News and Educations

2 nd Workshop on medicines regulatory affairs

19.08.2013

Following the announcement about one day workshops on medicines regulatory affairs, published on August 16, 2013 on the HALMED’s web pages, we inform all interested that all places for the first workshop are completely booked.
The second workshop will be held on Thursday, 10 October 2013 at 9 a.m. (the approximate duration until 4 p.m.) at HALMED’s premises , Robert Frangeš Mihanović Street 9 (Sky Business office), 1st Floor, 10000 Zagreb. The first workshop will be held on Friday, 27 September 2013, from 9 to 16 h.

The Agency for Medicinal Products and Medical Devices (HALMED) is informing applicants that the required Application form for granting the marketing authorisation in the Croatian language has been published.

16.08.2013

The Agency for Medicinal Products and Medical Devices (HALMED) is informing applicants that the required Application form for granting the marketing authorisation in the Croatian language has been published.
According to the current Croatian legislation, the applicant is required to submit the application in the original, in Croatian and for every pharmaceutical form and strength separately.
You may find the application form for granting the marketing authorisation on the HALMED’s web pages, in the section MRP and DCP procedures, or Croatia in the EU, or here.

Submission of temporary or permanent shortage of the medicinal product and the production cessation and supply chain disruption of the Croatian market

16.08.2013

According to the Art. 186 of the Medicines Act (Official Gazette, No 76/13), the marketing authorisation holder as well as legal and physical entities involved in distribution of medicines on the Croatian territory (wholesalers) are required within their scope of responsibilities to ensure an adequate and continued supply chain of medicines.
The marketing authorisation holder is required notify the Agency without delay about circumstances that may lead to disruption of the supply chain in Croatia or shortage of medicinal product.

Submission of notification on placing the medicinal product on the market

16.08.2013

According to the Art. 55 of the Medicines Act (Official Gazette, No 76/13), the marketing authorisation holder is required to notify the Agency in written form about the day of the first placing of the medicinal product on the market, without delay and no later than 15 days from the day of placing the product on the market for every pharmaceutical form and strength.

Workshop on medicines regulatory affairs

16.08.2013

The Agency for Medicinal Products and Medical Devices (HALMED) is organising one day workshops in Zagreb. “The Workshop on Medicines Regulatory Affairs” is intended to marketing authorisation holders and will be held at HALMED’s premises, Robert Frangeš Mihanović Street 9 (Sky Business office), 1st Floor, 10000 Zagreb. The first workshop will be held on Friday, 27 September 2013, from 9 to 16 h.
All interested in attending the workshop may register via registration form, available on the HALMED's web site in the Lectures & Workshops/Workshops on Medicines regulatory Affairs section or in the continuation of this information.

HALMED is giving the answers to most frequently asked questions related to the submission of Periodic Safety Update Reports (PSURs) after Croatia’s accession to the EU

14.08.2013

Information about the expected shortage of the medicinal product Anexate 0.5 mg/5 ml solution for injection or infusion (flumazenil)

14.08.2013

Roche d.o.o., the marketing authorisation holder for the medicinal product Anexate 0.5 mg/5 ml solution for injection or infusion (flumazenil), has informed the Agency for Medicinal Products and Medical Devices about the expected shortage of the aforementioned medicine on the Croatian market. The shortage is due to manufacturing problems.
The normalisation of the supply chain is expected by the end of October 2013. There will be another medicinal product available from the same therapeutic group, with the same active substance and pharmaceutical form for the treatment of Croatian patients.

The information about the cessation of production and supply of the medicinal product Peptoran 300 mg film-coated tablets (ranitidine)

14.08.2013

Pliva (Croatia) d.o.o., the marketing authorisation holder for Peptoran 300 mg film-coated tablets (ranitidine), has informed the Agency for Medicinal Products and Medical Devices about the cessation of production and supply of the medicinal product Peptoran 300 mg film-coated tablets (ranitidine) and withdrawal of the marketing authorisation. The decision about the cessation of production is not due to quality, efficacy or safe use of the medicine. If their shelf-life has not expired, the available batches may remain on the Croatian market no longer than 18 months after the withdrawal of the marketing authorisation.
For the treatment of Croatian patients, there are other medicinal products from the same therapeutic group that are not affected by that shortage.

List of approved products with new active substances

12.08.2013

Here you can find the list of medicinal products approved in the republic of Croatia from 1 January to 30 June 2013 containing new active substances, which means, substances newly approved in Croatia.

The European Commission has published the revised version of the Guideline on the Packaging Information of Medicinal Products for Human Use

07.08.2013

The Agency for Medicinal Products and Medical Devices (HALMED) informs marketing authorisation holders that the European Commission has published the revised version of the Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the EU. The Guideline includes also the Croatian requirements related to the “Blue box” that came in effect as of 1st July 2013.
The Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the EU is available on the web pages of the European Commission or in the continuation of this information.

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