggest priority steps and recommendations for achieving full alignment with EU acquis concerning Law on medicines
- Sub - result 5.2:
- A.5.2.1 Perform joint analysis of legal framework in Montenegro and suggest priority steps and recommendations for achieving full alignment with EU acquis concerning Law on medical devices
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Eligibility Criteria
Regions / countries for funding
Montenegro (Црна Гора)
eligible entities
Public Body (national, regional and local; incl. EGTCs)
Mandatory partnership
No
Project Partnership
Only Public Administrations and Mandated bodies as per Twinning Manual of European Union Member State may apply through European Union Member States’ National Contact Points.
Additional information
Topics
Relevance for EU Macro-Region
EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
project duration
11 months
Additional Information
Twinning proposals must be submitted by the Lead Member State Administration to the EU Member States National Contact Points for Twinning following the instructions of the Twinning Manual which must be strictly observed (including the use of the templte).
Only one Twinning proposal for Member State can be submitted by the Member State National Contact Points for Twinning to the Contracting Authority within the deadline for applications.
Call documents
EUROPEAID/180627/DD/ACT/ME Twinning Light FicheEUROPEAID/180627/DD/ACT/ME Twinning Light Fiche(1185kB)
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