New Laws on Medicines and Medical Devices Enter into force in Croatia

Earlier in the summer, the Croatian Parliament passed the new Law on Medicines and the new Law on Medical Devices (Official Gazette No. 76/2013) under the urgent procedure, ahead of Croatia’s EU accession. The two laws entered into force in Croatia on June 29, 2013.

The provisions of the former Law on Medicines, Medicinal Products and Devices and its amendments (Official Gazettes No. 71/07, 45/09 and 124/11) ceased to have effect in Croatia after the implementation of the two new laws.

After June 29, 2013, the Croatian Agency for Medicinal Products and Medical Devices initiated procedures to revoke the approval of marketing authorizations for medicines granted on the basis of the former law, and for those for which the period of data protection has not expired and which were authorized in the EU under the centralized procedure (CP).

Accordingly, for medicines or medical devices approved on the basis of the former law and for which the approval will cease to apply in the period from January 1 to March 31, 2014, the marketing authorization holders (MAHs) need to submit an application for the renewal of the approval no later than six months before the expiration of the marketing authorization.

Prior to the entry into force of the new laws, Croatia was obliged to upgrade the marketing authorization dossiers of the generics according to the EU acquis.

Croatia had no transitional period for applying the rules of data exclusivity. On the date of the accession, the decisions on the centrally authorized products applied immediately. These products, when used as reference products, are now protected for 8 years and not for 6 years.

According to Article 89 of the Regulation (EC) 726/2004, the data exclusivity period of “8+2+1” years refers only to reference drugs for which the initial application for the grant of the marketing authorization under the CP was submitted from November 20, 2005 onwards. Upon enactment of the new Law on Medicines on June 29, 2013, data exclusivity period is now explicitly governed by a provision of Article 235 of the new law stipulating that for the initial applications submitted under the CP before November 20, 2005, validity period of 10 years applies.

Based on the above, marketing authorizations for generic products granted on the basis of reference products for which the data exclusivity period in the EU (8 or 10 years) has not elapsed will have to be withdrawn. Also if the market exclusivity period of 2+1 years for a reference product has not elapsed, generic products cannot be on the market until after that period.

With respect to the CP, the decisions on the centrally authorized products were automatically extended to Croatia on July 1, 2013. However, the MAHs have to provide translations of the product information in Croatian, in line with the EU legislation. The MAHs should wait for the product information linguistic review (PALC) to be completed before putting the medicine on the Croatian market.

Croatia can be included in the Mutual Recognition Procedure (MRP) or the Decentralized Procedure (DCP) from the date of accession – July 1, 2013 was the first date that a MRP or DCP application could have been submitted to Croatia.

Marketing Medicinal Product Batches after EU Accession

Prior to Croatia’s EU accession, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) informed the authorization holders that in accordance with Paragraph 51 of Directive 2001/83/EZ, which Croatia was obligated to transpose into its legislation, each batch of a finished medicinal product with the marketing authorization in Croatia had to be marketed by a qualified person from the European Union/European Economic Area (EU/EEA).

This also means that a medicinal product manufactured in a country outside the EU/EEA had to be re-examined for batch quality after its import into the EU/EEA territory, unless a Mutual Recognition Agreement (MRA) had been signed with the country of production, or a similar relevant agreement that encompasses good production practices for the medicinal product being imported.

If such an agreement was already in effect, the quality control assessment for the medicinal product batch conducted in the country of production was accepted.

It is important to note that the MRAs only encompass the quality control (testing) of medicinal product batches, while the marketing of the product has to be carried out on the EU/EEA territory for each batch approved for marketing in Croatia.

For this reason, before July 1, 2013, authorization holders were urged to report, if necessary, any changes in the authorization without delay, so that the Agency for Medicinal Products and Medical Devices could issue the medicinal product authorization to the manufacturer responsible for the marketing, and situated on the territory of Croatia or the EU/EEA, and so that the uninterrupted supply to the Croatian market could be continued after the accession process was concluded.

In this case, a medical product manufacturer from the EU/EEA with an adequate production permit for medicinal product importation (importer status, according to Directive 2001/83/EZ) might have had to apply for the role of the manufacturer responsible for marketing the medicinal product, as well as the role of a medicinal product manufacturer from the Republic of Croatia with an adequate production permit.

More useful information can be found on the official website of the Croatian Agency for Medicinal Products and Medical Devices.

By: Anamarija Stancic Petrovic

For more information, please contact Anamarija Stancic Petrovic.