Exemption to the translation into the Croatian language for the labelling and patient leaflet

In accordance with the provisions of the Medicinal Products Act (Official Gazette, No. 76/13, 90/14 and 100/18), information on the immediate and/or outer packaging of the medicinal product (labelling of the medicinal product) and the package leaflet of the medicinal product authorised for marketing in the Republic of Croatia (HR) shall be written in the Croatian language.

Before marketing a medicinal product in the HR, the Agency for Medicinal Products and Medical Devices (HALMED) may grant an exemption to the obligation that the labelling and the package leaflet of the medicinal product must be in Croatian (hereinafter: Consent for translation exemption), according to Article 102, paragraph 2 of the Medicinal Products Act and Article 87 of the Ordinance on Granting Marketing Authorisations for Medicinal Products (Official Gazette, No. 83/13, 28/20 and 32/21).

The legal provision on the exemption from the obligation that the labelling and the package leaflet of the medicinal product must be in the Croatian language applies to a medicinal product with a marketing authorisation in the HR issued:

through the national procedure (NP) for granting authorisation by HALMED;
through the centralised procedure (CP) for granting authorisation by the European Commission (EC).

HALMED gives its Consent for translation exemption for a medicinal product that is not intended for direct use by the user or patient, or in the event of unavailability or shortage of a prescription medicinal product.

The request for granting the Consent for translation exemption is submitted by the marketing authorisation holder in the HR or a legal/natural person authorised by the marketing authorisation holder (hereinafter: the applicant), separately for each dosage form and strength of the medicinal product.

The request for granting the Consent for translation exemption shall include the following information:

name of the medicinal product;
name of the active substance;
pharmaceutical form and strength of the medicinal product;
type and size of the medicinal product packaging;
data on the size of the production batch and the shelf life of the medicinal product;
data on the annual consumption of the medicinal product in the HR or an estimate of the annual consumption of the medicinal product in the HR (if the medicinal product has been in distribution in the HR for less than a year);
batch number of the medicinal product (if the request for translation exemption is submitted for only a certain batch of medicinal product);
name of the country for whose market the medicinal product is presented;
grounds for the request; and
a number of unit packets of the medicinal product for which the translation exemption is requested.

Along with the request for granting the Consent for translation exemption, the applicant is obliged to submit to HALMED:

a statement of the marketing authorisation holder that the medicinal product has been manufactured and that its quality has been controlled in accordance with the marketing authorisation for the medicinal product in the HR;
a mock-up of the outer and the immediate packaging of the medicinal product in the language of the EU Member States and in the Latin alphabet characters;
if applicable, a comparative overview of the summary of product characteristics, a package leaflet and/or labelling of the medicinal product authorised in the HR in relation to the summary of product characteristics, and a package leaflet and/or labelling of the medicinal product for which the translation exemption is requested, with an explanation of the differences in the text; and
proof of payment of the costs of the procedure (service 5.2 in the HALMED price list)

For a medicinal product intended for use in a health care facility, HALMED grants its Consent for a full exemption from the obligation to label and provide the package leaflet for the medicinal product in Croatian, whereby the applicant undertakes to ensure that the authorised text of the summary of product characteristics in Croatian is available to healthcare professionals who will be using the medicinal product to treat patients.

In the event of a threat to the market supply (unavailability or shortage) of a medicinal product that is not intended for use in a health care facility and is prescribed to a user or patient by a doctor, HALMED may give its consent for a partial exemption:

from the obligation to provide the package leaflet in Croatian in such a way as to accompany the packaging of the medicinal product with the package leaflet in a foreign language with an authorised package leaflet in the Croatian language;
from the obligation to label the medicinal product in the Croatian language in such a way as to present the outer foreign language packaging of the medicinal product with a label with the authorised text of the outer labelling in the Croatian language.

Presentation of the medicinal product with a label and package leaflet in the Croatian language is performed by the holder of the manufacturing authorisation following the requirements of the good manufacturing practice.

All language versions of the medicinal product packaging must include information in accordance with the marketing authorisation for the medicinal product in the HR, including authorised elements in the name of the medicinal product (more information is provided in Croatian on Instructions for Name of the Medicinal Product).

HALMED gives its Consent for translation exemption within 8 (eight) days from the date of receipt of a valid request for the Consent.

Upon receipt of the Consent for translation exemption:

for a medicinal product that has not yet been placed on the HR market, the marketing authorisation holder or a local representative shall inform HALMED about the day of initial marketing in the HR in accordance with Article 55 paragraph 1 of the Medicinal Products Act (more information on Placing Medicinal Products on the Market);
where applicable, before placing the product on the market the marketing authorisation holder shall implement the additional risk minimisation measures whose content has been previously authorised by HALMED;
for a batch of authorised vaccine and medicinal product derived from human blood or human plasma, the marketing authorisation holder, local representative, or authorised wholesaler of medicinal products shall submit a request to HALMED for the administrative check of administrative-scientific data (the so-called administrative OCABR procedure) following the instructions for batches of vaccines and medicinal products derived from human blood or plasma that are placed on the HR market, provided here;
before placing a batch of authorised immunological medicinal products and medicinal products derived from human blood or human plasma on the HR market, the wholesaler shall submit a request to HALMED for granting the Consent for the entry of a medicinal product in accordance with Article 128 of the Medicinal Products Act (for more information the applicant may contact HALMED via e-mail stavljanjeupromet@halmed.hr).

The Consent for translation exemption is valid until the moment when the complete volume of the medicinal product authorised in the Consent has been entered for the patient or no later than one year from the day of granting the Consent.

Medicinal products for rare and severe diseases

According to Article 63.1 of the Directive 2001/83/EC (transposed in Article 101 of the Medicinal Products Act), a medicinal product authorised through the centralised authorisation procedure with the status of orphan medicinal product designation may be distributed throughout the European Union (EU) with information on the outer packaging in only one of the official languages of the EU Member States.

According to Article 63.1 of Directive 2001/83/EC, a request for an exemption is submitted to the European Medicines Agency (EMA) during the authorisation procedure or during other regulatory procedures in the post-authorisation phase, and the request is evaluated by the QRD Working Group (Working Group on Quality Review of Documents).

The agreed decision on the exemption to the obligation that the outer packaging (or immediate packaging, if no outer packaging) of the medicinal product must be in the local language of the Member State shall be valid for the duration of the orphan designation status of the medicinal product or, at the request of the applicant, this exemption shall be accepted as a provisional measure to ensure the supply of the EU market with the medicinal product until the local packaging becomes available.

Under the request for exemption from outer packaging for the orphan medicinal product, the QRD Working Group may also consider a request for an exemption from the translation of the immediate packaging text and the package leaflet into the local language of the EU Member State in accordance with Article 63.3 of the Directive 2001/83/EC.

A proposal for the presentation of the orphan medicinal product in two or more of the official languages of the EU Member States (the so-called "multilingual packaging”) may also be considered, provided that the texts in the different languages are legible, clearly demarcated and identical in content.

When a consensus within the QRD group cannot be reached, the request for exemption from the presentation of orphan medicinal products in the local language must be submitted separately to the competent authority for medicinal products of each Member State. More information is available on the EMA website, or here.

A request for an exemption from the obligation to label and provide the package leaflet for the medicinal product in the Croatian language relating to an orphan medicinal product submitted at a national level shall be considered by HALMED as it does for other medicinal products in accordance with Article 102 paragraph 2 of the Medicinal Products Act.

Applicants may send any questions about submitting a request under Article 102 of the Medicinal Products Act to HALMED via e-mail at interventniuvoz@halmed.hr.