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News

CHMP News May 2015
22.05.2015.

Eight new medicines have been recommended for approval, six recommendations on extensions of therapeutic indications have been givenat and a number of medicines for which authorisation in the European Union were primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India have been suspended at the May 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

Further information is accessible under the link below.

[more]

CMDh updated advice on use of high-dose ibuprofen
22.05.2015.

The CMDh has endorsed by consensus updated advice on the use of high-dose ibuprofen. This follows a review carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a small increased risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

Further information is accessible under the link below.

[more]

The Head of HALMED is a new CHMP member The Head of HALMED is a new CHMP member
19.05.2015.

The Head of the Agency for Medicinal Products and Medical Devices, Dr Viola Macolić Šarinić, MD,PhD, is the new Croatian member of the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP).

The EMA’s Committee for Human Medicinal Products is composed of the EU member states representatives and its task is to prepare EMA’s opinions on all issues related to human medicines.

[more]

HALMED’s expert participated at international audit in Switzerland
19.05.2015.

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.

[more]

HALMED’s representatives at pharmacovigilance workshop in CALIMS HALMED’s representatives at pharmacovigilance workshop in CALIMS
18.05.2015.

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.

[more]

Newly approved medicinal products
15.05.2015.

The list of newly approved medicinal products for the period between 1st April 2015 and 30th April 2015 is available in the continuation of this notice.

[more]

MRP i DCP postupci
Croatian Pharmacopoeia
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Events - HALMED

Workshop: “Regulatory framework in medicines distribution”

A workshop “Regulatory framework in medicines distribution” will be held in Zagreb and organised by the Agency for Medicinal Products and Medical Devices (HALMED). The workshop will be held in May 2015 at HALMED’s premises, Ksaverska cesta 4. The exact dates of the workshop will be announced later, depending on the number of registered participants.

[more]

Rovinj, 21-24 May 2015
5th Croatian Congress on Pharmacy with International Participation

The Croatian Pharmaceutical Society organises in collaboration with the Faculty of Pharmacy and Biochemistry and the Agency for Medicinal Products and Medical Devices (HALMED) the 5th Croatian Congress on Pharmacy with International Participation that will be held from 21 to 24 May 2015 in Rovinj.

More information is accessible under the link below.

[more]

Educational course “Distribution of medical devices”

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course “Distribution and good practice in medical device distribution”. The course will be held at the HALMED’s premises, Ksaverska cesta 4, and the exact date of the course will be determined when enough interested participants has gathered (the foreseen duration 6 school hours). The course is intended to wholesalers of medical devices and authorised manufacturer’s representatives from the third countries.

[more]

Educational course “Introduction to medical devices vigilance”

The educational course “Introduction to medical devices vigilance”, organised by the Agency for Medicinal Products and Medical Devices (HALMED), will take place at the HALMED’s premises at Ksaverska cesta 4. The exact date will be announced when enough interested participants have been gathered (the approximate duration is 6 school hrs).
More information is available in the continuation of this information.

[more]