News and Educations

Instructions for reporting variations in the documentation for medicine resulting from PRAC recommendations based on the safety signals assessment

07.10.2014

The European Medicines Agency (EMA) monthly publishes recommendations of the Pharmacovigilance Risk Assessment Committee adopted based on the safety signal assessment.

EC marketing authorisation holders for medicines containing active substances that are subject to adopted recommendations are required to undertake respective measures in accordance with these recommendations. In cases where PRAC recommendations include a regulatory procedure, like introducing new information in the summary of product characteristics (SPC) and package leaflet (PIL), marketing authorisation holders are required to submit an application for variation.

Detailed information is accessible under the link below.

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EMA begins to publish reports on clinical trials

03.10.2014

The European Medicines Agency (EMA) has decided to publish the clinical reports that underpin the decision-making process on medicines. Following extensive consultations held by the Agency with patients, healthcare professionals, academia, industry and other European entities over the past 18 months, the EMA Management Board unanimously adopted the new policy at its meeting on 2 October 2014. The policy will enter into force on 1 January 2015. . It will apply to clinical reports contained in all applications for centralised marketing authorisations after that date. The reports will be released as soon as a decision on the application has been taken.

After the EMA policy on access to documents has been implemented, the national harmonisation with this requirements will be implemented also in the Republic of Croatia.

Detailed information is accessible under the link below.

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Generic and original medicines – equally safe and efficacious

25.09.2014

The Agency for Medicinal Products and Medical Devices (HALMED) wants to provide hereby the information regarding the quality safety and efficacy of generic medicinal products in order to better clarify this issue:

Every medicinal product, regardless if it is an original or generic one, may be granted marketing authorisation and be accessible to patients, only if its safety and efficacy has been proved.

The generic medicinal product is a medicinal product containing the same amount of the same active substance as the original medicinal product acting in the same mechanism, same velocity and same efficacy as the original medicine. Generic medicines are equally well investigated and controlled as original medicines. Before being placed on the market, generic medicines must undergo bioequivalence studies, or clinical trials on patients where their equal efficacy to the reference original medicines must be proved.

The most important component of every medicine is its active substance. The active substance is a substance by which certain medicine achieves its therapeutic effect, it carries the therapeutic efficacy of the medicine. The generic medicine contains the same identical active substances in the same amount as the reference medicine, thus achieving an identical therapeutic effect. On the other side, in addition to the active substance, every medicine contains so called excipients without any therapeutic effect and therefore excipients may vary in certain generic medicines and their respective originals. So, only difference in the composition of generic and original medicines may be in their excipients used in their manufacturing, such as colours used to obtain different colouring of tablets to make them visually different, which is recommended for their easier differentiation. All these excipients of the generic medicine may obligatory fulfil the same criteria of quality and safety in the same manner as those in the original medicine.

Detailed information is accessible under the link below.

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Notification on possible occurrence of falsified medicines Retacrit, Silapo and Eporatio on the EU market

22.09.2014

The German competent authority for medicines has notified HALMED that certain amount of erythropoietin-containing medicinal products has disappeared from stocks of an authorised wholesaler. Taking account that disappeared medicines have been outside the legal cold chain, or controlled storage conditions, they will be considered as counterfeit, should they be placed again on the market.

Detailed information is accessible under the link below.

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Instructions for variation application in the medicinal product dossier as a result of a referral procedure

22.09.2014

The European Commission adopted on 4th September 2014 the Decision on marketing authorisations for human medicines acting on the renin-angiotensin system, under Article 31 of the Directive 2001/83/EC of the European Parliament and the Council (procedure number EMEA/H/A-31/1370). Detailed information on this decision are available on the European Commission’s webpages.

The mandatory reporting of variations in the dossier to HALMED concerns all medicinal products authorised via national procedure in Croatia that belong to the pharmaco-therapeutic group of medicines acting on the renin-angiotensin system (ATC code: C09) and containing the following active substances: enalapril, fosinopril, lisinopril, trandolapril, perindopril, ramipril, cilazapril, quinapril, zofenopril, losartan, valsartan, eprosartan, temisartan, irbesartan and candesartan.

HALMED calls upon all marketing authorisation holders in Croatia to submit as soon as possible the variation application to the dossier for medicines containing these active substances, taking account that the deadline for variation implementation in the summary of product characteristics and package leaflet is 30 days from the date of the Commission’s Decision.

Detailed information is accessible under the link below.

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