01.08.2013
The Agency for Medicinal Products and Medical Devices (HALMED) has received the information from the medical device wholesaler Ma-Co Plast d.o.o, about the preventive recall of the LOT 2013-01 of the Infusion Set due to its non-conformity with the Regulation (EC) 1907/2006.
more
01.08.2013
The European Medicines Agency’s Committee on Medicinal Products for Human Use has recommended changes to the use of metoclopramide-containing medicines in the European Union (EU), including restricting the dose and duration of use of the medicine to minimise the known risks of potentially serious neurological side effects.
more
31.07.2013
Here you can find a list of newly approved medicinal products between 1st June 2013 and 30th June 2013.
more
22.07.2013
According to the Art. 49 of the Medical Devices Act (Official Gazette, No 16/13), the Agency for Medicinal Products and Medical Devices is adopting a list of medical devices that may be sold out of pharmacy and specialised outlet for retail of medical devices. According to the Art. 47 of the Medical Devices Act, legal and natural persons executing a wholesale of medical devices from this list do not need to be entered into the registry of medical device wholesalers.
You may find the list under the following link.
more
11.07.2013
The Agency for Medicinal Products and Medical Devices (HALMED) has received an information from the holder of the enrolment into the medical device registry, Oktal Pharma d.o.o., Zagreb and retrospectively the information from the manufacturer’ representative, Medtronic B.V./Adriatic Region Zagreb about the corrective measures related to the Paradigm infusion sets manufactured by Medtronic MiniMed, USA.
The holder of the entering into the medical device registry, Oktal Pharma d.o.o., Zagreb, has in collaboration with the manufacturer’s representative Medtronic B.V./Adrioatic Region, Zagreb and manufacturer, Medtronic MiniMed, USA, initiated two corrective safety measures resulting in a preventive recall of certain lots of the medical device Paradigm reservoirs with lot numbers MMT326A and MMT-332A and providing further information and advice to healthcare professionals and users of the Paradigm infusion sets about the possibility of under- or over-delivery of insulin or other liquids coming in contact with the inside of the Medtronic Paradigm insulin infusion set’s connector.
You may find detailed information under the following link.
more
08.07.2013
The provision of the Article 46b of the Directive 2001/83/EC of the European Parliament and Council that has been transposed into the national legislation under Art 83 of the Medicinal Products Act (Official Gazette, No 76/13) came into effect on the 2nd July 2013. Taking account that this provision has not entirely entered into effect in all the EU Member States, the intergovernmental body Heads of Medicines Agency (HMA) published on the 1st July 2013 on its webpages a document defining a proposal for a common approach in all member States in case of import of active substances from third countries that are neither listed by the European Commission (under Art. 111b of the Directive 2001/83/EC of the European Parliament and Council), nor accompanied by a written statement from the exporting third country’s competent authority.
Detailed information is accessible under the link below.
more
04.07.2013
The Agency for Medicinal Products and Medical Devices (HALMED) informs all its clients that a new application Web offers has been launched. The application will enable applicants to create independantly offers for their procedures, upon which payments will be executed.
The application is accessible under the following link.
more
21.06.2013
With the accession of Croatia to the European Union on 1 July 2013, marketing authorisation holders are required to electronically submit information on all medicinal products for human use authorised in Croatia to the European Medicines Agency (EMA). This is in compliance with Article 57(2), second subparagraph of Regulation (EC) 726/2004.
Detailed information can be found in the continuation of this notice.
more
17.06.2013
Here you can find a list of newly approved medicinal products between 1st May 2013 and 31st May 2013.
more
17.06.2013
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) made four recommendations for the EU member states on four safety referrals at its June 2013 meeting.
Recommendations include further: restriction of the use of codeine for pain relief in children, the same precautions for diclofenac as for selective cox-2 inhibitors, the suspension of infusion solutions containing hydroxyethyl starch, the restriction of use of flupirtine-containing medicines.
Since these four PRAC recommendations concern medicinal products approved through national procedure, they will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).
Detailed information can be found in the continuation of this notice.
more
