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Forms

Medicinal Product Quality Defect Notification Form

Any 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 marketing the medicinal product;

in accordance with the provisions of the Ordinance on monitoring quality defects of medicinal products (Official Gazette, No. 36/05)

Quality defects should be reported in writing, so please make use of the Medicinal Product Quality Defect Notification Form (.pdf) (.doc). (available only in Croatian language)

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

Agencija za lijekove i medicinske proizvode
Ksaverska cesta 4
10000 Zagreb
Fax: +385 1 4884 110
Phone: +385 1 4884 100 (switchboard)

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

Phone: 0800 48 00 08 (number free of charge, 0 - 24 hours)
Fax: + 385 1 4884 120 (only for urgent reports that may lead to recall)

Any defect/adverse reaction reported to the Agency by yourself by phone, must be subsequently also reported in writing, on appropriate forms.

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:

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

  • Entry form for the Register of Manufacturers of Medical Devices (OČ-PR-OS Form), .doc, .pdf
  • Entry form for registration of the Class I medical device (OČ-MED/PROIZV-I Form), .doc, .pdf
  • Entry form for registration of the Class IIa, IIb and III medical device (OČ-MED/PROIZV-II/III Form), .doc, .pdf
  • Entry form for registration of In vitro diagnostic medical devices (OČ-IV/MED/PROIZV Form), .doc, .pdf

The procedure for entering legal persons into the Register of Manufacturers of Medical Devices, and for entering medical devices into the Register of Medical Devices, is described in more detail in the Agency website section under Entering Medical Devices into the Register.

All these forms are available only in Croatian language.

Medical Device Vigilance

  • Field Safety Corrective Action Form, .doc, .pdf (available only in Croatian)
  • Incident Report Form, .doc, .pdf (available only in Croatian)

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:

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

  • Application form for granting of the marketing authorisation for medicinal product, .doc, .pdf
  • Application form for renewal of the marketing authorisation for medicinal product, .doc, .pdf
  • Application form for variation of the marketing authorisation for medicinal product, .doc, .pdf

Application forms should be submitted in original signed by the applicant's responsible person.