News and Educations

4th Workshop on medicines regulatory affairs

01.10.2013

Following the announcement about one day workshops on medicines regulatory affairs, organised by the Agency for Medicinal Products and Medical Devices, we inform all interested that the fourth workshop will be held on Friday, 8 November 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.
All interested participants may register via registration form, that is alongside with detailed information about the workshop available on HALMED's web pages in the Lectures and Workshops/4th Workshop on Regulatory affairs Section or in the continuation of this notice.

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Information about the temporary distribution of Partusisten 5 mg tablets

01.10.2013

Boehringer Ingelheim Zagreb d.o.o. , the marketing authorisation holder for Partusisten 5 mg tablets (fenoterol) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to temporary interrupt the distribution of the medicinal product as a precaution measure until the outcome of the arbitration procedure in the course in the EU for short-acting beta agonists in obstetric indications, due to findings that indicate an insufficient efficacy of oral forms of these medicines.

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Report to the European Commission about the internal audit of the pharmacovigilance system in the Agency for Medicinal Products and Medical Devices

30.09.2013

Given that national competent authorities and marketing authorisation holders are required to carry out internal audits of their pharmacovigilance systems in accordance with the guideline on Good Pharmacovigilance Practice (GVP) Module IV – Pharmacovigilance audits, the Agency for Medicinal Products and Medical Devices (HALMED) submitted on 17 September 2013 a report to the European Commission about the internal audit of its pharmacovigilance system for the period between 1 July – 16 September 2013.
You may find the report along with additional information in the continuation of this notice.

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New application forms for transfer and revocation of marketing authorisation now available

27.09.2013

The Agency for Medicinal Products and Medical Devices (HALMED) has, in accordance with the Ordinance on granting the marketing authorisation, No 83/13) prepared the Application forms for transfer of marketing authorisation and Application form for revocation of marketing authorisation, that you may find in the continuation of this notice.
The prepared forms serve as a standard template for preparing applications and after they have been populated, only need to be printed on a memorandum, signed and sealed (it is not necessary to attach a cover letter).
Applications for transfer of marketing authorisations, revocation of marketing authorisations are submitted in original, in Croatian for every pharmaceutical form and strength separately.

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News from the PRAC – September 2013

17.09.2013

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) at its meeting held in September 2013 gave new recommendations for EU countries.
The recommendations include restrictions to the use of short-acting beta-agonists in obstetric indications, temporary suspension of the marketing authorisation and reformulation of Numeta G16%E, as well as risk minimisation measures for Numeta G16%E.
Besides, the PRAC has initiated a new safety assessment for bromocriptine-containing medicinal products. The PRAC will assess whether the benefits of these medicines outweigh the risk of potentially serious (including fatal) cardiovascular, neurological and psychiatric side effects.

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EDQM issued the accreditation to HALMED’s OMCL

13.09.2013

The Council of Europe’s European Directorate for the Quality of Medicines & Health Care (EDQM)has issued the accreditation to the Official Medicines Control Laboratory (OMCL) of the Agency for Medicinal Product and Medical Devices (HALMED), which represents a confirmation of competence, technical capacity, knowledge and quality work of the OMCL. HALMED’s OMCL has become an equal partner with other laboratories within the OMCL network. This accreditation enables an active participation and work share and exchange of testing results within the OMCL network on the entire EU/EEA territory.

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Information about the temporary suspension of distribution and use of three batches of Manit 10%

12.09.2013

The Agency for Medicinal Products and Medical devices has carried out a special quality control of the baches 2004032, 2004072 and 2050102 of Manit 10%.
We remind that on the 10th April 2013, HALMED informed about the initiation of the suspension of distribution and use of the batches 2004032, 2004072 and 2050102 of Manit 10%, upon a report from a healthcare professional to a suspected adverse reaction to trombolflebitis on the application site of manitol 10% in six patients.

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Start of a new HALMED’s campaign on promoting the importance of package leaflet reading and reporting of ADRs

11.09.2013

The Agency for Medicinal Products and Medical Devices (HALMED) has started a public education campaign aimed at promoting the importance of package leaflet reading and ADR reporting among patients and end consumers. The aim of the campaign is to inform citizens that, alongside the information provided by a qualified healthcare professional, additional information may be obtained through package leaflet reading and to motivate them to get actively involved in the medication and monitoring of safe use of medicines by reporting ADRs. This approach will further contribute to the improvement of the safe use of medicines and more efficient health care for patients and overall public health.
The campaign will intensively be carried out at the national level from the beginning of September to the end of October this year through billboard, press ads, radio spots, on-line banners, posters in doctors’ waiting rooms and information leaflets on ADRs reporting that will be available in pharmacies throughout the country.

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