About HALMED

Notification Form for Suspected Quality Defect in Medicinal Products

Suspected quality defects must be reported to the Agency for Medicinal Products and Medical Devices by:

  • Healthcare professionals in contact with the medicinal product in question or patients using the medicinal product in question;
  • Legal and natural persons manufacturing or distributing the medicinal product;

in accordance with the provisions of the Ordinance on the suspension of distribution and recall of medicinal products (Official Gazette, No. 122/14).

Suspected quality defects should be reported in writing, so please fill in the Notification Form for Suspected Quality Defect in Medicinal Products (.pdf) (.doc) (.docx) (available only in Croatian language).

A duly completed form should be sent by e-mail, fax, post or delivered personally to the Agency:

Agencija za lijekove i medicinske proizvode
Ksaverska cesta 4
10000 Zagreb
Fax: +385 1 4884 120
E-mail: neispravnost@halmed.hr

Outside the office hours of the Agency, suspected quality defects can be reported by calling the following phone numbers intended for urgent reporting of adverse reactions and quality defects in medicinal products/medical devices:

Telephone: 0800 48 00 08 (24/7, toll-free)
Mobile phone: +385 99 264 6417 (24/7)

Suspected quality defects reported to HALMED by phone must be subsequently reported in writing using Notification Form for Suspected Quality Defect in Medicinal Products mentioned above.

If you do not obtain an acknowledgement within 4 hours from reporting suspected quality defect via e-mail or fax, please call the abovementioned phone numbers to confirm that the report has been received.

Adverse Reaction Notification Form

  • Healthcare professionals can report adverse reaction/suspected adverse reaction to a medicinal product on the Adverse Reaction Notification Form for Healthcare professional (.doc) (.pdf) (available only in Croatian language)
  • Healthcare professionals can report adverse reaction/suspected adverse reaction to a vaccine on the Vaccines Adverse Reaction Notification Form (.doc), (.pdf) (available only in Croatian language)
  • Patients/users of the medicinal products can report adverse reaction/suspected adverse reaction to a medicinal product on the Adverse Reaction Notification Form for patients/users of the medicinal products (.doc) (.pdf) (available only in Croatian language)

A duly completed form should be sent by mail or delivered personally to the following Agency address:

Agencija za lijekove i medicinske proizvode
Ksaverska cesta 4
10000 Zagreb

Fax: + 385 1 4884 110
E-mail address: nuspojave@halmed.hr

Detailed instructions as to how to report any adverse reactions/suspected adverse reactions can be found in the Pharmacovigilance section of the Agency website.

Medical Devices Forms

  • Form for notification of Class IIa, IIb and III medical devices (MEDPRO-II/III), .docx
  • Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10, .doc

Template for the list of individual medical devices is accessible here (MEDPRO.xls).

The procedure for Medical Devices registration and notification is described in more detail in the Agency website section under Entering Medical Devices into the Register.

Medical Device Vigilance

  • Manufacturer Incident Report, .pdf
  • Field Safety Corrective Action, .pdf
  • Trend Report, .doc
  • Periodic Summary Report, .doc

A duly completed form should be sent by mail or delivered personally to the following Agency address:
Agencija za lijekove i medicinske proizvode
Ksaverska cesta 4
10000 Zagreb
or by fax to: + 385 1 4884 110
and by e-mail to: medpro@halmed.hr

Application forms for granting/renewal/variation of the marketing authorisation for medicinal products in the Republic of Croatia

Electronic Application Forms (eAF) for submitting applications for granting a marketing authorisation, renewal or variation are available here.

Form for the Transfer of Marketing Authorisation for a Medicinal Product

The form contains information necessary for the transfer of marketing authorisation for a medicinal product, in accordance with the Ordinance on Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 83/13). The attached form should be used a template, and once completed, should be printed on an official letterhead, signed and stamped (it is not necessary to additionally prepare a cover letter). The form for the transfer of marketing authorisation is submitted in its original form, in Croatian, separately for each pharmaceutical form and strength of medicinal product.

  • Form for the transfer of marketing authorisation of a medicinal product (in Croatian), .pdf

Form for the Withdrawal of Marketing Authorisation of a Medicinal Product

The form contains information necessary for the withdrawal of marketing authorisation of a medicinal product, in accordance with the Ordinance on Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 83/13).The attached form should be used a template, and once completed, should be printed on an official letterhead, signed and stamped (it is not necessary to additionally prepare a cover letter). The form for the withdrawal of marketing authorisation is submitted in its original form, in Croatian, separately for each pharmaceutical form and strength of a medicinal product.

  • Form for the withdrawal of marketing authorisation of a medicinal product (in Croatian), .pdf

Form for Notifying the Placement on the Market/Shortage of a Medicinal Product

The form contains information necessary for registering the market availability of a medicinal product, which needs to be submitted to HALMED in the following cases defined by the Medicinal Products Act (Official Gazette No. 76/13 and No. 90/14):

  1. First placement of medicinal product on the market, for each pharmaceutical form and dose

The notification form should be sent within 15 days since the day of placement* of the medicinal product on the market. The completed form should be sent to stavljanjeupromet@halmed.hr.

*the day of placement of a medicinal product on the market is the day when one type, package size, pharmaceutical form and strength of medicinal product have been placed on the market.

  1. Interruption in the supply chain/shortage of medicinal product

The completed form should be sent to nestasice@halmed.hr.

  • Form for notifying the placement on the market/shortage of medicinal product (in Croatian .doc, .pdf)

Notification of Temporary or Permanent Interruption in the Supply Chain of a Medicinal Product

In case of temporary or permanent interruption in the supply chain of a medicinal product, in accordance with Paragraph 2, Article 55 of the Medicinal Products Act (Official Gazette No. 76/13 and No. 90/14), the marketing authorisation holder is required to notify HALMED two months in advance of the interruption in the supply chain of a medicinal product by sending a Cover letter and a Table to ukidanje@halmed.hr. In cases when the notification needs to be sent to the European Medicines Agency, the Cover letter and Table are also to be sent to withdrawnproducts@ema.europa.eu.

More detailed information related to the process of notification of interruption in the supply chain of a medicinal product are available here.

  • Cover letter, .doc
  • Table with relevant data on the medicinal product, .xls

Application Form for Granting/Variation of License for Wholesale Distribution of Medicinal Products

The form contains information necessary for granting/variation of license for wholesale distribution of medicinal products, in accordance with the Ordinance on Good Practice in the Distribution of Medicinal Products, on Issuing Authorisations for Wholesale Distribution of Medicinal Products, Registration for Brokering of Medicinal Products and on Issuing Certificates on Good Practice in Wholesale Distribution of Medicinal Products (Official Gazette No. 83/13)

  • Application form WHOLESALE DISTRIBUTION for granting/variation of license for wholesale distribution of medicinal products, .doc, .pdf

Application Form for Granting/Variation of Brokerage License for Medicinal Products

The form contains information necessary for granting/variation of brokerage license for medicinal products, in accordance with the Ordinance on Good Practice in the Distribution of Medicinal Products, on Issuing Authorisations for Wholesale Distribution of Medicinal Products, Registration for Brokering of Medicinal Products and on Issuing Certificates on Good Practice in Wholesale Distribution of Medicinal Products (Official Gazette No. 83/13)

  • Application form BROKER for obtaining the brokerage license for medicinal products, .doc, .pdf

Form for the Inclusion of Physical or Legal Entities Seated Outside the Republic of Croatia, in Other EU Member States, in the Register of Wholesale Distributors and Brokers in the Republic of Croatia

The form contains information necessary for notifying the Agency on the initiation of wholesale distribution or brokerage of medicinal products in the Republic of Croatia, in accordance with the Ordinance on Good Practice in the Distribution of Medicinal Products, on Issuing Authorisations for Wholesale Distribution of Medicinal Products, Registration for Brokering of Medicinal Products and on Issuing Certificates on Good Practice in Wholesale Distribution of Medicinal Products (Official Gazette No. 83/13)

  • Form for the inclusion of physical or legal entities seated outside the Republic of Croatia, in other EU Member States, in the register of wholesale distributors and brokers in the Republic of Croatia, .doc, .pdf

Form MANUFACTURING AND IMPORTING for Granting/Variation of Manufacturing/Importing Authorisation

The form requires information necessary for granting/variation of manufacturing/importing authorisation, in accordance with the Ordinance on Good Practice in the Distribution of Medicinal Products, on Issuing Authorisations for Wholesale Distribution of Medicinal Products, Registration for Brokering of Medicinal Products and on Issuing Certificates on Good Practice in Wholesale Distribution of Medicinal Products (Official Gazette No. 83/13)

  • Form MANUFACTURING AND IMPORTING for granting/variation of manufacturing/importing authorisation, .doc, .pdf

Form for Registration of Manufacturers, Importers and Wholesale Distributors of Active Substances

The form requires information necessary for registration of manufacturers, importers and wholesale distributors of active substances and is applied in accordance with the provisions of the Ordinance on the Requirements and Method of Establishing the Requirements of Good Manufacturing Practice and Good Practice in the Wholesale of Active Substances and on the Procedure of the Entry in the Register of Manufacturers, Importers and Wholesale Distributors of Active Substances, and on Issuing the Certificate for the Implementation of Good Manufacturing Practice (Official Gazette No. 83/13)

  • Form for registration of manufacturers, importers and wholesale distributors of active substances, .doc, .pdf

Form for Registration and Evaluation of a Non-Interventional Study

The form is submitted alongside documentation for registration and evaluation of a non-interventional study, in accordance with the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14) and Ordinance on Pharmacovigilance (Official Gazette, No. 83/13).

  • Form for registration and evaluation of a non-interventional study (in Croatian), .doc, .pdf

Form for Submitting a Scientific Advice Request

The form is submitted alongside a request for scientific advice. Information required in the form include details on the person submitting the request and on the medicinal product/subject matter of the request for scientific advice.

  • Form for submitting a scientific advice request (in Croatian), .doc, .pdf

Form for Justifying Exemption from Revocation of Marketing Authorisation in Accordance with Article 54 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14)

Justification of exemption from revocation of marketing authorisation in accordance with article 54 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14) is submitted to HALMED via this Form.

More information is available here.

  • Form for justifying exemption from revocation of marketing authorisation in accordance with article 54 of the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14), .pdf