Pending national authorisation in Croatia

For pending national marketing authorisation applications in Croatia, rules concerning the obligation for Mutual recognition or DCP procedure for marketing authorisations in more than a Member state, (Articles 17(2) and 18 of Directive 2001/83/EC) are fully applicable. By the consequence, for pending national marketing authorisation applications in Croatia at the date of accession three scenarios are possible: No other marketing authorisation in EU are pending or approved for the same medicinal product: in this case the national procedure in Croatia will continue Another marketing authorisation application for the same medicinal product is under evaluation in another Member State: in this case, Croatia shall decline to assess the application and advise the Applicant that mutual recognition procedure should be applied. The Member State, which has already started the examination, will normally be the future RMS. The same medicinal product is already authorised, via a national, mutual recognition or decentralised procedure, in a Member State at the date of accession: Croatia shall reject the application, unless it was submitted via the Mutual Recognition Procedure and will inform the MS where the product has been authorised. Differences between the Summary of Product Characteristics, Product Information Leaflet and labelling approved in one Member State and the corresponding documents submitted in another MS, do not automatically prevent the latter from a MRP. If these differences have no therapeutic implications (no difference in the efficacy and safety profile), i.e. both products have the same qualitative and quantitative composition in active substances (i.e. the same strength) and the same pharmaceutical form, they have to be considered as being the same and the MRP has to be followed.

Generics and data and market exclusivity

Considering data and market exclusivity, Croatia is shifting from a 6-years data protection period to the European 8+2 data protection system. Pre-accession Croatian law allowed the generic to be authorised referring to a Reference Medicinal Product which was granted a marketing authorisation in the Republic of Croatia or any EU Member State not less than six years before. By the contrary European Union law defined a data protection period of 8 years, followed by a two years period of marketing exclusivity, meaning that generics medicinal products cannot be on the market earlier than 10 years after the first marketing authorisation of the generic. By the consequence there are some generic Medicinal Products nationally authorised in Croatia which are still under data protection in the EU. In these cases Accession agreements have defined different rules in case the Reference medicinal product is authorised in the EU through centralised or national (included MRP and DP) procedure. The national Croatian Marketing Authorisation of these generics should be withdrawn if the reference products have been authorised in Europe through centralised procedure and is still under protection in EU. By the contrary when the reference medicinal product is registered in one or more EU Countries through MRP, DCP o purely national procedure, a generic medicinal product authorised before the accession based on the previously valid Croatian legislation (data exclusivity six years), can remain on the Croatian market, so marketing authorisation for this product does not have to be withdrawn, providing that the dossier has been upgraded in compliance with Community acquits. Market exclusivity of Croatian medicinal products will follow, starting from July 1st 2013, the same rules applying to EU medicinal products: data protection period will start at the accession date. Nevertheless, until medicinal products authorised in Croatia become eligible to be reference medicinal products, a reference product authorised in another Member State can be identified (“European Reference Medicinal Product”) for purpose of generic applications in Croatia. The use of this provision will only be possible if the reference product is out of data protection in the Member State where it is authorised.