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Update from 14-Sep-2010:
On 26-Aug-2010 a slightly revised version of the Croatian electronic submission requirements document (see original News Article from 27-July-2010 below) has been released by the Croatian Drug Regulatory Agency AZLMP. The revised version is available for download from the AZLMP website in Croatian language and contains only minor changes of wording and some corrections.
For a copy of the professional translation of the revised version please contact info@exalon.com.
[Source: AZLMP website]
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Original News Article from 27-July-2010:
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The requirements for regional Croatian eCTDs and NeeS as well as the Croatian DTD, MOD-Files and Style sheet for eCTD have been published recently by the Croatian Drug Regulatory Agency AZLMP (Agencija za lijekove i medicinske proizvode).
The regional Croatian eCTD specification follows the EU regional specification, the respective DTD, Croatian codes for country, language, and agencies (Human and Veterinary) have been incorporated in the DTD and MOD Files derived from the original EU regional Module 1 specification 1.4. All eCTD technical files are available for download from the AZLMP website.
The requirements have been released currently in Croatian language only (see link at the bottom of this page). As mentioned above the follow in principle the EU requirements as laid down in the Guidance documents for eCTD and NeeS as published by TIGes. Below you will find an excerpt of more country - specific information from the Croation guidance as provided by professional translation service. A full copy of the translated guidance is available for free, please send an e-mail with your request to info@exalon.com.
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Professional Translation from Croatian by
beo Gesellschaft für Sprachen und Technologie mbH
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Start of Translation
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8. How should the drug dossier be submitted (depending on license for the marketing of a new drug subject to national or European procedures)?
When the Regulations on supplements or amendments to the Procedures for licensing the marketing of new drugs (Narodne Novine, No. 155/09) came into force, applicants were then permitted to submit drug dossiers in electronic form. In addition to dossiers in electronic form, modules 1-3 must be submitted in paper form.
Table 1: Submission of drug dossiers, depending on format and procedure MEDIA | NATIONAL PROCEDURE | EUROPEAN PROCEDURE | NUMBER OF COPIES |
Entire drug dossier on paper, working documents on separate CD or DVD |
M1-M5 in paper form + Croatian working documents in electronic form |
M1-M5 in paper form + Croatian M1 in paper form + Croatian working documents in electronic form | 1x |
M1-M3 on paper, electronic dossier on CD or DVD, working documents on separate CD or DVD |
M1-M3 in paper form + eCTD with Croatian DTD or NeeS + Croatian working documents in electronic form |
Original M1-M3 in paper form + Croatian M1 in paper form + eCTD with European DTD or NeeS + Croatian working documents in electronic form | 1x |
8.1 If drug dossiers for the granting, renewal or modification of a license are submitted on paper under national procedures, the full drug dossier must be submitted on paper and working documents must be submitted in electronic form on CD or DVD (Figure 3). One copy of the dossier should be submitted.
8.2 If the drug dossier is submitted on paper as part of the procedure for the granting, renewal or modification of a license for a drug that has a license for marketing in the countries of the European Union granted on the basis of a centralized procedure, a procedure for international recognition or a decentralized procedure, the entire original dossier must be submitted on paper, along with module 1 in Croatian in paper form, and working documents in electronic form on CD or DVD. One copy of the dossier should be submitted.
8.3 If the drug dossier is submitted as part of a national procedure for the granting, renewal or modification of a license, the eCTD or NeeS dossier must be submitted on CD or DVD, with electronic working documents for the last valid sequence or tracking on a separate CD or DVD (structure shown in Figure 3) and copies of modules 1 – 3 in paper form. eCTD drug dossiers should be produced using a DTD that contains Croatian elements, but NeeS drug dossiers should be produced using the same directory structure as the eCTD. One copy of the dossier should be submitted.
8.4 If the electronic drug dossier is submitted as part of a procedure for the granting, renewal or modification of a license for a drug that has a license for marketing in the countries of the European Union granted on the basis of a centralized procedure, a procedure for international recognition or a decentralized procedure, the original eCTD or NeeS drug dossier must be submitted on CD or DVD, the working documents for the last sequence or tracking structured in accordance with Figure 3 on a separate CD or DVD and copies of the original modules 1 - 3 and Croatian module 1 on paper.
It is anticipated that, in the future, paper copies of dossiers will be done away with entirely in the cases cited above (8.1 – 8.4). After Croatia joins the European Union, Module 1 Specification will also contain Croatian elements and, for this reason, there will be no need for a separate Croatian DTD.
9. What media should electronic drug dossiers be submitted on?
Electronic drug dossiers should be submitted on hard optical CD or DVD media. If there is insufficient capacity for the whole drug dossier to fit on a single disk, the dossier must be saved in such a way that at least one entire module is on each medium.
10. How should submitted media be labeled?
The following information must be provided on the cover (the CD or DVD jewel case):
No. of procedure (if it exists) | e.g. DE/H/512/01/001/DC | Submitter of the application | Name of applicant | Manufacturer of developed medicine | Name of manufacturer | At ATK | e.g. L01CA01 | Type of application | e.g. for a license | Name of product | e.g. wonder pill | Active ingredient (INN) | e.g. pioglitazone hydrochloride | Date dossier submitted | 12.01.2006 | Sequence | sequences or tracking included |
11. What happens after the primary dossier has been submitted for the approval or renewal of a license for marketing a new drug?
If a primary electronic NeeS drug dossier is submitted, when subsequent dossiers are submitted for the same medicine, they must be in NeeS or eCTD format.
If a primary eCTD drug dossier is submitted, when subsequent dossiers are submitted for the same medicine, they must be exclusively in eCTD format.
If an eCTD dossier is submitted for further amendment, it must be copied in as many root directories, with the relevant sequences for the life cycle for a root directory, as were submitted at the start of the eCTD life cycle.
12. How can one be sure that the electronic drug dossier will pass the technical validation procedures applied by the Agencija za lijekove i medicinske proizvode?
As well as verification of their validity, electronic drug dossiers are also subject to technical validation in accordance with European criteria.
EU criteria for the validation of NeeS drug dossiers, EU NeeS validation criteria, v.1.0, August 2009
EU criteria for the validation of eCTD drug dossiers eCTD validation criteria, v.2.1, April 2009
Applicants are advised to carry out their own technical validation of the drug dossier prior to submission. Validators are available to check the technical validity of electronic drug dossiers free of charge. Electronic drug dossiers must be checked for viruses using an anti-virus program.
End of Translation
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[Source: AZLMP website]
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