Anticipated National Specificities in Medicinal Product Documentation and the Procedure for Issuing Marketing Authorisations after the Accession of Croatia to the EU
The anticipated national specificities in medicinal product documentation and the procedure for issuing marketing authorisations after the accession of the Republic of Croatia into the European Union (version for May 27, 2013).
Considering the accession of the Republic of Croatia into the European Union, HALMED wishes to inform applicants for the authorisation procedure about the anticipated national demands regarding medicinal product documentation and the process of applying for market authorisations after July 1, 2013. The requirements listed here will be prescribed by the new Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products, with the caveat that these can differ from HALMED recommendations in the following:
Written application for marketing authorisation:
- Mutual Recognition Procedures and Decentralized Procedures the request for issuing authorisations (MRP/DCP procedures) has to be composed according to the form published on the web site of the MRP and DCP (CMDh) Co-ordination Group, written in Croatian
- National Procedure requests have to be composed so that they include at least the following information:
- o name of the product,
- active ingredient,
- dosage form and dosage strength,
- pharmacotherapy group according to ATC classification,
- name and address of the applicant,
- legal basis for issuing authorisation,
- medicinal product documentation information (eCTD, NeeS, written form),
- information on whether another application was submitted to HALMED earlier or concurrently using the same documentation for the marketing authorization of the same medicinal product under a different name (duplicate), calling upon another application/process type for issuing authorisation.
- the application has to include the date of application submission
- the application has to be signed by the party responsible for submitting the application, verified by a stamp and delivered in its original form
- the application has to be submitted separately for each pharmaceutical form and/or medicinal product grade.
The application form for issuing a medicinal product marketing authorisation:
- fill in the form published by the European Commission, written in English
- it is necessary to write the date of completing the form
- the form has to be signed by the party responsible for submitting the application, verified by a stamp and delivered in its original form
- the form has to be submitted separately for each pharmaceutical form and/or medicinal product grade
- the necessary information and documents have to be included in the application form, if applicable.
Additional information and documents to be added to the application form for medicinal product marketing authorisation:
In addition to the application form, the applicant shall submit all the information and documentation listed in the application form for medicinal product marketing authorisation, if applicable.
The following are recommendations for the preparation of particular documents, as well as nationally specific requirements for the addition of particular documents to the application form:
- proof of the applicant's situation within the EEA, not older than six months, in its original form or a notarized copy (note: if the future marketing authorisation holder is not the same as the applicant, proof of the future marketing authorisation holder's situation within the EU or EEA is required, not older than six months, in its original form or a notarized copy),
- written authorisation/s from the party responsible for the applicant by which the person is authorised to submit the application, sign the application form and communicate in the name of and on the behalf of the party represented during the authorisation issuing process, in its original form or a notarized copy,
- written authorisation from the party responsible for the future marketing authorisation holder, if the future marketing authorisation holder is not the same as the applicant, by which the person is authorised to grant permission on behalf of the party responsible, in its original form or a notarized copy,
- written statement of the authorisation holder without a seat in the Republic of Croatia on the appointment of a local representative with a seat in the Republic of Croatia and their contact information,
- contract between the medicinal product manufacturer/s responsible for medicinal product marketing and the future marketing authorisation holder (if they are not the same),
- proof that the future marketing authorisation holder has a HALMED-certified person with permanent residence in the Republic of Croatia who is responsible for pharmacovigilance, or proof that a request for HALMED approval of a person with permanent residence in the Republic of Croatia, responsible for pharmacovigilance, has been submitted to HALMED,
- proof of the payment of application processing fees,
- proof of the payment of administrative tax.
Delivering the mock-up within Croatian:
- the applicant for a marketing authorisation must deliver a mock-up of the outer and immediate medicinal product packaging to HALMED, in Croatian
- the applicant for authorisation by the Mutual Recognition Procedure and Decentralised Procedure must deliver a mock-up of the outer and immediate medicinal product packaging to HALMED in one of the languages of the European Union or EEA, but also in Croatian within 5 days of the conclusion of the Mutual Recognition Procedure and Decentralised Procedure.
