• Home
  • Legal Notices and Terms of Use
  • Sitemap
  • Contacts
  • Hrvatski
 
Search
Newsletter
Enquiries
Rapid Alert System
Generic Medicinal Products and Interchangeability
Application Web ponude
bullet News
bullet About Us
bullet Fees
bullet Public Procurement
bullet Central Ethics Committee
bullet International Cooperation
bullet Seminars and Workshops
bullet Useful Links
bullet Legislation
bullet Publications and Reports
bullet Forms
bullet Approval for the Import
bullet Job and Career
bullet MRP and DCP procedures
bullet Contacts
SPC and PIL
Latest Information
Quality Policy
Code of Conduct
Freedom of Information
User Satisfaction
Complaints Procedure
RSS - Really Simple Syndication
Informacije o lijekovima
On-line prijava nuspojava
Čitajte uputu o lijeku Prijavite nuspojave na lijekove
News

Registration for participation in the international conference “Croatian trail in the EU” opened
26.09.2014.

The Agency for Medicinal Products and Medical Devices (HALMED) organises the international and regulatory conference entitled "Croatian trail in the EU” that will be held from 11 to 12 November 2013 in the hotel "Ivan” in Solaris, in Šibenik.

The registration for the conference is opened today, 26 September 2014. All interested for participation may register via registration form, which is accessible with detailed information on the HALMED's webpages in the Conferences and workshops/Regulatory and pharmacovigilance conference "Croatian train in the EU" Section, or under the link below.

[more]

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.

[more]

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.

[more]

Newly approved medicinal products
22.09.2014.

The list of newly approved medicinal products for the period between 1st August 2014 and 31st August 2014 is available in the continuation of this notice.

[more]

Dear Healthcare Professional Letter on the new/modified storage conditions of Octanate 1000 IU powder and solvent for solution for injection and Octanate 500 IU powder and solvent for solution for injection
16.09.2014.

Jana Pharm d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new/modified storage conditions for Octanate.
Taking account that the new package leaflet indicating the new storage conditions at 2 to 9°C cannot be provided, in order to ensure a continuous supply chain, HALMED has exceptionally and temporarily allowed the placing of the product on the market containing the previous package leaflet with previously authorised storage conditions at 25°C that are not valid any more.
Detailed information and the Dear Healthcare Professional Letter are accessible under the link below.

[more]

HALMED applied for PIC/S membership
15.09.2014.

The Agency for Medicinal Products and Medical Devices (HALMED) received on 5 September 2014 from the PIC/S Secretariat a confirmation that HALMED’s application for membership in the Pharmaceutical Inspection and Co-operation Scheme (PIC/S) is valid.

Pharmaceutical Inspection Co-operation Scheme (PIC/S) ensures an active co-operation in the field of good manufacturing practice, facilitates experience and information exchange, promotes improvement and harmonisation of standards and inspection procedures of pharmaceutical manufacturers and maintains mutual trust among competent authorities. The competent authority’s PIC/S membership is also beneficial to manufacturers as it reduces double inspections and opens access to some international markets.

Detailed information is accessible under the link below.

[more]

MRP i DCP postupci
Croatian Pharmacopoeia
Scope
Events - HALMED

Šibenik, 11-12 November 2014
International regulatory and pharmacovigilance conference "Croatian trail in the EU"

The Agency for Medicinal Products and Medical Devices (HALMED) organises the international and regulatory conference entitled “Croatian trail in the EU” that will be held from 11 to 12 November 2013 in the hotel “Ivan” in Solaris, in Šibenik.

The registration for the conference is opened today, 26 September 2014. All interested for participation may register via registration form, which is accessible with detailed information on the HALMED's webpages in the Conferences and workshops/Regulatory and pharmacovigilance conference "Croatian train in the EU" Section, or under the link below.

[more]

Šibenik, 11-12 November, 2014
Regulatory and pharmacovigilance conference

The Agency for Medicinal Products and Medical Devices (HALMED) is orginising a regulatory and pharmacovigilance conference to be held from 11 to 12 November 2014 in Šibenik. The conference is intended for marketing authorisation holders in the Republic of Croatia (especially to those employed in regulatory affairs and pharmacovigilance), pharmacists, clinical pharmacologists, competent authorities for medicines and qualified persons for pharmacovigilance. The languages of the conference are Croatian and English.
The organiser will apply at the Croatian Medal Chamber and The Croatian Chamber of Pharmacy to obtain permanent education credits for attending the conference.
The conference programme and information related to registration for the conference will soon be available at the HALMED webpages.

[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]