News and Educations

HALMED’s expert participated at international audit in Switzerland


Upon invitation of the European Directorate for the Quality of Medicines and Healthcare (EDQM), Marta Pipić Kosanović, senior assessor at HALMED participated recently in a three-day international audit of the Official Medicines Control Laboratory (OMCL) in Berne, which is a part of the Swiss Agency for Therapeutic Products (Swissmedic).

Within this audit, our colleague was part of a mutual joint audit composed of the French, Belgian and Dutch OMCLs and she was responsible for audit of tests and methods for human blood and plasma products.


HALMED’s representatives at pharmacovigilance workshop in CALIMS


An educative workshop for qualified persons for pharmacovigilance was held on 15 May 2015 in Podgorica at the Medicines and Medical Devices Agency of Montenegro (CALIMS). In addition to CALIMS representatives, lectures on the key responsibilities of all stakeholders in the medicines safety monitoring were also held by HALMED representatives, Darko Krnić, MD and Sandra Dujmović.

Further information is accessible under the link below.


Dear Healthcare Professional Letter on the risk of clinically important arrhythmias when Harvoni (sofosbuvir+ledipasvir) or combination of Daklinza (daclatasvir) and Sovaldi (sofosbuvir) are used together with amiodarone


The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform healthcare professionals on the risk of clinically important arrhythmias when Harvoni (sofosbuvir+ledipasvir) or combination of Daklinza (daclatasvir) and Sovaldi (sofosbuvir) are used together with amiodarone.

Further information is accessible under the link below.


Notice on the audit in Institute of Immunology


The repeated procedure of granting/revoking manufacturing license in Institute of Immunology d.d. is currently undergoing. The procedure phase where initial review of the documentation submitted by Institute of Immunology d.d. has been completed and the new audit with the aim to verify the GMP compliance, will in agreement with Institute of Immunology be carried out in June.

We remind that HALMED’s intention was to repeat the audit of the Institute of Immunology already from 7 to 9 April, but Institute of Immunology asked for postponement in order to be better prepared. Therefore, the deadline for the audit of HALMED’s experts has been postponed, at manufacturer’s request. So, HALMED intended and was ready to conduct an urgent audit, however the audit was postponed exclusively on the existing of Institute of Immunology.


Instructions for marketing authorisation holders regarding variation applications for updates of product information following PRAC recommendations on safety signals available now


The Agency for Medicinal Products and Medical devices (HALMED) has published on its web pages recommendations for reporting variations in documentation based on signal safety reviews endorsed at the EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) meeting in April 2015. Recommendations concern the active substances daclatazvir, sofosbuvir, sofosbuvir+ledipasvir, interferon alpha-2a, interferon alpha-2b, interferon beta-1, interferon beta-1b, peginterferon alpha-2a, peginterferon alpha-2b, peginterferon beta-1a and trabectedin and are available in English here.

We would like to emphasize that these recommendations include recommendations for sodium-containing oral suspension, oral solution and effervescent forms, which translation is not expected to be at the same time with publication of other recommendations that were endorsed at the PRAC April 2015 meeting. The information on recommendation implementation for these sodium-containing medicines, will be published retrospectively on the HALMED’s web pages, as soon as the EMA’s renewed guideline “Excipients in the label and package leaflet of medicinal products for human use” has been published. The renewed guideline will contain the text that should be implemented for sodium-containing medicinal products as active substance or excipient and that should replace the existing text that has been included in the product information based on the current version of the guideline. On this occasion, Newsletter will be sent to users.

Further information is accessible under the link below.


Further information regarding the implementation of Commission’s Decision on the reclassification status of ellaOne


The Agency for Medicinal Products and Medical Devices (HALMED) would like to offer further information regarding the implementation of Commission’s Decision on the reclassification status of ellaOne from prescription only to OTC.

Medicinal products for the Croatian market may be authorised, depending on the regulatory procedure type, either HALMED or the European Commission. ellaOne is authorised by the European Commission, via centralised procedure, where the EC authorises the medicinal products in all EU member states, based on the scientific assessment by the European Medicines Agency.

Under Article 4, Paragraph 4 of Directive 2001/83/EC, Commission’s Decision on the reclassification of ellaOne will not impact the implementation of the national legislation prohibiting or restricting sale, distribution or use of medicines such as contraceptives or abortive products. So, those EU member states where the distribution of contraceptives is limited by legislation to prescription only, are not obliged to follow

Commission’s decision on the reclassification status (Rx-to OTC-Switch). Al other member states, not having this provision on prohibition or restriction in their national legislation, are required to implement Commission’s Decision.

This is exactly what HALMED posted on its webpages on 20 January 2015, where it was explicitly indicated that; “the implementation of this decision is planed gradually during 2015 in all EU member states, except in those, where distribution of contraceptive is by legislation required on prescription”, taking account that before coming into effect of this decision, ellaOne was being distributed in Croatia exclusively on prescription, but this was not stipulated by legislation.

Therefore, exactly opposite to the allegations in certain media, the European Commission in its answers to questions from delegates, confirmed the information on national exemptions that HALMED made publically available about, already in January 2015. However, as the Croatian legislation does not contain any provision prohibiting or restricting distribution of emergency contraceptives exclusively on prescription, Croatia is required to implement Commission’s Decision.

Also, on 22 April 2015, when we informed on our webpages on the beginning of distribution of ellaOne without prescription, we stated that Commission’s Decision is : “mandatory to all EU member states, including Croatia”, hence we even than were in the category of states not having other provisions stipulated by our national legislation and therefore obliged to implement Commission’s Decision.

Furthermore, opposite to certain media allegations, experts of the European Medicines Agency concluded that ellaOne is a contraceptive preventing pregnancy and not an abortive product. The mechanism of action of ellaOne is to prevent or delay ovulation and in case that the pregnancy has already occurred, ellaone will not disrupt it. Based on a thorough review of all benefits and risks of use of ellaOne, the European Medicines Agency concluded that this medicinal product may be used safely and efficaciously without medical prescription.