Additional guideline concerning the submission of conventional dossiers on medicinal products
02.03.2016
In 2016, Agency for Medicinal Products and Medical Devices of Croatia (HALMED) initiated the process of internal digitalisation of the submitted documentation on medicinal products, meaning that all the documentation on medicinal products delivered in paper form will be digitised after receipt and stored in HALMED's Digital Archiving Information System (DAIS). Digitalisation will be conducted in accordance with rules prescribed within standard operating procedures, and documentation delivered in paper form will be archived. Documentation which needs to be delivered on optical media will be uploaded into applications and also migrated into the above mentioned system, and optical media will afterwards be destroyed.
On HALMED's Internet portal, in the segment Medicinal Products/Instructions for Applicants/Preparation, Submission and Preservation of Documentation on Medicinal Products, Instructions for applicants for submitting the conventional dossier for medicinal products are already available. The available instructions contain information on the manner of marking, equipping and submitting documentation on medicinal products in paper form. Instructions which are applied if documentation on medicinal products is available in electronic form (eCTD or NeeS) are also available in the above mentioned segment of the portal.
Instructions for applicants for submitting the conventional dossier for medicinal products are updated with the following text:
4. Additional guideline concerning internal digitalisation of submitted documentation on medicinal products
In order to prepare the submitted documentation for digitalisation more quickly, we ask applicants who submit documentation in paper form, in addition to instructions under points 2 and 3, not to attach documents with clamps, fasteners and staples. Furthermore, please, do not use elastic rubber bands and plastic binders inside filing folders.
Document submitted on optical media (CD) should be delivered on separate CDs, as specified underneath. The type of document should be specified on the CD cover.
First CD: Working documents:
- Application form (eAF)
- Summary of Product Characteristics
- Package Leaflet
- Labelling
- Mock-up of outer and inner packaging of a medicinal product in Croatian language (if applicable)
Second CD: Modules 4 and 5
