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Archive – Croatia in the European Union – Guidelines and Useful Information
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The mock-up of medicinal product packaging
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Archive – Croatia in the European Union – Guidelines and Useful Information
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Information to Marketing Authorisation Holders on the Application Submission before the Accession to the EU
MRP & DCP and EU Enlargement - New Version of CMDh's Instructions
Marketing Medicinal Product Batches after the Accession of Croatia to the EU
Import of Medicinal Products from Third Countries after the Accession of Croatia to the EU
Requirements for ICSR Reports after the Croatian Accession to the EU
Deadlines for the Submission of Applications for Special and Regular Quality Control before the Accession to the EU
Anticipated National Specificities in Medicinal Product Documentation and the Procedure for Issuing Marketing Authorisations after the Accession of Croatia to the EU
Importing Active Ingredients from Third Countries after the Accession of Croatia to the EU
News Related to Importing Active Substances from Third Countries after the Accession of Croatia to the EU (10 August 2015) - NEW
Electronic Submission of Information on Medicines after Croatia's Accession to the EU
Import of Active Substances from Third Countries after the Accession of Croatia to the EU
Requirements for Submissions of PSURs to HALMED
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Official Medicines Control Laboratory Division - OMCL
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