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Institute of Immunology did not fulfil the conditions for manufacturing of sterile medicines and bacterial vaccines
26.03.2015.

The Agency for Medicinal Products and Medical Devices (HALMED) completely supports efforts of Direction and employees of Institute of Immunology aimed at fulfilling all necessary conditions for regaining manufacturing licenses and fully supports the initiative aimed at helping Institute of Immunology. At the same time, HALMED is as an independent scientific body obliged by its action to protect primarily the most important national interest and this is the safety and health of our patients. Therefore, we decidedly reject implications that we have protected any particular private interest by rejecting manufacturing licenses to Institute of Immunology. HALMED was guided in its procedures solely by the interest of Croatian patients, which means their safety protection.

Institute of Immunology did not fulfil stipulated conditions and requirements of Good manufacturing Practice and it was not in the capacity of eliminating discovered deficiencies that might represent a public health risk, or health of every individual patient using medicinal products manufactured at these premises. Therefore, with the aim to protect Croatian patients, HALMED had to reject granting a renewal of these manufacturing licenses to Institute of Immunology.

We would like to stress that there is no question about "too strict” requirements, but rather about the same standard conditions and requirements that all other pharmaceutical manufacturers in Croatia fulfil, and that are indispensable for producing sterile medicinal products and vaccines. With the necessary improvement and investment, Institute of Immunology would be in capacity to fulfil them, as all other local manufacturers do.

In the case of the annulment of HALMED’s decisions on rejection of manufacturing licenses to Institute of Immunology, it is about different interpretations of the Medicinal Products Act and Act on the Common Administrative Procedure, that in the end has no influence on the scientific decision that Institute of Immunology at that time did not fulfil the manufacturing conditions. To support this is the fact that Institute of Immunology has never initiated any administrative court appeal against these HALMED’s decisions, which testifies that did not contradict the established situation according to which they do not fulfil the manufacturing conditions. Exactly opposite, even the Institute of Immunology’s Directorate at that time on several occasions publically confirmed the existence of discovered important and critical deficiencies that they were not in the capacity to remedy in order to fulfil the necessary prerequisites for renewal of manufacturing licenses.

When granting decisions on rejecting manufacturing licenses to Institute of Immunology, HALMED completely acted in accordance with the Medicinal Products Act and Act on Common Administrative Procedure. Based on all relevant facts, it was established that Institute of immunology d.d. at that time did not fulfil the conditions for producing sterile medicinal products and bacterial vaccines, which was unbiasedly established by a scientific committee, composed from HALMED’s experts and the Ministry of Health’s pharmaceutical inspector.

The main objection to HALMED’s decisions is that they are allegedly founded on the opinion of the Ministry of Health’s pharmaceutical inspector, but rather opposite – they are based on the opinion of the legally responsible HALMED’s inspector and they are additionally referring to the opinion of the inspector who previously was the only inspector in Croatia. Namely, the procedure of granting/rejecting manufacturing licenses to Institute of Immunology was initiated before Croatia’s accession to the EU, when the GMP inspection was responsibility of the Ministry of Health. However, during the procedure, with the day of accession to the EU, the new medicinal Products Act came into effect, where the GMP inspection started to be part of HALMED’s responsibilities and the decision on rejection of manufacturing licenses to Institute of Immunology was based on the opinion of the responsible HALMED’s inspector.

It is a paradox that the fact that HALMED did not take account of its own inspector only, but rather included a scientific opinion of the Ministry’s inspector which is even more relevant when taking account of her long GMP inspection experiences, is considered to be a mistake. Also like the fact that the Report was not signed only by the HALMED’s inspector, but also by members of the Committee that the Agency under the relevant Ordinance was entitled to appoint.

The attempt to oppose the competency of the scientific Committee is completely wrong, because under Art. 26 the Ordinance clearly indicates that the Agency may appoint a committee composed of different experts, which the Agency in that case did, in order to support the scientific decision.

In addition, by incorrectly interpreting certain words in the opinion of the HALMED’s inspector and their pulling out of context in the Ministerial decision a wrong conclusion is indicated that the Agency’s inspector was possibly considering to grant a conditional license. However, just opposite, the Agency’s inspector in its opinion clearly states that 6 important deficiencies and even 2 critical ones, which means those that might put patients at risk, were discovered during the audit in Institute of Immunology.

Therefore, the opinion of the Agency’s inspector was completely in accordance with the Ministry’s pharmaceutical inspector, so the opinion of the Ministry’s inspector could have not changed the final decision. In other words, both these opinions are equally indicating the existence of critical deficiencies in manufacturing at Institute of Immunology, according to which licenses could have not been renewed or granted again.

We remind that Institute of immunology was already in 2012 granted conditional licenses with a one year deadline to remedy the discovered deficiencies. Bearing in mind that Institute of Immunology was not in the capacity to remedy the discovered deficiencies and ensure the relevant conditions for producing sterile vaccines and medicinal products, it was not possible to renew manufacturing licenses.

HALMED stays firmly behind this decision on rejecting manufacturing licenses that was taken completely in compliance with laws and bylaws and in compliance with our role as a an independent national regulatory body obliged to protect the interest of Croatian patients.

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Institute of Immunology d.d. did not fulfil the conditions for manufacturing of sterile medicinal products and bacterial vaccines
25.03.2015.

With regard to the annulment of HALMED’s decisions on rejection of manufacturing licenses to Institute of Immunology d.d. HALMED acted completely in accordance with the Medicinal Products Act and Act on the Common Administrative Procedure. Based on all relevant facts, it was concluded that Institute of Immunology d.d. at that time did not fulfil the conditions for producing sterile medicinal products and bacterial vaccines, which was unbiasedly discovered by a scientific Committee, composed of the Ministry of Health’s Pharmaceutical Inspector and HALMED’s experts.

Namely, in the case of the annulment of decisions, it is about different interpretation of the Medicinal Products Act and Act on the Common Administrative Procedure that in the end does not influence the scientific decision that Institute of Immunology at that time did not fulfil the conditions for manufacturing.

To support this, the fact that Institute of Immunology d.d. has never initiated an administrative appeal procedure against these HALMED’s decisions, which testifies that they did not contradict the established situation of having unmet manufacturing conditions.

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Notice on recall of one batch of Oronazol 20 mg/g shampoo
23.03.2015.

Johnson & Johnson S.E. d.o.o., the marketing authorisation holder for Oronazol 20 mg/g shampoo has notified the Agency for Medicinal Products and Medical Devices (HALMED) of the recall of the batch EKB1Z00, EUR code: 6160803 from wholesalers and pharmacies. The recall is being conducted due to a batch labelled in Slovenian and mistakenly placed on the Croatian market during distribution.

This recall of the medicine labelled for the Slovenian market will not affect the regular supply chain with this medicine in Croatia.

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Dear Healthcare professional Letter on the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol
19.03.2015.

Remedia d.o.o. , in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is sending a letter to healthcare professionals to inform them of the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol.

Further information is accessible under the link below.

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The European Medicines Agency celebrates its 20th anniversary
19.03.2015.

On 18th March 2015 theEuropean Medicines Agency (EMA) celebrated the 20th anniversary of its establishiment. On this occasion, a scientific conference entitled "Science, Medicines, Health: Patients at the heart of future innovation conference”, where the EMA representatives together with representatives of academia, pharmaceutical industry, patient organisations, health technology assessment authorities, international competent authotrities, European Commission and EU members states medicines agencies discussed the best practices of providing support and shaping innovations in order to improve the health of patients in the EU. Dr Viola Macolić Šarinić, MD, PhD, the Head of HALMED, joined the ceremony on behalf of the Croatian Agency for Medicinal Products and Medical Devices (HALMED).

Further information is accessible under the link below.

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Newly approved medicinal products
17.03.2015.

The list of newly approved medicinal products for the period between 1st February 2015 and 28th February 2015 is available in the continuation of this notice.

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MRP i DCP postupci
Croatian Pharmacopoeia
Web-Eadr
Scope
Events - HALMED

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.

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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.

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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.

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Other Events

Leiden, The Netherlands, 24-24 April 2015
Conference on patient reporting: Current perspectives and future possibilities

The Netherlands Pharmacovigilance Centre Lareb, WHO collaborating Centre for Pharmacovigilance in Education and Patient Reporting is organising a conference on patient reporting entitled Current perspectives and future possibilities.
The conference deals with the following topics: the role of the patient in pharmacovigilance, added value of patient reporting in pharmacovigilance, maintenance, development and promotion of patient reporting system-

Further information is accessible under the link below..

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