Medicinal Products

Upgrading of Documentation for Medicinal Products

Upgrading of documentation for medicinal products (Version 2, 1 September 2012)

The upgrading of documentation for medicinal products is a harmonisation of the documentation content with the Directive 2001/83/EC of the European Parliament and Council from 6 November 2001, the Community Code relating to medicinal products for human use (OJ L311, 28 November 2001), for medicinal products authorised in Croatia before the accession to the EU.

Regulatory framework

The authorisation of medicinal products in Croatia is regulated by provisions of the Medicinal Products Act (Official Gazette No. 71/07, 45/09 and 124/11), the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 113/08 and 155/09) and Ordinance on Special Conditions for Placing Medicinal Products Authorised in the Member States of the European Union on the Market of the Republic of Croatia (Official Gazette, No. 10/08).

The aforementioned law and bylaws are harmonised with the Directive 2001/83/EC (as amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC) in the part related to legal basis for granting the marketing authorisation for medicinal products. However, the data exclusivity period (8+2+1) and authorisation of generic medicines associated therewith, the name of the medicine displayed in Braille and the readability testing of the patient information leaflet will be implemented as of the date of Croatian accession to the EU.

The documentation upgrading is set out in the actual Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 113/08, put into effect on 11 October 2008), in Articles 72, 73 and 74 of the Section VII Upgrading of medicinal products documentation for authorised medicinal products in Croatia.

For medicinal products whose marketing authorisation has been granted according to the Ordinance on Special Conditions for Placing Medicinal Products Authorised in the Member States of the European Union on the Market of the Republic of Croatia (Official Gazette No. 10/08) the dossier upgrading is set out in Articles 19, 20, 21 of the Section V of the Ordinance The dossier harmonisation for medicinal products in Croatia with the approved documentation for medicinal products in the EU.

Requirements for dossier upgrading emanate from the Treaty concerning the Accession of the Republic of Croatia to the European Union (hereinafter: Accession Treaty).

In the Part I: Free movement of goods of the Annex V of the Treaty it is quoted as follows:
"32001 L 0083: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
By way of derogation from the requirements of quality, safety and efficacy laid down in Directive 2001/83/EC, marketing authorisations for medicinal products, which are not subject to Article 3(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and which are on the list (in the Appendix to this Annex as provided by Croatia) issued under Croatian law prior to the date of accession shall remain valid until they are renewed in compliance with the Union acquis or until four years from the date of accession, whichever is earlier.

The marketing authorisations covered by this derogation shall not benefit from mutual recognition in the Member States as long as these products have not been authorised according to Directive 2001/83/EC. TR/EU/HR/ACT/Annex V/en 2
The national marketing authorisations granted under national law before accession and not covered by this derogation and every new marketing authorisation shall, as of the date of accession, be in compliance with Directive 2001/83/EC."

Deadlines for dossier upgrading

According to the actual pharmaceutical legislation in Croatia and according to the Accession Treaty, marketing authorisations granted according to the national legislation before the accession of the Republic of Croatia to the European Union as well as the documentation that marketing authorisations have been approved of have to be harmonised with the Directive 2001/83/EC, which means upgraded according to following deadlines:

  1. Until 30 June 2017 for medicinal products listed in the Appendix to the Annex V of the Accession Treaty.
    For medicinal products listed in the Appendix to the Annex V of the Treaty, the dossier upgrading for medicinal products, as well as the display of the name of the medicine in Braille and the readability testing of the patient information leaflet should be provided within the approved transitional period of four years after the accession of Croatia to the EU.
    Marketing authorisation holders are required to submit an application to HALMED related to dossier upgrading either alongside with a renewal or as a self-standing application for dossier upgrading, whichever is earlier with regard to the deadline of transitional measures and no later than 30 September 2016, so that HALMED may adequately complete the assessment procedure of the upgraded documentation.
    The application for dossier upgrading for the aforementioned medicinal products may be submitted even before the accession to the EU, according to the provisions of the Article 74 of the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette, Nos. 113/08 and 155/09) and the Article 19 of the Ordinance on Special Conditions for Placing Medicinal Products Authorised in the Member States of the European Union on the Market of the Republic of Croatia (Official Gazette No. 10/08).
  2. Until 30 June 2013 for medicinal products that are not listed in the Appendix to the Annex V of the Accession Treaty
    For certain number of medicinal products, the dossier upgrading is required hence their marketing authorisations have been granted according to the national pharmaceutical legislation, in effect until 11 October 2008 (in compliance with the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products, Official Gazette No. 143/98). However, there is no transitional period for those products; hence they are not listed in the Appendix of the Annex V of the Accession Treaty.
    Marketing authorisations for those products were granted after the submission of the products list by the Republic of Croatia to the European Commission during the accession negotiations (the list was drafted by HALMED in the beginning of 2008 according to the current status of valid marketing authorisations at the time the list was requested, and comprises marketing authorisations issued by the end of 2007) and therefore, those products could not be retrospectively listed in the Appendix to the Annex V of the Accession Treaty.

For products referred to in the point 2, the dossier upgrading should be provided before the accession of the Republic of Croatia to the EU and marketing authorisation holders are required to submit an application for dossier upgrading to HALMED no later than 28 February 2013.
For those products the implementation of the display of the medicine's name in Braille on the outer packaging and readability testing will be provided at dossier upgrading or variation:

  1. before the accession of Croatia to the EU, if the marketing authorisation holder is ready for that implementation (according to instructions that will be available on HALMED webpage)
  2. mandatory after the accession during the transition period that will be defined by HALMED in agreement with marketing authorisation holders/product manufacturers.

Renewals

Documentation is not considered upgraded for all the products whose renewals were granted before the accession to the EU (refers to medicinal products whose marketing authorisations were granted according to the provisions of legislation in effect before 11 October 2008). For the aforementioned products, upon receipt of an application, HALMED will proceed with the assessment of the dossier and inform the marketing authorisation holder about the outcome.

For those products, the documentation should be upgraded before either 30 June 2013 or June 2017, depending on whether the product is listed in the Appendix to the Annex V of the Accession Treaty.

Dossier upgrading is not mandatory for medicinal products whose:

  1. marketing authorisations have been granted via centralised procedure in the EU according to Regulation (EC) 726/2004,
  2. marketing authorisations have been granted or whose documentation has been harmonised according to the Ordinance on Special Conditions for Placing Medicinal Products Authorised in the Member States of the European Union on the Market of the Republic of Croatia (Official Gazette No. 10/08), which means for products whose notification on the outcome of granting the marketing authorisation or procedure for retrospective inclusion into nCADREAC have been granted by HALMED (according to the Annex II to the New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern European Countries/nCADREAC, Annex 2).
  3. marketing authorisations have been granted according to pharmaceutical legislation in effect in Croatia (applications for granting marketing authorisation received on 11 October 2008 and later) whose documentation is considered in compliance with Directive 2001/83/EC.

For medicinal products referred to in points II and III, the display of the medicinal product's name in Braille and user/readability testing of patient information leaflet will be implemented as variation:

  1. before the accession of Croatia to the EU, if the marketing authorisation holder is ready for that implementation (according to instructions that will be available on HALMED's webpages)
  2. mandatory after the accession during the transition period that will be defined by HALMED in agreement with marketing authorisation holders/product manufacturers.

Preparations for dossier upgrading

With regard to deadlines and commitments, it is HALMED's goal to, in collaboration with marketing authorisation holders, promptly gather data on:

  • medicinal products not benefiting from the transitional measures of the Treaty and who need to be upgraded by 30 June 2013.
  • planned dossier upgrading for those products, and accordingly, motivate marketing authorisation holders to submit as soon as possible applications for dossier upgrading, if not already submitted to HALMED.

This set of data is important for monitoring/implementation of the dossier upgrading procedure for medicinal products and for establishing/managing HALMED's database on dossier upgrading, and it will be gathered by filling in HALMED's web application, available as of 1 September 2012 under the link https://nadogradnja.halmed.hr.

Marketing authorisation holders need to submit requested data for all their medicinal products (apart from centrally authorised products in the EU) via aforementioned web application to HALMED by 30 September 2012 (please do not submit data partially, or in a different form).

More detailed instructions for dossier upgrading can be found here:

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