Information on brokering medicinal products in the Republic of Croatia, minimal rules for brokers, wholesaler’s responsibility in the case of purchasing medicinal products from brokers and public accessibility of brokers’ register
27.05.2015
Information on brokering medicinal products in the Republic of Croatia, minimal rules for brokers, wholesaler’s responsibility in the case of purchasing medicinal products from brokers and public accessibility of brokers’ register
Under Article 85b(1) of Directive 2001/83/EC of the European Parliament and Council and Article 116 of Medicinal Products Act (Official Gazette No 76/13, 90/14) medicinal products brokering may be performed by natural and legal persons with the seat in the Republic of Croatia and an EU Member State, having a permanent address and contact in the Republic of Croatia and EU Member State to ensure identification, location and supervision of their activities.
Under Article 85(b) of Directive 2001/83/EC, brokers may broker only those medicinal products having a marketing authorisation granted by HALMED or the European Commission.
In addition to the requirements set out in Ordinance on good distribution practice, granting a distribution license and license for brokering medicinal products and granting a certificate on good distribution practice (Official Gazette, No 83/13), brokering authorisation holder should fulfil the following requirements:
- have a plan on emergency recall from the market as requested by the Agency or as agreed with the manufacturer or marketing authorisation holder and set up a documentation that will ensure such a recall
- run record on brokering in written, electronic or other form
- set up a quality assurance system defining processes, responsibilities and risk management
- immediately report to the Agency a falsified medicine that is being offered or a suspected falsified medicine
According to the obligation under Article 126, Paragraph 1 of Medicinal Products Act, the broker is required to notify the Agency in written on all changes relating to conditions, documents and data based on which the brokering authorisation has been granted.
The Agency will revoke the authorisation for brokering medicinal products granted to brokers with the seat in the Republic of Croatia, if it finds out that a brokering authorisation holder does not fulfil the conditions based on which the brokering authorisation has been granted, or regulations for performing this activity.
If a wholesaler purchases medicinal products from a broker, it is obliged under provisions of Article 80 of Directive 2011/62/EU and Article 27, Paragraph 2 of Ordinance on good distribution practice, granting a distribution license and license for brokering medicinal products and granting a certificate on good distribution practice verify whether the broker has a brokering authorisation and whether it complies to provisions of the Ordinance and good distribution practice.
Under Article 85b(2) of Directive 2011/62/EU, HALMED makes publically available data on granted authorisations for brokering medicinal products. Data on brokers with medicinal product brokering authorisation are available here.
Intergovernmental body Heads of Medicines Agency (HMA) has in agreement with other national competent authorities of the EU Member States, coordinated a list with links to registries of brokers in the EU territory that is accessible here.
