Medicinal Products

Conditions for approval of the prescription and distribution status of a medicinal product

In accordance with Article 110 of the Medicinal Products Act (Official Gazette Nos. 76/13, 90/14, 100/18 and 136/25, hereinafter referred to as the Act), the Agency for Medicinal Products and Medical Devices (HALMED) upon learning of new facts, reviews the current classification of a medicinal product by applying the criteria laid down in Article 109 of the Act and the Ordinance on Benchmarks for the Classification of Medicinal Products and on the Prescription and Distribution of Prescription Medicinal Products (Official Gazette No. 86/13, 90/13, 102/14, 107/15 and 72/16)

In accordance with Article 35 of the Ordinance on Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 83/13, 28/20 and 32/21, hereinafter referred to as the Ordinance), the Agency publishes on its website the conditions for approving changes to the prescription and distribution status of a medicinal product, taking into consideration the safety profile of the active substance, route of administration of the medicinal product, pharmaceutical form, packaging size, maximum single daily dose, indication or other conditions for use of the medicinal product.

The conditions for the approval of the prescription and distribution status of a medicinal product "without a prescription, in a pharmacy" and "without a prescription, in a pharmacy and non-pharmacy outlets" are listed below, and include key information that must be included in the summary of product characteristics, package leaflet and labelling of the medicinal product, where applicable.

1. Medicinal products for which an application for a marketing authorisation is submitted with the prescription and distribution status "without a prescription, in a pharmacy" or "without a prescription, in a pharmacy and and non-pharmacy outlets"

a) Medicinal products with active substances for which HALMED has published conditions for the approval of the prescription and distribution status of the medicinal product "without a prescription, in a pharmacy" or "without a prescription, in a pharmacy and non-pharmacy outlets", must meet the conditions prescribed in the table in Croatian language. In the expert report on the clinical documentation, the applicant is obliged to confirm that all prescribed conditions are fully met without the need to submit a critical review of the safety of the medicinal product with regard to the method and place of distribution of the medicinal product.

b) For medicinal products with active substances for which HALMED has not published the conditions for approval of the prescription and distribution status of a medicinal product "without a prescription, in a pharmacy" or "without a prescription, in a pharmacy and non-pharmacy outlets", or when the proposed conditions of use of the medicinal product are not covered by the published conditions, the applicant is obliged to submit an expert report on the clinical documentation, which shall include:

• a critical review of the safety of the medicinal product with regard to the distribution of the medicinal product without a prescription in accordance with the current European Commission guideline: Guideline on changing the classification for the supply of a medicinal product for human use (European Commission, 2006 revision),
• critical review of the safety of medicinal product use with regard to the distribution of the medicinal product outside pharmacies.

2. Medicinal products for which a variation is submitted for a change of the prescription and distribution status of a medicinal product to "without a prescription, in a pharmacy" or "without a prescription, in a pharmacy and non-pharmacy outlets"

a) Medicinal products with active substances for which HALMED has published conditions for the approval of the prescription and distribution status of a medicinal product "without a prescription, in a pharmacy" or "without a prescription, in a pharmacy and non-pharmacy outlets", must meet the conditions prescribed in the table in Croatian language. In the expert report on the clinical documentation, the applicant is obliged to confirm that all prescribed conditions are fully met without the need to submit a critical review of the safety of the medicinal product with regard to the method and place of distribution of the medicinal product.

The variation shall be classified in accordance with Article 31 of the Ordinance as type IB C.z. Safety, efficacy, pharmacovigilance changes - Other variation

In the request for approval of the variation and in the Application form (in the section Precise scope and background for change, and justification for grouping, worksharing and classification of unforeseen changes), it is necessary to specify the change in the method and/or place of distribution of the medicinal product.

b) For medicinal products with active substances for which HALMED has not published the conditions for approval of the prescription and distribution status of a medicinal product "without a prescription, in a pharmacy" or "without a prescription, in a pharmacy and non-pharmacy outlets", or when the proposed conditions of use of the medicinal product are not covered by the published conditions, the marketing authorisation holder is obliged to submit an expert report on the clinical documentation, which shall include:

• a critical review of the safety of the medicinal product with regard to the distribution of the medicinal product without a prescription in accordance with the current European Commission guideline: Guideline on changing the classification for the supply of a medicinal product for human use (European Commission, 2006 revision),
• a critical review of the safety of medicinal product use with regard to distribution of the medicinal product outside pharmacies.

The variation for a change of the prescription and distribution status of a medicinal product shall be submitted in accordance with Articles 33 and 34 of the Ordinance, and the variation shall be classified in accordance with Article 31 of the Ordinance as type II C.z. Safety, efficacy, pharmacovigilance changes - Other variation.

In the request for approval of the variation and in the Application form (in the section Precise scope and background for change, and justification for grouping, worksharing and classification of unforeseen changes), it is necessary to specify the change in the method and/or place of distribution of the medicinal product.

3. Medicinal products for which the prescription and distribution status "without a prescription, in a pharmacy" or "without a prescription, in a pharmacy and non-pharmacy outlets" has been approved

For medicinal products for which the prescription and distribution status "without a prescription, in a pharmacy" or "without a prescription, in a pharmacy and non-pharmacy outlets" has been approved and which contain active substances for which HALMED has published conditions for approval of the prescription and distribution status, and where the conditions of use of the medicinal product do not fully comply with those conditions, the Marketing authorisation holder is obliged in accordance with Article 50, paragraph 2 of the Act to submit a request for a variation to amend the medicinal product documentation in order to comply with the specified conditions.

The variation shall be classified in accordance with Article 31 of the Ordinance as type IB C.z. Change(s) in the SmPC, labelling or package leaflet of human medicinal products in order to adapt to a recommendation of a competent authority according to the recommendations of the Coordination Group for Mutual Recognition and Decentralised Procedure for Human Medicinal Products (CMDh) Recommendation for classification on unforseen variations according to Article 5 of Commission Regulation (EC) No1234/2008.

4. Data protection in the request for variation for a change of the prescription status of a medicinal product from "on prescription" to " without a prescription"

Article 112 of the Act stipulates that after the first approval of a variation in the prescription status of a medicinal product from "on prescription" to "without a prescription" based on significant non-clinical or clinical trials, HALMED shall not use the results of these trials for one year from the date of approval when assessing the request of another marketing authorisation holder for a variation in the prescription status for a medicinal product with the same active substance.

The definition of data protection and its scope are described in more detail in the European Commission's Guidelines, Part III (Guideline on changing the classification for the supply of a medicinal product for human use, the Rules governing Medicinal products in the European Community, Notice to Applicants, Volume 2C)

Conditions for approval of the non-prescription and distribution status of a medicinal product for certain individual active substances: