For Industry Representatives

Databases

• Medicinal Products Database
• Medical Devices Database
• Manufacturing and Distribution Licences Database

New Safety Information

• Medicinal Products
• Medical Devices

How To Report An Adverse Drug Reaction

• Procedure
• Forms
• On-Line Reporting of ADRs

Central Ethics Committee (CEC)

• About CEC
• Meetings Schedule
• Application Forms
• Instructions for Applicants
• Clinical Trial - A Manual for Patients and Their Families

Variation Applications - Referrals, PSUSA Procedures and PRAC Signals

• Instructions for Variation Application after Referral
• Instructions for Variation Applications Following the Outcome of the PSUSA Procedure
• Variation Applications - PRAC Safety Signals

Medical Devices Area – Instructions

• Procedure for registration in the register and information on medical devices
• Manufacturers of medical devices
• Placing on the market of medical devices
• Advertising of medical devices

Other Useful Information And Contacts

• Legislation
• Publications and Reports
• Newsletter
• Enquiries
• Contacts

Application Web Ponude

Using application Web ponude (Web offers), applicants for HALMED's services can independently create offers for procedures they wish to start, upon which payments will be executed.

HALMED's Services

• Services and Fees
• Forms

Access To Databases Of Suspected ADRs

• EMA's European Database of Suspected ADR Reports
• VigiAccess - Global Database for Suspected ADRs

Medicinal Products Area – Instructions

• Procedure for Granting Marketing Authorisation
• Renewal of Marketing Authorisation
• Variations
• Transfer of Marketing Authorisation
• MRP and DCP Procedures - Specific National Requirements
• Croatia as a Reference Member State (RMS) in MRP and DCP Procedures
• Forms
• Submission of Scientific Advice Application
• Instructions and product information templates (QRD) in the national procedure
• The mock-up of medicinal product packaging
• Instructions for Implementation of Braille Script on the Packaging
• Instructions About the Readability and Simplicity Testing of the Package Leaflet
• Instructions for the Name of a Medicinal Product
• Recommended Translations of Scientific Terms
• Marketing Authorisation Number
• Over-the-counter (OTC) Medicines
• Preparation, Submission and Archiving of Dossiers for Medicinal Products
• Introduction of safety features on the packaging of medicinal products authorised via the national, CP, MRP and DCP procedure
• Archive – Croatia in the European Union – Guidelines and Useful Information

Pharmacovigilance Area – Instructions

• Questions and answers related to Periodic Safety Update Report (PSUR) submission
• Adverse Drug Reactions in Summaries of Product Characteristics and Patient Information Leaflets
• Instructions for Submitting Applications for Scientific Advice
• Questions & answers regarding the RMP and RMM submission
• Inclusion of information as regard the medicinal product status under additional monitoring
• Electronic ADR reporting in E2B standard (EudraVigilance) - Questions and Answers
• Information on Authorisation Holders' ADR reporting obligation

Professional And Scientific Events

• Seminars, Workshops and Other Events
• Lectures in Cooperation with Croatian Pharmaceutical Society