Manufacturing and Importation
Medicinal products and active substances manufactured or imported into the European Union, including medicinal products intended for export and those intended for clinical trials, must be manufactured in accordance with the principles and guidelines of good manufacturing practice (GMP).
Manufacturers and importers located within the European Economic Area (EEA) must have authorisation from the competent body of the member state for manufacturing and importing, as well as good manufacturing practice inspection results for activities undertaken in their territory.
The competent body of the member state that conducted the inspection and ascertained that manufacturing takes place in compliance with GMP principles will issue the Certificate of Good Manufacturing Practice. In the event the inspection reveals that the manufacturer does not comply with GMP principles, the competent body will issue a Statement on Non-Compliance. The Certificate of Good Manufacturing Practice and Statement on Non-Compliance can be issued by the competent body to manufacturers of medicinal products for human or veterinary use and to manufacturers of active substances where such manufacturers are located within the European Union, as well as outside of EU.
Information on issued manufacturing and import authorisations and results of inspections of good manufacturing practice are entered by competent bodies of member states into the publicly accessible European database EudraGMDP.
Authorisation for manufacturing / importing medicinal products
The competent body of each member state is responsible for issuing authorisations for manufacturing which take place in their territory. Natural and legal persons with headquarters in the Republic of Croatia are to submit the application for the issuing of manufacturing authorisation to the Agency for Medicinal Products and Medical Devices of Croatia (HALMED).
Natural or legal persons in the Republic of Croatia who undertake activities involving the importing of medicinal products for the territory of the Republic of Croatia are to submit an application for acceptance of the manufacturing authorisation from the competent body of the member state for parts of the manufacturing process taking place on the territory of the European Union for the manufacturing site of the imported medicinal product.
For acceptance of the manufacturing authorisation for medicinal products manufactured in third countries, when submitting the application natural or legal persons in the Republic of Croatia are also to attach the Certificate of Good Manufacturing Practice issued by a competent body of an EU member state.
If the applicant fulfils all stipulated conditions, HALMED will issue the manufacturing authorisation for a limited time, and if it is ascertained that the applicant does not fulfil all stipulated conditions, HALMED may issue a conditional manufacturing authorisation with deadlines for rectifying identified inadequacies.
Information on issued manufacturing authorisations is published in the Croatian database which is accessible on HALMED’s website, or here and entered into the EudraGMDP database which is available here.
Registration of API manufacturers, importers of active substances
The competent body of each member state is responsible for registering the manufacturing of active substances which takes place on their territory. Natural and legal persons in the Republic of Croatia which manufacture active substances or certain parts of the manufacturing process for active substances, are to submit the registration application to HALMED.
The importing of active substances may be performed by a manufacturer of a medicinal product, investigational medicinal product, manufacturer and importer of active substances. Natural and legal persons in the Republic of Croatia who import active substances are to submit to HALMED an application for entry into the Registry of manufacturers, importers and wholesalers of actives substances.
The applicants entered into the Registry for the activities of manufacturing and importing must adhere to good manufacturing practice requirements which are available here and good distribution practice which is available here.
If the active substance is imported from a third country, the delivery of the active substance must also include a certificate confirming that the active substance was manufactured at the manufacturing site where the good manufacturing practice requirements are applied, where the certificate is issued from a competent body of an EU member state.
Information on licence holders for the Registry of manufacturers and importers of active substances is published in the database, which is accessible on HALMED’s website, i.e., here and is entered in the EudraGMDP database which is available here.